CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 16 enrolled
Drug / intervention
Truvada +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03842436
NCT03842436Phase 4Completed
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Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use

Brigham and Women's Hospital·interventional·Posted Feb 15, 2019·Updated Dec 22, 2022

In Brief

A Phase 4 clinical trial evaluating Digital pill and Truvada for HIV/AIDS and 2 related conditions. Completed, enrolled 16 participants across 1 site.

Detailed Summary

This study deploys a novel digital pill with Emtricitabine/Tenofovir (TDF/FTC) among MSM with substance use to monitor PrEP adherence. The investigators will enroll N=15 HIV uninfected MSM with self reported substance use who are on PrEP or initiating PrEP to use digital pills over encapsulating TDF/FTC for 3 months. The investigators will assess the feasibility of using digital pills in this study population as well as understand the acceptability of digital pills for adherence measurement using semi-structured individual interviews. Additionally, the investigators will measure adherence over time, as well as episodes of suboptimal PrEP adherence.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV/AIDS, Substance Use Disorders, Adherence, Medication
CountriesUnited States
CollaboratorsGilead Sciences

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedFeb 15, 2019
Enrollment StartOct 1, 2018
Primary CompletionApr 22, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.4 years ago

Interventions

Digital pilldevice

Digital pills over encapsulating Truvada

Truvadadrug

Truvada prescribed with digital pills for PrEP