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ACTIVE NOT RECRUITING
NCT06138600
PHASE3

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

View on ClinicalTrials.gov

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

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.

Locations (1)

Ezintsha, a division of Wits Health Consortium

Johannesburg, Gauteng, South Africa