A Cohort for Evaluation of Open-label PrEP Use 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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

16 year–31 year

Sex eligibility

Female

Study type

Observational

Primary location

ICAP, eSwatini Prevention Center, Mbabane, Hhohho Region, Eswatini

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

16-30 years of age
Female

Exclusion criteria

not sexually active
over 31 years of age at consent

Treatment and study plan

PrEP

Drug

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.

Other names: Truvada

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

Bill and Melinda Gates Foundation

Registry information

Official study title

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

Acronym: INSIGHT

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Feb 27, 2023
Registry last updated: May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed