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.

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.

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.

Effectiveness outcome data: We will extract medical record data from participants at the HIV clinics who have detectable, or presumed detectable, HIV and screen positive for depression. This will include depression, HIV RNA viral load, and demographic information.

The earliest possible start of data entry for implementation outcomes would be July 2026. After this, available data will be deposited every six months thereafter following the usual NDA data submission dates, as new data are collected.

The research community will have access to data when the award ends. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now. (Unending).

Data will be made available through NIMH's Data Archive (NDA). To request access of the data, researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable. We do not anticipate that any data will need to be restricted.