BetterInfo on Women's PrEP Choices and Outcomes in Malawi
Recruiting · NCT07579754 · Interventional (participants receive a specific treatment) · Lead sponsor: Johns Hopkins Bloomberg School of Public Health
View the official record on ClinicalTrials.gov →Interventions studied
Tracing Strategy
What this trial is about
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 take part
Age range
18 Years to 110 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Johns Hopkins Research Project Malawi - Blantyre, Malawi