Clinical trial NCT06554223: The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care
Official title: The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: Differentiated Service Delivery
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 at clinics?
* Does SUSTAIN-DSD intervention help reduce treatment interruptions?

Participants will:

* for 24 months, either receive the SUSTAIN-DSD intervention (i.e. be enrolled in an adherence club where they will pick up 6-months of ART medication and have the option to use peer support group sessions and additional counseling), and or enhanced standard of care (i.e. visit the clinic for treatment and participate in optional counseling sessions)
* Visit the adherence club to get their blood drawn for viral load tests at 6 months, 12 months, and every 12 months (for SUSTAIN-DSD participants only)
* Visit the clinic to get their blood drawn for viral load tests repeated 3 months after restart of ART medication, then at 12 months and annually there-after, if they are virally suppressed (enhanced standard of care participants only)
* Participate in interviews to discuss their 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 their parent study and clinics (SUSTAIN, R01MH125703, MPI: Orrell/Sabin; UCT Ethics Reference 568/2021), through which the investigators have identified persistent engagement gaps in 43% 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.

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.
* 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.

Primary outcomes:
measure: Viral suppression (Viral load <50 c/ml)
timeFrame: 24 months post-enrollment
Secondary outcomes:
measure: Viral suppression (Viral load <50 c/ml) at 12 months
timeFrame: 12 months post-enrollment
measure: Retention in care at study clinics
timeFrame: 12 and 24 months post-enrollment
measure: Treatment interruptions
timeFrame: 0-24 months post-enrollment
measure: ART adherence using urine tenofovir rapid assays
timeFrame: 12 and 24 months post-enrollment
measure: ART adherence using pharmacy data
timeFrame: 12 and 24 months post-enrollment
measure: Success in HIV self-management of care
timeFrame: 12 and 24 months post-enrollment
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Ingrid T Katz, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: