A Prospective, observational, open-label cohort study to evaluate daily oral PrEP uptake, adherence, persistence and preferences for attributes of PrEP formulations among young African women. Follow-up will be for 6 months.
Background
Daily oral PrEP is a component of the standard of care (SOC) for HIV prevention in these countries. However, PrEP persistence has been a challenge in open-label studies and programmatic delivery, and understanding strategies to support PrEP persistence and user values and preferences related to long-acting PrEP are needed.
This project will offer a PrEP delivery package within a prospective cohort study of sexually active HIV negative women ages 16-30 to understand PrEP uptake, use, persistence and preferences for attributes of PrEP products and PrEP delivery with a focus on long-acting PrEP
Eligibility criteria
- At screening:
– Age 16-30 years.
– Able and willing to provide written informed consent; parental assent will be obtained for 16- and 17-year-old women if required by national guidelines.
– Recently sexually active
I- Interested in the use of PrEP for HIV prevention.
- For eligibility of enrollment into a longitudinal cohort with open-label PrEP use:
– HIV uninfected based on negative HIV rapid tests.
– Women are eligible to participate regardless of prior PrEP use and regardless of pregnancy or contraception use at enrollment.
Study sites
- Kenya
- Malawi
- South Africa
- Uganda
- Zambia
- Zimbabwe
- Eswatini
Sample size
Enrollment of up to 3000 HIV uninfected women in Africa, across all sites, ages 16-30 in a prospective cohort (up to 150 women per site)..
Objectives
- Estimate HIV incidence using the 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 procedures
Visits will take place at screening, enrollment, 1 month, 3 and 6 months after enrolment.
STUDY DESIGN
| Study type: | Observational study |
| Estimated enrolment: | 3000 (150 at Kisumu site) |
| Study intervention/ treatment: | Truvada: Tenofovir/ emtricitabine (TDF/ FTC) |
| Masking: | None (non- blinded) |
| Primary Purpose: | Prevention |
| Official Title: | A cohort for evaluation of open-label PrEP delivery and PrEP preferences among African women |
| Short Title: | INSIGHT cohort |
| Estimated study start date: | July 2022 |
| Estimated study completion date: | June 2023 |
RCTP-cmr 