BetterInfo on Women's PrEP Choices and Outcomes in Malawi
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tracing Strategy.
- Who it may be relevant to
- Registry conditions: Long-acting Injectable Cabotegravir for PrEP, Oral Pre-Exposure Prophylaxis (PrEP). Basic parameters: 18 years — 110 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malawi
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
BetterInfo Tracing Approach to Evaluate HIV PrEP Choices and Use Over Time Among Women in Blantyre, Malawi
Overview
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.
Detailed description
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:
1. Ascertain clinical and engagement outcomes among disengaged PrEP users 2. Document experiences and perceptions of key stakeholders from PathToScale regarding program implementation and user retention 3. Investigate factors contributing to discontinuation of PrEP 4. 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.
The study design leverages the existing infrastructure from the PathToScale study (NCT06319105) and mimics the approach used in Zambia, with human-centered design adaption from the formative phase of the study. The study team will leverage existing Electronic Medical Records (EMR) from PathToScale at clinics to identify all clients initiating PrEP during the PathToScale study who have become LTFU, (i.e., 3 months late for a return visit) in accordance with Ministry of Health (MOH) guidelines. The list of clients LTFU will be randomly sorted using statistical software and consecutively sampled for tracing; this process will be stratified by site proportional to the number of female PrEP clients.
Additionally, the study team will prospectively screen PrEP clients at clinics prior to loss to follow-up. Potential participants will be informed of the study and confirm follow-up phone contacts for themselves and any other individuals the participant would be comfortable being contacted. The study team will also request permission to share home locator information and if participants are comfortable, the study team will seek the participant's permission for in-person follow-up should the participant be lost to followup (LTFU) and randomly selected for the study. In all cases the study team will attempt to contact via phone a client at least three times prior to initiating home-based tracing and only if verbal consent was indicated for this visit.
The study team will classify the following outcomes of those participants contacted/traced: (1) discontinued PrEP and no longer at increased acquisition risk; (2) discontinued PrEP and remaining at high risk for HIV acquisition; (3) on PrEP but transferred sites/on PrEP at the same site but data error identified; (4) re-initiated PrEP after an interruption; and (5) newly acquired HIV cases (those known to the client already and those identified through the study).
Interventions
- Behavioral Tracing Strategy
Participants will receive the SoC per national guidelines and the tracing strategy. The purpose of this intervention is to ascertain the PrEP outcome of clients who have become LTFU (3 months late for a follow-up visit. The strategy includes 1) phone tracing and 2) field tracing with consent.
Primary outcome measures
- PrEP users LTFU (Prep Engagement) [Time frame: From 3 months LTFU up to 24 months]
- LTFU PrEP users traced who returned (Impact of tracing on return) [Time frame: 6 months]
Secondary outcome measures (2)
- Number of clients traced with any drug level in dried blood sample [Time frame: Immediately after the tracing intervention]
- Participant re-engagement preferences estimated by discrete choice experiment [Time frame: Within 24 months of PrEP LTFU]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Malawi · 1 center
- Johns Hopkins Research Project Malawi — Blantyre
Identifiers
NCT: NCT07579754 · IRB00034918 · R01MH137795 · P.1125-1975