NCT07032363

Implementing Depression and Adherence Treatment

Implementing Depression and Adherence Treatment in South Africa HIV Care

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Objectives: Our primary objective is to compare a core set to an enhanced set of implementation strategies for extending the reach of evidence-based treatments for depression to patients with uncontrolled HIV in South Africa (SA) HIV care settings. Using RE-AIM as the implementation outcome framework, the primary outcome is reach, defined as the percent of patients who start an evidence-based treatment for depression (i.e., CBT-AD and/or psychopharmacotherapy). To further inform optimal implementation strategies, we will also examine possible moderators and mediators of implementation outcomes including the hypothesized mechanisms of the Implementation Research Logic Model (IRLM) (e.g., clinic level variables, self-efficacy, capacity for training, intervention delivery). Our secondary objectives are effectiveness focused in order to assess differences in patient-level depression and HIV outcomes when using the enhanced versus the core set of strategies. Study Procedures: This is a cluster (clinic based), staged, randomized implementation trial, in 10 public primary HIV care clinics surrounding Cape Town, SA. We will compare a core and an enhanced set of implementation strategies. Because this is a type 3 hybrid implementation/effectiveness study, we are primarily examining implementation outcomes (i.e., reach). However, we will also collect information about whether the effectiveness of the interventions varies as a function of the implementation strategies used to support them. The primary "participants" in this trial are the 10 randomized clinics. In order to evaluate implementation and effectiveness outcomes, patient data will be extracted from clinic records. Research materials that we will extract will consist of 1) PHQ data to assess depression, 2) records relating to depression treatment (e.g., medications prescribed, psychosocial treatments received), 3) HIV viral load lab results 4) Demographic information, and 5) HIV treatment history (e.g. number of years living with HIV, other HIV history). Data will be abstracted from records at regular intervals for one year.

Conditions

• Depression
• HIV
• Adherence, Treatment
• AIDS

Interventions

Type	Name	Description
OTHER	Core Implementation Strategies	* Task Sharing/Revise Professional Roles * Distribute educational materials/Dynamic Training/Address Stigma * Clinician Implementation Team Meetings * Partner with CoCT DoH * Champion * Audit and Feedback * Stage Scale Up/Tailoring
OTHER	Enhanced Implementation Strategies	* Train the trainer * Ongoing supervision and consultation

Timeline

• Start date: 2026-04-07
• Primary completion: 2030-05-01
• Completion: 2030-05-01
• First posted: 2025-06-24
• Last updated: 2026-04-03

Locations

3 sites across 2 countries: United States, South Africa