HIV/AIDS Clinical Trial
Official title:
Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use
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.
Eligible study participants will be screened and enrolled at Fenway Health (Boston, MA). Participants will complete a quantitative assessment on their history fo substance use, sexual risk and PrEP adherence, and be trained to use the digital pill for 90 days and instructed to take PrEP daily during the course of the study. Participants will return each month for a study visit to assess their use of the technology. At study visit 1 and 3, we will obtain dried blood spots (DBS) to measure drug levels and to confirm adherence detected by the digital pill. The investigators will also obtain drugs of abuse screens from DBS. At the final study visit (3 months), participants will undergo a semi-structured qualitative interview to understand the user response to digital pills. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03413696 -
Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
|
||
| Completed |
NCT03289676 -
Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV
|
Phase 1 | |
| Completed |
NCT03215901 -
Life Plans Intervention Study
|
N/A | |
| Completed |
NCT03268551 -
MEMO-Medical Marijuana and Opioids Study
|
||
| Active, not recruiting |
NCT04064567 -
Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK
|
N/A | |
| Completed |
NCT04121962 -
A Pilot Peer Mentor Intervention That Trains Black Men Who Have Sex With Men (BMSM) to Use and Promote Uptake of HIV/STI Self-Testing to Peers and Sex Partners: STAR Study (Self-Testing at Your Residence)
|
N/A | |
| Completed |
NCT04013295 -
Prize-linked Savings Initiatives for Promoting Better Health and Economic Outcomes in Kenya
|
N/A | |
| Recruiting |
NCT04405700 -
Measuring Adverse Pregnancy and Newborn Congenital Outcomes
|
||
| Recruiting |
NCT03984136 -
HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM
|
N/A | |
| Completed |
NCT02928900 -
Patient Actor Training to Improve HIV Services for Adolescents in Kenya
|
N/A | |
| Recruiting |
NCT03268109 -
COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
|
||
| Not yet recruiting |
NCT05813964 -
Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.
|
Phase 3 | |
| Completed |
NCT02797262 -
Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System
|
N/A | |
| Completed |
NCT02376582 -
Safety and Immunogenicity Study of a DNA Vaccine Combined With Protein Vaccine Against HIV/AIDS
|
Phase 1 | |
| Completed |
NCT01957865 -
Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
|
N/A | |
| Terminated |
NCT01443923 -
Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV
|
Phase 4 | |
| Completed |
NCT01616940 -
Minority AIDS Initiative Retention and Re-Engagement Project
|
N/A | |
| Completed |
NCT01910714 -
Adapting and Evaluating an EBI to Prevent HIV/AIDS Risk Among Apache Youth
|
N/A | |
| Completed |
NCT01084421 -
A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos
|
N/A | |
| Completed |
NCT01596322 -
International HIV Antiretroviral Adherence, Resistance and Survival
|
N/A |