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Trial Outcomes & Findings for A Key Link for Transmission Prevention (NCT NCT01450189)

NCT ID: NCT01450189

Last Updated: 2018-04-19

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

46 participants

Primary outcome timeframe

1 year

Results posted on

2018-04-19

Participant Flow

Participants were recruited through screening in two sexually transmitted disease clinics and two HIV testing sites in Lilongwe, Malawi.

Participants were evaluated in two stages: screening for acute HIV infection (AHI) and enrollment of persons with AHI for follow-up. As this is a pilot study, some outcomes refer to screening only. The original protocol called for 115 persons with AHI; only 46 persons were enrolled as the study period ended and funding expired.

Participant milestones

Participant milestones
Measure
Standard Counseling Arm
The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection. Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Behavioral Intervention Arm
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Overall Study
STARTED
9
18
19
Overall Study
COMPLETED
9
18
19
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Key Link for Transmission Prevention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Standard Counseling Arm
n=9 Participants
The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection. Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Behavioral Intervention Arm
n=18 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=19 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Total
n=46 Participants
Total of all reporting groups
Age, Continuous
31.6 years
STANDARD_DEVIATION 8.1 • n=99 Participants
26.7 years
STANDARD_DEVIATION 5.1 • n=107 Participants
27.1 years
STANDARD_DEVIATION 7.9 • n=206 Participants
27.7 years
STANDARD_DEVIATION 7.0 • n=157 Participants
Sex: Female, Male
Female
4 Participants
n=99 Participants
7 Participants
n=107 Participants
7 Participants
n=206 Participants
18 Participants
n=157 Participants
Sex: Female, Male
Male
5 Participants
n=99 Participants
11 Participants
n=107 Participants
12 Participants
n=206 Participants
28 Participants
n=157 Participants
Region of Enrollment
Malawi
9 participants
n=99 Participants
18 participants
n=107 Participants
19 participants
n=206 Participants
46 participants
n=157 Participants

PRIMARY outcome

Timeframe: 1 year

Population: All persons screened

Outcome measures

Outcome measures
Measure
Overall
n=14755 Participants
All arms combined
Behavioral Intervention Arm
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening
0.622 proportion of participants screened
Interval 0.614 to 0.63
—
—

PRIMARY outcome

Timeframe: 1 year

Prevalence of AHI among all persons screened. This measure is among all persons screened, prior to randomization.

Outcome measures

Outcome measures
Measure
Overall
n=9171 Participants
All arms combined
Behavioral Intervention Arm
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Prevalence of AHI Among Persons Screened
0.0073 proportion of participants
Interval 0.0057 to 0.0093
—
—

PRIMARY outcome

Timeframe: 1 year

This outcome reflects the ability to recruit persons with AHI into a study. The outcome is based on the population prior to randomization.

Outcome measures

Outcome measures
Measure
Overall
n=67 Participants
All arms combined
Behavioral Intervention Arm
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Proportion of Persons With AHI Successfully Recruited Into the Study
0.69 Proportion of persons with AHI recruited
Interval 0.56 to 0.79
—
—

PRIMARY outcome

Timeframe: 1 year

Population: Number of persons in BIA arm eligible for study-provided ARVs

Proportion of participants in the BIA arm receiving full course of ARVs. This outcome is calculated among the BIA arm only, as that

Outcome measures

Outcome measures
Measure
Overall
All arms combined
Behavioral Intervention Arm
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=12 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Proportion of Participants Completing Full Course of ARVs in Arm BIA
—
—
0.917 proportion of BIA participants
Interval 0.615 to 0.998

PRIMARY outcome

Timeframe: 1 year

Population: All persons in the two behavioral intervention arms

In this pilot study, we addressed our ability to complete the behavioral intervention quickly. As two arms received the behavioral intervention, this outcome is combined across those two arms.

