NCT07032363

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
10

participants targeted

Target at below P25 for not_applicable depression

Timeline
72mo left

Started Jan 2029

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
3.6 years until next milestone

Study Start

First participant enrolled

January 20, 2029

Expected
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2034

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2034

Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

5.9 years

First QC Date

June 19, 2025

Last Update Submit

June 24, 2025

Conditions

DepressionHIVAdherence, TreatmentAIDS

Keywords

implementation scienceHIVdepression

Outcome Measures

Primary Outcomes (1)

  • Reach of depression treatment

    Proportion of patients who start an evidence-based treatment for depression

    1 year

Secondary Outcomes (2)

  • Depression

    1 year

  • Viral undetectability

    1 year

Study Arms (2)

Core

OTHER

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

Other: Core Implementation Strategies

Enhanced

OTHER

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

Other: Core Implementation StrategiesOther: Enhanced Implementation Strategies

Interventions

Core Implementation StrategiesOTHER

* 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

CoreEnhanced
Enhanced Implementation StrategiesOTHER

* Train the trainer * Ongoing supervision and consultation

Enhanced

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (4)

  • Everitt-Penhale B, Kagee A, Magidson JF, Joska J, Safren SA, O'Cleirigh C, Witten J, Lee JS, Andersen LS. 'I went back to being myself': acceptability of a culturally adapted task-shifted cognitive-behavioural therapy (CBT) treatment for depression (Ziphamandla) for South African HIV care settings. Psychol Health Med. 2019 Jul;24(6):680-690. doi: 10.1080/13548506.2019.1566624. Epub 2019 Jan 17.

    PMID: 30652921BACKGROUND

  • Safren SA, Bedoya CA, O'Cleirigh C, Biello KB, Pinkston MM, Stein MD, Traeger L, Kojic E, Robbins GK, Lerner JA, Herman DS, Mimiaga MJ, Mayer KH. Cognitive behavioural therapy for adherence and depression in patients with HIV: a three-arm randomised controlled trial. Lancet HIV. 2016 Nov;3(11):e529-e538. doi: 10.1016/S2352-3018(16)30053-4. Epub 2016 Sep 19.

    PMID: 27658881BACKGROUND

  • Safren SA, O'Cleirigh C, Andersen LS, Magidson JF, Lee JS, Bainter SA, Musinguzi N, Simoni J, Kagee A, Joska JA. Treating depression and improving adherence in HIV care with task-shared cognitive behavioural therapy in Khayelitsha, South Africa: a randomized controlled trial. J Int AIDS Soc. 2021 Oct;24(10):e25823. doi: 10.1002/jia2.25823.

    PMID: 34708929BACKGROUND

  • Safren SA, O'Cleirigh C, Tan JY, Raminani SR, Reilly LC, Otto MW, Mayer KH. A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected individuals. Health Psychol. 2009 Jan;28(1):1-10. doi: 10.1037/a0012715.

    PMID: 19210012BACKGROUND

MeSH Terms

Conditions

DepressionTreatment Adherence and ComplianceAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorHealth BehaviorHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 19, 2025

First Posted

June 24, 2025

Study Start (Estimated)

January 20, 2029

Primary Completion (Estimated)

December 31, 2034

Study Completion (Estimated)

December 31, 2034

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

following NIH rules

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
This really depends on if the study will be reinstated
Access Criteria
This really depends on if the study will be reinstated

Locations

US(1)