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

University of Washington

Status

Completed

Conditions

HIV Infections

Treatments

Drug: PrEP

Study type

Observational

Funder types

Other

Identifiers

NCT05746065

STUDY00015634

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,087 patients

Sex

Female

Ages

16 to 31 years old

Volunteers

No Healthy Volunteers

Inclusion criteria