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NCT Number: NCT06152003

Intervention Development for Syndemics Among PWH in SA

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 75% of participants randomized to CBT-SA attend at least 66% of the sessions

    Time frame: 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.

  2. 75% of the participants randomized to CBT-SA attend the 6-month follow-up visit.

    Time frame: 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 outcomes

  1. ART adherence

    Time frame: 6-month follow-up

    ART adherence via dried blood spots on TDF-based regimens

  2. Presence of depression measured by the DIAMOND diagnostic instrument

    Time frame: 6-month follow-up

    Whether participants meet criteria or not on the depression module of the DIAMOND Diagnostic Measure.

  3. Presence of PTSD measured by the DIAMOND diagnostic instrument

    Time frame: 6-month follow-up

    Whether participants meet criteria or not on the PTSD module of the DIAMOND Diagnostic Measure.

Study contacts

Contact information is provided by the study sponsor or research team.

Jasper S Lee, Ph.D.

CONTACT

[email protected]

8572385000 ext. 1111330133

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • University of Cape Town
  • University of Maryland
  • University of Miami
  • University of Stellenbosch
  • University of the Western Cape

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Nov 30, 2023
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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