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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • SUSTAIN-DSD
  • Enhanced (guideline-driven) Standard of Care (E-SoC)

Treatment groups

310 Participants
are divided into 2 treatment groups

Sponsors and collaborators