SUSTAIN 2: Sustained HIV treatment support after interruptions in care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

SUSTAIN 2 is a randomized, hybrid Type 1 trial comparing a six-month adherence club model (SUSTAIN-DSD) versus an enhanced guideline-driven standard of care among adults with HIV who have had a care gap or a recent raised viral load. The intervention offers flexible, community-based services including six-month ART dispensing, lay counselor and peer support, and optional counseling, while controls receive optimized clinic-based care. The trial plans to enroll about 300 participants in Cape Town and follow them for 24 months, with viral load testing at baseline and annually. A purposive subset of participants will complete in-depth interviews to examine acceptability and participant experience.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults (≥18 years or age)
* Living with HIV
* On a dolutegravir-based first-line ART regimen
* Evidence of a care gap (\>28 days late for appointment) or having a raised viral load (≥50 copies/ml) in the preceding year, either from SUSTAIN study data or from clinic records.
* Able to provide full informed consent.
* Willingness to comply with study procedures, including providing regular update of contact details or locator information.

A purposively selected subset of 30 enrolled participants will be invited for a semi-structured, in-depth interview at (or within 2 months after) the month 24 visit (for experience and perceptions; aim 2); and 20 different participants will be invited to participate in in-depth interviews to determine acceptability and feasibility (aim 3) within the same time frame.

Exclusion Criteria at Enrollment:

* Clinical conditions as assessed by the ART clinicians as requiring clinic-based follow-up e.g. tuberculosis or epilepsy.
* Pregnant at enrollment and requiring care in the antenatal clinic system.
* Sustained retention in care (no gaps of \>28days) and viral suppression in the preceding year.
* Plans to leave Cape Town permanently within the next 24 months.

Where it's running

• University of Cape Town
  Cape Town, South Africa Recruiting

Study contacts

• Principal investigator: Ingrid T Katz, MD, MHS — Brigham and Women's Hospital
• Study coordinator: Ingrid T Katz, MD, MHS
• Email: ikatz2@bwh.harvard.edu
• Phone: 617-525-8194

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.