Clinical trial NCT05746065: A Cohort for Evaluation of Open-label PrEP Use and PreP Preferences Among African Women
Official title: A Cohort for Evaluation of Open-label PrEP Delivery and PrEP Preferences Among African Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2023-02-27
Enrollment: 3087
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 31
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This project will offer a PrEP delivery package within a prospective cohort study of sexually active HIV negative women ages 16-30 in locations in eSwatini, Kenya, Malawi, South Africa, Uganda, Zambia, and Zimbabwe to understand PrEP uptake, use, persistence and preferences for attributes of long-acting PrEP products and aspects of PrEP delivery for long-acting PrEP

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.

Eligibility criteria: Inclusion Criteria:

* 16-30 years of age
* Female

Exclusion Criteria:

* not sexually active
* over 31 years of age at consent

Primary outcomes:
measure: A cohort for evaluation of open-label PrEP delivery and PrEP preferences among African women
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Kenya Medical Research Institute (KEMRI)
city: Blantyre
country: Malawi
facility: Queen Elizabeth Central Hospital
city: Johannesburg
country: South Africa
facility: Perinatal HIV Research Unit (PHRU)
state: Gauteng
city: Johannesburg
country: South Africa
facility: Wits Reproductive Health & HIV Institute (WRHI)
state: Gauteng
city: Johannesburg
country: South Africa
facility: Helen Joseph Hospital--CHRU
state: Gauteng
city: Pretoria
country: South Africa
facility: Human Sciences Research Council (HSRC)
state: Gauteng
city: Pretoria
country: South Africa
facility: Setshaba Research Center
state: Gauteng
city: Chatsworth
country: South Africa
facility: SA Medical Research Councit, Chatsworth
state: Kwazulu-Natal
city: Durban
country: South Africa
facility: Maternal Adolescent & Child Health Research (MatCH)
state: Kwazulu-Natal
city: Ladysmith
country: South Africa
facility: Qhakaza Mbokodo Research Clinic
state: Kwazulu-Natal
city: Brits
country: South Africa
facility: Madibeng Centre for Research
state: North-West
city: Klerksdorp
country: South Africa
facility: Aurum Institute Klerksdorp (CRS)
state: North-West
city: Rustenburg
country: South Africa
facility: Aurum Institute--Rustenburg
state: North-West
city: Cape Town
country: South Africa
facility: University of Cape Town--Khayekutsha
state: Western Cape
city: Cape Town
country: South Africa
facility: UCT-Masi
state: Western Cape
city: Nyanga
country: South Africa
facility: Emavundleni Research Center, DTHF
state: Western Cape
city: Mbabane
country: Swaziland
facility: ICAP, eSwatini Prevention Center
state: Hhohho
city: Kampala
country: Uganda
facility: Makerere University
city: Lusaka
country: Zambia
facility: Kamwala Health Centre
state: Lusake
city: Harare
country: Zimbabwe
facility: University of Zimbabwe
Study officials:
affiliation: University of Washington
name: Connie Celum, MD
role: PRINCIPAL_INVESTIGATOR
References: