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

August 31, 2023 updated by: Connie Celum, University of Washington

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Meighan Krows
  • Phone Number: 206-520-3833
  • Email: meigs@uw.edu

Study Locations

  • Kenya
      • Nairobi, Kenya, 00200
        • Kenya Medical Research Institute (KEMRI)
  • Malawi
      • Blantyre, Malawi, 312200
        • Queen Elizabeth Central Hospital
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1864
        • Perinatal HIV Research Unit (PHRU)
      • Johannesburg, Gauteng, South Africa, 2000
        • Wits Reproductive Health & HIV Institute (WRHI)
      • Johannesburg, Gauteng, South Africa, 2092
        • Helen Joseph Hospital--CHRU
      • Pretoria, Gauteng, South Africa, 0001
        • Human Sciences Research Council (HSRC)
      • Pretoria, Gauteng, South Africa, 0152
        • Setshaba Research Center
    • Kwazulu-Natal
      • Chatsworth, Kwazulu-Natal, South Africa, 3370
        • SA Medical Research Councit, Chatsworth
      • Durban, Kwazulu-Natal, South Africa, 4001
        • Maternal Adolescent & Child Health Research (MatCH)
      • Ladysmith, Kwazulu-Natal, South Africa, 3370
        • Qhakaza Mbokodo Research Clinic
    • North-West
      • Brits, North-West, South Africa, 0250
        • Madibeng Centre for Research
      • Klerksdorp, North-West, South Africa, 0299
        • Aurum Institute Klerksdorp (CRS)
      • Rustenburg, North-West, South Africa, 2671
        • Aurum Institute--Rustenburg
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7784
        • University of Cape Town--Khayekutsha
      • Cape Town, Western Cape, South Africa, 7975
        • UCT-Masi
      • Nyanga, Western Cape, South Africa, 7750
        • Emavundleni Research Center, DTHF
  • Swaziland
    • Hhohho
      • Mbabane, Hhohho, Swaziland, H100
        • ICAP, eSwatini Prevention Center
  • Uganda
      • Kampala, Uganda, 10216
        • Makerere University
  • Zambia
    • Lusake
      • Lusaka, Lusake, Zambia, 00000
        • Kamwala Health Centre
  • Zimbabwe
      • Harare, Zimbabwe, 7784
        • University of Zimbabwe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 31 years (Child, Adult)

Accepts Healthy Volunteers

N/A

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

Description

Inclusion Criteria:

  • 16-30 years of age
  • Female

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A cohort for evaluation of open-label PrEP delivery and PrEP preferences among African women
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Bill and Melinda Gates Foundation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2022

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

May 22, 2024

Study Registration Dates

First Submitted

January 5, 2023

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Actual)

February 27, 2023

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00015634

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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