HIV and Alcohol Reduction Program in Zambia
Common Elements Treatment Approach HIV Alcohol Reduction Trial in Zambia
This study is testing whether a new program that combines therapy for alcohol use and mental health can help people living with HIV in Zambia feel better compared to regular treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 680 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 3 sites (Lusaka and 2 other locations) |
| Trial ID | NCT05121064 on ClinicalTrials.gov |
What this trial studies
This program aims to evaluate the effectiveness of cognitive behavioral therapy-based interventions for reducing unhealthy alcohol use and improving mental health among individuals living with HIV in Zambia. Participants will be randomly assigned to receive either a brief intervention, a brief intervention plus a referral to a comprehensive treatment approach, or standard care. The study seeks to determine whether integrated treatment for alcohol use and mental health comorbidities is more effective than traditional alcohol-focused treatments alone. The interventions are designed to be resource-efficient while addressing the complex needs of this population.
Who should consider this trial
Good fit: Ideal candidates for this program are adults aged 18 and older living with HIV who exhibit hazardous alcohol use and have at least one mental health or substance use comorbidity.
Not a fit: Patients who are actively suicidal, currently psychotic, or those who plan to relocate out of Lusaka in the next six months may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve treatment outcomes for patients living with HIV who also struggle with alcohol use and mental health issues.
How similar studies have performed: Other studies have shown promise in integrating treatment for alcohol use and mental health conditions, but this specific approach is relatively novel in the context of HIV care in sub-Saharan Africa.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older * Living with HIV * Receiving HIV care at study site * Hazardous alcohol use plus at least one mental health or other substance use comorbidity or moderate to severe alcohol use disorder regardless of comorbidity * 6 months since initiation of Antiretroviral Treatment (ART) * Suboptimal HIV care outcome based on at least 1 of the following occurences in the past year: Late (at least 14 days from scheduled) Antiretroviral Treatment (ART) drug pick up, HIV viral load (VL) above the limit of assay detection, or referral to enhanced adherence Exclusion Criteria: * Plan to relocate out of Lusaka in next 6 months * No access to a telephone * Actively suicidal or alcohol intoxication and in need of immediate care * Currently psychotic * Participating in another interventional study that would interfere with participation
Where this trial is running
Lusaka and 2 other locations
- Chilenje Level 1 Hospital — Lusaka, Zambia (Recruiting)
- Kalingalinga Health Centre — Lusaka, Zambia (Recruiting)
- Kamwala Health Centre — Lusaka, Zambia (Recruiting)
Study contacts
- Study coordinator: Michael Vinikoor, M.D.
- Email: michael.vinikoor@cidrz.org
- Phone: 265980013335
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.