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

Phase 4

Active, not recruiting

• Conditions: HIV Infection
• Interventions: Drug: Tenofovir disoproxil fumarate + lamivudine/emtricitabine (TDF+3TC /FTC)

• Registration Number: NCT07006246
• Lead Sponsor: Professor Francois Venter

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).

Study Timeline

• Study Start: 2023-05-19
• Study First Submitted: 2025-03-25
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-27
• Last Update Submitted: 2025-05-27
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1900

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of pharmacies providing Prep services over 13 months	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.
Number of participants accessing PrEP online services over 13 months	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.

Secondary Outcome Measures

Name	Time	Method
To describe user experiences and perceptions of pharmacy and online-delivered PrEP	13 Months	User perspectives on service delivery using semi-structured interviews using REAIM
To describe provider experiences and perceptions of pharmacy and online-delivered PrEP	13 Months	Provider Perspectives on service delivery using semi-structured interviews using REAIM

Trial Locations

Locations (1)

Ezintsha, a division of Wits Health Consortium; 🇿🇦 Johannesburg, Gauteng, South Africa