Innovative Strategies to Promote Biomedical HIV Prevention Uptake and Retention Among High-risk Adults at Drinking Venues in Kenya and Uganda
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 6
- 主要终点
- Proportion of follow up time on biomedical prevention with PrEP or PEP
研究概览
简要总结
This study will evaluate the effect of a brief alcohol counseling intervention on PrEP and PEP adherence among adults with heavy alcohol use at high risk for HIV, while gaining insights into the facilitators, barriers, and cost-effectiveness of this approach.
详细描述
The investigators have developed a mobilization strategy of integrating HIV testing within multi-disease screening to recruit >2,000 people from drinking venues in Kenya and Uganda and invite them to begin biomedical HIV prevention if eligible (OPAL Aim 1; NCT05862857)
Following uptake of biomedical HIV prevention, persons with heavy alcohol use face challenges with retention in care and adherence to PrEP/PEP. The investigators have adapted a brief alcohol counseling intervention (Health Living Intervention) to reduce alcohol use and promote antiretroviral therapy (ART) adherence and HIV viral suppression among persons with HIV in Kenya and Uganda. The investigators now need to determine whether this intervention can promote retention in biomedical prevention and PrEP/PEP adherence among adults with heavy alcohol use.
Specific Aims:
- Determine the efficacy of the Healthy Living Intervention (HLI) to reduce heavy alcohol use vs. standard care (control) on retention in biomedical HIV prevention in a randomized trial among adults with heavy alcohol use.
- Determine the cost-effectiveness of interventions that increase biomedical HIV prevention retention among adults at high-risk for HIV who attend drinking venues.
The proposed research will address the critical intersection of alcohol use and HIV risk in SSA, by promoting retention of biomedical HIV prevention and exploring associated facilitators and barriers.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (≥18 years)
- •HIV-uninfected (by rapid HIV antibody test)
- •AUDIT-C score of >=4 for men and >=3 for women
- •Attending a clinical visit for initiation of biomedical HIV prevention with oral or injectable PrEP or oral PEP (or the dapivirine vaginal ring, if available)
- •Has access to a mobile phone
排除标准
- •Ineligible for PrEP based on MoH guidelines
- •Intention to move away from the study community in the coming year
- •Gross inebriation or inability to provide informed consent
研究组 & 干预措施
Standard of Care (Control)
Standard of care; alcohol counseling per Ministry of Health (MoH) guidelines
干预措施: Standard of Care (Behavioral)
Healthy Living Intervention
Healthy Living Intervention in-person alcohol counseling with booster phone calls
干预措施: Healthy Living Intervention (HLI) (Behavioral)
结局指标
主要结局
Proportion of follow up time on biomedical prevention with PrEP or PEP
时间窗: Measured 24 weeks after PrEP or PEP initiation
The proportion of time during the 24 weeks after PrEP/PEP initiation that a person is protected from HIV with PrEP/PEP, assessed by prescription refill data. Prescription refill data will be collected from MoH medical and pharmacy records, augmented by OPAL case report forms.
次要结局
- Proportion of follow up time on biomedical prevention with PrEP or PEP- 48 weeks(Measured over 48 weeks after PrEP or PEP initiation)
- Proportion of participants with unhealthy alcohol use (defined by AUDIT-C ≥3 for women, ≥4 for men, and phosphatidylethanol (PEth) ≥50 ng/mL) at week 48(Measured 48 weeks after PrEP or PEP initiation)
- Proportion of participants with HIV seroconversion by week 48(Measured 48 weeks after PrEP or PEP initiation)
- Proportion of participants with unhealthy alcohol use (defined by AUDIT-C ≥3 for women, ≥4 for men, and phosphatidylethanol (PEth) ≥50 ng/mL) at week 48(Measured 48 weeks after PrEP or PEP initiation)
- Proportion of participants with HIV seroconversion by week 48(Measured 48 weeks after PrEP or PEP initiation)