The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 6, 2023
First Posted Date  ICMJE September 13, 2023
Last Update Posted Date September 28, 2023
Estimated Study Start Date  ICMJE May 2024
Estimated Primary Completion Date May 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2023)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2023)		 Biomedical HIV Prevention coverage [ 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2023)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2023)
  • Alcohol use [ 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 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 at baseline and 48-weeks for confirmation of self-reported alcohol use.
  • HIV seroconversion [ 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Outreach and Prevention at ALcohol Venues in East Africa Study (OPAL-East Africa- Aim 2) (OPAL-Aim 2)
Official Title  ICMJE Innovative Strategies to Promote Biomedical HIV Prevention Uptake and Retention Among High-risk Adults at Drinking Venues in Kenya and Uganda
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV/AIDS
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Standard of Care (Control)
    Standard of care; alcohol counseling per Ministry of Health (MoH) guidelines
    Intervention: Behavioral: Standard of Care
  • Experimental: Healthy Living Intervention
    Healthy Living Intervention in-person alcohol counseling with booster phone calls
    Intervention: Behavioral: Healthy Living Intervention (HLI)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 6, 2023)		 400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2026
Estimated Primary Completion Date May 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kara Marson, MPH 650-346-5774 kara.marson@ucsf.edu
Contact: Gabriel Chamie, MD, MPH gabriel.chamie@ucsf.edu
Listed Location Countries  ICMJE Kenya,   Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06036238
Other Study ID Numbers  ICMJE 22-37054-2
1R01AA030464-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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).
Current Responsible Party University of California, San Francisco
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, San Francisco
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of California, Berkeley
  • Makerere University
  • Infectious Diseases Research Collaboration, Uganda
  • Kenya Medical Research Institute
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Gabriel Chamie, MD, MPH University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP