MedTrace Logo

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

NCT06554223 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2025-11-24

No results posted yet for this study

Summary

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

  • Human Immunodeficiency Virus

Interventions

BEHAVIORAL

SUSTAIN-DSD

Participants randomized to SUSTAIN-DSD will be enrolled into an Adherence Club and will have 6 months of ART dispensed through a pre-packed dispensing service. Participants may choose to use the decentralized pick-up point solely for medication retrieval or may opt into the peer-support aspect of the Clubs by attending the group session of up to 30 PWH, who will meet once every 6 months in a safe space (e.g., clinic meeting room, church, or local library). At 6 months, 12 months, and every 12 months thereafter, a visiting nurse will draw a blood specimen for viral load. Optional process uptake will be recorded. Participants with a raised viral load will be called and offered enhanced adherence counselling; then recalled for a repeat viral load in 3 months.

OTHER

Enhanced (guideline-driven) Standard of Care (E-SoC)

As per current SA ART guidelines, all patients who are \>28 days late for a scheduled visit are offered enhanced adherence counselling (EAC) at reengagement and restarted on ART. Patients who are \>90 days late also have blood drawn for a CD4 count to test for advanced HIV disease. Individual clinic visits occur every 3 months, with 3-month ART dispensing. VL testing is repeated 3 months after restart, then at 12 months and annually there-after, if suppressed. These visits will be managed by clinic staff (nurse or doctor). EAC is a single counselling session delivered by a lay counsellor. The study team will ensure all SoC processes are complete as per the guidelines; and reported to the COCT team as appropriate.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Ingrid T Katz, MD, MHS · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-14
Primary Completion
2028-12-30
Completion
2029-03-31

Countries

  • South Africa

Study Locations

More Related Trials

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 NCT06554223 on ClinicalTrials.gov