RecruitingNCT06807736

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.

PrEPared to Choose (PtC): An Implementation Study of the Delivery of Cabotegravir Long-acting Injectable Pre-exposure Prophylaxis (PrEP) as an HIV Prevention Product Option Within a PrEP Choice Context in a Real World Setting in Cape Town.


Sponsor

Desmond Tutu HIV Foundation

Enrollment

1,800 participants

Start Date

Feb 13, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This study in Cape Town, South Africa, is offering different HIV prevention options — including a new injectable medication called cabotegravir (given every 2 months), daily oral pills, and a monthly vaginal ring — to people at risk of HIV, to understand how these options are used and accepted in real-world settings. **You may be eligible if...** - You are HIV-negative - You are 15 years or older - You weigh more than 35 kg - You currently live in the study area - You are willing and able to receive an injectable HIV prevention medication **You may NOT be eligible if...** - You test HIV-positive or show symptoms of a new HIV infection - You have a medical condition that makes one of the study's prevention options unsafe for you - You are allergic to any of the study products - You do not spend enough time in the study area to attend clinic visits - You are enrolled in another HIV prevention clinical trial that may interfere with this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCabotegravir long-acting

3ml intramuscular injection containing 600mg of Cabotegravir

DRUGTenofovir emtricitabine

Oral tablet taken daily to PrEP HIV infection.

DRUGDapivirine containing vaginal ring

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


Locations(1)

Desmond Tutu Health Foundation

Cape Town, Western Province, South Africa

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NCT06807736


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