Intervention Development for Syndemics Among PWH in SA

HIV Infections Clinical Trial

Official title:

Developing and Piloting a Multilevel Intervention to Address Psychosocial and Structural Syndemics in People With HIV in South Africa

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06152003
• Other study ID #: 2023P002344
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: June 2028

Study information

• Verified date: November 2023
• Source: Massachusetts General Hospital
• Contact: Jasper S Lee, Ph.D.
• Phone: 8572385000
• Email: jlee333[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Massachusetts General Hospital	University of Cape Town, University of Maryland, University of Miami, University of Stellenbosch, University of the Western Cape

Outcome

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