Intervention Development for Syndemics Among PWH in SA

Not Applicable

Not yet recruiting

• Conditions: HIV Infections
• Interventions: Behavioral: Cognitive Behavioral Therapy for Syndemics and Adherence (CBT-SA)

• Registration Number: NCT06152003
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

South Africa (SA) has a generalized HIV epidemic, and the highest HIV prevalence rate (19%). Psychosocial (e.g., depression, post-traumatic stress) and structural problems (e.g., food insecurity) are associated with worse antiretroviral therapy (ART) adherence and higher viral load. Depression, post-traumatic stress, and food insecurity are also highly comorbid and are thought to interact synergistically to confer greater risk for worse HIV outcomes (i.e., syndemic problems). The proposed specific aims are to: 1) explore the complex interrelationships between food insecurity, depression, and post-traumatic stress, as they relate to engagement in HIV care, and explore attitudes to potential intervention components; 2) develop a multilevel intervention to address syndemic problems and improve adherence (CBT-SA) and conduct an iterative proof-of-concept pilot trial use syndemic theory; 3a) assess the feasibility and acceptability of CBT-SA in a pilot RCT; and 3b) identify barriers and facilitators of CBT-SA engagement among PWH and uptake among care providers and other key local partners to inform a future hybrid effectiveness/implementation R01 trial. If successful, this intervention would be further tested for effectiveness and implementation in a future application.

Study Timeline

• Study First Submitted: 2023-11-16
• Study First Submitted QC: 2023-11-21
• Study First Posted: 2023-11-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Study Start: 2025-06
• Primary Completion: 2027-12
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patient receiving HIV care in Khayelitsha (confirmed by medical record)

2. Currently prescribed TDF-based ART, with recent difficulties with ART adherence (self-reported in past 30 days / confirmed by pharmacy refill data)

3. Mild, moderate, or severe food insecurity (measured by HFIAS categories) AND ≥1 of the following:

   • Clinically significant depressive symptoms (CES-D ≥ 16)
   • Clinically significant post-traumatic stress symptoms (SPAN ≥ 5)

4. 18 years of age or older

Exclusion Criteria

1. Unable or unwilling to provide informed consent
2. In the past year: received CBT for depression or PTSD, or received supplemental food parcels or nutritional counseling
3. Current untreated or undertreated serious mental health issue that would interfere with participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy for Syndemics and Adherence (CBT-SA)	Cognitive Behavioral Therapy for Syndemics and Adherence (CBT-SA)	We anticipate the intervention condition (CBT-SA) will contain the following: cognitive behavioral therapy for syndemics and adherence (CBT-SA; n=30) likely will be comprised of both psychosocial and structural intervention components, based on the results of Aim 1 and refinement in Aim 2. In addition to food parcels, we expect the CBT-SA condition will also receive nutritional counseling, linkage to care, and case management. Only the CBT-SA condition will receive the psychological intervention for depression and PTSD and adherence counseling. Specific intervention components will be informed by prior aims.

Primary Outcome Measures

Name	Time	Method
75% of the participants randomized to CBT-SA attend the 6-month follow-up visit.	6-month follow-up	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.
75% of participants randomized to CBT-SA attend at least 66% of the sessions	6-month follow-up	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.

Secondary Outcome Measures

Name	Time	Method
ART adherence	6-month follow-up	ART adherence via dried blood spots on TDF-based regimens
Presence of depression measured by the DIAMOND diagnostic instrument	6-month follow-up	Whether participants meet criteria or not on the depression module of the DIAMOND Diagnostic Measure.
Presence of PTSD measured by the DIAMOND diagnostic instrument	6-month follow-up	Whether participants meet criteria or not on the PTSD module of the DIAMOND Diagnostic Measure.

Trial Locations

Locations (1)

University of Cape Town; 🇿🇦 Cape Town, Western Cape, South Africa