Clinical trial NCT03842436: Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use
Official title: Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV/AIDS
Substance Use Disorders
Adherence, Medication
Keywords: PrEP
Substance Use Disorder
Digital Pills
Medication Adherence
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2019-02-15
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group pilot demonstration project
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. MSM (cisgender male)
2. Self-reported use of non-alcohol substances of abuse in past 6 months
3. Currently taking PrEP
4. Has qualifying laboratory tests (Cr, hepatitis B immunization, STI testing and syphilis)
5. Age 18 or older

Exclusion Criteria:

1. Does not speak English
2. HIV positive
3. Identifies as transgender
4. Estimated creatinine clearance \<60ml/min
5. Active hepatitis B treatment
6. Does not own a smartphone
7. Taking proton pump inhibitors
8. History of Crohn's disease or ulcerative colitis
9. History of bowel surgery, gastric bypass, bowel stricture
10. History of GI malignancy or radiation to abdomen
11. Unable/unwilling to ingest digital pill

Primary outcomes:
measure: Feasibility of Digital Pills to Measure PrEP Adherence
timeFrame: Months 1, 2, and 3
Secondary outcomes:
measure: Digital Pill Performance - Number of Recorded Ingestions
timeFrame: Months 1, 2, and 3
measure: Digital Pill Performance - System Accuracy
timeFrame: Months 1, 2, and 3
measure: Digital Pill Performance - Manually Reported Ingestions
timeFrame: Months 1, 2, and 3
measure: Digital Pill Performance - Successful Operation of System
timeFrame: Months 1, 2, and 3
measure: Dried Blood Spot Correlation With Digital Pill Adherence
timeFrame: Months 1 and 3
Other outcomes:
measure: Number of Participants That Completed Qualitative Interview to Evaluate Acceptability of Digital Pills
timeFrame: Month 3
Locations:
city: Boylston
country: United States
facility: Fenway Health
state: Massachusetts
Study officials:
References:
citation: Chai PR, Goodman GR, Bronzi O, Gonzales G, Baez A, Bustamante MJ, Najarro J, Mohamed Y, Sullivan MC, Mayer KH, Boyer EW, O'Cleirigh C, Rosen RK. Real-World User Experiences with a Digital Pill System to Measure PrEP Adherence: Perspectives from MSM with Substance Use. AIDS Behav. 2022 Jul;26(7):2459-2468. doi: 10.1007/s10461-022-03594-9. Epub 2022 Jan 28.
citation: Chai PR, Mohamed Y, Bustamante MJ, Goodman GR, Najarro J, Castillo-Mancilla J, Baez A, Bronzi O, Sullivan MC, Pereira LM, Baumgartner SL, Carnes TC, Mayer KH, Rosen RK, Boyer EW, O'Cleirigh C. DigiPrEP: A Pilot Trial to Evaluate the Feasibility, Acceptability, and Accuracy of a Digital Pill System to Measure PrEP Adherence in Men Who Have Sex With Men Who Use Substances. J Acquir Immune Defic Syndr. 2022 Feb 1;89(2):e5-e15. doi: 10.1097/QAI.0000000000002854.