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)
Study Design
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).
Population
Healthcare workers:
- Adult >18 years men and women working in clinical roles at the selected clinics
- Provide informed consent (only those participating in the qualitative components)
Participants:
Young women (age ≥ 18 years) and men (age ≥ 18 years) who are confirmed HIV negative (by a rapid blood test) at the time of study enrolment and assessed to be of high risk for contracting HIV (those individuals who request PrEP and meet the inclusion criteria will also be eligible for the study).
The eligibility criteria will be in line with the 2021 Guidelines for the Provision of Oral Pre-Exposure Prophylaxis (PrEP) to persons at substantial risk of HIV infection.
Inclusion Criteria: Each participant must meet all the following criteria to be enrolled in this study:
- Adult male (18 years and older) or female 18 years and older)
- 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 (eGFR) ≥ 50 mL/min/1.73m2
- 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: Participants meeting any of the following criteria will be excluded from the study:
- 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 and adolescents ≥16 years
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- 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 a determination made by the nurse conducting the consultation (or the investigator),, based on the medical history of the participant. This includes, but is not limited to:
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- Severe hepatic impairment or history of liver cirrhosis with or without viral hepatitis co-infection.
- Participant is judged by the nurse conducting the consultation (or 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 (at screening/enrolment visit)
*Participants who become pregnant during the study will be eligible to continue in the study, provided they wish to continue taking PrEP. Doctor to complete a pregnancy outcome form (and report on tier.net) if delivery occurs during the trial period.
Pharmacy Sites
Selected Clicks, Dischem and Independent Community Pharmacy Association (ICPA) sites in in Gauteng and the Western Cape.
Drug(s) to be dispensed at selected site
Fixed dose combination: Tenofovir disoproxil fumarate + lamivudine/emtricitabine (TDF+3TC /FTC)
Objectives and Endpoints
Primary Objective
- To evaluate the feasibility, acceptability, and suitability of pharmacies as PrEP initiation sites over 13 months
- To evaluate feasibility and acceptability of a PrEP virtual initiation and continuation package over 13 months
Primary Endpoint
- Uptake rate
- Persistence % Of patients who are satisfied with all components of the intervention
- Qualitative assessment of acceptability and feasibility
Secondary Objectives
- To evaluate in-pharmacy and virtual model provider facilitators and barriers
- To evaluate patient facilitators and barriers
Secondary Endpoints
- Qualitative assessment of provider perceptions on barriers and facilitators to PrEP service delivery and uptake
- Qualitative assessment of user/patient/client/participant perspectives on barriers and facilitators of PrEP service delivery and uptake
Sample Size
Participants:
- 1700 participants to be initiated on oral PrEP in-pharmacy from selected sites in Gauteng and the Western Cape
- 200 participants to be initiated on oral PrEP by making use of the virtual platform
- At least 1 healthcare provider per participating pharmacy (process/outcome/impact assessment)
Study duration
13 months
