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

Sponsor
University of Washington (Other)
Overall Status
Recruiting
CT.gov ID
NCT05746065
Collaborator
Bill and Melinda Gates Foundation (Other)
3,000
Enrollment
20
Locations
24.1
Anticipated Duration (Months)
150
Patients Per Site
6.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Cohort for Evaluation of Open-label PrEP Delivery and PrEP Preferences Among African Women
Actual Study Start Date :
May 20, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
May 22, 2024

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 31 Years
Sexes Eligible for Study:
Female
Inclusion Criteria:

  • 16-30 years of age

  • Female

Exclusion Criteria:

  • not sexually active

  • over 31 years of age at consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kenya Medical Research Institute (KEMRI) Nairobi Kenya 00200
2 Queen Elizabeth Central Hospital Blantyre Malawi 312200
3 Perinatal HIV Research Unit (PHRU) Johannesburg Gauteng South Africa 1864
4 Wits Reproductive Health & HIV Institute (WRHI) Johannesburg Gauteng South Africa 2000
5 Helen Joseph Hospital--CHRU Johannesburg Gauteng South Africa 2092
6 Human Sciences Research Council (HSRC) Pretoria Gauteng South Africa 0001
7 Setshaba Research Center Pretoria Gauteng South Africa 0152
8 SA Medical Research Councit, Chatsworth Chatsworth Kwazulu-Natal South Africa 3370
9 Maternal Adolescent & Child Health Research (MatCH) Durban Kwazulu-Natal South Africa 4001
10 Qhakaza Mbokodo Research Clinic Ladysmith Kwazulu-Natal South Africa 3370
11 Madibeng Centre for Research Brits North-West South Africa 0250
12 Aurum Institute Klerksdorp (CRS) Klerksdorp North-West South Africa 0299
13 Aurum Institute--Rustenburg Rustenburg North-West South Africa 2671
14 University of Cape Town--Khayekutsha Cape Town Western Cape South Africa 7784
15 UCT-Masi Cape Town Western Cape South Africa 7975
16 Emavundleni Research Center, DTHF Nyanga Western Cape South Africa 7750
17 ICAP, eSwatini Prevention Center Mbabane Hhohho Swaziland H100
18 Makerere University Kampala Uganda 10216
19 Kamwala Health Centre Lusaka Lusake Zambia 00000
20 University of Zimbabwe Harare Zimbabwe 7784

Sponsors and Collaborators

  • University of Washington
  • Bill and Melinda Gates Foundation

Investigators

  • Principal Investigator: Connie Celum, MD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Connie Celum, Professor: School of Medicine, University of Washington
ClinicalTrials.gov Identifier:
NCT05746065
Other Study ID Numbers:
  • STUDY00015634
First Posted:
Feb 27, 2023
Last Update Posted:
Feb 27, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
HIV Infections
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Study Results

No Results Posted as of Feb 27, 2023