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 | Active Not Recruiting Phase 3

• 1 other identifier: EZ-FV-035
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pre-Exposure Prophylaxis (PrEP); Long Acting Injectable; Cabotegravir

Outcome Measures

Primary Outcomes (2)

• To describe acceptability of CAB-LA (Long-Acting Cabotegravir) PrEP, amongst different PrEP modalities, including PrEP deferment, in eligible men and women.

  Acceptability of CAB-LA (Long-Acting Cabotegravir) as determined by qualitative and quantitative assessment using piloted and validated semi-structured questionnaires for acceptability. (Quantitative data will be expressed as ratios)

  15 Months

• To describe acceptability of CAB-LA (Long-Acting Cabotegravir) PrEP, amongst different PrEP modalities, including PrEP deferment, in eligible men and women.

  Acceptability of Intervention Measure (AIM)/ Intervention Appropriateness Measure/ (IAM), at 12 months and end of study. (Expressed as ratios where applicable)

  12 Months

Secondary Outcomes (10)

• To describe feasibility of CAB-LA (Long-Acting Cabotegravir) PrEP implementation, amongst different PrEP modalities, including PrEP deferment, in eligible men and women.

  15 Months

• To describe feasibility of CAB-LA (Long-Acting Cabotegravir) PrEP implementation, amongst different PrEP modalities, including PrEP deferment, in eligible men and women.

  12 Months

• To describe the association of socio-demographic factors, reported sexual behaviour, PrEP knowledge and previous PrEP use on PrEP choice.

  15 Months

• To describe the association of socio-demographic factors, reported sexual behaviour, PrEP knowledge and previous PrEP use on PrEP choice.

  12 Months

• To describe the uptake, persistence and patterns of transition on each form of PrEP.

  15 Months

Other Outcomes (5)

• To describe patient reported and clinical significant adverse events of CAB LA (Long-Acting Cabotegravir) and oral PrEP(TDF/FTC[3TC]) over 15 months

  15 Months

• To describe patient reported and clinical significant adverse events of CAB LA (Long-Acting Cabotegravir) and oral PrEP(TDF/FTC[3TC]) over 15 months

  15 Months

• To describe patient reported and clinical significant adverse events of CAB LA (Long-Acting Cabotegravir) and oral PrEP(TDF/FTC[3TC]) over 15 months

  15 Months

Study Arms (2)

Cabotegravir Long Acting Injectable

ACTIVE COMPARATOR

Investigational Product: Cabotegravir Dosage Formulation: 600 mg suspension for injection Route of Administration: Intra-muscular injection Dosing Instructions: 1 vial (600 mg) injected monthly for the initial visit (Month 1 and 2), then every 2 months thereafter (from Month 2 onwards)

Drug: Cabotegravir Injection [Apretude]

Tenofovir disoproxil fumarate + Emtricitabine/Lamivudine (TDF/FTC[3TC])

ACTIVE COMPARATOR

Investigational Product: Tenofovir disoproxil fumarate / emtricitabine (or lamivudine) Dosage Formulation: 300 mg / 200 mg (300mg) fixed dose combination tablet Route of Administration: Oral Dosing Instructions: 1 tablet (300/200/ TDF/FTC) daily or (300/300/TDF/3TC) daily

Drug: Tenofovir disoproxil fumarate / emtricitabine (or lamivudine)

Interventions

Cabotegravir Injection [Apretude] DRUG

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.

Also known as: Apretude

Cabotegravir Long Acting Injectable

Tenofovir disoproxil fumarate / emtricitabine (or lamivudine) DRUG

TDF/FTC is currently available as standard of care for PrEP in the public sector as per the department of health guidelines.

Also known as: Tenemine

Tenofovir disoproxil fumarate + Emtricitabine/Lamivudine (TDF/FTC[3TC])

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Each participant must meet all of the following criteria to be enrolled in this study:
• Adult male or female (≥18 and ≤ 35 years old)
• Is self-reported sexually active
• HIV negative at the time of study enrolment (as determined by a rapid blood test for HIV 1)
• Body weight ≥ 35 kilograms.
• Creatinine clearance ≥ 60 mL/min.
• Willingness to sign informed consent.

You may not qualify if:

• Participants meeting the following criteria will be excluded from participating in the study:
• Symptoms of HIV seroconversion (see Table 1).
• 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.
• 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.
• Known hypersensitivity to or specific contraindications to the use of TDF or FTC/3TC or CABLA.
• Hep B surface antigen positive or known active Hep B infection.
• 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:
• tuberculosis therapy (i.e., rifampicin, rifapentine, rifabutin)
• anticoagulation agents;
• anti-convulsants (e.g. carbamazepine, oxcarbazepine, phenobarbital, phenytoin);
• herbal products (e.g. St John's Wort).
• Concurrent use of PrEP from a different medical provider, other than the study site
• 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.

Sponsors & Collaborators

• University of Witwatersrand, South Africa: lead
• ViiV Healthcare: collaborator

Study Sites (1)

Ezintsha, a division of Wits Health Consortium

Johannesburg, Gauteng, 2193, South Africa

Location

MeSH Terms

Conditions

HIV Infections

Interventions

cabotegravir; Tenofovir; Emtricitabine; Lamivudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Zalcitabine; Dideoxynucleosides

Study Officials

• Francois WD Venter, MBBCh

  Ezintsha, a division of Wits Health Consortium

  STUDY DIRECTOR

• Simiso M Sokhela, MBBCh

  Ezintsha, a division of Wits Health Consortium

  PRINCIPAL INVESTIGATOR

• Nonkululeko M Mashabane, BPharm

  Ezintsha, a division of Wits Health Consortium

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director: Ezintsha

Model Details: Adult (≥18 and ≤ 35 years old) male or female willing to access PrEP at the same pharmacy for up to 2 years

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: November 18, 2023
• Study Start: November 1, 2023
• Primary Completion: October 31, 2025
• Study Completion: January 31, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following publication
• Access Criteria: Anyone who wishes to access the data

Locations

ZA (1)