Expanding access to depression treatment for adults with HIV to improve mood and viral control.
Implementing Depression and Adherence Treatment in South Africa HIV Care
This project tests whether giving HIV clinics extra training and support helps more adults with HIV and depression start proven depression treatments and reach viral suppression within a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 3 sites (Miami, Florida and 2 other locations) |
| Trial ID | NCT07032363 on ClinicalTrials.gov |
What this trial studies
This is a cluster randomized, type 3 hybrid implementation-effectiveness trial comparing a core set of implementation strategies to an enhanced, more resource-intensive package across 10 public primary HIV clinics around Cape Town, South Africa. Clinics are randomized to receive either the core strategies or the core plus enhanced training and supports, and the primary implementation outcome is reach, defined as the percent of patients who start evidence-based depression treatment (CBT-AD and/or pharmacotherapy). Secondary effectiveness outcomes include patient-level changes in depression and the proportion attaining viral undetectability within one year. The study will also examine moderators and mediators of implementation outcomes using RE-AIM and the Implementation Research Logic Model.
Who should consider this trial
Good fit: Ideal participants are adults (18+) receiving care at one of the participating Cape Town HIV clinics who have a detectable viral load and screen positive for depression.
Not a fit: Children under 18, people who receive care outside the participating clinics, or people without depression or with already suppressed viral loads are unlikely to benefit from the trial's interventions.
Why it matters
Potential benefit: If successful, the approach could increase the number of people with HIV and depression who begin effective depression treatment and improve viral suppression rates.
How similar studies have performed: Integrated depression treatments such as CBT and antidepressant therapy have improved mood and adherence in other HIV care settings, though direct head-to-head comparisons of core versus enhanced implementation packages are less common.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for Clinics (the primary "participants"): * Clinics are eligible if they provide HIV primary care via the City of Cape Town (CoCT) Department of Health * Clinics will be assigned to the study upon notice of funding and before start up. Inclusion Criteria for Patient-level Outcomes: Although the unit of randomization is at the clinic level, the study will be looking at adult patient level data at each clinic. All patients engaged in care at one of the 10 primary care/HIV treatment clinics in the study will be included if they: * Are 18 years of age or older and * Have a detectable HIV viral load (operationalized as the lower limit of detection on the standard test is used at the local clinic), or presumed detectable viral load per clinic standards * Screen in for depression via the PHQ (following detection standards set in clinics) Exclusion Criteria: -Children below the age of 18 will not be included in the proposed study for adults.
Where this trial is running
Miami, Florida and 2 other locations
- University of Miami — Miami, Florida, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Cape Town — Cape Town, South Africa (Recruiting)
Study contacts
- Study coordinator: Steven A Safren, PhD
- Email: ssafren@miami.edu
- Phone: 305-243-3471
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.