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A Key Link for Transmission Prevention

NCT01450189 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-04-19

Study results available
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Summary

This pilot study will assess the feasibility for the potential public health benefit of behavioral and antiretroviral interventions during acute HIV infection.

Central Hypothesis The investigators hypothesize that delivering behavioral and antiretroviral interventions to acutely infected persons will reduce onward transmission.

Conditions

Interventions

BEHAVIORAL

Standard HIV prevention messages

A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BEHAVIORAL

BI: Information-Motivation-Behavioral Skills Model

The behavioral intervention 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.

DRUG

Raltegravir

raltegravir (400 mg) administered orally twice daily for 12 weeks

DRUG

emtricitabine/tenofovir disoproxil fumarate

emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • William C Miller, MD, PhD, MPH · University of North Carolina, Chapel Hill

  • Audrey Pettifor, PhD, MPH · University of North Carolina, Chapel Hill

  • Sam Phiri, PhD, MSc · Kamuzu Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01450189 on ClinicalTrials.gov