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

NCT07006246 | Active Not Recruiting Phase 4

• 1 other identifier: EZ-FV-032
• Study Type: interventional
• Target: 1,900
• Locations: 1 country
• Sites: 1

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)

Conditions

HIV Infection

Keywords

tenofovir disoproxil fumarate/emtricitabine (TDF/FTC); pre-exposure prophylaxis (PrEP); Private Pharmacies; Implementation study

Outcome Measures

Primary Outcomes (2)

• Number of pharmacies providing Prep services over 13 months

  Acceptability of pharmacy-delivered PrEP services will be determined by qualitative and quantitative assessment using piloted and validated semi-structured questionnaires for acceptability.

  13 Months

• Number of participants accessing PrEP online services over 13 months

  Acceptability of online-delivered PrEP services will be determined by qualitative and quantitative assessment using piloted and validated semi-structured questionnaires for acceptability.

  13 Months

Secondary Outcomes (2)

• To describe provider experiences and perceptions of pharmacy and online-delivered PrEP

  13 Months

• To describe user experiences and perceptions of pharmacy and online-delivered PrEP

  13 Months

Study Arms (1)

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

OTHER

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 + lamivudine/emtricitabine (TDF+3TC /FTC)

Interventions

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

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

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Professor Francois Venter: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Ezintsha, a division of Wits Health Consortium

Johannesburg, Gauteng, 2193, South Africa

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Tenofovir; Lamivudine; Emtricitabine; Racivir

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; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Fanscois Venter, PhD in Medicine

  Ezintsha, a subdivision of Wits Health Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Director: Ezintsha

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

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: June 5, 2025
• Study Start: May 19, 2023
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After the study results are published
• Access Criteria: Anyone who needs to access the data

Locations

ZA (1)