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

University of Washington3,087 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

3,087

Conditions

HIV Infections

Interventions

PrEPDRUG

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.

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 31 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 16-30 years of age * Female Exclusion Criteria: * not sexually active * over 31 years of age at consent

Locations (20)

ICAP, eSwatini Prevention Center

Mbabane, Hhohho Region, Eswatini

Kenya Medical Research Institute (KEMRI)

Outcomes

Primary Outcomes

A cohort for evaluation of open-label PrEP delivery and PrEP preferences among African women

We will collect data on STI prevalence, contraception use, sexual behavior, risk perception as correlates for PrEP uptake, persistence and adherence. Adherence will be measured by the timing of PrEP refills, self-reported PrEP use, and drug level testing for tenofovir (TFV) levels .PrEP adherence will be assessed during periods of risk, based on behavioral data and self-perceived risk. Participants in this cohort will be informed of other HIV prevention efficacy trials. A discrete choice experiment will be used to assess women's preferences around PrEP delivery form (pill and injection), dosing frequency, and relative dose forgiveness for different PrEP formulations. A patient-facing decision support tool about PrEP options will be evaluated with respect to its utility in assisting young women to consider their HIV prevention needs and PrEP preferences.

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.