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Could a shot every 2 months replace daily HIV pills for women?

NCT ID NCT03164564

Ongoing Prevention Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This large phase 3 study tests whether a long-acting injectable drug called cabotegravir, given every 2 months, is safe and effective for preventing HIV in women. Over 3,200 HIV-negative women are taking part, comparing the shot to daily oral Truvada. The goal is to see if the injection offers a more convenient prevention option.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
Cabotegravir (long-acting injectable)
What this could lead to
If successful, this could provide women with a convenient, long-acting injection for HIV prevention, reducing the need for daily pills.
What could go wrong
This is a large phase 3 trial, but results are not yet final. The injection may not be as effective as daily pills for all women, and side effects like injection site reactions are possible.

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

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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.

HIV INFECTIONS

Contacts and locations

Locations

  • Baylor-Uganda CRS

    Kampala, Uganda

  • Blantyre CRS

    Blantyre, Malawi

  • Botha's Hill CRS

    Durban, KwaZulu-Natal, 3660, South Africa

  • Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS

    Cape Town, Western Cape, 7505, South Africa

  • Emavundleni CRS

    Cape Town, Western Cape, 7750, South Africa

  • Eswatini Prevention Center CRS

    Mbabane, Eswatini

  • Gaborone CRS

    Gaborone, South-East District, Botswana

  • Isipingo CRS

    Isipingo, KwaZulu-Natal, 4110, South Africa

  • Kisumu Crs

    Kisumu, Nyanza, 40100, Kenya

  • MU-JHU Research Collaboration (MUJHU CARE LTD) CRS

    Kampala, Uganda

  • Malawi CRS

    Lilongwe, Central Region, Malawi

  • Milton Park CRS

    Harare, Zimbabwe

  • Seke South CRS

    Chitungwiza, Zimbabwe

  • Soweto HPTN CRS

    Johannesburg, Gauteng, 1862, South Africa

  • Spilhaus CRS

    Harare, Zimbabwe

  • St Mary's CRS

    Chitungwiza, Zimbabwe

  • UVRI-IAVI HIV Vaccine Program LTD. CRS

    Entebbe, Uganda

  • Verulam CRS

    Verulam, KwaZulu-Natal, 4340, South Africa

  • Ward 21 CRS

    Johannesburg, Gauteng, 2001, South Africa

  • Zengeza CRS

    Chitungwiza, Mashonaland East Province, Zimbabwe

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