IGHID 12219 - A Brief Alcohol Intervention to Reduce Alcohol Use and Improve PrEP Outcomes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 562
- 试验地点
- 1
- 主要终点
- PrEP Persistence
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of a brief alcohol intervention (BAI) vs. standard of care (SOC) to improve pre-exposure prophylaxis (PrEP) use among PrEP initiators and re-initiators.
详细描述
This is a two-arm effectiveness randomized controlled trial (RCT) to compare the brief alcohol intervention (BAI) to the standard of care (SOC) among PrEP initiators and re-initiators with unhealthy alcohol use who are initiating or reinitiating oral, event-driven, or injectable PrEP.
The BAI draws from Motivational Interviewing (MI)/Motivational Enhancement Therapy (MET) and Cognitive Behavioral Therapy (CBT) and includes 2 in-person sessions and 2 telephone sessions.
Eligible participants (n=564) will be randomized 1:1 to each arm (282 per arm). Additional assessments among a subset of participants in the BAI arm will assess acceptability of the intervention (n=48).
Study activities will span 5 years. Individual PrEP initiators and re-initiators will be followed-up for 12 months with assessment visits at 3, 6, 9, and 12 months after enrollment.
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)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly initiating PrEP or re-initiating PrEP after at least 3 months from a missed PrEP appointment, based on local PrEP guidelines
- •AUDIT-C score ≥ 4 or CRAFFT score ≥ 2 (for those ≤21 years old)
- •16 years of age or older
- •Intention to receive PrEP care in Hanoi for 12 months
- •Willingness to provide informed consent
排除标准
- •Psychological disturbance, cognitive impairment, or threatening behavior
- •Unwilling to provide locator information
- •Current participation in alcohol programs or studies
- •Current participation in other research studies (including HIV and PrEP studies)
- •Ever enrolled in an HIV vaccine study
- •Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA) ≥ 10, indicating risk for alcohol withdrawal
结局指标
主要结局
PrEP Persistence
时间窗: 12 months
PrEP persistence is a measure of ongoing PrEP usage, defined as consistent presentation for care and refills.
Heavy Drinking Days (Binge drinking)
时间窗: 12 months
The number of days with ≥6 standard drinks of alcohol per occasion among the previous 30 days as assessed on the Timeline Followback.
Incremental Cost-Effectiveness Ratio (ICER)
时间窗: 12 months
The incremental cost-effectiveness ratio (ICER) is expressed as the incremental cost of the Brief Alcohol Intervention (BAI) per quality adjusted life-year (QALY) gained. ICER is defined as \[Ci - Ca\]/\[Ei - Ea\] with Ci and Ca being the respective costs of the BAI \[i\] and assessment only \[a\], and Ei and Ea the corresponding effectiveness.
Acceptability of the brief alcohol intervention, as measured with mHIST
时间窗: 3 months
Acceptability is an implementation-focused outcome and will be assessed using the Mental Health Implementation Science Tools (mhIST) Acceptability Scale for consumers, which consists of 15 items containing responses on a 4-point Likert scale. The mhIST score is calculated as the mean score of all responses ranging from 0-3. Higher mhIST scores indicate higher acceptability.
Feasibility - proportion completed 4 sessions (intervention arm)
时间窗: 17 weeks
Feasibility is an implementation-focused outcome and will be measured as the BAI completion rate among participants. Three metrics will be considered. The first metric will be the proportion of participants who completed all 4 sessions among those who were assigned to the intervention arm, measured from the date of randomization.
Feasibility - proportion completed 2 sessions (intervention arm)
时间窗: 17 weeks
Feasibility is an implementation-focused outcome and will be measured as the BAI completion rate among participants. Three metrics will be considered. The second metric will be the proportion of participants who completed at least 2 sessions among those who were assigned to the intervention arm, measured from the date of randomization.
Feasibility - proportion completed 4 sessions (among initiators)
时间窗: 10 weeks
Feasibility is an implementation-focused outcome and will be measured as the BAI completion rate among participants. Three metrics will be considered. The third metric will be the proportion of participants who completed at least 4 sessions among those who initiated at least one session, measured from the date of the first in-person session.
次要结局
- Penetration(Up to 7 weeks)
- PrEP Adherence(Up to 12 months)
- Risk-aligned PrEP use(Up to 12 months)
- Number of Drinking Days(Up to 12 months)
- Number of Drinks Per Drinking Day(Up to 12 months)