INSIGHT Study

INSIGHT: Advancing PrEP Discovery and Delivery for African Women

Rationale

The INSIGHT cohort study addresses critical gaps in understanding the uptake, adherence, and preferences for pre-exposure prophylaxis (PrEP) among adolescent girls and young women (AGYW) in sub-Saharan Africa. Despite being disproportionately affected by HIV, this group often experiences challenges in sustaining PrEP use. This study aims to inform strategies for improving PrEP delivery and tailoring interventions to meet the needs of African women.

Primary Objectives

1. HIV Incidence: Estimate HIV incidence using recency testing on screening samples and prospectively within the cohort.
2. PrEP Initiation: Assess characteristics of women who initiate PrEP versus those who do not.
3. PrEP Preferences: Evaluate preferences for long-acting PrEP formulations through a discrete choice experiment.
4. Decision Support Tool: Assess the acceptability of a patient-facing PrEP decision support tool to enhance informed choices about PrEP options.
5. HLA Genotypes: Determine the diversity of HLA variants among young women in East and Southern Africa.

Study Design

The INSIGHT study is a prospective, observational, open-label cohort conducted in eSwatini, Kenya, Malawi, South Africa, Uganda, Zambia, and Zimbabwe.

• Study Population: 3,000 HIV-uninfected, sexually active AGYW aged 16–30 years.
• Study Duration: August 2022 – July 2023, with participants followed for six months.
• Intervention: Participants attended follow-up visits at Months 1, 3, and 6, where they were offered PrEP, adherence counseling, and real-time adherence feedback using a novel point-of-care urine tenofovir (TFV) assay.

Sponsors

• Bill and Melinda Gates Foundation

Investigators

Prof Sinead Delany-Moretlwe and the INSIGHT study team.

Study Status

• Results were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) in March 2024:

High PrEP Uptake and Adherence Measured Objectively Among Young African Women in the INSIGHT Cohort

Mirembe BG, Krows M, Zwane Z, Bukusi E, Panchia R, Louw C, Mwelase N, Selepe P, Senne M, Naidoo L, Kawalzaira R, Kasaro M, Gandhi M, Heffron R, Celum C, CROI, Denver, Colorado, 2024. 03 – 06 March 2024.

Background: Adolescent girls and young women (AGYW) account for 1 in 5 new HIV infections in sub– Saharan Africa and can greatly benefit from PrEP. While studies among AGYW show high oral PrEP uptake, early discontinuation is common. Objective adherence measures may enhance counselling and promote adherence, but are often costly, require specialized tests and require long turnaround times for spectrometry- based metrics. We evaluated a novel point-of-care urine tenofovir (TFV) assay, using antibody-based technology, to measure adherence and its alignment with self-reported adherence and HIV seroconversion among AGYW.

Methods: From August 2022-July 2023, we enrolled an open label PrEP cohort of sexually active AGYW aged 16-30 years and interested in PrEP from 20 sites (15 in South Africa and 1 site each in Eswatini, Kenya, Malawi, Uganda, and Zambia). Participants attended study visits 1, 3 and 6 months after enrollment and were offered PrEP and adherence counselling at each visit. PrEP use was assessed via self-report and a qualitative lateral flow urine TFV assay, for which a predetermined threshold of >1500 ng/ml indicates TFV use in the past 4 days. Acceptability of urine TFV testing was assessed at Month 6 via questionnaire.

Results: The INSIGHT cohort enrolled 3087 AGYW. At enrolment, 95.6% of participants-initiated PrEP. At months 1, 3, and 6, 95.7%, 94.4%, and 88.8% received PrEP refills and 77.5%, 79.6%, and 64.1% of those with urine tests had TFV detected in the urine assay respectively. The 3 main reasons for PrEP discontinuation were side effects, low risk perception, and peer influence. Self-reported good, very good, or excellent adherence was well aligned with positive results from the urine TFV test (OR=8.5, 95% CI 7.4-9.8). HIV incidence was 1.38/100 person-years (95% CI 0.97-2.08). At Month 6, 58.3% of women reported that a positive urine TFV result motivated them to take PrEP, 23.6% reported that the counsellor helped them identify ways to remember PrEP, and 21% reported that a negative urine test result was not surprising.

Conclusion: Oral PrEP uptake was >95% among a multisite cohort African AGYW with almost 90% refilling PrEP at Month 6 and the majority (64-80%) had evidence of recent use, based on a novel urine TFV assay, which is higher PrEP adherence than in prior studies. Oral PrEP can be an effective PrEP option for African AGYW. Real time drug feedback using the urine TFV assay is acceptable and warrants further study to support PrEP adherence.

Latest Update

November 2024

For more information about the INSIGHT study, please contact rhicomms@wrhi.ac.za