BetterInfo on Women's PrEP Choices and Outcomes in Malawi (NCT07579754) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
BetterInfo on Women's PrEP Choices and Outcomes in Malawi
Malawi384 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range
18 Years – 110 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 refu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PrEP users LTFU (Prep Engagement)
Timeframe: From 3 months LTFU up to 24 months
2
LTFU PrEP users traced who returned (Impact of tracing on return)
Timeframe: 6 months
Trial details
NCT IDNCT07579754
SponsorJohns Hopkins Bloomberg School of Public Health