HIV PrEP Formulation Preference among Women in the Qualitative Component of the MTN-020/ASPIRE Study Ariane van der Straten1,7, Mary Kate Shapley-Quinn1, Krishnaveni Reddy2 , Helen Cheng1, Juliane Etima3, Kubashni Woeber4, Petina Musara5, Thesla Palanee-Phillips2, Jared Baeten6, Elizabeth T. Montgomery1 on behalf of the MTN-020/ASPIRE study team 1Women’s Global Health Imperative (WGHI) RTI International, San Francisco, CA, USA; 2 Wits Reproductive Health and HIV Institute (Wits RHI), Johannesburg, South Africa; 3Makerere University – Johns Hopkins University Research Collaboration, Kampala, Uganda; 4Medical Research Council, Durban, South Africa; 5UZ- UCSF Collaborative Research Programme, Harare, Zimbabwe; 6University of Washington, Seattle, WA, USA; 7Center for AIDS Prevention Studies (CAPS), University of California San Francisco, CA, USA

Study setting and design Potential product formulations for HIV prevention: visual tool ASPIRE: Phase 3 trial of a monthly dapivirine vaginal ring in Africa. ASPIRE Qualitative Component: Conducted at 6 ASPIRE sites in 4 countries: South Africa, Uganda, Malawi & Zimbabwe. We explored preference among 9 PrEP formulations in a subsample (N=71) of women receiving exit In-Depth Interview (IDI). Participants were asked to select most and least preferred products and explain their choice(s), including what attributes of the product were (un)appealing compared to others

HIV PrEP: Product Formulations and Preferences Short-acting (coital or daily) Long-acting Preferred:

Highlight of Attributes’ Preferences Components of acceptability Favorable views (e.g.) Unfavorable views (e.g.) Efficacy and safety Known efficacy (condoms) Continuous protection (ring) Reversibility (ring; condom) Unreliable (condom, pills) Systemic toxicity (injection) S.E such as weight gain Product attributes LA/ infrequent administration Simple/easy to apply (injection) Removable (ring) Daily/frequent administration Vaginal route (gel, film, insert) Painful, invasive (implant) Use attributes Familiarity (FP method, ring) Low use burden (implant) Discreet (injections) Unknown formulation (film) Forgettable (pills, condoms) Noticeable (implant) Sexual encounter Protects in all sexual situations (LA method) Requires planning (coital meth.) Noticeable (gel, condom) Partner’s attitude Not felt or seen (injection, ring) Requires his approval (gel)

Conclusions Duration of protection, low user burden, and discreetness were favored attributes of long-acting formulations. However, the appeal for injections or implants was mitigated  by concerns with pain upon administration, invasiveness, low reversibility and potential toxicity. Being tedious to use and unreliable/easy to forget were salient unfavorable attributes for short-acting (daily & coital) products. For several participants high product efficacy (hypothetical or real) trumped formulation. Products administered vaginally were less favored among younger women (age <25). In the case of the ring, dislike for vaginal administration was mitigated by infrequent (monthly) re-administration, perceived safety, lack of side effects, familiarity, comfort and discretion once in place. Knowledge of contraceptive methods (based on perceptions or experience) influenced formulation & attribute preferences for HIV PrEP.

Acknowledgements We are grateful to the women who participated in the ASPIRE qualitative study, to the study staff, to the communities who partnered with us to conduct the trial, and to all of our collaborators. The Microbicide Trials Network is funded by the National Institute of Allergy and Infectious Diseases (UM1AI068633, UM1AI068615, UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health

Preferences regarding long-acting HIV PrEP formulations Favorable Unfavorable I am afraid ...I don’t know how it is going to be like in my body [the injection], I don’t know if it is going to affect my health. (South Africa, age 23) Ease of administration Familiarity It [ring] doesn’t give me a tough time, because once you have inserted it, you are done, unlike the pills, which you have to be taking daily, and sometimes you can forget. (Malawi, age 19) …I would use an injection because I normally use it [inject] every 3 months for family planning. (South Africa, age 42) Efficacy Safety/toxicity …You just know that if it has been inserted [the implant] for 3 years you know that I am living with something that is protecting me and you won’t have to worry about …I forgot to take the pill or I have forgotten to insert the vaginal film. (Zimbabwe, age 24) Discretion Pain/discomfort I would go for that which is inserted in the arm [implant].. because no one can ever tell that I am using it & I would be protected all the time. (Uganda, age 26) I am afraid of the implant, I do not like it. I used to see people who insert it, my sister, their arms are blue as if a person has been beaten. (South Africa, age 27)

Preferences regarding short-acting HIV PrEP formulations Ease of Administration Favorable Unfavorable Discretion I’m scared of anything that goes inside me like this paper [vaginal film]. (South Africa, age 18) Because you should ask for the gel every time you have a sexual desire. I feel it cannot be good. A good method can be a ring because once inserted even your sexual partner cannot know that you have it. (Malawi, age 24) Efficacy and safety Familiarity I do not like these oral tablets because even those for family planning we forget to take them and end up being pregnant. (Zimbabwe, age 31) I do not know how this one works [vaginal gel], I know that one [ring]. (South Africa, age 27) Efficacy Condom is a sure thing to protect against HIV. (South Africa, age 30) Familiarity I prefer the condoms because I have used a condom before. (Uganda, age 25)