Implementing Depression and Adherence Treatment

Official title

Implementing Depression and Adherence Treatment in South Africa HIV Care

Overview

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

Objectives:

Our primary objective is to compare a core set to an enhanced set of implementation strategies for extending the reach of evidence-based treatments for depression to patients with uncontrolled HIV in South Africa (SA) HIV care settings. Using RE-AIM as the implementation outcome framework, the primary outcome is reach, defined as the percent of patients who start an evidence-based treatment for depression (i.e., CBT-AD and/or psychopharmacotherapy).

To further inform optimal implementation strategies, we will also examine possible moderators and mediators of implementation outcomes including the hypothesized mechanisms of the Implementation Research Logic Model (IRLM) (e.g., clinic level variables, self-efficacy, capacity for training, intervention delivery).

Our secondary objectives are effectiveness focused in order to assess differences in patient-level depression and HIV outcomes when using the enhanced versus the core set of strategies.

Study Procedures:

This is a cluster (clinic based), staged, randomized implementation trial, in 10 public primary HIV care clinics surrounding Cape Town, SA. We will compare a core and an enhanced set of implementation strategies. Because this is a type 3 hybrid implementation/effectiveness study, we are primarily examining implementation outcomes (i.e., reach). However, we will also collect information about whether the effectiveness of the interventions varies as a function of the implementation strategies used to support them. The primary "participants" in this trial are the 10 randomized clinics. In order to evaluate implementation and effectiveness outcomes, patient data will be extracted from clinic records. Research materials that we will extract will consist of 1) PHQ data to assess depression, 2) records relating to depression treatment (e.g., medications prescribed, psychosocial treatments received), 3) HIV viral load lab results 4) Demographic information, and 5) HIV treatment history (e.g. number of years living with HIV, other HIV history). Data will be abstracted from records at regular intervals for one year.

Interventions

• Other 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
• Other Enhanced Implementation Strategies
  * Train the trainer * Ongoing supervision and consultation

Primary outcome measures

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

Secondary outcome measures (2)

• Depression [Time frame: 1 year]
• Viral undetectability [Time frame: 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 2 centers

• University of Miami — Miami
• Massachusetts General Hospital — Boston

South Africa · 1 center

• University of Cape Town — Cape Town

Publications

• 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 30652921
• 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 27658881
• 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 34708929
• 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 19210012

Identifiers

NCT: NCT07032363 · 20241034 · R01MH136972

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