NCT05746065

A Cohort for Evaluation of Open-label PrEP Use and PreP Preferences Among African Women

A Cohort for Evaluation of Open-label PrEP Delivery and PrEP Preferences Among African Women

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,087 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Female
• Age: 16 Years – 31 Years
• Healthy volunteers: —

Summary

INSIGHT is a Prospective, Observational, open-label cohort study on women in Sub-Saharan Africa on PrEP screening, informed choice, and compliance. There are no specific intervention arms or comparative treatment plans. We will follow and observe participants taking PrEP, not taking PrEP, as well as those who begin or end PrEP during the course of the observational period.

Detailed description

Primary goals: * Estimate HIV incidence using recency testing on samples from women who screen out due to HIV infection, as well as assess HIV incidence prospectively in the cohort. * Assess the characteristics of women who initiate PrEP compared to those who do not initiate PrEP. * Evaluate young women's preferences for attributes of long-acting formulations of PrEP, using a discrete choice experiment. * Assess the acceptability of a patient-facing PrEP decision support tool to provide young women more informed choice about PrEP options.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	PrEP	Eligible women will be prescribed PrEP intake in accordance to standard of care should they choose. We are interested in observing adherence, barriers to adherence, and other factors that effect sexual health.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-08-01
• Completion: 2023-08-01
• First posted: 2023-02-27
• Last updated: 2024-05-08

Locations

20 sites across 7 countries: Eswatini, Kenya, Malawi, South Africa, Uganda, Zambia, Zimbabwe