NCT07579754 BetterInfo on Women's PrEP Choices and Outcomes in Malawi
| NCT ID | NCT07579754 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins Bloomberg School of Public Health |
| Condition | Long-acting Injectable Cabotegravir for PrEP |
| Study Type | INTERVENTIONAL |
| Enrollment | 384 participants |
| Start Date | 2026-07-14 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 384 participants in total. It began in 2026-07-14 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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)
Contact & Investigator
Sheree Schwartz, PhD, MPH
PRINCIPAL INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Frequently Asked Questions
Who can join the NCT07579754 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 110 Years, studying Long-acting Injectable Cabotegravir for PrEP. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07579754 currently recruiting?
Yes, NCT07579754 is actively recruiting participants. Contact the research team at aabdul23@jh.edu for enrollment information.
Where is the NCT07579754 trial being conducted?
This trial is being conducted at Blantyre, Malawi.
Who is sponsoring the NCT07579754 clinical trial?
NCT07579754 is sponsored by Johns Hopkins Bloomberg School of Public Health. The principal investigator is Sheree Schwartz, PhD, MPH at Johns Hopkins Bloomberg School of Public Health. The trial plans to enroll 384 participants.