Implementing Depression and Adherence Treatment
Recruiting · NCT07032363 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Miami
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
3 locations listed across 2 US states.
- University of Miami - Miami, Florida, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- University of Cape Town - Cape Town, South Africa