BetterInfo Tracing Approach to Evaluate HIV PrEP Choices and Use Over Time Among Women in Blantyre, Malawi
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 384
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to understand PrEP user choices, preferences and implementation impact of the roll-out of long-acting injectable PrEP alongside oral PrEP among women in Blantyre, Malawi.
详细描述
The study aims to understand PrEP user choices, preferences and implementation impact of the roll-out of long-acting injectable (LAI) PrEP alongside oral PrEP among women in Malawi. The Broad Objective of this study is to use the adapted BetterInfo tracing approach to evaluate PrEP choices and oral and long-acting injectable PrEP use over time among women lost-to-follow up (LTFU) within the prior 2 years in Blantyre, Malawi and preferences for PrEP re-engagement strategies. Concurrently with this tracing approach, the study team will assess decision making among disengaged women and the women's providers.
The study has Specific Objectives:
- Ascertain clinical and engagement outcomes among disengaged PrEP users
- Document experiences and perceptions of key stakeholders from PathToScale regarding program implementation and user retention
- Investigate factors contributing to discontinuation of PrEP
- Evaluate the impact of BetterInfo tracing approach on re-engaging former PrEP users and improving long term retention outcomes.
These objectives will be achieved through tracing a random sample of women LTFU from oral and injectable PrEP services from implementing sites in Blantyre, Malawi for whom outcomes are unknown, and which are achieved through two data collection activities. The first comprises cross-sectional quantitative survey including stated preference assessments with discontinued (former) PrEP users. The second comprises in-depth qualitative interviews (IDIs) with sub-sets of the traced discontinued PrEP users, as well as healthcare providers/ implementing partner stakeholders. Activities from this study will inform the design of strategies for optimizing PrEP continuation and re-engagement to achieve implementation and prevention impact for women in Malawi.
The study team will utilize epidemiological principles to sample women on PrEP lost to follow-up with unknown outcomes with the purpose of utilizing this sample to re-estimate PrEP outcomes across all women lost on PrEP in the facilities. Using a sampling and tracing approach the study team will then leverage a sequential mixed methods design. First, the study team will conduct a quantitative study among women traced, including a questionnaire, HIV outcomes assessment and stated preference questions. Then a subset of women will be included, alongside healthcare providers, in follow-up qualitative in-depth interviews to gain greater insights into women's PrEP journeys and the circumstances and considerations around discontinuation of PrEP and re-engagement on PrEP. Study processes will take approximately 2 years to successfully trace the targeted sample.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The population for this research includes women aged 18 years or older at risk of HIV who initiated injectable or oral PrEP at one of the 20 Blantyre sites supported through PathToScale. PathToScale supports various types of facilities including public health clinics, drop-in centers for prioritized populations (DICs), and private hospitals/clinics.
- •Those eligible for sampling are as follows:
- •Adult women ≥18 years; and
- •Initiated PrEP (injectable or oral) at the implementing facilities and lost to follow up within prior 2 years prior to sampling; and
- •Lost-to-follow-up (missed their PrEP visit by ≥3 months and for whom outcomes are unknown); and
- •Has a registered phone number for contact
- •Those eligible for tracing are as follows:
- •Women sampled per eligibility criteria above; and
- •Women who have indicated permission for in-person follow-up
- •Health Care Providers, Implementing Partners, Ministry of Health (MOH) Stakeholers
- •providers and implementing partners from PathtoScale, and Ministry of Health stakeholders will be consented to participate in in-depth-interviews
排除标准
- •Those excluded from sampling or tracing include:
- •Women who have an EMR record of a documented case of discontinuation of PrEP in consultation with a provider; or
- •Women who are known to have died; or
- •Women who have EMR documented transfers out of PathToScale supported facilities; or
- •Women refusing follow-up via phone on their ScanForm; or
- •Women refusing follow-up in person (during phone tracing); or
- •Women who do not speak Chichewa or English; or
- •Men (excluded from client interviews only)
研究组 & 干预措施
Standard of Care (SoC)
Participants will receive standard of care (SoC) per Ministry of Health national guidelines of PrEP counseling, national program quality improvement activities, and follow up text messages and phone calls after missed visit.
Tracing Strategy
Participants will receive the SoC and tracing strategy to ascertain their PrEP outcome if they missed a visit.
干预措施: Tracing Strategy (Behavioral)