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Twice-Yearly shot could revolutionize HIV prevention for young women

NCT ID NCT04994509

Prevention Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study tested two ways to prevent HIV in over 5,000 adolescent girls and young women at risk. One group received a long-acting shot every six months, while others took daily pills. The goal was to see how well each method works to keep participants HIV-free.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

5,368 people

The number who actually took part.

Started

Aug 2021

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 25 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Incidence Phase * HIV-1 status unknown at initial screening and no prior human immunodeficiency virus (HIV)-1 testing within the last 3 months. * Sexually active (has had \> 1 vaginal intercourse within the last 3 months) with cisgender male individuals (CGM). * Randomized Phase * Negative fourth generation HIV-1 antibody (Ab)/antigen (Ag) test confirmed with central HIV-1 testing. * Estimated glomerular filtration rate (GFR) ≥ 60 mL/min at screening. * Body weight ≥ 35 kg. Key Exclusion Criteria: * Prior receipt of an HIV vaccine. * Prior use of any long-acting systemic HIV pre-exposure prophylaxis (PrEP) or prior HIV postexposure prophylaxis (PEP) in the past 12 weeks. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pre-exposure prophylaxis of HIV infection

Contacts and locations

Locations

  • AMBSO Masaka Clinical Research site

    Kyotera- Masaka Region, Uganda

  • Africa Health Research Institute

    Mtubatuba, 3935, South Africa

  • Botha's Hill Clinical Research Site, HIV Prevention Research Unit

    Durban, 3660, South Africa

  • CAPRISA Umlazi Clinical Research Site

    Umlazi, 4066, South Africa

  • CAPRISA Vulindlela Clinical Research Site

    Durban, 4001, South Africa

  • CAPRISA eThekwini Clinical Research Site

    Durban, 4001, South Africa

  • Chatsworth Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit

    Kwa Zulu Natal, South Africa

  • Desmond Tutu Health Foundation - Masiphumelele Research Office

    Sunnydale, 7705, South Africa

  • Desmond Tutu Health Foundation Clinical Trials Unit

    Cape Town, 7925, South Africa

  • Emavundleni Research Centre

    Cape Town, 7750, South Africa

  • FPD-DTHF Ndevana Community Research Site

    Vincent, 5217, South Africa

  • Madibeng Centre for Research

    Brits, 2500, South Africa

  • Makerere University- John Hopkins University (MU-JHU) Mityana Research Site (MU-JHU) Care Ltd

    Mityana Town, Uganda

  • Makerere-Kalangala Clinical Research site

    Kalangala, Uganda

  • MatCH Research Unit, Suite 1112, 11th Floor

    Durban, 4001, South Africa

  • Perinatal HIV Research Unit (PHRU) Soweto Kliptown

    Kliptown, 1809, South Africa

  • Phoenix Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit

    Kwa Zulu Natal, 4061, South Africa

  • Qhakaza Mbokodo Research Clinic

    Ladysmith, 3370, South Africa

  • Setshaba Research Centre

    Gauteng, 152, South Africa

  • Synergy Biomed Research Institute (SBRI)

    East London, South Africa

  • The Aurum Institute: Gavin J Churchyard Legacy Centre, Klerksdorp Clinical Research Centre

    Klerksdorp, 2571, South Africa

  • The Aurum Institute: Pretoria Clinical Research Centre

    Pretoria, 0087, South Africa

  • The Aurum Institute: Rustenburg Clinical Research Centre

    Rustenburg, 299, South Africa

  • The Aurum Institute: Tembisa Clinical Research Centre

    Tembisa, 1632, South Africa

  • Tongaat Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit

    Kwa Zulu Natal, 4400, South Africa

  • Verulam Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit

    Kwa Zulu Natal, 4340, South Africa

  • Vuka Research Clinic

    Cape Town, 7784, South Africa

  • Wits Reproductive Health & HIV Institute (Wits RHI)

    Johannesburg, 2038, South Africa

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Other studies related to the condition(s) this trial covers.