The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Viral suppression (Viral load <50 c/ml)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 at Enrollment:
- •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.
排除标准
- 未提供
结局指标
主要结局
Viral suppression (Viral load <50 c/ml)
时间窗: 24 months post-enrollment
Viral suppression (Viral load c/ml) will be measured at 24 months post-enrollment.
次要结局
- 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)
- ART adherence using pharmacy data(12 and 24 months post-enrollment)
- Success in HIV self-management of care(12 and 24 months post-enrollment)
- 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)
- ART adherence using pharmacy data(12 and 24 months post-enrollment)
- Success in HIV self-management of care(12 and 24 months post-enrollment)
研究者
Ingrid Theresa Katz, M.D.
Multiple Principal Investigator
Brigham and Women's Hospital