BetterInfo on Women’s PrEP Choices and Outcomes in Malawi

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an implementation science study examining the rollout of long-acting injectable PrEP alongside oral PrEP for women in Blantyre. Researchers will trace women who have been lost to follow-up within the last two years to understand their PrEP choices, experiences, and reasons for discontinuation. The study uses a mixed-methods approach with a cross-sectional survey and in-depth interviews to assess engagement, decision-making, and the impact of the BetterInfo tracing strategy on re-engagement and long-term retention. It involves health facilities supported by PathToScale and seeks input from healthcare providers and stakeholders to inform program implementation and retention strategies.

Why it matters

Who can join: the full rules

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)

Where it's running

• Johns Hopkins Research Project Malawi
  Blantyre, Malawi Recruiting

Study contacts

• Principal investigator: Sheree Schwartz, PhD, MPH — Johns Hopkins Bloomberg School of Public Health
• Study coordinator: Amal Abdulrahman, MSPH
• Email: aabdul23@jh.edu
• Phone: + 1 443-983-4376

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Universal Test and Connect for HIV services in Cape Town emergency departments

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• Assessing HIV prevention methods during pregnancy and breastfeeding

  This study is testing whether a long-acting injectable HIV prevention method is safer than a daily pill for pregnant women and their babies in Malawi.

  Recruiting Phase 4 University of North Carolina, Chapel Hill · Lilongwe · NCT06158126

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.