BetterInfo on Women's PrEP Choices and Outcomes in Malawi

Recruiting now · Not applicable

Conditions studied: Long-acting Injectable Cabotegravir for PrEP, Oral Pre-Exposure Prophylaxis (PrEP)

In brief

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.

Key facts

Study ID

NCT07579754

Run by

Johns Hopkins Bloomberg School of Public Health

People needed

384

Starts

2026-07-14

Expected to finish

2029-04-01

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older, up to 110. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Johns Hopkins Research Project Malawi — Blantyre, Malawi (enrolling)

Full record on ClinicalTrials.gov

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