Recruiting

Core vs. Enhanced

Sponsor:

University of Miami

Code:

NCT07032363

Conditions

Depression

HIV

Adherence, Treatment

AIDS

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Core Implementation Strategies

Enhanced Implementation Strategies

Study Details

Brief 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.

Conditions

Depression

HIV

Adherence, Treatment

AIDS

Study ID

NCT07032363

Start date

May 20, 2026

Status verified date

Jun, 2026

Completion date

May, 2030

Anticipated

Primary completion date

May, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Core

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

other: Enhanced

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

Interventions

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

Enhanced Implementation Strategies

  • Train the trainer
  • Ongoing supervision and consultation

Primary outcome measure

  • Reach of depression treatment [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Steven A Safren, PhD

305-243-3471ssafren@miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Steven A Safren, PhD

305-243-3471ssafren@miami.edu

Marc Puccinelli, PhD

305-243-3508mpuccinelli@miami.edu

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

University of Miami

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Keywords

  • implementation science
  • HIV
  • depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-06-24.