AXIS – (Gauteng only)
Protocol Synopsis:
Title: Acceptability and feasibility of injectable cabotegravir pre-exposure prophylaxis (PrEP) versus oral PrEP in routine care up to 15 months in private pharmacies in South Africa
Short Title: AXIS Protocol
Number: EZ-FV-035
Principal Investigator: Professor WD Francois Venter
Co-ordinating Investigator: Dr Simiso Sokhela
Study Design: This is a mixed methods study employing a convergence model triangulation design. Sexually active, young women and men starting PrEP at private pharmacies will be consented and offered either CAB- LA, oral PrEP(TDF/FTC[3TC]) or PrEP deferment at each of their routine visits, with the option to move between either option, up to 15 months, with a final exit-interview after transition to standard-of care.
Population: The study aims to recruit populations at risk of HIV acquisition accessing PrEP services in routine care, to assess future offerings of CAB- LA in the PrEP care package.
Inclusion Criteria Each participant must meet all of the following criteria to be enrolled in this study:
- 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)
- Is self-reported sexually active.
- Body weight ≥35 kilograms.
- Creatinine clearance ≥ 60 mL/min
- Willingness to sign informed consent.
Exclusion Criteria Participants meeting the following criteria will be excluded from participating in the study:
- Symptoms of HIV seroconversion (Table 1).
- Pregnant (participant must have a negative beta human chorionic gonadotrophin (b-hCG) urine test at screening) or lactating women, or women intending to become pregnant or breastfeed during the study.
- Is in good health, with no surgical or medical condition which may significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the volunteer or the objectives of the study or impair their ability to comply with the dosing schedule and/or protocol evaluations. The Investigator should make this determination in consideration of the volunteer’s medical history. This including, but not limited to, the following: a. Severe hepatic impairment, history of liver cirrhosis with or without viral hepatitis co-infection b. Unstable or poorly controlled seizure disorder c. History of coagulopathies, or current or anticipated need for chronic anticoagulation d. Presence of a tattoo or other dermatological condition overlying the gluteus region which would realistically obstruct administration of an intramuscular injection.
- Known hypersensitivity to or specific contraindications to the use of TDF or FTC/3TC or CAB-LA.
- Hep B surface antigen positive or known active Hep B infection.
- Is receiving or has received the following agents within 28 days prior to screening, and cannot discontinue their use for the duration of the study:
- tuberculosis therapy (i.e., rifampicin, rifapentine, rifabutin)
- anticoagulation agents;
- anti-convulsants (e.g. carbamazepine, oxcarbazepine, phenobarbital, phenytoin);
- herbal products (e.g. St John’s Wort)
- Concurrent use of PrEP from a different medical provider, other than the study site
- 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, including plans to move out the study geographical area in the next 12 months or otherwise unable to participate in the study visits as determined by the PI.
Drug Interventions: Cabotegravir (CAB) LA OR Tenofovir disoproxil fumarate + Emtricitabine/Lamivudine (TDF/FTC[3TC]) OR PrEP deferment.
Objectives and Endpoints
Primary Objective
- To describe acceptability of CAB-LA PrEP, amongst different PrEP modalities, including PrEP deferment, in eligible men and women.
Primary Endpoint
- Acceptability of CAB-LA as determined by qualitative and quantitative assessment using piloted and validated semi-structuredquestionnaires for acceptability. (Quantitative data will be expressed as ratios)
- Acceptability of Intervention Measure (AIM)/ Intervention Appropriateness Measure/ (IAM), at 12 months and end of study. (Expressed as ratios where applicable)
Secondary Objectives
- To describe feasibility of CAB-LA PrEP implementation, amongst different PrEP modalities, including PrEP deferment, in eligible men and women.
- To describe the association of socio-demographic factors, reported sexual behaviour, PrEP knowledge and previous PrEP use on PrEP choice.
- To describe the uptake, persistence and patterns of transition on each form of PrEP.
- To describe a risk profile of those taking up both PrEP regimens, as well as those deferring PrEP.
- To describe operational suggestions from the participants regarding how health services could be improved regarding better/more comfortable/faster/cheaper/other add-on sexual reproductive services
- To describe the provider experiences and perceptions of CAB-LA PrEP implementation, amongst different PrEP modalities, including PrEP deferment, in eligible men and women.
- To describe participant willingness[1]to-pay for PrEP services at the end of the study.
Secondary Endpoints
- Feasibility of CAB-LA as determined by qualitative and quantitative assessment using piloted or validated semi-structured questionnaires and on feasibility conducted with participants and healthcare workers.
- Feasibility of Intervention Measure (FIM) completed by healthcare workers at exit and participants at 12 months and end of study.
RE-AIM indicators
- Tests of association between PrEP choice and selected predictor variables.
- Proportion of individuals who are using each type of PrEP collected at study start, month 12 and end of study
- Attending all study visits/retention extracted from participant EDC visit forms.
- Willingness to take CAB-LA for the entire study duration extracted from participant EDC forms
- Willingness to take CAB-LA post study stop collected at end of study using semi-structured interviews.
- Extent to which the study staff could easily administer CAB-LA.
- Healthcare worker perspectives on maintenance, demand creation and service delivery post study completion collected during a focus group discussion conducted at the end of the study.
- Willingness to pay for CAB-LA collected at the end of the study using semi-structured interviews.
Sample Size: 200 participants
Follow Up: Up to 18 month:
