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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

NCT06138600 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-06-21

No results posted yet for this study

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.

Conditions

  • HIV Infections

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.

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • University of Witwatersrand, South Africa

    lead OTHER

Principal Investigators

  • Francois WD Venter, MBBCh · Ezintsha, a division of Wits Health Consortium

  • Simiso M Sokhela, MBBCh · Ezintsha, a division of Wits Health Consortium

  • Nonkululeko M Mashabane, BPharm · Ezintsha, a division of Wits Health Consortium

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06138600 on ClinicalTrials.gov