HIV InfectionPhase 4PPREPP-SANCT07006246
Utilizing Private Pharmacies to Initiate High-risk Young Individuals on PrEP in South Africa
A Phase 4 study testing Tenofovir disoproxil fumarate + lamivudine/emtricitabine (TDF+3TC /FTC) in people with HIV Infection, run by Professor Francois Venter at 1 site in South Africa.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- Tenofovir disoproxil fumarate + lamivudine/emtricitabine (TDF+3TC /FTC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,900 participants
- Where
- 1 siteSouth Africa
- Study dates
- 19 May 2023to 30 Nov 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Ezintsha, a division of Wits Health Consortium
Johannesburg, Gauteng, 2193
About this study
Official title: Utilizing Private Pharmacies to Initiate High Risk Young Women and Men on Pre-exposure Prophylaxis (PrEP) in South Africa
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)
Read the 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
- Being tested
- Tenofovir disoproxil fumarate + lamivudine/emtricitabine (TDF+3TC /FTC)
- Keywords
- tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), pre-exposure prophylaxis (PrEP), Private Pharmacies, Implementation study
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Tenofovir disoproxil fumarate + lamivudine/emtricitabine (TDF+3TC /FTC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 13 Months
Secondary outcomes (2)
To describe provider experiences and perceptions of pharmacy and online-delivered PrEP
Provider Perspectives on service delivery using semi-structured interviews using REAIM
Measured: 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
Measured: 13 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start19 May 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Professor Francois Venter
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor-investigator, Professor Francois Venter, University of Witwatersrand, South Africa
- Investigators
- Fanscois Venter, PhD in Medicine, Principal investigator, Ezintsha, a subdivision of Wits Health Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006246
- Sponsor's protocol ID
- EZ-FV-032
- Acronym
- PPREPP-SA
- Status last verified
- May 2025
- First submitted
- 25 Mar 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After deidentification, the data will be shared with the study participants of the trial.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Private Pharmacies to Initiate High Risk Young Women and Men on Pre-exposure Prophylaxis (PrEP) in South Africa
- ClinicalTrials.gov ID
- NCT07006246
- Acronym / sponsor ID
- PPREPP-SA / EZ-FV-032
- Conditions
- HIV Infection
- Keywords
- tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), pre-exposure prophylaxis (PrEP), Private Pharmacies, Implementation study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,900 participants (estimated)
- Lead sponsor
- Professor Francois VenterUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 19 May 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tenofovir disoproxil fumarate + lamivudine/emtricitabine (TDF+3TC /FTC) | Other | Drug: 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- Confirmed HIV positive by routine antibody testing
- Presence of symptoms of acute HIV infection*
- Creatinine clearance (eGFR) of:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Tenofovir disoproxil fumarate + lamivudine/emtricitabine (TDF+3TC /FTC) |
Primary outcome
Number of pharmacies providing Prep services over 13 months
Time frame: 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
Time frame: 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.
2 secondary outcomes
To describe provider experiences and perceptions of pharmacy and online-delivered PrEP
Time frame: 13 Months
To describe user experiences and perceptions of pharmacy and online-delivered PrEP
Time frame: 13 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: Yes. After deidentification, the data will be shared with the study participants of the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fanscois Venter, PhD in Medicine principal investigator
Ezintsha, a subdivision of Wits Health Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenofovir disoproxil fumarate + lamivudine/emtricitabine (TDF+3TC /FTC) in people with HIV Infection, run by Professor Francois Venter at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of pharmacies providing Prep services over 13 months (time frame: 13 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.