Outcome measures

Outcome measures
Measure
Overall
n=37 Participants
All arms combined
Behavioral Intervention Arm
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment.
0.216 proportion of participants
Interval 0.098 to 0.382
—
—

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure
Overall
n=9 Participants
All arms combined
Behavioral Intervention Arm
n=18 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=19 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Proportion of Persons Completing All Scheduled Visits in Each Study Arm
0.44 Proportion of participants
Interval 0.14 to 0.79
0.44 Proportion of participants
Interval 0.22 to 0.69
0.37 Proportion of participants
Interval 0.16 to 0.62

PRIMARY outcome

Timeframe: one year

Mean number of adverse events per group

Outcome measures

Outcome measures
Measure
Overall
n=9 Participants
All arms combined
Behavioral Intervention Arm
n=18 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=19 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Number of Adverse Events
0.78 number of events
Interval 0.31 to 1.6
1.3 number of events
Interval 0.81 to 1.9
1.3 number of events
Interval 0.85 to 1.9

SECONDARY outcome

Timeframe: 12 weeks

Population: Number includes enrolled persons who completed the ACASI interview within the window for this visit

The mean number of unprotected sex acts in previous one week, assessed at 12 weeks

Outcome measures

Outcome measures
Measure
Overall
n=6 Participants
All arms combined
Behavioral Intervention Arm
n=16 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=15 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Unprotected Sex Acts in Previous One Week - 12 Weeks
0 unprotected sex acts/week
Interval 0.0 to 0.6
0.5 unprotected sex acts/week
Interval 0.2 to 1.0
1.2 unprotected sex acts/week
Interval 0.7 to 1.9

SECONDARY outcome

Timeframe: 26 weeks

Population: Number includes enrolled persons who completed the ACASI interview within the window for this visit

The mean number of unprotected sex acts in previous one week, assessed at 26 weeks

Outcome measures

Outcome measures
Measure
Overall
n=8 Participants
All arms combined
Behavioral Intervention Arm
n=14 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=15 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Unprotected Sex Acts in Previous One Week - 26 Weeks
0.25 unprotected sex acts/week
Interval 0.03 to 0.9
0.1 unprotected sex acts/week
Interval 0.02 to 0.5
0.5 unprotected sex acts/week
Interval 0.2 to 1.0

SECONDARY outcome

Timeframe: 52 weeks

Population: Number includes enrolled persons who completed the ACASI interview within the window for this visit

The mean number of unprotected sex acts in previous one week, assessed at 52 weeks

Outcome measures

Outcome measures
Measure
Overall
n=6 Participants
All arms combined
Behavioral Intervention Arm
n=10 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=13 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Unprotected Sex Acts in Previous One Week - 52 Weeks
0.8 unprotected sex acts/week
Interval 0.3 to 1.9
0.2 unprotected sex acts/week
Interval 0.02 to 0.7
0 unprotected sex acts/week
Interval 0.0 to 0.3

SECONDARY outcome

Timeframe: 12 weeks

Population: Number includes enrolled persons who completed the ACASI interview within the window for this visit

The mean number of unprotected sex acts in previous one month, assessed at 12 weeks

Outcome measures

Outcome measures
Measure
Overall
n=6 Participants
All arms combined
Behavioral Intervention Arm
n=16 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=15 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Unprotected Sex Acts in Previous One Month - 12 Weeks
0 unprotected sex acts/month
Interval 0.0 to 0.6
0.8 unprotected sex acts/month
Interval 0.4 to 1.4
0 unprotected sex acts/month
Interval 0.0 to 0.3

SECONDARY outcome

Timeframe: 26 weeks

Population: Number includes enrolled persons who completed the ACASI interview within the window for this visit

The mean number of unprotected sex acts in previous one month, assessed at 26 weeks

Outcome measures

Outcome measures
Measure
Overall
n=8 Participants
All arms combined
Behavioral Intervention Arm
n=14 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=15 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Unprotected Sex Acts in Previous One Month - 26 Weeks
0.25 unprotected sex acts/month
Interval 0.03 to 0.9
0.2 unprotected sex acts/month
Interval 0.04 to 0.6
0.4 unprotected sex acts/month
Interval 0.1 to 0.9

SECONDARY outcome

Timeframe: 52 weeks

Population: Number includes enrolled persons who completed the ACASI interview within the window for this visit

The mean number of unprotected sex acts in previous one month, assessed at 52 weeks

