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

HIV/AIDS Clinical Trial

— OPAL-Aim 2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06036238
• Other study ID #: 22-37054-2
• Secondary ID: 1R01AA030464-01
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2024
• Est. completion date: May 2026

Study information

• Verified date: June 2024
• Source: University of California, San Francisco
• Contact: Kara Marson, MPH
• Phone: 650-346-5774
• Email: kara.marson[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• Healthy Living Intervention (HLI)
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.
• Standard of Care
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.

Locations

Country	Name	City	State
Kenya	Kenya Medical Research Institute (KEMRI)	Mbita
Uganda	Infectious Diseases Research Collaboration (IDRC)	Mbarara

Sponsors (6)

Lead Sponsor	Collaborator
University of California, San Francisco	Infectious Diseases Research Collaboration, Uganda, Kenya Medical Research Institute, Makerere University, National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of California, Berkeley

Countries where clinical trial is conducted

Kenya,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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