The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care
- Conditions
- Human Immunodeficiency Virus
- Interventions
- Behavioral: SUSTAIN-DSDOther: Enhanced (guideline-driven) Standard of Care (E-SoC)
- Registration Number
- NCT06554223
- Lead Sponsor
- Brigham and Women's Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 310
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SUSTAIN-DSD Arm SUSTAIN-DSD - Enhanced (guideline-driven) Standard of Care (E-SoC) Enhanced (guideline-driven) Standard of Care (E-SoC) -
- Primary Outcome Measures
Name Time Method Viral suppression (Viral load <50 c/ml) 24 months post-enrollment Viral suppression (Viral load c/ml) will be measured at 24 months post-enrollment.
- Secondary Outcome Measures
Name Time Method Treatment interruptions 0-24 months post-enrollment Treatment interruptions will be measured using pharmacy refill data.
Viral suppression (Viral load <50 c/ml) at 12 months 12 months post-enrollment Viral suppression (Viral load \<50 c/ml) will be measured at 12 months post-enrollment.
Retention in care at study clinics 12 and 24 months post-enrollment Retention in care at study clinics (and in care at any other clinic) will be measured at 12 and 24 months (measured by proportion attending club or clinic visits at months 12 and 24).
ART adherence using urine tenofovir rapid assays 12 and 24 months post-enrollment ART adherence will be measured using urine tenofovir rapid assays to detect Tenofovir concentrations in participants.
ART adherence using pharmacy data 12 and 24 months post-enrollment ART adherence will be measured using medication possession ratio calculated from pharmacy refill data.
Success in HIV self-management of care 12 and 24 months post-enrollment This outcome will be assessed with the self-regulatory processes 4-item scale, which includes these items:
I closely monitor whether I take all my ARVs every day (never - always) I make sure that I get new ARVs at the clinic before my ARVs are finished (never - always) If I notice that I have not taken my ARVs or I have taken them too late, I think about what the reason for that was and how I can prevent that from happening again (never - always) I watch carefully that I take all my ARVs every day (never - always)
Potential responses are given on a scale from 'never' (1) to 'always' (5). The minimum score is 4 and the maximum score is 20. Higher scores are associated with more successful HIV self-management of care.