Game Plan for PrEP: A Pilot Trial of a Web-based Intervention to Help High-risk Men on PrEP Adhere to Their Medication, Reduce Alcohol Use, and Encourage Safe Sex
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Persistence With Pre-exposure Prophylaxis (PrEP)
研究概览
简要总结
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.
详细描述
This small, pilot randomized controlled trial will explore preliminary evidence for the efficacy of Game Plan for PrEP, a brief, web-based intervention inspired by brief motivational interventions. The study will test whether Game Plan for PrEP is efficacious in reducing heavy drinking and sexually-transmitted infection (STI) incidence, and improving PrEP adherence/persistence, among heavy drinking men who have sex with men who are on PrEP, but who report a recent history of missing 3 or more consecutive doses in the past month. In this study, we will randomize 50 gay and bisexual men to receive either (1) Game Plan for PrEP (GP4PrEP) or (2) an attention-matched control at the same PrEP care/monitoring visit that they reported meeting eligibility criteria. We will use self-report measures of alcohol use collected at 1-, 3-, and 6-months and changes in a biomarker of alcohol use collected at baseline, 3-, and 6-months to explore whether Game Plan for PrEP reduces binge drinking compared with control. We will also use data from a biomarker of PrEP adherence to explore whether Game Plan for PrEP improves PrEP adherence versus control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators will be blinded to study condition. Staff collecting dried blood spot samples will also be blinded to condition. Participants will be encouraged to complete online surveys using an automated email system, so outcomes assessors will not be present.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Persistence With Pre-exposure Prophylaxis (PrEP)
时间窗: Past 6 months
Whether or not participants explicitly stopped taking PrEP at some point during the 6-month study period
Number of Alcohol Drinking Days
时间窗: Month 1, Month 3, and Month 6
The total number of days in which participants reported drinking alcohol in the past 30 days
Average Number of Drinks Consumed Per Drinking Day
时间窗: Month 1, Month 3, and Month 6
The average number of standard alcoholic drinks consumed when participants reported drinking over the past 30 days
Number of Heavy Drinking Days (5+ Drinks on a Single Occasion)
时间窗: Month 1, Month 3, and Month 6
The total number of days on which participants reported drinking 5+ drinks in a single day over the past 30 days
Pre-exposure Prophylaxis (PrEP) Lapse Days
时间窗: 6 months
Number of participants who reported missing 4+ consecutive days of PrEP doses
次要结局
- Tenofovir Diphosphate Adherence(Month 3 and Month 6)
- Any Sexually-transmitted Infection (STI) Diagnosis(6 Months)
- Phosphatidylethanol Level(Month 3 and Month 6)