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Implementing Depression and Adherence Treatment in South Africa HIV Care

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to compare a core set and enhanced set of implementation strategies in increasing the reach of evidence-based treatments to patients with HIV and depression. The main questions it aims to answer are: What proportion of patients start an evidence-based treatment for depression (reach)? What percentage of patients show clinical improvement in depression and what percentage attain viral undetectability within one year (effectiveness)? Researchers will compare high and low reach clinics to further inform tailored implementation strategies for uptake and maintenance. Clinics will be randomized into one of two study arms: core versus enhanced strategies. In both arms, core strategies will be utilized. Enhanced clinics will also receive more resource-intensive training.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

⁃ 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)

Locations
United States
Florida
University of Miami
RECRUITING
Miami
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Other Locations
South Africa
University of Cape Town
RECRUITING
Cape Town
Contact Information
Primary
Steven A Safren, PhD
ssafren@miami.edu
305-243-3471
Time Frame
Start Date: 2026-04-07
Estimated Completion Date: 2030-05
Participants
Target number of participants: 10
Treatments
Other: Core
Clinics in this arm will receive strategies that involve capacity building for nurses and education on mental health.
Other: Enhanced
Clinics in the enhanced arm will receive core strategies along with enhanced strategies that involve more intensive training on depression treatment.
Related Therapeutic Areas
Sponsors
Collaborators: Massachusetts General Hospital, National Institute of Mental Health (NIMH), University of Cape Town
Leads: University of Miami

This content was sourced from clinicaltrials.gov