Reducing Mobility-associated Interruption in HIV Treatment in Malawi (REMIT): Pilot Trial to Assess Acceptability and Feasibility of a Mobility-specific Intervention Package
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Acceptability of REMIT intervention package
研究概览
简要总结
The goal of this pilot clinical trial is to assess the feasibility and acceptability of an intervention package designed to reduce mobility-associated interruptions in HIV treatment in people living with HIV in Malawi who are initiating or returning to antiretroviral treatment (ART) after interruption. The main questions it aims to answer are:
- Is the intervention acceptable to healthcare workers and ART clients?
- Is the intervention feasible in the context of Malawi's health system, and what are the major operational challenges, resource requirements, and implementation barriers?
In addition, researchers will compare HIV treatment outcomes (specifically ART retention rates) between intervention and control groups to establish a preliminary estimate of the intervention's efficacy.
Participants will complete a survey on the day of enrollment and some participants will complete an in-depth interview and/or a survey after completion of the 6-month follow-up period. Facilities assigned to the intervention group will receive the full package of interventions (training on mobility-specific counseling for counsellors, access to a toll-free hotline for clients and healthcare workers, and training on multi-month dispensing for providers), while facilities assigned to the control group will provide standard of care.
详细描述
RATIONALE FOR RESEARCH: While Malawi has made tremendous progress towards ending the HIV epidemic - nearly reaching UNAIDS' 95-95-95 target goals (95% of people living with HIV know their status, 95% of people living with HIV have initiated ART, and 95% of those on ART reach viral suppression) - certain sub-groups of people living with HIV continue to face challenges remaining in care. One key issue that perpetuates this cycle of interruption, re-initiation, and re-interruption is mobility, or temporary travel, which is the number one reason for interruption in treatment (IIT) across several of our recent studies. Mobile people living with HIV require additional interventions to stay in care and reduce IIT. In the REMIT study (Reducing Mobility-associated Interruption in HIV Treatment), we will pilot a package of interventions that have been co-created with ART clients, healthcare workers (HCWs), and community and national stakeholders. The REMIT intervention package will include: enhanced counselling at initiation or re-initiation; a toll-free line for mobile clients and HCWs; and trainings for HCWs on the benefits of multi-month dispensing (MMD).
Study design and rationale: We propose a cluster-randomized control trial to pilot these interventions at three facilities, comparing results with three control facilities (total n=6 facilities). This cluster-randomized design is appropriate for testing interventions that are offered to healthcare workers (specifically training on an enhanced counselling curriculum and the benefits of MMD); each intervention facility will receive the full intervention package.
Population: The study population will include ART clients (≥15 years) who are initiating or re-initiating ART >28 days after a missed appointment. We will enrol n=400 men and women attending ART clinic for their own care.
We will randomly select a subset of participants from intervention facilities for additional in-depth interviews. We will also conduct focus group discussions with healthcare workers working in the ART clinic at intervention facilities.
People living with HIV and health care providers will be included in the study. Participants will be in good health so that they are feeling well and able to participate in the study. Participants will not be excluded if they are experiencing minor illness symptoms.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •15 years of age or older
- •Living with HIV
- •Attending ART clinic to initiate OR re-initiate care:
- •Initiate: initiating ART for the first time, per self-report
- •Re-initiate: returning to care after missing a refill appointment by >28 days
排除标准
- •Attending ART clinic on behalf of someone else (i.e. guardian)
- •Attending ART clinic only to obtain emergency refill
- •Attending ART clinic for a routine refill without a recent >=28 days interruption in treatment
- •Transferring in to study facility without a preceding interruption in treatment of >=28 days
结局指标
主要结局
Acceptability of REMIT intervention package
时间窗: From day of intervention launch (healthcare workers) or enrollment (clients) to 6 months after final participant is enrolled
To assess acceptability, we will analyse qualitative data from participant IDIs and HCW FGDs. We will code data from all IDIs and FGDs in Atlas.ti using inductive and deductive codes. Coded text will be analysed using grounded theory and guided by Human Centered Design principles.
Feasibility of REMIT intervention package
时间窗: From day of intervention launch (healthcare workers) or enrollment (clients) to 6 months after final participant is enrolled
To assess feasibility, we will analyse qualitative data from participant IDIs and HCW FGDs. We will code data from all IDIs and FGDs in Atlas.ti using inductive and deductive codes. Coded text will be analysed using grounded theory and guided by Human Centered Design principles. We will also review process implementation data, such as counselling recordings (fidelity of implementation and quality of counselling), the hotline register and recordings (number of calls, fidelity of implementation, and quality of counselling), and rates of MMD (compared between control and intervention facilities to assess the effectiveness of our MMD training, a component of fidelity of implementation).
次要结局
- Preliminary estimate of efficacy(From day of enrollment to 6 months after enrollment)
研究者
Marguerite Thorp, MD, MPA/ID
Assistant Professor
University of California, Los Angeles