Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use
| Status: | Recruiting |
|---|---|
| Conditions: | HIV / AIDS, Psychiatric |
| Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/3/2019 |
| Start Date: | October 1, 2018 |
| End Date: | December 10, 2019 |
| Contact: | Peter R Chai, MD, MMS |
| Email: | pchai@fenwayhealth.org |
| Phone: | 857-313-6722 |
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.
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.
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.
Inclusion Criteria:
- man who has sex with men (MSM)
- self-reported substance use in the past 6 months
- on Truvada for PrEP or initiating PrEP
Exclusion Criteria:
- HIV positive
- Transgender individuals
- History of GI neoplasm
- unable/unwilling to ingest digital pills
- Allergy to components of Truvada
- History of bowel surgery, bowel structure, or gastric bypass
- History of Crohn's Disease or Ulcerative Colitis
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