Intervention Development for Syndemics Among PWH in SA
ConditionHIV Infections
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
In South Africa, the country with the highest HIV prevalence (19%), co-occurring problems such as depression, post-traumatic stress, and food insecurity interact to enhance one another (i.e., syndemic problems) and are associated with worse HIV outcomes such as worse antiretroviral therapy (ART) adherence and worse viral load. This study proposes to: 1) explore how syndemic problems work together to make health worse for people with HIV (PWH) and explore what people think about a potential treatment; 2) develop a treatment to address syndemic problems and improve ART adherence (CBT-SA); 3a) assess whether people are willing to receive the CBT-SA we it can actually be done; and 3b) identify factors that make it easier or more difficult to receive CBT-SA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient receiving HIV care in Khayelitsha (confirmed by medical record)
Currently prescribed TDF-based ART, with recent difficulties with ART adherence (self-reported in past 30 days / confirmed by pharmacy refill data)
Clinically significant depressive symptoms (CES-D ≥ 16)
Clinically significant post-traumatic stress symptoms (SPAN ≥ 5)
Disqualifiers
Unable or unwilling to provide informed consent
In the past year: received CBT for depression or PTSD, or received supplemental food parcels or nutritional counseling
Current untreated or undertreated serious mental health issue that would interfere with participation
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Behavioral Therapy for Syndemics and Adherence (CBT-SA)
BehavioralWe anticipate the intervention will contain the following: CBT for depression and trauma, Life-Steps for ART adherence, nutritional counseling, supplementary food parcels, case management, linkage to care. Specific intervention components will be informed by prior aims.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Enhanced Treatment as Usual (ETAU)No intervention 0 interventions
Group B: Cognitive Behavioral Therapy for Syndemics and Adherence (CBT-SA)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
75% of participants randomized to CBT-SA attend at least 66% of the sessions
We will calculate the percentage of participants randomized to the CBT-SA condition who attend 66% or greater of the total number of sessions. CBT-SA will be considered feasible and acceptable if 75% of the participants attend 66% or more of the sessions.
Time frame
6-month follow-up2
75% of the participants randomized to CBT-SA attend the 6-month follow-up visit.
We will calculate the percentage of participants randomized to the CBT-SA condition who attend the 6-month follow-up visit. CBT-SA will be considered feasible and acceptable if 75% of the participants attend the 6-month follow-up visit.
Time frame
6-month follow-upSecondary outcomes
1
ART adherence
ART adherence via dried blood spots on TDF-based regimens
Time frame
6-month follow-up2
Presence of depression measured by the DIAMOND diagnostic instrument
Whether participants meet criteria or not on the depression module of the DIAMOND Diagnostic Measure.
Time frame
6-month follow-up3
Presence of PTSD measured by the DIAMOND diagnostic instrument
Whether participants meet criteria or not on the PTSD module of the DIAMOND Diagnostic Measure.
Time frame
6-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
University of Cape Town
Collaborator
University of Miami
Collaborator
University of the Western Cape
Collaborator
University of Stellenbosch
Collaborator
University of Maryland
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: