Alcohol counseling to improve HIV prevention in East Africa
Innovative Strategies to Promote Biomedical HIV Prevention Uptake and Retention Among High-risk Adults at Drinking Venues in Kenya and Uganda
NA · University of California, San Francisco · NCT06036238
This study tests whether a brief counseling program about alcohol can help heavy drinkers in Kenya and Uganda stick to their HIV prevention treatments better than standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Locations | 2 sites (Mbita and 1 other locations) |
| Trial ID | NCT06036238 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of a brief alcohol counseling intervention on adherence to PrEP and PEP among adults with heavy alcohol use who are at high risk for HIV in Kenya and Uganda. The research involves recruiting over 2,000 individuals from drinking venues and integrating HIV testing with multi-disease screening. Participants will be randomized to receive either the Healthy Living Intervention or standard care to assess the efficacy of the intervention in promoting retention in biomedical HIV prevention. Additionally, the study will explore the cost-effectiveness of this approach and identify barriers and facilitators to adherence.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are HIV-uninfected, have heavy alcohol use, and are seeking biomedical HIV prevention.
Not a fit: Patients who are ineligible for PrEP based on Ministry of Health guidelines or those who are grossly inebriated will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve adherence to HIV prevention methods among individuals with heavy alcohol use, thereby reducing HIV transmission rates.
How similar studies have performed: Other studies have shown promise in integrating alcohol counseling with HIV prevention strategies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Mbita and 1 other locations
- Kenya Medical Research Institute (KEMRI) — Mbita, Kenya (RECRUITING)
- Infectious Diseases Research Collaboration (IDRC) — Mbarara, Uganda (RECRUITING)
Study contacts
- Principal investigator: Gabriel Chamie, MD, MPH — University of California, San Francisco
- Study coordinator: Kara Marson, MPH
- Email: kara.marson@ucsf.edu
- Phone: 650-346-5774
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HIV/AIDS, Alcohol use, Biomedical HIV prevention, Uganda, Kenya, Counseling intervention