The Outreach and Prevention at ALcohol Venues in East Africa Study (OPAL-East Africa- Aim 2) (OPAL-Aim 2)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Innovative Strategies to Promote Biomedical HIV Prevention Uptake and Retention Among High-risk Adults at Drinking Venues in Kenya and Uganda

Conditions
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HIV/AIDS

Intervention / Treatment
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* Behavioral: Healthy Living Intervention (HLI)
* Behavioral: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care (Control)<br>Standard of care; alcohol counseling per Ministry of Health (MoH) guidelines | Behavioral: Standard of Care<br>* Participants who are randomized to the control arm will receive basic alcohol counseling through the Ministry of Health if it is provided as standard of care.<br>|
| Experimental: Healthy Living Intervention<br>Healthy Living Intervention in-person alcohol counseling with booster phone calls | Behavioral: Healthy Living Intervention (HLI)<br>* The Healthy Living Intervention (HLI) is a brief alcohol counseling intervention developed using the Information, Motivation, and Behavioral skills (IMB) model, a framework in which information, motivation, and behavioral skills are key determinants of health behavior. Participants initiating PrEP will be randomized to either HLI or standard of care alcohol counseling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of follow up time on biomedical prevention with PrEP or PEP | The proportion of time during the 48 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. Secondary analysis of the primary outcome will integrate drug levels measured in hair samples collected at 48 weeks. | Measured 48 weeks after PrEP or PEP initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Study staff will assess AUDIT-C scores (modified to refer to the prior 3 months, with a minimum of 0, indicating no alcohol use, and a maximum of 12) with a standard drink guide adapted to local context at baseline and every 12-weeks post-baseline. Blood will also be collected, and dried blood spots prepared for phosphatidylethanol (PEth) testing (measured in ng/mL with higher levels associated with greater alcohol use) at baseline and 48-weeks for confirmation of self-reported alcohol use. | Measured 48 weeks after PrEP or PEP initiation | 
| Proportion of participants with HIV seroconversion by week 48 | HIV seroconversion will be measured as documented rapid HIV antibody test positivity with Geenius confirmation or documented detectable HIV viral load, with rapid HIV testing. HIV testing will occur at PrEP refill and injection visits, or completion of a course of PEP. | Measured 48 weeks after PrEP or PEP initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol use, Biomedical HIV prevention, Uganda, Kenya, Counseling intervention