Outcome measures

Outcome measures
Measure
Overall
n=6 Participants
All arms combined
Behavioral Intervention Arm
n=10 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=13 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Unprotected Sex Acts in Previous One Month - 52 Weeks
0.8 unprotected sex acts/month
Interval 0.3 to 1.9
0.5 unprotected sex acts/month
Interval 0.2 to 1.2
0 unprotected sex acts/month
Interval 0.0 to 0.3

SECONDARY outcome

Timeframe: 26 weeks

Population: Number includes all persons with gonorrhea, chlamydia, and trichomoniasis results who had not withdrawn from the study by the first scheduled STI tests

Cumulative incidence, definied as at least one incident infection with either gonorrhea, chlamydia or trichomoniasis

Outcome measures

Outcome measures
Measure
Overall
n=7 Participants
All arms combined
Behavioral Intervention Arm
n=15 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=17 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)
0.14 proportion of participants
Interval 0.004 to 0.58
0.33 proportion of participants
Interval 0.12 to 0.62
0.12 proportion of participants
Interval 0.015 to 0.36

SECONDARY outcome

Timeframe: 52 weeks

Population: Number includes all persons with gonorrhea, chlamydia, and trichomoniasis results and who had at least one visit after Week 26

At least one incident infection with either gonorrhea, chlamydia or trichomoniasis

Outcome measures

Outcome measures
Measure
Overall
n=7 Participants
All arms combined
Behavioral Intervention Arm
n=12 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=13 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)
0.14 proportion of participants
Interval 0.004 to 0.58
0.42 proportion of participants
Interval 0.15 to 0.72
0.15 proportion of participants
Interval 0.019 to 0.45

SECONDARY outcome

Timeframe: 26 weeks

Population: Number includes all persons who were confirmed HSV-2 negative at baseline and who had an informative test on or before Week 26

cumulative incidence of herpes simplex virus type 2, assessed at 26 weeks. Persons with baseline positivity were excluded.

Outcome measures

Outcome measures
Measure
Overall
n=2 Participants
All arms combined
Behavioral Intervention Arm
n=4 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=4 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Cumulative Incidence Herpes Simplex Virus Type 2
0.5 Proportion of participants
Interval 0.01 to 1.0
0.5 Proportion of participants
Interval 0.07 to 0.9
0.25 Proportion of participants
Interval 0.006 to 0.8

SECONDARY outcome

Timeframe: 52 weeks

Population: Number includes all persons who were confirmed HSV-2 negative at baseline and who had an informative test on or before Week 52

cumulative incidence of herpes simplex virus type 2, assessed at 52 weeks. Persons with baseline positivity were excluded.

Outcome measures

Outcome measures
Measure
Overall
n=2 Participants
All arms combined
Behavioral Intervention Arm
n=3 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=3 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Cumulative Incidence Herpes Simplex Virus Type 2
0.5 Proportion of participants
Interval 0.01 to 1.0
1.0 Proportion of participants
Interval 0.3 to 1.0
0.3 Proportion of participants
Interval 0.008 to 0.9

SECONDARY outcome

Timeframe: 52 weeks

Number of partners per index reporting for HIV testing at any time during follow-up

Outcome measures

Outcome measures
Measure
Overall
n=9 Participants
All arms combined
Behavioral Intervention Arm
n=18 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=19 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Number of Partners Reporting for HIV Testing
0.4 partners per index participant
Interval 0.1 to 1.1
0.4 partners per index participant
Interval 0.2 to 0.9
0.4 partners per index participant
Interval 0.1 to 0.8

SECONDARY outcome

Timeframe: 52 weeks

Population: The number of sexual partners named by the index participants is the denominator. For example, the 9 index participants in the standard arm named 35 partners. 4 partners presented, giving a proportion of 0.1 (4/35)

Proportion of sexual partners reporting for HIV testing among all sexual partners named by the index participants

Outcome measures

Outcome measures
Measure
Overall
n=35 sexual partners
All arms combined
Behavioral Intervention Arm
n=78 sexual partners
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=47 sexual partners
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Proportion of Partners Reporting for HIV Testing
0.1 proportion of sex partners
Interval 0.03 to 0.3
0.1 proportion of sex partners
Interval 0.04 to 0.2
0.1 proportion of sex partners
Interval 0.01 to 0.3

