At Risk for HIV Clinical Trial
Official title:
PrEP SMART PHASE I TRIAL
The goal of this Phase I study is to conduct a proof-of-concept trial of a contingency management (CM) targeting adherence to oral HIV antiretroviral pre-exposure prophylaxis (PrEP) administered via a smartphone-based medication adherence platform (PrEP SMART, "the app").
The goal of this Phase I study is to conduct a proof-of-concept trial of a contingency
management (CM) targeting adherence to oral HIV antiretroviral pre-exposure prophylaxis
(PrEP) administered via a smartphone-based medication adherence platform (PrEP SMART, "the
app").
PrEP provides a strong preventative benefit to individuals at-risk for HIV. While oral PrEP
adherence is highly correlated with its efficacy in clinical trials, adherence rates are
variable and range from 29-80%. In real-world practice settings, PrEP adherence may even be
lower. As such, interventions are needed to improve and sustain adherence to oral PrEP,
thereby maximizing preventative benefits in at-risk populations.
CM is a behavioral intervention that involves the systematic use of reinforcement dependent
on the occurrence of a predefined behavior. CM improves adherence to antiretroviral therapy
and post-exposure prophylaxis, but CM has yet to be applied to PrEP adherence. The
investigative team recently developed a smartphone-based platform for medication adherence
that can integrate CM. Given that mobile technologies such as smartphones are increasingly
ubiquitous, a CM-based program administered via smartphone may be a practical intervention
that augments PrEP adherence.
In the proposed research, PrEP SMART will provide medication reminders; monetary incentives
for daily, verified adherence to PrEP; education about oral PrEP; and assess potential
adherence barriers. This will be a 4-week open-label, stage I trial in a community sample of
young men who have sex with men (YMSM, n = 12) already prescribed and taking oral PrEP (ages
18-30). YMSM were selected because they are the only high risk group experiencing an
increase in HIV incidence in the U.S.
The investigative team is particularly well-positioned as we have expertise in the
development of mobile apps to improve medication adherence, including in the context of HIV
care; oral PrEP efficacy trials; and are conducting research using the "parent version" of
PrEP SMART (mSMART; Mobile App based Personalized Solutions and Tools for Medication
Adherence of Rx Pill) platform in another clinical context.
The primary aim of this study is to conduct a proof-of-concept trial of PrEP SMART.
- Aim 1a: User interaction with the app will allow for evaluation of feasibility (e.g.,
the number of app uses/day)
- Aim 1b: Acceptability will be assessed via self-report ratings and qualitative
interviewing
- Aim 1c: Medication adherence will be evaluated via daily smartphone camera-based
medication event assessments to establish preliminary data on the impact of mSMART for
future efficacy trials.
- Aim 1d: Adherence barriers will be evaluated by mSMART following missed doses.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03080597 -
PrEP for HBCUs (Study 2)
|
N/A | |
| Completed |
NCT01347164 -
Evaluation of a New HIV Prevention Intervention for Black Bisexually-active Men
|
Phase 2 |