Implementing Depression and Adherence Treatment

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07032363
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Core Implementation Strategies — 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 — OTHER
    * Train the trainer * Ongoing supervision and consultation

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Apr 2026
Primary completion
May 31, 2030
Completion
May 31, 2030

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

Reach of depression treatment [ Time Frame: 1 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Steven A Safren, PhD
305-243-3471
Marc Puccinelli, PhD
305-243-3508
Massachusetts General HospitalBostonMassachusetts02114-

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