Health TrialsbyHealthPanel

Implementing Depression and Adherence Treatment

ConditionsDepressionHIVAdherence, TreatmentAIDS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Core Implementation Strategies

    Other intervention

    * 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

  • Enhanced Implementation Strategies

    Other intervention

    * Train the trainer * Ongoing supervision and consultation

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: CoreOther 1 intervention
Group B: EnhancedOther 2 interventions

Trial outcomes

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

Time frame
1 year

Secondary outcomes

1

Depression

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).

Time frame
1 year
2

Viral undetectability

Of those identified with detectable virus and depression, the percentage of patients who attain an undetectable HIV RNA viral load across the two arms.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Massachusetts General Hospital

Collaborator

University of Cape Town

Collaborator

Source ClinicalTrials.gov
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