Expanding access to depression treatment for adults with HIV to improve mood and viral control.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.