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

NCT05746065 | Completed DMC

• 1 other identifier: STUDY00015634
• Study Type: observational
• Target: 3,087
• Locations: 6 countries
• Sites: 19

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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.

Also known as: Truvada

Eligibility Criteria

• Age: 16 Years - 31 Years
• Gender Eligibility Details: Female participants
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• years of age
• Female

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (20)

ICAP, eSwatini Prevention Center

Mbabane, Hhohho Region, H100, Eswatini

Location

Kenya Medical Research Institute (KEMRI)

Nairobi, 00200, Kenya

Location

Queen Elizabeth Central Hospital

Blantyre, 312200, Malawi

Location

Perinatal HIV Research Unit (PHRU)

Johannesburg, Gauteng, 1864, South Africa

Location

Wits Reproductive Health & HIV Institute (WRHI)

Johannesburg, Gauteng, 2000, South Africa

Location

Helen Joseph Hospital--CHRU

Johannesburg, Gauteng, 2092, South Africa

Location

Human Sciences Research Council (HSRC)

Pretoria, Gauteng, 0001, South Africa

Location

Setshaba Research Center

Pretoria, Gauteng, 0152, South Africa

Location

SA Medical Research Councit, Chatsworth

Chatsworth, KwaZulu-Natal, 3370, South Africa

Location

Maternal Adolescent & Child Health Research (MatCH)

Durban, KwaZulu-Natal, 4001, South Africa

Location

Qhakaza Mbokodo Research Clinic

Ladysmith, KwaZulu-Natal, 3370, South Africa

Location

Madibeng Centre for Research

Brits, North West, 0250, South Africa

Location

Aurum Institute Klerksdorp (CRS)

Klerksdorp, North West, 0299, South Africa

Location

Aurum Institute--Rustenburg

Rustenburg, North West, 2671, South Africa

Location

University of Cape Town--Khayekutsha

Cape Town, Western Cape, 7784, South Africa

Location

UCT-Masi

Cape Town, Western Cape, 7975, South Africa

Location

Emavundleni Research Center, DTHF

Nyanga, Western Cape, 7750, South Africa

Location

Makerere University

Kampala, 10216, Uganda

Location

Kamwala Health Centre

Lusaka, Lusake, 00000, Zambia

Location

University of Zimbabwe

Harare, 7784, Zimbabwe

Location

Related Publications (2)

• Mukui I, Peacock S, Donnell D, Gati-Mirembe B, Krows M, Bukusi EA, Imaan L, Kotze P, Gill KM, Macdonald P, Louw C, Jaggernath M, Marais A, Peters RPH, Delany-Moretlwe S, Ward A, du Preez P, Kasaro M, Gandhi M, Heffron R, Celum C; INSIGHT Study Team. High prevalence and incidence of curable sexually transmitted infections among young women using oral HIV pre-exposure prophylaxis in sub-Saharan Africa: results from the INSIGHT Cohort study. Sex Transm Infect. 2025 Dec 25:sextrans-2025-056625. doi: 10.1136/sextrans-2025-056625. Online ahead of print.

  PMID: 41448908 DERIVED

• Gati Mirembe B, Donnell D, Krows M, Zwane Z, Bukusi E, Panchia R, Louw C, Mwelase N, Selepe P, Senne M, Naidoo L, Chihana R, Kasaro M, Nuwagaba-Biribonwoha H, Kotze P, Gill K, MacDonald P, vanHeerden A, Bosman S, Jaggernath M, du Preez P, Ward A, Peters RPH, Delany-Moretlwe S, Peacock S, Johnson R, Caucutt J, Morrison S, Wang G, Gandhi M, Velloza J, Heffron R, Celum C; INSIGHT Study Team. High recent PrEP adherence with point-of-care urine tenofovir testing and adherence counselling among young African women: results from the INSIGHT cohort. J Int AIDS Soc. 2024 Dec;27(12):e26389. doi: 10.1002/jia2.26389.

  PMID: 39653676 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine collection to test for syphilis, trichomonas, gonorrhea, chlamydia and HIV.

MeSH Terms

Conditions

HIV Infections

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Connie Celum, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: School of Medicine

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: February 27, 2023
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1); ZA (14); ZI (1); KE (1); ES (1); UG (1)