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    v: **BACKGROUND:** Oral pre-exposure prophylaxis has been introduced in more than 70 countries, including many in sub-Saharan Africa, but women experience considerable barriers to daily pill-taking, such as stigma, judgement, and the fear of violence. Safe and effective long-acting agents for HIV prevention are needed for women. We aimed to evaluate the safety and efficacy of injectable cabotegravir compared with daily oral tenofovir diphosphate plus emtricitabine (TDF-FTC) for HIV prevention in HIV-uninfected women. **METHODS:** HPTN 084 was a phase 3, randomised, double-blind, double-dummy, active-controlled, superiority trial in 20 clinical research sites in seven countries in sub-Saharan Africa. Participants were eligible for enrolment if they were assigned female sex at birth, were aged 18-45 years, reported at least two episodes of vaginal intercourse in the previous 30 days, were at risk of HIV infection based on an HIV risk score, and agreed to use a long-acting reversible contraceptive method. Participants were randomly assigned (1:1) to either active cabotegravir with TDF-FTC placebo (cabotegravir group) or active TDF-FTC with cabotegravir placebo (TDF-FTC group). Study staff and participants were masked to study group allocation, with the exception of the site pharmacist who was responsible for study product preparation. Participants were prescribed 5 weeks of daily oral product followed by intramuscular injections every 8 weeks after an initial 4-week interval load, alongside daily oral pills. Participants who discontinued injections were offered open-label daily TDF-FTC for 48 weeks. The primary endpoints of the study were incident HIV infection in the intention-to-treat population, and clinical and laboratory events that were grade 2 or higher in all women who had received at least one dose of study product. This study is registered with ClinicalTrials.gov, NCT03164564. **FINDINGS:** From Nov 27, 2017, to Nov 4, 2020, we enrolled 3224 participants (1614 i…
  copyright:
    v: Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.
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      v: Desmond Tutu TB Centre, University of Stellenbosch, Stellenbosch, South Africa.
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      v: HIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa.
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      v: HIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa.
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      v: International AIDS Vaccine Initiative, Uganda Virus Research Institute, Entebbe, Uganda.
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v: Practitioner
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v: Mgodi N

v: N

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    v: Baylor College of Medicine Children's Foundation Uganda, Kampala, Uganda.

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    v: Desmond Tutu Health Foundation, University of Cape Town, Cape Town, South Africa.

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    v: Nakabiito C
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    v: Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.

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    v: Nuwagaba-Biribonwoha H
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    v: Eswatini Prevention Center, International Center for AIDS Care and Treatment Program at Columbia University Mailman School of Public Health, New York, NY, USA.

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    v: Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.

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    v: HIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa.

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    v: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.

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    v: FHI 360, Durham, NC, USA.

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    v: FHI 360, Durham, NC, USA.

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    v: Anderson PL
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    v: Anschutz Medical Campus, University of Colorado, Aurora, CO, USA.

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    v: Eshleman SH
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    v: Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

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    v: Marzinke MA
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    v: Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

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    v: Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

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    v: Beigel-Orme S
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    v: Statistical Centre for HIV/AIDS Research and Prevention, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.

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    v: Department of Psychiatry, Stroger Hospital of Cook County, Chicago, IL, USA.

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    v: FHI 360, Durham, NC, USA.

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    v: Sista N
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    v: FHI 360, Durham, NC, USA.

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    v: Adeyeye A
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    v: Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.

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    v: Rooney JF
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    v: Gilead Sciences, Foster City, CA, USA.

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    v: ViiV Healthcare, Durham, NC, USA.

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    v: ViiV Healthcare, Durham, NC, USA.

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    v: Hanscom B
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    v: Statistical Centre for HIV/AIDS Research and Prevention, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.

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    v: Cohen MS
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  v: MS
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    v: University of North Carolina (UNC) at Chapel Hill, Chapel Hill, NC, USA.

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    v: Hosseinipour MC
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    v: University of North Carolina (UNC) at Chapel Hill, Chapel Hill, NC, USA; UNC Project-Malawi, Lilongwe, Malawi.

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    v: HPTN 084 study group