SUSTAIN 2: Sustained HIV treatment support after interruptions in care
The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care
This trial will test whether a six-month adherence club model with multi-month ART dispensing and peer support helps adults with HIV who missed care or have a raised viral load stay on treatment and reach viral suppression over 24 months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 310 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Cape Town) |
| Trial ID | NCT06554223 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (18+) living with HIV on a dolutegravir-based first-line regimen who have had a care gap (>28 days late) or a recent viral load ≥50 copies/ml and can provide informed consent are eligible.
Not a fit: People requiring clinic-based follow-up for active clinical conditions (for example, active tuberculosis or uncontrolled epilepsy), pregnant people, or those not on a dolutegravir-based first-line regimen are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could increase retention and viral suppression by reducing treatment interruptions through community-based multi-month ART dispensing and peer support.
How similar studies have performed: Differentiated service delivery (DSD) models have improved retention and viral suppression among clinically 'stable' patients, but applying DSD to people with recent treatment interruptions or unsuppressed viral load is relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cape Town
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.