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NCT05746065 Clinical Trial

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

HIV Infections Clinical Trial

— INSIGHT  

Official title:
A Cohort for Evaluation of Open-label PrEP Delivery and PrEP Preferences Among African Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05746065
Other study ID # STUDY00015634
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2022
Est. completion date August 1, 2023

Study information
Verified date May 2024
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 3087
Est. completion date August 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers
Gender Female
Age group 16 Years to 31 Years
Eligibility Inclusion Criteria: - 16-30 years of age - Female Exclusion Criteria: - not sexually active - over 31 years of age at consent

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• PrEP
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.

Locations
Country Name City State
Kenya Kenya Medical Research Institute (KEMRI) Nairobi
Malawi Queen Elizabeth Central Hospital Blantyre
South Africa Madibeng Centre for Research Brits North-West
South Africa UCT-Masi Cape Town Western Cape
South Africa University of Cape Town--Khayekutsha Cape Town Western Cape
South Africa SA Medical Research Councit, Chatsworth Chatsworth Kwazulu-Natal
South Africa Maternal Adolescent & Child Health Research (MatCH) Durban Kwazulu-Natal
South Africa Helen Joseph Hospital--CHRU Johannesburg Gauteng
South Africa Perinatal HIV Research Unit (PHRU) Johannesburg Gauteng
South Africa Wits Reproductive Health & HIV Institute (WRHI) Johannesburg Gauteng
South Africa Aurum Institute Klerksdorp (CRS) Klerksdorp North-West
South Africa Qhakaza Mbokodo Research Clinic Ladysmith Kwazulu-Natal
South Africa Emavundleni Research Center, DTHF Nyanga Western Cape
South Africa Human Sciences Research Council (HSRC) Pretoria Gauteng
South Africa Setshaba Research Center Pretoria Gauteng
South Africa Aurum Institute--Rustenburg Rustenburg North-West
Swaziland ICAP, eSwatini Prevention Center Mbabane Hhohho
Uganda Makerere University Kampala
Zambia Kamwala Health Centre Lusaka Lusake
Zimbabwe University of Zimbabwe Harare

Sponsors (2)
Lead Sponsor Collaborator
University of Washington Bill and Melinda Gates Foundation

Countries where clinical trial is conducted

Kenya,  Malawi,  South Africa,  Swaziland,  Uganda,  Zambia,  Zimbabwe, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 1 year
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