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PrEPared to Choose (PtC) is an Implementation Study of the Delivery of Cabotegravir Long-acting, an Injectable Pre-exposure Prophylaxis (PrEP) Option for HIV Prevention. Injectable PrEP Will be Offered Alongside Oral and Vaginal Ring PrEP From Within a Real-world Context in Cape Town, South Africa.

NCT06807736 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1800

Last updated 2025-02-04

No results posted yet for this study

Summary

The goal of this clinical trial is to offer adolescents and young people in Cape Town, South Africa different HIV pre-exposure prophylaxis (PrEP) products and describe how they use these products over an 18-month period. The study has both clinical and implementation primary aims. The primary clinical aim is short and long-term persistence on PrEP. Persistence is defined as the length of time that a participant shows continuous use of a PrEP product as intended, without stopping PrEP or switching to another PrEP product. The primary implementation aim involves the determination of factors that either enable or serve as a barrier to PrEP uptake and continuation.

Participants will be offered a choice between three antiretroviral-containing PrEP products: (1) a Tenofovir-based oral tablet that needs to be taken daily; (2) a vaginal ring containing Dapivirine that provides HIV protection for up to one month; and (3) an intramuscular injection containing Cabotegravir that provides HIV protection for up to two months. Participants will be able to use the same product throughout the study, switch between products, or stop and restart on PrEP at any point.

The study will be offered from two study sites: the first is a mobile clinic that rotates on a fixed schedule across the study area and the second is a fixed-location government primary healthcare clinic. The study will be open to confirmed HIV-negative individuals, including adolescent girls and young women (aged 15-29 years), young gender and sexually diverse populations aged 15-29 years (including men who have sex with men, transgender people, and non-binary people), and their collective sexual partners (including heterosexual, cisgender men) of any age.

Conditions

  • HIV Infection
  • Sexual and Reproductive Health

Interventions

DRUG

Cabotegravir long-acting

3ml intramuscular injection containing 600mg of Cabotegravir

DRUG

Tenofovir emtricitabine

Oral tablet taken daily to PrEP HIV infection.

DRUG

Dapivirine containing vaginal ring

Intra-vaginal silicone ring containing slow-release Dapivirine, replaced every 28 days

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • ViiV Healthcare

    collaborator INDUSTRY

  • Desmond Tutu HIV Foundation

    lead OTHER

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-13
Primary Completion
2025-12-31
Completion
2026-03-31
FDA Drug
Yes

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06807736 on ClinicalTrials.gov