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

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method

Locations (20): UCT-Masi
🇿🇦
Cape Town, Western Cape, South Africa
Queen Elizabeth Central Hospital
🇲🇼
Blantyre, Malawi
Kenya Medical Research Institute (KEMRI)
🇰🇪
Nairobi, Kenya
Makerere University
🇺🇬
Kampala, Uganda
Kamwala Health Centre
🇿🇲
Lusaka, Lusake, Zambia
Maternal Adolescent & Child Health Research (MatCH)
🇿🇦
Durban, Kwazulu-Natal, South Africa
Qhakaza Mbokodo Research Clinic
🇿🇦
Ladysmith, Kwazulu-Natal, South Africa
Aurum Institute Klerksdorp (CRS)
🇿🇦
Klerksdorp, North-West, South Africa
Emavundleni Research Center, DTHF
🇿🇦
Nyanga, Western Cape, South Africa
Setshaba Research Center
🇿🇦
Pretoria, Gauteng, South Africa
Perinatal HIV Research Unit (PHRU)
🇿🇦
Johannesburg, Gauteng, South Africa
Wits Reproductive Health & HIV Institute (WRHI)
🇿🇦
Johannesburg, Gauteng, South Africa
Helen Joseph Hospital--CHRU
🇿🇦
Johannesburg, Gauteng, South Africa
SA Medical Research Councit, Chatsworth
🇿🇦
Chatsworth, Kwazulu-Natal, South Africa
Madibeng Centre for Research
🇿🇦
Brits, North-West, South Africa
Aurum Institute--Rustenburg
🇿🇦
Rustenburg, North-West, South Africa
ICAP, eSwatini Prevention Center
🇸🇿
Mbabane, Hhohho, Swaziland
University of Zimbabwe
🇿🇼
Harare, Zimbabwe
Human Sciences Research Council (HSRC)
🇿🇦
Pretoria, Gauteng, South Africa
University of Cape Town--Khayekutsha
🇿🇦
Cape Town, Western Cape, South Africa