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

NCT ID: NCT06554223

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-14
• Study Completion Date: 2029-03-31

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.

Detailed Description

Differentiated Service Delivery (DSD) models have been shown to provide equivalent or better retention in healthcare and viral (VL) suppression for people with HIV than conventional care models. However, to date, DSD models have been offered only to people with HIV (PWH) considered 'stable' (i.e., retained in care and virally suppressed). Thus, those at high risk of poor outcomes are ineligible for DSD models. In response, the investigators will work with the City of Cape Town to provide the data needed to impact policy guidelines. The investigators designed SUSTAIN2: SUStained HIV Treatment Adherence After INterruption, which will test a scalable, evidence-based DSD model (SUSTAIN-DSD) to address individual, social, and structural barriers to long-term engagement and to increase VL suppression among PWH with an ART treatment interruption or unsuppressed VL (PWH-Gaps).

SUSTAIN-DSD is a six-month adherence club model of care that offers flexible services with multi-month dispensing of medication (de-linked from clinic processes) and support from lay counselors and peers, which has been proven to help PWH to sustain retention and viral suppression in the Western Cape. The study will implement a Hybrid Type 1 randomized controlled trial (RCT) to evaluate the effectiveness of SUSTAIN-DSD on viral suppression among PWH-Gaps at 24 months post-enrollment, as compared to an enhanced standard-of-care (an optimized guidelines-based approach). The investigators will recruit 300 participants from the parent study and clinics (SUSTAIN, R01MH125703, MPI: Orrell/Sabin; UCT Ethics Reference 568/2021), through which the investigators have identified persistent engagement gaps in approximately 45% of the participants, despite adherence counseling, to test this model of care. The investigators will then assess the mechanisms of intervention impact using mixed methods, guided by the Capability, Opportunity, and Motivation model of Behavior (COM-B), and determine implementation outcomes using Proctor's model.

Ultimately, the investigators' goal is to ensure that PWH are able to achieve and maintain virologic suppression through provision of an effective and efficient model of care, which can be used in South Africa's efforts to reach the 2030 goals.

The investigators' central hypothesis is that PWH-Gaps receiving SUSTAIN-DSD will have higher rates of viral suppression than those who receive enhanced routine care. The investigators will use a Hybrid Type 1 RCT design to answer the study questions.

Conditions

Human Immunodeficiency Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SUSTAIN-DSD

Intervention Type: 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.

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.

Group Type: OTHER

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

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ingrid Theresa Katz, M.D.

Multiple Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ingrid T Katz, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

University of Cape Town

Cape Town, , South Africa

Site Status: RECRUITING

Countries

South Africa

Central Contacts

Ingrid T Katz, MD, MHS

Role: CONTACT

ikatz2@bwh.harvard.edu

617-525-8194

Trishathi Malagar Nandakumar, MPH

Role: CONTACT

tnandakumar@bwh.harvard.edu

8572005055

Facility Contacts

Catherine Orrell, MBChB, PhD

Role: primary

catherine.orrell@mrc.ac.za

+27834561969

Other Identifiers

2024P001983

Identifier Type: -

Identifier Source: org_study_id