Intervention Development for Syndemics Among PWH in SA

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06152003

Collaborator

University of Cape Town (Other), University of Miami (Other), University of the Western Cape (Other), University of Stellenbosch (Other), University of Maryland (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Behavioral: Cognitive Behavioral Therapy for Syndemics and Adherence (CBT-SA)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Independent assessors will be used to measure study outcomes of the RCT at follow-up assessments.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2024

Anticipated Primary Completion Date :

Dec 1, 2027

Anticipated Study Completion Date :

Jun 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Enhanced Treatment as Usual (ETAU) We anticipate the control condition will contain the following: the enhanced treatment as usual (ETAU; n=30) will consist of PWH receiving treatment at their HIV primary care clinic as usual, enhanced by supplemental food parcels and referrals for mental health care and food service organizations. Treatment as usual for mental health care is evaluation by a nurse and referral to a medical officer or to a traveling psychologist available 1 day per week. Because there is no standard of care for food insecurity, we propose that all participants will receive food parcels, but ETAU participants will not receive case management or psychosocial intervention.
Experimental: 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.	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.

Arm

Intervention/Treatment

No Intervention: Enhanced Treatment as Usual (ETAU)

We anticipate the control condition will contain the following: the enhanced treatment as usual (ETAU; n=30) will consist of PWH receiving treatment at their HIV primary care clinic as usual, enhanced by supplemental food parcels and referrals for mental health care and food service organizations. Treatment as usual for mental health care is evaluation by a nurse and referral to a medical officer or to a traveling psychologist available 1 day per week. Because there is no standard of care for food insecurity, we propose that all participants will receive food parcels, but ETAU participants will not receive case management or psychosocial intervention.

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Massachusetts General Hospital
University of Cape Town
University of Miami
University of the Western Cape
University of Stellenbosch
University of Maryland

Investigators

Principal Investigator: Conall O'Cleirigh, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Conall O'Cleirigh, Associate Professor, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT06152003

Other Study ID Numbers:

2023P002344

First Posted:

Nov 30, 2023

Last Update Posted:

Nov 30, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Conall O'Cleirigh, Associate Professor, Massachusetts General Hospital

Post-traumatic Stress Disorder

Additional relevant MeSH terms:

HIV Infections

Study Results

No Results Posted as of Nov 30, 2023