Implementing Depression and Adherence Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2029-01-20

Study Completion Date

2034-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Depression HIV Adherence, Treatment AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Core

Clinics in this arm will receive strategies that involve capacity building for nurses and education on mental health.

Group Type OTHER

Core Implementation Strategies

Intervention Type OTHER

* 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

Enhanced

Clinics in the enhanced arm will receive core strategies along with enhanced strategies that involve more intensive training on depression treatment.

Group Type OTHER

Core Implementation Strategies

Intervention Type OTHER

* 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

Enhanced Implementation Strategies

Intervention Type OTHER

* Train the trainer
* Ongoing supervision and consultation

Interventions

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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

Intervention Type OTHER

Enhanced Implementation Strategies

* Train the trainer
* Ongoing supervision and consultation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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 included in the study will be eligible to enroll 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).
* Screen in for depression on the PHq-9 (score of 10 or above).

* For the qualitative data which involve interviewing clinic staff (specifically, nurses, physicians, clinic managers, or other involved in implementation) and patients, individuals will be eligible to participate if they are:
* employees (occupying the pre-specified roles) or patients (who met eligibility criteria for the implementation phase, regardless of whether or not they choose to enroll in the implementation phase) of a clinic that was randomized to the experimental condition.
* Clinic staff will be 18 years and older