N/A
Completed N=73
Game Plan for PrEP
Human Immunodeficiency Virus Exposure · Alcohol; Harmful Use
Source: ClinicalTrials.gov NCT04973267 ↗
Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Pre-exposure Prophylaxis (PrEP) Lapse Days — 3; 3 Participants
Summary
This small pilot randomized controlled trial will test whether a brief, web-based intervention inspired by the principles of motivational interviewing helps high-risk men who take pre-exposure prophylaxis (PrEP) moderate their alcohol use, and improve key outcomes of PrEP care, including adherence, persistence, and STI rates. Men with a history of "lapses" in PrEP adherence will be randomly assigned to either (1) use the web-based intervention, called Game Plan for PrEP, or (2) watch video clips encouraging healthy lifestyles (e.g., sleep hygiene, balanced diet; attention-matched control). Participants will complete STI testing and submit dried blood spot (DBS) samples to facilitate analyses of alcohol use and PrEP adherence biomarkers at baseline, 3-months, and 6-months during the study period. Participants will also complete online surveys at baseline, 1-month, 3-months, and 6-months during the study period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre-exposure Prophylaxis (PrEP) Lapse Days |
3; 3 | — |
| PRIMARY Persistence With Pre-exposure Prophylaxis (PrEP) |
5; 7 | — |
| PRIMARY Number of Alcohol Drinking Days |
9.98; 11.38; 9.12; 7.49; 7.21; 9.25 | — |
| PRIMARY Average Number of Drinks Consumed Per Drinking Day |
3.89; 4.02; 4.37; 4.60; 3.94; 4.49 | — |
| PRIMARY Number of Heavy Drinking Days (5+ Drinks on a Single Occasion) |
2.70; 3.84; 2.70; 2.58; 2.82; 3.65 | — |
| SECONDARY Phosphatidylethanol Level |
95.57; 77.61; 72.47; 93.58 | — |
| SECONDARY Tenofovir Diphosphate Adherence |
0.68; 0.83; 0.76; 0.74 | — |
| SECONDARY Any Sexually-transmitted Infection (STI) Diagnosis |
— | — |
Eligibility Criteria
Inclusion Criteria
- Current male gender
- 18+ years old
- Fluent in English
- Heavy alcohol use in the past month (>5 drinks on a single occasion or >14 drinks in a week)
- Currently prescribed and actively taking PrEP
- Report missing > 3 PrEP doses in a row at least once in the past 3 months.
Exclusion Criteria
- Reporting a history or risk of complicated alcohol withdrawal
- Reporting currently receiving medications or counseling for an alcohol or drug use disorder
- Injection drug use in the past year
- Positive screen for drug-related disorders
Data sourced from ClinicalTrials.gov (NCT04973267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.