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

NCT06554223 | Recruiting

• 1 other identifier: 2024P001983
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Differentiated Service Delivery

Outcome Measures

Primary Outcomes (1)

• Viral suppression (Viral load <50 c/ml)

  Viral suppression (Viral load c/ml) will be measured at 24 months post-enrollment.

  24 months post-enrollment

Secondary Outcomes (7)

• Viral suppression (Viral load <50 c/ml) at 12 months

  12 months post-enrollment

• Viremia

  12-24 months

• Retention in care at study clinics

  12 and 24 months post-enrollment

• Treatment interruptions

  0-24 months post-enrollment

• ART adherence using urine tenofovir rapid assays

  12 and 24 months post-enrollment

Study Arms (2)

SUSTAIN-DSD Arm

EXPERIMENTAL

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.

Behavioral: SUSTAIN-DSD

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

OTHER

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.

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

Interventions

SUSTAIN-DSD BEHAVIORAL

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.

SUSTAIN-DSD Arm

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

University of Cape Town

Cape Town, South Africa

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ingrid T Katz, MD, MHS

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingrid T Katz, MD, MHS

CONTACT

617-525-8194; ikatz2@bwh.harvard.edu

Trishathi Malagar Nandakumar, MPH

CONTACT

8572005055; tnandakumar@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Multiple Principal Investigator

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 15, 2024
• Study Start: November 14, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: As required by NDA, the first data submission date will be the second cycle after the grant is awarded, with subsequent submission made bi-annually. Studies will also be created that contain the data used for every publication resulting from the project. Those studies will be shared when the pre-print is available. NDA studies have digital object identifiers (DOI) to aid in findability. The investigators will include that DOI in relevant publications. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now to our knowledge.
• Access Criteria: To request access of the data, researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable.

Locations

ZA (1)