Enhancing HIV Pre-Exposure Prophylaxis (PrEP) by Targeting Hazardous Alcohol Use and Concurrent Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 6
- 主要终点
- Alcohol Consumption: Phosphatidylethanol (PEth)
研究概览
简要总结
The present investigation entails a pilot randomized controlled trial to explore whether a stand-alone, alcohol-reduction, brief intervention (with a module on substance use and depression) would be feasible, acceptable, and potentially efficacious within the context of HIV pre-exposure prophylaxis (PrEP) treatment.
详细描述
Although HIV pre-exposure prophylaxis (PrEP) is an effective tool that can help prevent the acquisition of HIV, its degree of effectiveness has been shown to be linked to a number of key behaviors, including treatment adherence, attendance in follow-up care, and the concurrent use of condoms. Hazardous alcohol consumption has the potential to contribute to suboptimal PrEP adherence, poor retention in PrEP care, and condomless sex/sexually transmitted infections (STIs); and its impact on these PrEP-related behaviors may also become exacerbated in the presence of concurrent issues such as substance use and depression, thus reflecting a potential syndemic effect. The present investigation entails a pilot randomized controlled trial in which 120 hazardous drinking, PrEP-prescribed men who have sex with men (MSM) will be randomly assigned to receive either a tablet-based, alcohol-reduction brief intervention or treatment-as-usual. Participants assigned to the former condition for whom substance use- and/or depression-related concerns are identified will additionally be provided with links to relevant supportive resources. Feasibility and acceptability of the intervention will be examined. Furthermore, biomarker testing and self-report electronic surveys at baseline, 3-months, and 6-months will be employed to assess the preliminary impact of the intervention on alcohol use, PrEP adherence, retention in PrEP care, and the engagement in condomless sex/STI acquisition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
This is not a double-blind study. Participants in the intervention arm will be aware that they are receiving the intervention but the investigators will not know as the randomization will take place within the software program.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participants must be:
- •aged 18 years or older,
- •be a patient of Toronto General Hospital (TGH) or Maple Leaf Medical Clinic (MLMC),
- •be a man who identifies as gay, bisexual, and/or a man who has sex with other men,
- •have been prescribed PrEP for at least 3 months, and
- •meet the criteria for hazardous drinking, (i.e., based on a score of ≥4 on the Alcohol Use Disorders Identification Test-Consumption measures (AUDIT-C)).
排除标准
- •Participants will be excluded if they do not meet all of the above-mentioned inclusion criteria.
结局指标
主要结局
Alcohol Consumption: Phosphatidylethanol (PEth)
时间窗: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
PEth levels will be measured from dried blood spot (DBS) samples using liquid chromatography-tandem mass spectrometry to identify hazardous drinking. PEth will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions.
Intervention Feasibility: Intervention Completion
时间窗: At study baseline
Intervention completion will be employed as an indicator of intervention feasibility. This outcome will entail the proportion of participants assigned to the intervention condition who complete the intervention module.
Intervention Feasibility: Intervention Uptake
时间窗: At study baseline
Intervention uptake will be employed as an indicator of intervention feasibility. Intervention uptake will entail the proportion of eligible, hazardous drinking, PrEP-prescribed MSM who express a willingness to take part in the intervention trial.
Alcohol Consumption: Alcohol Use Disorders Identification Test (AUDIT)
时间窗: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
Self-report-based Alcohol Use Disorders Identification Test (AUDIT) scores will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. Babor TF, Higgins-Biddle JC, Saunders JB, Monteiro MG, World Health Organization. Dept. of Mental Health and Substance Dependence. The Alcohol Use Disorders Identification Test. Guidelines for Use in Primary Care. 2nd ed. Geneva: World Health Organization; 2001. A cut-off based on AUDIT-C (i.e., AUDIT-consumption) criteria categorizes the presence (i.e., AUDIT-C scores ≥4) or absence (i.e., AUDIT-C scores \<4) of hazardous drinking. Minimum and maximum scores of the AUDIT-C are 0 and 12, respectively.
Alcohol Consumption: Drinks Consumed in a Typical Week
时间窗: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
A single self-report question will ask "How many drinks containing alcohol do you have on a typical week when you are drinking?" Responses will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions.
Alcohol Consumption: Maximum Drinks on One Day in the Last 3 Months
时间窗: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
A single self-report question will ask "What is the greatest number of drinks you've had on one day in the last 3 months?" Responses will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions.
Intervention Acceptability
时间窗: At 6-months post-baseline
Intervention acceptability will be assessed using a 13-item self-report measure that is comprised of two published scales (references shown below) and three items created by the investigators. Bauermeister JA, Pingel ES, Jadwin-Cakmak L, et al. Acceptability and preliminary efficacy of a tailored online HIV/STI testing intervention for young men who have sex with men: the Get Connected! program. AIDS Behav 2015 Oct;19(10):1860-74. NDA-NIH. NIMH Data Archive (NDA). 2020. Acceptability of Intervention, Intervention Appropriateness, and Feasibility of Intervention Measure. https://nda.nih.gov/data\_structure.html?short\_name=aimiamfim01
次要结局
- PrEP Adherence: Past Month Visual Analog Scale (VAS)(Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline))
- Sexually Transmitted Infection (STI) Incidence(Six-month follow-up period)
- PrEP Adherence: 7-day ACTG-based Measure(Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline))
- PrEP Adherence: Tenofovir-diphosphate (TFV-DP) and Emtricitabine-triphosphate Concentrations(Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline))
- Retention in PrEP Care: PrEP Appointment Attendance(Six-month follow-up period)
- Condomless Sex(Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline))
研究者
Paul Shuper
Senior Scientist and Section Head
Centre for Addiction and Mental Health