HIV/AIDSOPAL-Aim 2NCT06036238
The Outreach and Prevention at ALcohol Venues in East Africa Study (OPAL-East Africa- Aim 2) (OPAL-Aim 2)
A study testing Healthy Living Intervention (HLI) in people with HIV/AIDS, run by University of California, San Francisco at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Healthy Living Intervention (HLI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 17 May 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Innovative Strategies to Promote Biomedical HIV Prevention Uptake and Retention Among High-risk Adults at Drinking Venues in Kenya and Uganda
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.
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- Healthy Living Intervention (HLI), Standard of Care
- Keywords
- Alcohol use, Biomedical HIV prevention, Uganda, Kenya, Counseling intervention
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Living Intervention (HLI)Behavioural
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 CareBehavioural
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 group | Role | What they receive |
|---|---|---|
| Standard of Care (Control) | Active comparator | Standard of care; alcohol counseling per Ministry of Health (MoH) guidelines Receives: Behavioral: Standard of Care |
| Healthy Living Intervention | Experimental | Healthy Living Intervention in-person alcohol counseling with booster phone calls Receives: Behavioral: Healthy Living Intervention (HLI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of follow up time on biomedical prevention with PrEP or PEP
The proportion of time during the 24 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.
Measured: Measured 24 weeks after PrEP or PEP initiation
Secondary outcomes (3)
Proportion of follow up time on biomedical prevention with PrEP or PEP- 48 weeks
Secondary analysis of the primary outcome will measure the proportion of time that a person is protected from HIV with PrEP/PEP over 48 weeks, with integrated drug levels measured in hair samples collected at 48 weeks.
Measured: Measured over 48 weeks after PrEP or PEP initiation
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: Measured 48 weeks after PrEP or PEP initiation
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: Measured 48 weeks after PrEP or PEP initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start17 May 2024
- Primary completion23 Dec 2025
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Berkeley, Makerere University, Infectious Diseases Research Collaboration, Uganda, Kenya Medical Research Institute, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Gabriel Chamie, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036238
- Sponsor's protocol ID
- 22-37054-2
- Other IDs
- 1R01AA030464-01
- Acronym
- OPAL-Aim 2
- Status last verified
- Jul 2026
- First submitted
- 6 Sep 2023
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Strategies to Promote Biomedical HIV Prevention Uptake and Retention Among High-risk Adults at Drinking Venues in Kenya and Uganda
- ClinicalTrials.gov ID
- NCT06036238
- Acronym / sponsor ID
- OPAL-Aim 2 / 22-37054-2
- Conditions
- HIV/AIDS
- Keywords
- Alcohol use, Biomedical HIV prevention, Uganda, Kenya, Counseling intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California, Berkeley, Makerere University, Infectious Diseases Research Collaboration, Uganda, Kenya Medical Research Institute, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 17 May 2024 (actual)
- Primary completion
- 23 Dec 2025 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (Control) | Active comparator | Behavioral: Standard of CareStandard of care; alcohol counseling per Ministry of Health (MoH) guidelines |
| Healthy Living Intervention | Experimental | Behavioral: Healthy Living Intervention (HLI)Healthy Living Intervention in-person alcohol counseling with booster phone calls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Healthy Living Intervention |
| Standard of CareParticipants 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. | Behavioural | Standard of Care (Control) |
Primary outcome
Proportion of follow up time on biomedical prevention with PrEP or PEP
Time frame: Measured 24 weeks after PrEP or PEP initiation
The proportion of time during the 24 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.
3 secondary outcomes
Proportion of follow up time on biomedical prevention with PrEP or PEP- 48 weeks
Time frame: Measured over 48 weeks after PrEP or PEP initiation
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
Proportion of participants with HIV seroconversion by week 48
Time frame: Measured 48 weeks after PrEP or PEP initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel Chamie, MD, MPH principal investigator
University of California, San Francisco
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Living Intervention (HLI) in people with HIV/AIDS, run by University of California, San Francisco at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of follow up time on biomedical prevention with PrEP or PEP (time frame: Measured 24 weeks after PrEP or PEP initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.