Intervention Development for Syndemics Among PWH in SA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Behavioral Therapy for Syndemics and Adherence (CBT-SA).
- Who it may be relevant to
- Registry conditions: HIV Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Africa
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Developing and Piloting a Multilevel Intervention to Address Psychosocial and Structural Syndemics in People With HIV in South Africa
Overview
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.
Interventions
- Behavioral Cognitive Behavioral Therapy for Syndemics and Adherence (CBT-SA)
We 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.
Primary outcome measures
- 75% of participants randomized to CBT-SA attend at least 66% of the sessions [Time frame: 6-month follow-up]
- 75% of the participants randomized to CBT-SA attend the 6-month follow-up visit. [Time frame: 6-month follow-up]
Secondary outcome measures (3)
- ART adherence [Time frame: 6-month follow-up]
- Presence of depression measured by the DIAMOND diagnostic instrument [Time frame: 6-month follow-up]
- Presence of PTSD measured by the DIAMOND diagnostic instrument [Time frame: 6-month follow-up]
Eligibility criteria
Inclusion criteria
- 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)
- 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)
- 18 years of age or older
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
South Africa · 1 center
- University of Cape Town — Cape Town
Identifiers
NCT: NCT06152003 · 2023P002344