Study of HIV and STI Prevention for Young Men
This study is looking at ways to help young men prevent HIV and sexually transmitted infections (STIs). It's testing a set of mobile health (mHealth) tools, called the 3P mHealth package, to see if they help with taking HIV pre-exposure prophylaxis (PrEP) and sticking to it. PrEP options include F/TDF, F/TAF, or CAB-LA. The study also looks at using doxycycline as post-exposure prophylaxis (doxy-PEP) to prevent STIs. We want to see how many people use these tools and medicines, and if they use them correctly. You might be able to join if you are a man between 18 and 29 years old, have had anal sex with men in the last 6 months, and live in communities significantly affected by HIV. The study aims to enroll 400 participants.
- Study design
- This is a randomized controlled trial, meaning participants will be assigned by chance to different groups. It aims to enroll 400 young men.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will follow participants for 52 weeks to measure PrEP uptake and adherence, and assess doxy-PEP use.
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Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy
At a glance
Conditions
Where it's being run
5 sites across 5 statesStudy leadership
- Susan Buchbinder, MD · STUDY_CHAIR · San Francisco Department of Public Health and University of California San Francisco
- Jorge Gallardo-Cartagena, MD · STUDY_CHAIR · Centro de Investigaciones Tecnológicas Biomédicas y Medioambientales
- Thiago Torres, MD · STUDY_CHAIR · Instituto Nacional de Infectología Evandro Chagas
Who to contact
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What this trial measures
- To determine the efficacy of the 3P mHealth package on PrEP uptake among participants52 weeks
PrEP uptake is defined as the proportion of enrolled participants who elect to initiate PrEP (with a documented PrEP dispensation by the site) at any time during the 52 weeks of follow-up. Participants who did not initiate PrEP before loss to follow-up will be classified as non-initiators. PrEP uptake will be assessed at Week 52 for each study arm with 95% confidence limits computed using the binomial distribution. A logistic regression model will be used to compare PrEP uptake between the study arms.
- To determine the efficacy of the 3P mHealth package on PrEP adherence among participantsWeeks 20, 36, and 52
PrEP adherence is assessed at Weeks 20, 36 and 52 through biomedical testing for oral PrEP regimens and documentation of CAB-LA injection for CAB-LA. Adherence measures are described in Section 8.7. Participants on oral PrEP missing an assessment visit and with no PrEP dispensed at their most recent visit will be considered non-adherent. Also, participants who have not yet initiated PrEP at a visit will be considered non-adherent at that visit. The average PrEP adherence at a visit will be computed as the proportion of participants who are determined to be adherent at that visit by study arm. The associated 95% confidence limits will be computed using the binomial distribution. Generalized estimating equations (GEE) with a logit link function will be used to examine differences in adherence proportions between the 3P and Control arms at Weeks 20, 36 and 52, while accounting for potential correlation between PrEP adherence measures over time for each participant.
- To assess doxycycline PEP uptake and associated factorsWeek 52
doxy-PEP uptake is defined as the proportion of participants dispensed doxy-PEP during the 52 weeks of study follow-up period. doxy-PEP uptake will be computed with 95% confidence limits at Week 52. Multivariable logistic regression models will be used to assess association between doxy-PEP uptake and factors including study group, demographic and behavioral characteristics.
- To assess doxycycline PEP use and associated factorsWeeks 20, 36, and 52
doxy-PEP use will be assessed at Weeks 20, 36 and 52. Doxy-PEP use at an assessment visit will be computed as the proportion of participants reporting use following sex acts, reported at that visit. The corresponding 95% confidence limits will be computed based on the binomial distribution. Multivariable GEE models will be used to investigate possible associations between doxy-PEP use and factors including study group, demographic and behavioral characteristics.
- To assess doxycycline PEP acceptability and associated factorsWeek 52
Descriptive statistics will be used to summarize doxy-PEP acceptability. Multivariable generalized linear models (with a link function that is appropriate to the scale of the measure for doxy-PEP acceptability) will be used to investigate associations between doxy-PEP acceptability and factors including study group, sociodemographic, and behavioral characteristics.
- To assess the incidence of HIV infections among participants choosing to use CAB-LAWeek 52
Uptake of CAB-LA is defined as the proportion of participants choosing to initiate CAB-LA with a documented receipt of a CAB-LA injection during the study follow-up period. CAB-LA uptake will be computed with 95% confidence interval. Incidence of HIV infection between the date of CAB-LA initiation and the date of switch to oral PrEP (for participants switching from CAB-LA to oral PrEP) or end of follow-up (for participants staying on CAB-LA from initiation through the end of the follow-up period) will be computed with 95% confidence interval among participants choosing to use CAB-LA.