Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06554223

The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care

Led by Brigham and Women's Hospital · Updated on 2025-11-24

310

Participants Needed

1

Research Sites

176 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn if the DSD model (SUSTAIN-DSD) is effective in improving participants HIV treatment adherence. The main questions it aims to answer are: * Does the SUSTAIN-DSD intervention significantly improve participants' treatment adherence and increase rates of viral suppression? * Does the SUSTAIN-DSD intervention help retain people in care? * Does SUSTAIN-DSD intervention help reduce the length of treatment interruptions? * for 24 months, Participants will either receive the SUSTAIN-DSD intervention (i.e. be enrolled in an adherence club where the participants will pick up 6-months of ART medication and have the option to use peer support and additional counseling), and or enhanced standard of care (i.e. visit the clinic for treatment and participate in optional counseling sessions). Blood will be drawn from the participants at the adherence club visits for viral load tests at baseline and every 12 months. \- Participants will take part in interviews to discuss the participants' experience with the SUSTAIN-DSD intervention.

CONDITIONS

Official Title

The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults (≥18 years of age)
  • Living with HIV
  • Currently on a dolutegravir-based first-line ART regimen
  • Evidence of a care gap (>28 days late for appointment) or a raised viral load (≥50 copies/ml) in the past year
  • Able to provide full informed consent
  • Willing to comply with study procedures, including providing updated contact details
Not Eligible

You will not qualify if you...

  • Clinical conditions requiring clinic-based follow-up such as tuberculosis or epilepsy
  • Pregnant at enrollment and requiring antenatal clinic care
  • Sustained retention in care without gaps >28 days and viral suppression in the past year
  • Plans to leave Cape Town permanently within 24 months

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Cape Town

Cape Town, South Africa

Actively Recruiting

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Research Team

I

Ingrid T Katz, MD, MHS

CONTACT

T

Trishathi Malagar Nandakumar, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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