Utilizing Private Pharmacies to Initiate High-risk Young Individuals on PrEP in South Africa

NCT ID: NCT07006246

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 1900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-19
• Study Completion Date: 2025-11-30

Brief Summary

This is a funded implementation study designed to evaluate the efficacy of recruiting and retaining high-risk individuals on pre-exposure prophylaxis (PrEP) within multiple private pharmacies (and online platforms in South Africa)

Detailed Description

This is a two-stage (formative and implementation) study. It will employ a mixed-method approach-specifically, a divergent parallel design. The study will use the EPIS framework (Exploration, Preparation, Implementation, and Sustainability) as an overarching implementation structure to Formalise stakeholder partnerships and tailor the proposed service delivery models (intervention package) for the implementation context.

The study chose EPIS as it considers the multilevel nature of healthcare, organizations within systems, and patient needs. Using the capability, opportunity, and motivation for behaviour (COM-B) change model, the study will assess the readiness of pharmacists, pharmacy nurses, and pharmacy clinics to adopt and implement the service delivery models. The study will use participatory human-centred stakeholder engagement to inform appropriateness, acceptability, and feasibility of the service delivery models, priorities for tailoring, and responsibilities for implementation.

As a multi-centre pharmacy-initiated implementation study, the project is designed to assess the feasibility and acceptability of in-pharmacy oral PrEP initiation, and oral PrEP initiation utilizing a virtual model and in-pharmacy administration. Additionally, this study will provide information about tolerability, safety, and preferences on accessing prophylactic HIV services. In the formative phase, cross-sectional data collection will take place, while during the implementation stage, young women and men will be screened and recruited to the study across sites in Gauteng and the Western Cape and will be followed over 13 months (prospective, longitudinal).

Conditions

HIV Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Tenofovir disoproxil fumarate + lamivudine/emtricitabine (TDF+3TC /FTC)

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

Group Type: OTHER

Tenofovir disoproxil fumarate + lamivudine/emtricitabine (TDF+3TC /FTC)

Intervention Type: DRUG

Tenofovir disoproxil fumarate + emtricitabine/ 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

Interventions

Tenofovir disoproxil fumarate + lamivudine/emtricitabine (TDF+3TC /FTC)

Tenofovir disoproxil fumarate + emtricitabine/ 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult male or female (≥18 and ≤ 35 years old)
• HIV negative at the time of study enrolment (as determined by a rapid blood test for HIV 1,2)
• Absence of symptoms of acute HIV infection*
• Body weight ≥ 35 kg
• Creatinine clearance ≥ 50 mL/min
• Willingness to take PrEP as prescribed and to comply with study procedures.
• Willingness to be followed up throughout the duration of the study.

Exclusion Criteria

• Confirmed HIV positive by routine antibody testing
• Presence of symptoms of acute HIV infection*
• Creatinine clearance (eGFR) of:

• Less than 50 mL/min/1.73m2 for adults
• For pregnant women: serum creatinine (sCr) greater than 85 µmol/L
• Known hypersensitivity to or specific contraindications to the use of TDF or FTC/3TC
• Self-reported presence or history of liver cirrhosis (Child-Pugh Class B or greater), with or without viral hepatitis co-infection
• Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the participant. This will be an investigator-led determination based on the medical history of the participant. This includes, but is not limited to:

• Severe hepatic impairment or history of liver cirrhosis with or without viral hepatitis co-infection.
• 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.
• Inability or unwillingness to be followed up for the study period
• Pregnant and lactating women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Professor Francois Venter

OTHER

Sponsor Role: lead

Responsible Party

Professor Francois Venter

Executive Director: Ezintsha

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Fanscois Venter, PhD in Medicine

Role: PRINCIPAL_INVESTIGATOR

Ezintsha, a subdivision of Wits Health Consortium

Locations

Ezintsha, a division of Wits Health Consortium

Johannesburg, Gauteng, South Africa

Countries

South Africa

Other Identifiers

EZ-FV-032

Identifier Type: -

Identifier Source: org_study_id