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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
Sponsor: University of Witwatersrand, South Africa
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.
Key Details
Gender
All
Age Range
18 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2023-11-01
Completion Date
2026-01-31
Last Updated
2024-06-21
Healthy Volunteers
Yes
Conditions
Interventions
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.
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.
Locations (1)
Ezintsha, a division of Wits Health Consortium
Johannesburg, Gauteng, South Africa