HIV Infections
Conditions
Brief 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.
Interventions
DRUGPrEP
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.
Sponsors
Bill and Melinda Gates Foundation
University of Washington
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 31 Years
Inclusion criteria
* 16-30 years of age * Female
Exclusion criteria
* not sexually active * over 31 years of age at consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A cohort for evaluation of open-label PrEP delivery and PrEP preferences among African women | 1 year | 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. |
Countries
Eswatini, Kenya, Malawi, South Africa, Uganda, Zambia, Zimbabwe
Outcome results
None listed