SECONDARY outcome

Timeframe: 12 weeks

Proportion of persons in each arm with viral load \<1000copies/ml at 12 weeks

Outcome measures

Outcome measures
Measure
Overall
n=9 Participants
All arms combined
Behavioral Intervention Arm
n=18 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=19 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Suppression of HIV RNA to <1000c/ml at 12 Weeks
0.5 Proportion of participants
Interval 0.16 to 0.84
0.25 Proportion of participants
Interval 0.07 to 0.52
0.72 Proportion of participants
Interval 0.47 to 0.9

SECONDARY outcome

Timeframe: From date of randomization until viral load suppression, up to 52 weeks

median time to viral load suppression (\<1000 c/ml)

Outcome measures

Outcome measures
Measure
Overall
n=9 Participants
All arms combined
Behavioral Intervention Arm
n=18 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=19 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Time to HIV RNA Suppression <1000 c/ml
39 weeks
Interval 26.0 to 52.0
26 weeks
Interval 26.0 to 39.0
16 weeks
Interval 14.0 to 19.0

SECONDARY outcome

Timeframe: 12 weeks

Population: Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit.

Outcome measures

Outcome measures
Measure
Overall
n=6 Participants
All arms combined
Behavioral Intervention Arm
n=16 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=15 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Blood HIV RNA Concentration at Week 12
19411 copies/ml
Interval 0.0 to 351974.0
22734 copies/ml
Interval 20.0 to 741360.0
20 copies/ml
Interval 0.0 to 2313294.0

SECONDARY outcome

Timeframe: 26 weeks

Population: Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit.

Outcome measures

Outcome measures
Measure
Overall
n=8 Participants
All arms combined
Behavioral Intervention Arm
n=14 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=15 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Blood HIV RNA Concentration at Week 26
8661 copies/ml
Interval 0.0 to 208087.0
58504 copies/ml
Interval 20.0 to 438579.0
6788 copies/ml
Interval 0.0 to 196903.0

SECONDARY outcome

Timeframe: 52 weeks

Population: Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit.

Outcome measures

Outcome measures
Measure
Overall
n=6 Participants
All arms combined
Behavioral Intervention Arm
n=10 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=11 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Blood HIV RNA Concentration at Week 52
3248.5 copies/ml
Interval 0.0 to 35668.0
6467.5 copies/ml
Interval 0.0 to 432656.0
10876 copies/ml
Interval 0.0 to 101615.0

SECONDARY outcome

Timeframe: 12 weeks

Population: Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit.

median HIV RNA concentration in cervical lavage fluid

Outcome measures

Outcome measures
Measure
Overall
n=2 Participants
All arms combined
Behavioral Intervention Arm
n=5 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=4 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Genital HIV RNA Concentration - Week 12, Women
82.5 copies/ml
Interval 0.0 to 165.0
0 copies/ml
Interval 0.0 to 6501.0
38.5 copies/ml
Interval 0.0 to 90.0

SECONDARY outcome

Timeframe: 26 weeks

Population: Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit.

median HIV RNA concentration in cervical lavage fluid

Outcome measures

Outcome measures
Measure
Overall
n=4 Participants
All arms combined
Behavioral Intervention Arm
n=4 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=3 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Genital HIV RNA Concentration - Week 26, Women
11.5 copies/ml
Interval 0.0 to 564.0
0 copies/ml
Interval 0.0 to 92.0
164 copies/ml
Interval 0.0 to 2500.0

SECONDARY outcome

Timeframe: 52 weeks

Population: Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit.

median HIV RNA concentration in cervical lavage fluid

Outcome measures

Outcome measures
Measure
Overall
n=3 Participants
All arms combined
Behavioral Intervention Arm
n=2 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=2 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Genital HIV RNA Concentration - Week 52, Women
0 copies/ml
Interval 0.0 to 124.0
219 copies/ml
Interval 0.0 to 438.0
2111 copies/ml
Interval 350.0 to 3872.0

SECONDARY outcome

Timeframe: 12 weeks

Population: Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit.

