Implementing Depression and Adherence Treatment

Not Applicable

Suspended

• Conditions: Depression; HIV; Adherence, Treatment; AIDS

• Registration Number: NCT07032363
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-19
• Study First Submitted QC: 2025-06-19
• Study First Posted: 2025-06-24
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-29
• Study Start: 2029-01-20
• Primary Completion: 2034-12-31
• Study Completion: 2034-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reach of depression treatment	1 year	Proportion of patients who start an evidence-based treatment for depression

Secondary Outcome Measures

Name	Time	Method
Depression	1 year	Percentage of patients, after one year, who are considered depression treatment responders (categorized as a responder if they achieve 50% reduction in symptoms on the PHQ-9 or if they no longer meet clinical criteria for depression).
Viral undetectability	1 year	Percentage of patients who attain an undetectable HIV RNA viral load across the two arms.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States