The words we use matter in the response to HIV

Effective communication plays a crucial role in shaping attitudes and perceptions surrounding HIV. This content emphasizes the importance of using language that empowers and respects individuals living with HIV, while also highlighting key study objectives related to PrEP acceptance and delivery methods.

• HIV response
• Positive language
• Study objectives
• PrEP acceptance
• Effective communication

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1. The words we use matter in the response to HIV This slide is a note to the author please read, then delete Do Don't... label people as: HIV-infected; infected; co-infected; cases; carriers; victims; patients; sufferers. use: people or person living with HIV; person or people with COVID-19; person or people with TB; person or people living with HIV and TB; healthcare seekers or clients. spell out the names of key populations: gay men and other men who have sex with men sex workers and their clients trans people people who inject drugs people in prisons and other closed settings use acronyms for key and vulnerable populations unless you have genuine space constraints, possibly in a graphic. talk of the response to HIV or COVID-19 and ending the HIV pandemic as a public health threat. use war talk and fearmonger. 22 26 July Munich, Germany and virtual aids2024.org

2. Angela Tembo, Ezintsha, University of the Witwatersrand, Johanneburg Welcome to the era of PrEP choice Early learning from delivery of PrEP choice in AXIS 22 26 July Munich, Germany and virtual aids2024.org

3. Study objectives Primary Objective: To describe acceptability of CAB-LA PrEP, amongst different PrEP modalities, including PrEP deferment, in eligible men and women. Secondary Objectives 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 . To describe the provider experiences and perceptions of CAB-LA PrEP implementation To describe participant willingness-to-pay for PrEP services at the end of the study. 22 26 July Munich, Germany and virtual aids2024.org

4. Study design Observational (phase 3B) clinical trial embedded in private pharmacy implementation project (PREPP-SA) Private pharmacies are already a site for immunizations and injectable contraceptives. Also played a major role in providing SARS-CoV-2 vaccines Procedures: Offered either CAB-LA, oral PrEP (TDF/FTC[3TC]), or PrEP deferment Option to switch between options for up to 15 months (followed up to 18months) Baseline/ 1 year and exit interviews Up to 9 study visits Sites: 3 pharmacies in Johannesburg (RSA) Sample size: 200 participants 22 26 July Munich, Germany and virtual aids2024.org

5. Project timelines September 2023 Ethics approval February 2024 Arrival of product March 2024 Start of enrolment February 2026 LPLV 22 26 July Munich, Germany and virtual aids2024.org

6. Enrolment progress AXIS month 4 of implementation 200 184 participants were screened with 172 (93%) enrolling on AXIS. 180 160 140 132/172 (77%) opted for CAB LA 120 Number of people 117/172 (68%) men initiated on PrEP 100 80 84/117 (72%) men on CAB LA 60 48/55 (87%) of females on CAB LA 40 20 12 screen failures (HIV positive, pregnancy, others) 0 Total 184 172 132 40 Men 121 117 84 33 Women 63 55 48 7 Screened Iniated PrEP CAB LA Oral Screened Iniated PrEP CAB LA Oral 22 26 July Munich, Germany and virtual aids2024.org Source: REDCap (Accessed 8 July 2024)

7. Enrolment progress Participants enrolled by age and PrEP choice 120 101 100 81 80 142/172 (83%) aged 18 24 years 71 Number of people 60 51 40 20 20 20 0 Total CAB-LA Oral 18-25 26-35 22 26 July Munich, Germany and virtual aids2024.org Source: REDCap (Accessed 8 July 2024)

8. Continuation & switching 34/64 (53%) participants that were due for month 1 came back No of people Sex Reasons for switching CAB LA to Oral 1 Women Hip joint pain 2 participants (1 male and 1 female) switched products Oral to CAB LA 1 Men Personal preference Source: REDCap (Accessed 8 July 2024) 22 26 July Munich, Germany and virtual aids2024.org