median HIV RNA concentration as measured in semen

Outcome measures

Outcome measures
Measure
Overall
n=2 Participants
All arms combined
Behavioral Intervention Arm
n=5 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=7 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Genital HIV RNA Concentration - Week 12, Men
25364 copies/ml
Interval 1636.0 to 49092.0
446 copies/ml
Interval 0.0 to 23798.0
0 copies/ml
Interval 0.0 to 782.0

SECONDARY outcome

Timeframe: 26 weeks

Population: Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit.

median HIV RNA concentration as measured in semen

Outcome measures

Outcome measures
Measure
Overall
n=2 Participants
All arms combined
Behavioral Intervention Arm
n=3 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=4 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Genital HIV RNA Concentration - Week 26, Men
9456 copies/ml
Interval 788.0 to 18124.0
292 copies/ml
Interval 0.0 to 2024.0
0 copies/ml
Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 52 weeks

Population: Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit.

median HIV RNA concentration as measured in semen

Outcome measures

Outcome measures
Measure
Overall
n=1 Participants
All arms combined
Behavioral Intervention Arm
n=2 Participants
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=5 Participants
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Genital HIV RNA Concentration - Week 52, Men
13088 copies/ml
Interval 13088.0 to 13088.0
66 copies/ml
Interval 0.0 to 132.0
0 copies/ml
Interval 0.0 to 826.0

Adverse Events

Standard Counseling Arm

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Behavioral Intervention Arm

Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths

Behavioral Intervention Plus Antiretrovirals (BIA)

Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Standard Counseling Arm
n=9 participants at risk
The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection. Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Behavioral Intervention Arm
n=18 participants at risk
The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction. 5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention Plus Antiretrovirals (BIA)
n=19 participants at risk
The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks.
Reproductive system and breast disorders
genital discharge/sores
0.00%
0/9 • 1 year
16.7%
3/18 • Number of events 4 • 1 year
21.1%
4/19 • Number of events 4 • 1 year
General disorders
fever/chills
22.2%
2/9 • Number of events 2 • 1 year
5.6%
1/18 • Number of events 1 • 1 year
10.5%
2/19 • Number of events 2 • 1 year
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/9 • 1 year
0.00%
0/18 • 1 year
5.3%
1/19 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders
Chest pain
0.00%
0/9 • 1 year
0.00%
0/18 • 1 year
5.3%
1/19 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders
Cough
22.2%
2/9 • Number of events 2 • 1 year
0.00%
0/18 • 1 year
5.3%
1/19 • Number of events 1 • 1 year
Nervous system disorders
Dizziness
0.00%
0/9 • 1 year
11.1%
2/18 • Number of events 2 • 1 year
0.00%
0/19 • 1 year
Nervous system disorders
Numbness (feet)
0.00%
0/9 • 1 year
0.00%
0/18 • 1 year
5.3%
1/19 • Number of events 2 • 1 year
Skin and subcutaneous tissue disorders
finger nail changes
0.00%
0/9 • 1 year
5.6%
1/18 • Number of events 1 • 1 year
0.00%
0/19 • 1 year
General disorders
headache
0.00%
0/9 • 1 year
11.1%
2/18 • Number of events 2 • 1 year
5.3%
1/19 • Number of events 1 • 1 year
Gastrointestinal disorders
nausea/vomiting/diarrhea/abdominal pain
22.2%
2/9 • Number of events 2 • 1 year
22.2%
4/18 • Number of events 5 • 1 year
31.6%
6/19 • Number of events 10 • 1 year
Skin and subcutaneous tissue disorders
Skin rash/skin sores/itching
11.1%
1/9 • Number of events 1 • 1 year
27.8%
5/18 • Number of events 7 • 1 year
15.8%
3/19 • Number of events 3 • 1 year
Gastrointestinal disorders
toothache
0.00%
0/9 • 1 year
0.00%
0/18 • 1 year
5.3%
1/19 • Number of events 1 • 1 year
General disorders
weakness
0.00%
0/9 • 1 year
5.6%
1/18 • 1 year
0.00%
0/19 • 1 year

Additional Information

William C Miller

University of North Carolina at Chapel Hill

Phone: 9199669407

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place