NCT07006246Active, not recruitingPhase 4
Utilizing Private Pharmacies to Initiate High-risk Young Individuals on PrEP in South Africa
Utilizing Private Pharmacies to Initiate High Risk Young Women and Men on Pre-exposure Prophylaxis (PrEP) in South Africa
Source: ClinicalTrials.gov · Last updated 5 Jun 2025
Brief summary (registry, in English)
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)
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1900 (estimated)
- First submitted
- 25 Mar 2025
- Start date
- 19 May 2023
- Primary completion date
- 30 Nov 2025
- Lead sponsor
- Professor Francois Venter
- Diseases
- HIV
- NCT number
- NCT07006246
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1900
- From 19 May 2023 to the primary completion date, 30 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Confirmed HIV positive by routine antibody testing
- Presence of symptoms of acute HIV infection\*
- 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.
Lab values
- Creatinine clearance (eGFR) of:
- Less than 50 mL/min/1.73m2 for adults
- For pregnant women: serum creatinine (sCr) greater than 85 µmol/L
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 35 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ezintsha, a division of Wits Health Consortium Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.