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Wits RHI

PURPOSE 1 Study

A Phase 3, Randomized, Double-Blind Study Evaluating Long-Acting Subcutaneous Lenacapavir and Oral Emtricitabine/Tenofovir Alafenamide for HIV Prevention in Adolescent Girls and Young Women.

Rationale

Although daily oral PrEP options like F/TDF have demonstrated high efficacy and are recommended for HIV prevention among women, adherence challenges especially among adolescent girls and young women (AGYW) in sub-Saharan Africa have limited impact at the population level. Factors such as pill fatigue, stigma, fear of disclosure, and limited access to health services affect uptake and continuation.

The PURPOSE 1 study evaluates two promising alternatives:

  • F/TAF, which may offer improved safety and acceptability, especially for women with renal or bone health concerns

  • Lenacapavir (LEN), a novel long-acting agent requiring only twice-yearly subcutaneous injections, offering a discreet and less burdensome prevention option

This study addresses a critical gap by investigating long-acting HIV prevention methods tailored to the needs of AGYW, a population disproportionately impacted by HIV and historically underrepresented in clinical trials. It also explores biological, behavioral, and social factors influencing PrEP use in this group.

Primary Objective

To assess the efficacy of LEN and F/TAF in preventing HIV-1 infection among adolescent girls and young women, in comparison to the background HIV incidence rate in the studied population.

Study Population

Sexually active, HIV-negative adolescent girls and young women (AGYW), aged 16–25 years, at risk of HIV-1 infection.

Study Site

Hillbrow, Johannesburg

Investigators:

  • Prof Thesla Palanee-Phillips – Co-Principal Investigator

  • Dr Nkosiphile Ndlovu – Co-Investigator

  • Dr L Kew – Co-Investigator

  • Dr L Kgoa – Co-Investigator

  • Dr H Ismail – Co-Investigator

Publications

Published 24 July 2024:Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women

Media Coverage

  1. Media Release, 20 June 2024: Gilead’s Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention

Latest Update

July 2024

For more details about the PURPOSE 1 Study please email rhicomms@wrhi.ac.za

Click here for further details regarding the PURPOSE 1 Study.

Research Brief

PURPOSE 1 Study