Adherence, Treatment, AIDS, Depression, HIV
Conditions
Keywords
implementation science, HIV, depression
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
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
* 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
OTHEREnhanced Implementation Strategies
* Train the trainer * Ongoing supervision and consultation
Sponsors
University of Miami
National Institute of Mental Health (NIMH)
Massachusetts General Hospital
University of Cape Town
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reach of depression treatment | 1 year | Proportion of patients who start an evidence-based treatment for depression out of patients identified with positive depression and a detectable viral load |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression | 1 year | Of those identified as having depression and detectable virus, the percentage of patients, after one year, who are considered depression treatment responders (categorized as a responder if they achieve significant reduction in symptoms on the PHQ or if they no longer meet clinical criteria for depression). |
| Viral undetectability | 1 year | Of those identified with detectable virus and depression, the percentage of patients who attain an undetectable HIV RNA viral load across the two arms. |
Countries
South Africa, United States
Contacts
CONTACTSteven A Safren, PhD
Outcome results
None listed