NCT06138600

Acceptability and Feasibility of Injectable Cabotegravir Pre-exposure Prophylaxis (PrEP) Versus Oral PrEP in Routine Care up to 15 Months in Private Pharmacies in South Africa

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Witwatersrand, South Africa · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

This is a mixed methods study employing a convergence model triangulation design. Participants in the study will be sexually active young adults starting Pre-exposure Prophylaxis at private pharmacies, who will be offered either Cabotegravir Long-Acting Injectable, oral Pre-exposure Prophylaxis (TDF/FTC\[3TC\]), or Pre-exposure Prophylaxis deferment at each of their regular visits, with the option to switch between options for up to 15 months, with a final exit interview following the transition to standard-of-care. The number of study visits will vary, depending on participant Pre-exposure Prophylaxis choices. Those choosing oral Pre-exposure Prophylaxis will be seen 3 monthly from V2 onwards, but those choosing Cabotegravir Long-Acting Injectable will be seen 2 monthly from V2. A maximum of 9 visits is possible.

Detailed description

In the ATLAS study participants were asked, after they had transitioned back to conventional oral antiretroviral therapy, whether they preferred injectable or oral treatment. Their feedback on their preference overwhelming favoured injectables9. Women and men will be recruited from existing Ezintsha programs operating within the pharmacies, using current government criteria for Pre-exposure Prophylaxis initiation. Pre-exposure Prophylaxis will be initiated and monitored according to these and the Pharmacist-Initiated Management of Antiretroviral Therapy guidelines. Pre-exposure Prophylaxis, through these programs, will be offered free of charge. The study is designed to be as "real-world" as possible. Adaptations to routine Pre-exposure Prophylaxis guidelines have been made to accommodate visit-based HIV testing (based on the injectable regimens, which require more frequent access to the clinic). Participant reimbursement will therefore be for the baseline, mid and end-of-study interviews in participants consenting to these interviews. The maximum amount of time a participant in the study can be on either Cabotegravir Long-Acting Injectable or oral Pre-exposure Prophylaxis, or a combination, or, indeed, on neither drug, is therefore 15 months (and an additional three months on oral Pre-exposure Prophylaxis during the transition, as standard of care). The Investigator anticipates that participants will favour Cabotegravir Long-Acting Injectable, but also anticipates that there may be interesting patterns of use when they learn that they may defer access to Cabotegravir Long-Acting Injectable or oral Pre-exposure Prophylaxis. Participants may favour Pre-exposure Prophylaxis, as they may prefer three monthly visits over the two monthly injection requirements. The Investigator may see participants initially choosing oral Pre-exposure Prophylaxis, and then moving to Cabotegravir Long-Acting Injectable, or even vice versa. The Investigator is unclear on what men may favour versus women. The Investigator will endeavor to recruit at least 20 men in the study, appreciating that not much is known about this group in the sub-Saharan Africa context. One of the most important analyses that will flow from information collected when assessing for Pre-exposure Prophylaxis eligibility is the risk profile of the participants taking up Pre-exposure Prophylaxis, a key issue when assessing cost-effectiveness. Finally, the investigator is not excluding women or men who defer Pre-exposure Prophylaxis initially. These various combinations will provide interesting quantitative, but more importantly, qualitative data on preferences, and on how services may be improved to accommodate participants' choices.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Cabotegravir Injection [Apretude]	White to slightly pink free flowing suspension suspension for injection contained in a brown coloured vial. Each vial is for single use and does not require dilution prior to administration.
DRUG	Tenofovir disoproxil fumarate / emtricitabine (or lamivudine)	TDF/FTC is currently available as standard of care for PrEP in the public sector as per the department of health guidelines.

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-10-31
• Completion: 2026-01-31
• First posted: 2023-11-18
• Last updated: 2024-06-21

Locations

1 site across 1 country: South Africa