A Phase 4 interventional study of Tenofovir disoproxil fumarate + lamivudine/emtricitabine (TDF+3TC /FTC) in HIV Infection, sponsored by Professor Francois Venter. Active, not recruiting at 1 site in South Africa. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-05.
Sponsored by Professor Francois Venter · Phase 4, Interventional, and Prevention
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)
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).
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's planned enrollment of 1,900 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Professor Francois Venter is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Creatinine clearance (eGFR) of:
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:
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)
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
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.
Time frame: 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.
Time frame: 13 Months
To describe provider experiences and perceptions of pharmacy and online-delivered PrEP
Provider Perspectives on service delivery using semi-structured interviews using REAIM
Time frame: 13 Months
To describe user experiences and perceptions of pharmacy and online-delivered PrEP
User perspectives on service delivery using semi-structured interviews using REAIM
Time frame: 13 Months
Plan to share: Yes — After deidentification, the data will be shared with the study participants of the trial.
Supporting information: Study protocol, Icf, Csr
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Professor Francois Venter