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

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
South Africa
University of Cape Town
RECRUITING
Cape Town
Contact Information
Primary
Ingrid T Katz, MD, MHS
ikatz2@bwh.harvard.edu
617-525-8194
Backup
Trishathi Malagar Nandakumar, MPH
tnandakumar@bwh.harvard.edu
8572005055
Time Frame
Start Date: 2025-11-14
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 310
Treatments
Experimental: SUSTAIN-DSD Arm
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 baseline 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.
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital

This content was sourced from clinicaltrials.gov