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Intervention Development for Syndemics Among PWH in SA

NCT06152003 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Cape Town

    collaborator OTHER

  • University of Miami

    collaborator OTHER

  • University of the Western Cape

    collaborator OTHER

  • University of Stellenbosch

    collaborator OTHER

  • University of Maryland

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Conall O'Cleirigh, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-12-31
Completion
2028-06-30

Countries

  • South Africa

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06152003 on ClinicalTrials.gov