Clinical trial NCT06152003: Intervention Development for Syndemics Among PWH in SA
Official title: Developing and Piloting a Multilevel Intervention to Address Psychosocial and Structural Syndemics in People with HIV in South Africa
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV Infections
Keywords: Syndemic Problems
ART Adherence
Food Insecurity
Depression
Post-traumatic Stress Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Cape Town
name: University of Miami
name: University of the Western Cape
name: University of Stellenbosch
name: University of Maryland
First posted: 2023-11-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 75% of participants randomized to CBT-SA attend at least 66% of the sessions
timeFrame: 6-month follow-up
measure: 75% of the participants randomized to CBT-SA attend the 6-month follow-up visit.
timeFrame: 6-month follow-up
Secondary outcomes:
measure: ART adherence
timeFrame: 6-month follow-up
measure: Presence of depression measured by the DIAMOND diagnostic instrument
timeFrame: 6-month follow-up
measure: Presence of PTSD measured by the DIAMOND diagnostic instrument
timeFrame: 6-month follow-up
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: University of Cape Town
state: Western Cape
Study officials:
affiliation: Massachusetts General Hospital
name: Conall O'Cleirigh, PhD
role: PRINCIPAL_INVESTIGATOR
References: