Intervention Development for Syndemics Among PWH in SA

Last updated: December 20, 2024
Sponsor: Massachusetts General Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Hiv Infections

Treatment

Cognitive Behavioral Therapy for Syndemics and Adherence (CBT-SA)

Clinical Study ID

NCT06152003
2023P002344
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofthe following:

  • Clinically significant depressive symptoms (CES-D ≥ 16)

  • Clinically significant post-traumatic stress symptoms (SPAN ≥ 5)

  1. 18 years of age or older

Exclusion

Exclusion Criteria:

  1. Unable or unwilling to provide informed consent

  2. In the past year: received CBT for depression or PTSD, or received supplemental foodparcels or nutritional counseling

  3. Current untreated or undertreated serious mental health issue that would interferewith participation

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Cognitive Behavioral Therapy for Syndemics and Adherence (CBT-SA)
Phase:
Study Start date:
June 01, 2025
Estimated Completion Date:
June 30, 2028

Study 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.

Connect with a study center

  • University of Cape Town

    Cape Town, Western Cape
    South Africa

    Site Not Available

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