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

EZ-FV-035

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.

2023-11-01

2025-10-31

2026-01-31

Active (not recruiting)

Early phase I

200

Inclusion Criteria: - Each participant must meet all of the following criteria to be enrolled in this study: 1. Adult male or female (≥18 and ≤ 35 years old) 2. Is self-reported sexually active 3. HIV negative at the time of study enrolment (as determined by a rapid blood test for HIV 1) 4. Body weight ≥ 35 kilograms. 5. Creatinine clearance ≥ 60 mL/min. 6. Willingness to sign informed consent. Exclusion Criteria: - Participants meeting the following criteria will be excluded from participating in the study: 1. Symptoms of HIV seroconversion (see Table 1). 2. Pregnant (participant must have a negative beta human chorionic gonadotrophin (b-hCG) urine test at screening) or lactating women, or women intending to become pregnant or breastfeed during the study. 3. Is in good health, with no surgical or medical condition which may significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the volunteer or the objectives of the study or impair their ability to comply with the dosing schedule and/or protocol evaluations. The Investigator should make this determination in consideration of the volunteer's medical history. This including, but not limited to, the following: a. History of severe hepatic impairment, history of liver cirrhosis with or without viral hepatitis co-infection. b. Unstable or poorly controlled seizure disorder. c. History of coagulopathies, or current or anticipated need for chronic anticoagulation. d. Presence of a tattoo or other dermatological condition overlying the gluteus region which would realistically obstruct administration of an intramuscular injection. 4. Known hypersensitivity to or specific contraindications to the use of TDF or FTC/3TC or CABLA. 5. Hep B surface antigen positive or known active Hep B infection. 6. Is receiving or has received the following agents within 28 days prior to screening, and cannot discontinue their use for the duration of the study: 1. tuberculosis therapy (i.e., rifampicin, rifapentine, rifabutin) 2. anticoagulation agents; 3. anti-convulsants (e.g. carbamazepine, oxcarbazepine, phenobarbital, phenytoin); 4. herbal products (e.g. St John's Wort). 7. Concurrent use of PrEP from a different medical provider, other than the study site 8. Participant is judged by the Investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results. 9. Inability or unwillingness to be followed up for the study period, including plans to move out the study geographical area in the next 12 months or otherwise unable to participate in the study visits as determined by the PI.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Adult (≥18 and ≤ 35 years old) male or female willing to access PrEP at the same pharmacy for up to 2 years', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2023-11-30