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

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ClinicalTrials.gov Identifier: NCT06036238
Recruitment Status : Not yet recruiting
First Posted : September 13, 2023
Last Update Posted : September 28, 2023
Sponsor:
Collaborators:
University of California, Berkeley
Makerere University
Infectious Diseases Research Collaboration, Uganda
Kenya Medical Research Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Healthy Living Intervention (HLI) Behavioral: Standard of Care Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Innovative Strategies to Promote Biomedical HIV Prevention Uptake and Retention Among High-risk Adults at Drinking Venues in Kenya and Uganda
Estimated Study Start Date : May 2024
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard of Care (Control)
Standard of care; alcohol counseling per Ministry of Health (MoH) guidelines
 Behavioral: 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.
Experimental: Healthy Living Intervention
Healthy Living Intervention in-person alcohol counseling with booster phone calls
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of follow up time on biomedical prevention with PrEP or PEP [ Time Frame: Measured 48 weeks after PrEP or PEP initiation ]
    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.


Secondary Outcome Measures :
  1. 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 [ Time Frame: Measured 48 weeks after PrEP or PEP initiation ]
    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.

  2. Proportion of participants with HIV seroconversion by week 48 [ Time Frame: Measured 48 weeks after PrEP or PEP initiation ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06036238


Contacts
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Contact: Kara Marson, MPH 650-346-5774 kara.marson@ucsf.edu
Contact: Gabriel Chamie, MD, MPH gabriel.chamie@ucsf.edu

Locations
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Kenya
Kenya Medical Research Institute (KEMRI)
Mbita, Kenya
Contact: Jaqui Mwango       jabermwango@gmail.com   
Principal Investigator: James Ayieko, MBChB, MPH, PhD         
Uganda
Infectious Diseases Research Collaboration (IDRC)
Mbarara, Uganda
Contact: Brian Beesiga, MBChB    +256 (0) 312 281 479    bbeesiga@idrc-uganda.org   
Principal Investigator: Moses R Kamya, MBChB, MMed, PhD         
Sponsors and Collaborators
University of California, San Francisco
University of California, Berkeley
Makerere University
Infectious Diseases Research Collaboration, Uganda
Kenya Medical Research Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Gabriel Chamie, MD, MPH University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT06036238    
Other Study ID Numbers: 22-37054-2
1R01AA030464-01 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Per the approved Data Sharing agreement with the NIAAA Data Archive, the investigators will share de-identified IPD from our baseline questionnaire, which includes questions about subject demographics, HIV risk, and alcohol use.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data requests can be submitted starting 3 months after article publication and the data will be made accessible for up to 36 months. Extensions will be considered on a case-by-case basis.
Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Alcohol use
Biomedical HIV prevention
Uganda
Kenya
Counseling intervention
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
 Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases