Implementing Depression and Adherence Treatment
2 other identifiers
interventional
10
2 countries
3
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable depression
Started May 2026
Longer than P75 for not_applicable depression
3 active sites
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
CompletedFirst Posted
Study publicly available on registry
June 24, 2025
CompletedStudy Start
First participant enrolled
May 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2030
June 24, 2026
June 1, 2026
4 years
June 19, 2025
June 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reach of depression treatment
Proportion of patients who start an evidence-based treatment for depression out of patients identified with positive depression and a detectable viral load
1 year
Secondary Outcomes (2)
Depression
1 year
Viral undetectability
1 year
Study Arms (2)
Core
OTHERClinics in this arm will receive strategies that involve capacity building for nurses and education on mental health.
Enhanced
OTHERClinics in the enhanced arm will receive core strategies along with enhanced strategies that involve more intensive training on depression treatment.
Interventions
* 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
* Train the trainer * Ongoing supervision and consultation
Eligibility Criteria
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 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)
You may not qualify if:
- Children below the age of 18 will not be included in the proposed study for adults.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- National Institute of Mental Health (NIMH)collaborator
- Massachusetts General Hospitalcollaborator
- University of Cape Towncollaborator
Study Sites (3)
University of Miami
Miami, Florida, 33136, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Cape Town
Cape Town, South Africa
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: 30652921BACKGROUNDSafren 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: 27658881BACKGROUNDSafren 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: 34708929BACKGROUNDSafren 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
Condition Hierarchy (Ancestors)
Central Study Contacts
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
May 20, 2026
Primary Completion (Estimated)
May 1, 2030
Study Completion (Estimated)
May 1, 2030
Last Updated
June 24, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- The earliest possible start of data entry for implementation outcomes would be July 2026. After this, available data will be deposited every six months thereafter following the usual NDA data submission dates, as new data are collected. The research community will have access to data when the award ends. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now. (Unending).
- Access Criteria
- Data will be made available through NIMH's Data Archive (NDA). To request access of the data, researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable. We do not anticipate that any data will need to be restricted.
Effectiveness outcome data: We will extract medical record data from participants at the HIV clinics who have detectable, or presumed detectable, HIV and screen positive for depression. This will include depression, HIV RNA viral load, and demographic information.