9. Side effects reported after injection 32mm or 38mm length needle with 22g gauge used to administer injection (depending on BMI) At enrolment 2 AE s reported after injection 1 injection site pain 1 nausea At month 1 18 AE s reported at Month 1 2 injection site reactions 16 injection site pain 22 26 July Munich, Germany and virtual aids2024.org

10. Qualitative interviews insights (over 100 interviews conducted at baseline) Most clients had some basic knowledge of PrEP. Clients expressed a stronger preference for long-acting injectable PrEP over daily oral PrEP pills for varying reasons including adherence, pill size, convenience, ease of use, being prepared/safety. It was noted that oral PrEP is still important for people who fear needles and those who are used to taking oral medication chronically (like older people). Views on injection Views on switching PrEP time during the study Ideal injection preference It (pills) was too big for my liking. It was too big to swallow, and I felt like I don't need it. I'm just doing it for safety's sake. It's not that I might get (sex), you know, it's not that I was, like, busy busy. ... That's why I thought, like, the injection is going to be more effective for people who can't be consistent like me. AX-01-001, 20 years old Female It shouldn't have pain... For so many days. That heart pumping. It's not comfortable (referring to swelling)... Sometimes, on your left leg, your left leg, it's stiff like this. (Size of needle and side effects), I don't mind. Honestly, I don't mind. AX-03-003, 20 years old Female Consistency is going to be a problem .. If you just going from pill and injection, pill and injection its hard for you to actually adapt. I feel like one day you are going to make a mistake and then one day turns to two days and three days AX-01-65, 24 years old Male It's convenient, but I don't think I'm going to switch, not just my fear of needles. AX-02-057, 32 years old Male It should be quick and painless. In, out don t be rough, be bump lasting a week (swelling). AX-03-27, 20 years old Male I wouldn't know, but I think speaking to one thing would be better than switching over. If you find something working for you, I don't think switching over would be a good idea. Maybe the side effects, they are not the same, or maybe you don't react the same way to the other one. AX-03-005, 27 years old Female gentle Just a CAB LA, it's convenient because it's injectable. It's in your body, you won't forget it. Pills, it's not really convenient. It's like you always have to carry the pills around you and then you get to be asked questions. What's that? You know, you get to be criticized. About the injections, nobody knows what. AX-03-005, 27 years old Female 22 26 July Munich, Germany and virtual aids2024.org

11. Challenges and mitigations All processes (recruitment, clinic flow, etc) were in place in pharmacies due to the main implementation project already running in pharmacies. Study was approved as Phase 3b trial due to the use of trial- manufactured IP as there is currently no commercial stock despite SAHPRA approval of CAB-LA for PrEP. Phase 3b clinical trial requires investigator oversight: The project could only be implemented close to pharmacies near the Ezintsha clinical trials site. Pharmacy staff received training to conduct clinical trials for compliance with regulations. Additional resources were required to comply with clinical trial regulations such as emergency trolleys. 22 26 July Munich, Germany and virtual aids2024.org

12. Key lessons 1. Overall, CAB LA is popular for both male and female participants 77% opted for CAB LA 2 people switched from their initial method of choice Availability of choice attracts more men 2. Pharmacy nurses are comfortable with offering CAB LA to clients 67% injections administered upper outer dorsogluteal vs ventrogluteal 3. The injection is well tolerated: 2 injection site reactions reported thus far. 17/132 (13%) who received CAB LA experienced injection pain (11 on the left side and 6 on the right side) 22 26 July Munich, Germany and virtual aids2024.org

13. PICASSO The Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options (PICASSO) Trial is a two-phase interventional study to identify the optimally safe and effective ART regimen for individuals with newly detected HIV infection after recent CAB-LA PrEP exposure Objectives To evaluate the efficacy of TLD as first-line antiretroviral therapy (ART) in participants with HIV-1 infection and CAB-LA PrEP exposure in the past 12 months To describe the epidemiology (i.e., prevalence and correlates) of HIV drug resistance patterns in participants with HIV-1 infection and prior CAB-LA PrEP exposure Progress: Ethics approvals received Contracting underway 22 26 July Munich, Germany and virtual aids2024.org

14. 22 26 July Munich, Germany and virtual aids2024.org