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 — AXIS  

HIV Infections Clinical Trial

Official title: 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

Clinical Trial Summary

This is a mixed methods study employing a convergence model triangulation design. Participants in the study will be sexually active young adults starting PrEP at private pharmacies, who will be offered either CAB-LA, oral PrEP (TDF/FTC[3TC]), or PrEP 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 PrEP choices. Those choosing oral PrEP, will be seen 3 monthly from V2 onwards, but those choosing CAB-LA, will be seen 2 monthly from V2. A maximum of 9 visits is possible.

Clinical Trial 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 PrEP initiation. PrEP will be initiated and monitored according to these and the PIMART guidelines. PrEP, through these programs, will be offered free of charge. The study is designed to be as "real-world" as possible. Adaptations to routine PrEP guidelines have been made to accommodate visit-based HIV testing (based on the injectable regimens, which require more frequent access to the clinic). Participant re-imbursement will therefore be for the baseline, midand end-of-study interviews in participants consenting to these interviews. The maximum amount of time a participant on the study can be on either CAB- LA or oral PrEP, or a combination, or, indeed, on neither drug, is therefore 15 months (and an additional three months on oral PrEP during the transition, as standard of care). The Investigator anticipate that participants will favour CAB- LA, but also anticipate that there may be interesting patterns of use when they learn that they may defer access to CAB- LA or oral PrEP. Participants may favour PrEP, as they may prefer three monthly visits over the two monthly injection requirements. The Investigator may see participants initially choosing oral PrEP, and then moving to CAB- LA, or even vice versa. The Investigator is unclear on what men may favour versus women. The Investigator will endeavour 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 PrEP eligibility is the risk profile of the participants taking up PrEP, a key issue when assessing cost effectiveness. Finally, the investigator is not excluding women or men who defer PrEP 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. ;

Related Conditions & MeSH terms

• HIV Infections

• NCT number: NCT06138600
• Study type: Interventional
• Source: University of Witwatersrand, South Africa
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 1, 2023
• Completion date: January 31, 2026