Peer-Educator-coordinated vs Nurse-coordinated ART Refill for Adolescents and Young Adults Living With HIV in Lesotho - a Cluster Randomized Clinical Trial (PEBRA Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 307
- 试验地点
- 20
- 主要终点
- In care with documented viral suppression
研究概览
简要总结
Sub-Saharan Africa (SSA) is home to 85% of the adolescents and young people living with HIV (AYPLHIV) globally and they are heavily affected by the HIV/AIDS epidemic: AYPLHIV in SSA are the only population group for whom HIV-related mortality continues to increase, and they have overall poorer outcomes than all other age groups. Lesotho with worldwide the second-highest HIV prevalence shows a viral suppression rate among AYPLHIV of only 49%.
In order to address the multiple barriers in the adolescent HIV care cascade and their unique needs, multicomponent packages of differentiated service delivery (DSD) are a promising approach.
In close collaboration with different local stakeholders, the researchers designed a DSD model specifically for AYPLHIV, called the PEBRA model. In the PEBRA model the peer-educator (PE) plays a pivotal role, by coordinating the ART refill/care according to the patient's preferences using a tablet-based application, called PEBRApp (https://github.com/chrisly-bear/PEBRApp). The PEBRApp helps the PE to assess each participant's preference, to adapt the ART refill according to these preferences in a feasible manner, to keep track of the ART refill, and to ensure regular contact between the PE and the participant. The model includes key innovative options such as individualized automatic SMS notifications and decentralized ART delivery.
The PEBRApp was developed with ❤️ by Technify Maseru, Lesotho (www.technifyls.com) & Christoph Schwizer Zurich, Switzerland (www.christophschwizer.ch).
详细描述
STUDY DESIGN
PEBRA study is a cluster randomized, open-label, superiority trial in a resource-limited setting. The rational for a cluster randomized design with health facilities as clusters, is the high risk of cross-contamination between the study arms if randomization would be done at individual level. The clusters (health facilities) will be randomized (randomly-varying block sizes, 1:1 allocation) into the 2 groups using a computer-generated randomization list, stratified by district and size of the AYPLHIV cohort of each facility (<15 vs ≥15). The study will be conducted at 20 health facilities in three districts of Lesotho (Leribe, Butha-Buthe, Mokhotlong).
OBJECTIVES
The overall objective of this study is to evaluate the feasibility and effectiveness of a DSD model ("PEBRA model") among AYPLHIV.
As primary objective this study seeks to assess the rate of viral suppression among AYPLHIV 12 months after enrolment between the intervention clusters, where AYPLHIV were offered the PEBRA model, and the control clusters, where AYPLHIV were offered standard of care.
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
- 15 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility - clusters
- •Inclusion criteria:
- •the cluster is a public or missionary health center from the study districts, that offers ART services
- •the cluster has at least one PE who is willing to participate and fulfills the following criteria:
- •underwent the Sentebale Peer-Educator two-weeks training
- •attended and successfully passed the study training assessment
排除标准
- •health facility authority opposed to trial participation (verbal assent)
- •the health facility is a hospital
- •the health facility is situated in an area without cellphone signal
- •Eligibility - individuals
- •Individual is living with HIV and in care in a participating cluster
- •Individual is 15-24 years old (AYPLHIV)
- •Informed consent given
- •Declares to seek the next follow-up visit at the same health facility
研究组 & 干预措施
Intervention
Participants in the intervention clusters are offered the PEBRA model. In the PEBRA model the ART visit/refill is coordinated by the Peer-Educator (PE) according to the participants' preferences, using a tablet-based application, called PEBRApp. The preference assessment entails the following three domains of DSD:
- ART Refill
- SMS notifications
- Support In each of the domains, the participants' preferences will be assessed and the most feasible option will be selected. The PEBRApp not only helps the PE to assess each participants' preference, but also to keep track of the ART refill, and to ensure regular contact between the PE and the participant. The model includes key innovative options such as individualized automatic SMS notifications and decentralized ART delivery.
干预措施: PEBRA model (Other)
Control
Participants in the control clusters are offered standard of care: ART visit/refill is coordinated by the nurse, is mostly clinic-based, not adapted to youth, and differentiated according to clinical values (i.e. if VL suppressed then option of ART Refill in a Community Adherence Club).
结局指标
主要结局
In care with documented viral suppression
时间窗: 12 months (range: 9 - 15 months) after enrolment
In care with documented viral suppression at 12 months, defined as the proportion of participants in care with a documented VL \<20 copies/mL 12 months (range: 9 - 15 months) after enrolment out of all participants enrolled
次要结局
- All-cause mortality(6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment)
- Adherence to ART at 3 months (range 2.5 - 3.5), 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment(3 months (range 2.5 - 3.5), 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment)
- Quality of Life (QoL) at 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment(6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment)
- Perceived quality of ART Care / patient service satisfaction at 6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment(6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment)
- Engagement in care at 6 months(6 months (range 5 - 8) after enrolment)
- Engagement in care at 12 months(12 months (range 9 - 15) after enrolment)
- Transfer out at 6 and 12 months(6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment)
- Alternative viral suppression at 12 months(12 months (range 9 - 15) after enrolment)
- LTFU at 6 and 12 months(6 months (range 5 - 8) and 12 months (range 9 - 15) after enrolment)
研究者
Amstutz Alain
MD
Swiss Tropical & Public Health Institute