drugset / Trial / 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

NCT06138600

Non-randomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2023-11-01
Primary completion
2025-10-31
Completion
2026-01-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cabotegravir Small molecule 600 mg Intramuscular
Comparator Lamivudine Other / unclassified 300 mg Oral
Comparator Tenofovir disoproxil fumarate Small molecule 300 mg Oral
Comparator emtricitabine Other / unclassified 200 mg Oral