Intervention Development for Syndemics Among PWH in SA

NCT06152003 | Not Yet Recruiting DMC

• 1 other identifier: 2023P002344
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Syndemic Problems; ART Adherence; Food Insecurity; Depression; Post-traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• ART adherence

  6-month follow-up

• Presence of depression measured by the DIAMOND diagnostic instrument

  6-month follow-up

• Presence of PTSD measured by the DIAMOND diagnostic instrument

  6-month follow-up

Study Arms (2)

Enhanced Treatment as Usual (ETAU)

NO INTERVENTION

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.

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

EXPERIMENTAL

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)

Interventions

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• University of Cape Town: collaborator
• University of Miami: collaborator
• University of the Western Cape: collaborator
• University of Stellenbosch: collaborator
• University of Maryland: collaborator

Study Sites (1)

University of Cape Town

Cape Town, Western Cape, South Africa

Location

MeSH Terms

Conditions

HIV Infections; Depression; Stress Disorders, Post-Traumatic

Interventions

Cognitive Behavioral Therapy; Syndemic

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Epidemiologic Factors; Public Health; Environment and Public Health

Study Officials

• Conall O'Cleirigh, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasper S Lee, Ph.D.

CONTACT

8572385000; jlee333@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent assessors will be used to measure study outcomes of the RCT at follow-up assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 30, 2023
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 19, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available one year after we have achieved the main aims of the project (i.e., publication of the main outcome papers). ICPSR will make decisions about how long to preserve the data; however, ICPSR permanently archives deposited files.
• Access Criteria: TBD.

Locations

ZA (1)