Implementing Depression and Adherence Treatment

University of Miami

Status: Suspended

Conditions: AIDS; Adherence, Treatment; HIV; Depression

Treatments: Other: Core Implementation Strategies; Other: Enhanced Implementation Strategies

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07032363

R01MH136972 (U.S. NIH Grant/Contract)

20241034

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Clinics:

• 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 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).

Exclusion Criteria:

-Children below the age of 18 will not be included in the proposed study for adults.

Inclusion Criteria for Qualitative data:

• 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

Exclusion Criteria for Qualitative data:

• Children less than 18 will not be included

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Core

Other group

Description:

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

Treatment:

Other: Core Implementation Strategies

Enhanced

Other group

Description:

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

Treatment:

Other: Enhanced Implementation Strategies

Other: Core Implementation Strategies