Trial Outcomes & Findings for Feasibility of Short-Term PrEP Uptake for MSM With Episodic High-Risk for HIV (NCT NCT02495779)
NCT ID: NCT02495779
Last Updated: 2019-03-27
Results Overview
Biological measure of medication in the blood. Adherence will be measured using plasma analyses. We used the cut off of 4 doses/week to determine protective levels of adherence. The determination of this was drug levels equal to TFV 4.2 ng/mL FTC 4.6 ng/mL.
COMPLETED
NA
54 participants
Blood will be drawn upon within 3 days post-vacation (average 2 weeks after starting PrEP)
2019-03-27
Participant Flow
Participant milestones
| Measure |
Intervention
Given emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence
emtricitabine/tenofovir: Short-term episodic use for 2-3 weeks.
CBT-based counseling: Brief CBT-based counseling to promote adherence
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility of Short-Term PrEP Uptake for MSM With Episodic High-Risk for HIV
Baseline characteristics by cohort
| Measure |
Intervention
n=54 Participants
Given emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence
emtricitabine/tenofovir: Short-term episodic use for 2-3 weeks.
CBT-based counseling: Brief CBT-based counseling to promote adherence
|
|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 11.85 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Blood will be drawn upon within 3 days post-vacation (average 2 weeks after starting PrEP)Biological measure of medication in the blood. Adherence will be measured using plasma analyses. We used the cut off of 4 doses/week to determine protective levels of adherence. The determination of this was drug levels equal to TFV 4.2 ng/mL FTC 4.6 ng/mL.
Outcome measures
| Measure |
Intervention
n=48 Participants
Given emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence
emtricitabine/tenofovir: Short-term episodic use for 2-3 weeks.
CBT-based counseling: Brief CBT-based counseling to promote adherence
|
|---|---|
|
Number of Participants With PrEP Adherence
|
45 Participants
|
Adverse Events
Intervention
Serious adverse events
| Measure |
Intervention
n=48 participants at risk
Given emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence
emtricitabine/tenofovir: Short-term episodic use for 2-3 weeks.
CBT-based counseling: Brief CBT-based counseling to promote adherence
|
|---|---|
|
Infections and infestations
HIV seroconverstion
|
2.1%
1/48 • Number of events 1 • 4 months
Systematic Assessment of participant reported events at post-trip visit and 3-month follow up.
|
Other adverse events
Adverse event data not reported
Additional Information
James Egan
University of Pittsburgh, Graduate School of Public Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place