Outcomes of Differentiated Models of Antiretroviral Treatment (ART) Provision: Multi-Month Dispensing (MMD) of ART in Community ART Distribution for Stable HIV Infected Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5,760
- 试验地点
- 2
- 主要终点
- retention in care
研究概览
简要总结
The aim of this study is to evalulate the effectiveness and cost-effectiveness of three models of ART provision for stable ART patients. The objectives are to measure patient retention, virological suppression, provider and patient costs, cost-effectiveness, and patient acceptability amongst stable patients who receive ART at intervals of three and six months within community distribution models, and to compare these to patients who receive ART directly from the clinic at three month intervals.
Methods
A prospective, parallel, cluster-randomized non-inferiority trial with three study arms will be conducted. 30 Clusters (sites) will be randomized in strata according to geographic location (urban and rural) to the 3 study arms as follows:
- Control arm: sites at which patients will receive three monthly ART supply at the facility (arm 3MF).
- Intervention arm 1: sites at which patients will receive three monthly ART supply in CAGs (arm 3MC)
- Intervention arm 2: sites at which patients will receive six monthly ART supply in the community by a healthcare worker (arm 6MCD).
The study population will consist of stable, HIV-infected adults who have received first-line ART for at least six months, who have a viral load <1000 copies/ml at baseline, and who provide informed consent for inclusion in the study. An average of 192 participants from each study site will be included, with a total sample size of approximately 5760 participants.
The primary outcome is retention in care defined as the proportion of patients remaining in care 12 months after study enrolment, with the hypothesis that patient retention within the intervention arms will be non-inferior compared to the control arm. Retention in care will also be compared between the three arms after 24 months.
The secondary outcomes are:
- Viral suppression: defined as the proportion of patients with virological suppression (<1000 copies/ml) 12 and 24 months after study enrolment;
- Cost of providing ART: defined as the cost per patient of providing ART in each of the three arms (from a provider perspective);
- Cost of retaining a patient: defined as the provider cost per patient retained and provider cost per patient retained with virological suppression in each of the three arms, and the incremental cost-effectiveness ratio for the comparative arms.
详细描述
Background In 2015, sub-Saharan Africa was still the region most affected by the HIV epidemic, with 25.6 (23.1-28.5) million people living with HIV in 2015. It is estimated that 42% of all people living with HIV (PLHIV) in Lesotho were receiving ART by 2015.The United States Government's President's Emergency Plan for AIDS Relief (PEPFAR) has adopted the goals of 90-90-90 from UNAIDS, and is supporting a swift implementation of the new World Health Organization'sTest and Start guidelines.With these goals, PEPFAR also sets out to reduce new infections by 75% and to attain zero discrimination and stigma for all PLHIV.
To assist countries to reach the goal of universal coverage, EQUIP Innovation for health (a new field support award from the USAID Office of HIV and AIDS that supports innovations in HIV clinical and community-based HIV treatment related services) is evaluating communitybased care, treatment and support models to create an enabling environment for massive scale-up of ART delivery and adherence support. Based on this background, EQUIP and and Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) propose to conduct operational research that seeks to understand and measure the effectiveness of implementing a package of services that include multi-month dispensing (MMD) of ART drugs, Community ART distribution models through Community ART Groups (CAGs) and Community Distribution points and routine viral load monitoring of stable patients in communities of PEPFAR/USAID Lesotho scale-up districts.
The aim of this study is to evalulate the effectiveness and cost-effectiveness of three models of ART provision for stable ART patients. The objectives are to measure patient retention, virological suppression, provider and patient costs, cost-effectiveness, and patient acceptability amongst stable patients who receive ART at intervals of three and six months within community distribution models, and to compare these to patients who receive ART directly from the clinic at three month intervals.
Methods
A prospective, parallel, cluster-randomized non-inferiority trial with three study arms will be conducted. 30 Clusters (sites) will be randomized in strata according to geographic location (urban and rural) to the 3 study arms as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age and willing and able to provide written informed consent for participation in this study.
- •Willing to participate in the multi-month dispensing model that the patient's study site has been randomized to.
- •On ART ≥ 6 months with no periods of defaulting from ART since the last viral load result (ART default defined as missing 7 or more consecutive days of ART)
- •On first-line ART regimen (substitutions within the first-line regimen prior to the last viral load test are permissible).
- •No ARV drug substitutions since the last viral load result < 1,000 copies per ml
- •Plasma or dried-blood spot viral load < 1,000 copies/ml in a patient who has been on first-line ART for at least 6 months, with viral load drawn within last 12 months of enrollment while patient is receiving ART
排除标准
- •On second-line ART regimen.
- •Patients with co-morbidities requiring facility visits more often than 6 monthly.
- •ART substitutions since last VL test.
- •Diagnosed with a WHO clinical stage 3 or 4 condition within the past 3 months.
- •Pregnant or less than 12 months postpartum and breastfeeding mothers.
- •Participating in another study that involves dispensing interval, adherence, or retention or involves receiving medications.
结局指标
主要结局
retention in care
时间窗: 12 months
The proportion of patients remaining in care 12 months after study enrolment
次要结局
- Cost of retaining a patient(12 months)
- Viral suppression(12 months)
- Cost of providing ART(12 months)