RecruitingNot ApplicableNCT06036238

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

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


Sponsor

University of California, San Francisco

Enrollment

400 participants

Start Date

May 17, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria3

  • 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

Interventions

BEHAVIORALHealthy 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.

BEHAVIORALStandard 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(2)

Kenya Medical Research Institute (KEMRI)

Mbita, Kenya

Infectious Diseases Research Collaboration (IDRC)

Mbarara, Uganda

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NCT06036238


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