1. PARTNERS DEMONSTRATION PROJECT Experiences of PrEP Discontinuation in African HIV Serodiscordant Couples: Qualitative Results from the Partners Demonstration Project Monique A. Wyatt, Emily E. Pisarski, Melanie Tam, Edith Nakku-Joloba, Timothy R. Muwonge, Elly T. Katabira, Norma C. Ware AIDS 2016, Durban, South Africa

2. Disclosures I have no conflicts of interest to disclose.

3. Background Updated treatment guidelines recommend ART as pre-exposure prophylaxis for all individuals at substantial risk for HIV. PrEP is taken during limited periods of high risk exposure and discontinued when transmission risk is reduced. Understanding user experiences of PrEP uptake and discontinuation will inform future implementation efforts in public health settings.

4. The Partners Demonstration Project Open-label, prospective implementation study that evaluated an integrated strategy of delivering PrEP and ART to HIV serodiscordant couples All HIV-uninfected partners were offered daily oral FTC/TDF and HIV-infected partners were offered ART according to national guidelines. PrEP was discontinued when the infected partner had been taking ART for at least 6 months.

5. Qualitative Study Design Qualitative evaluation study at the Partners Demonstration Project site in Kampala, Uganda Multiple in-depth interviews with a subset of 48 couples were conducted. Interview topics explored understandings of PrEP and ART, adherence, experiences of PrEP use and discontinuation. Interviews were audio-recorded, transcribed into English and coded using Atlas.ti software.

6. Data Analysis Coded data were inductively analyzed to identify themes on PrEP use and discontinuation. Categories representing the themes were developed and organized to describe user preferences for discontinuing PrEP.

7. Results: Participant Characteristics Characteristics of HIV-uninfected Partners (N=48) % (IQR) Gender (Female) 56% Age (Median) 32 (IQR 26-37) Initiated PrEP90% Days on PrEP before PrEP Stop (Median)252 days (IQR 168-378) Reason for PrEP Stop Reached “bridge” Pregnancy Other reasons Suspected seroconversion 70% 14% 2%

8. Initial Doubts about PrEP HIV-uninfected participants expressed concerns about PrEP efficacy. They worried about possible side effects and felt taking pills when not sick would “be harmful” to their health. Taking medicine for HIV prevention was a new concept for them.

9. Concerns About PrEP “I was worried to take a drug that I did not know or had ever even heard about.… Between the screening and enrolment visit, I was thinking a lot about [PrEP]. First I was asking myself how I can take medicine when I am not sick. The medicine that was talked about, I had never heard about it not even once in my life.” Male, Age 35

10. Confidence in PrEP for Protection As users adjusted to taking PrEP, fears diminished. Side effects were manageable and disappeared quickly. Study staff reassured couples about the importance of PrEP as part of a combination package of HIV prevention tools. Repeated HIV-negative tests reinforced PrEP efficacy in preventing HIV and established “trust” in PrEP.

11. Growing Confidence in PrEP “I did not really believe at first that PrEP would protect me. However, I really got surprised and confirmed that PrEP can protect against HIV. I confirmed from my experience. I myself am the testimony since an accident happened. The condom broke. I conceived and gave birth to an HIV negative child…. When I went back to the clinic… they used to test me for HIV but I would still test negative, so I am the evidence.” Female, Age 23

12. Experiences of PrEP Discontinuation Participants understood that PrEP use was time- limited and they would discontinue once their infected partner took ART for at least 6 months. Although some were happy and “relieved” to stop taking PrEP, most preferred to remain on PrEP.

13. Worries about PrEP Stop “[The doctor said,] ’When we tell you that we are going to stop you from taking PrEP, have you got any worries about that?’ And I said, ‘Yes, I have got some worries’. And the doctor asked me, ‘Why?’ I told the doctor: ‘Before I was taking PrEP and I was confident knowing that I will not be infected with the HIV virus, but now when you stop me from taking PrEP, I get some worries.’” Male, Age 27

14. PrEP Stop Increases Sense of Risk Discontinuing PrEP resulted in a heightened sense of risk in HIV-uninfected individuals. They were worried that they were no longer protected against HIV. Some were unable to negotiate consistent condom use and/or had active fertility intentions. Concerns about their partner’s “commitment” to ART adherence also increased fears about HIV risk.

15. Preferences to Remain on PrEP Most uninfected partners in serodiscordant relationships preferred to remain on PrEP for “added protection.” They felt “safer” using PrEP than relying on condoms alone. They were reluctant to rely on their HIV-infected partner for HIV protection.

16. ART for HIV Prevention The concept of an infected partner taking ART to prevent HIV acquisition in the uninfected partner was difficult for serodiscordant couples to understand. “What I am trying to say is that I know ART works but you cannot tell me that it can be used to reduce the chances of infecting another with HIV. It may be true but I do not believe such. I believe that it can be used by that person himself … who has the virus.” Male, Age 34

17. Lack of Confidence in ART for Prevention Uninfected partners lacked confidence in ART to protect them from HIV. Distrust in ART for prevention explains partners’ reluctance to discontinue PrEP. “I was worried about being with my husband, because as I told you I do not have confidence in the medicine ART which he takes. I have confidence in the medicine which I was taking, PrEP. It is not harmful, and I cannot acquire HIV when I take it.” Female, Age 26

18. Summary Most HIV-uninfected partners in serodiscordant relationships in our study sample preferred to remain on PrEP. PrEP gave uninfected individuals the opportunity to play an active role in their HIV prevention choices and be in control of their own health. Resistance to discontinuing PrEP may be explained by lack of confidence in ART to prevent HIV acquisition in uninfected partners.

19. Implications Messaging about PrEP discontinuation should address users’ concerns about HIV risk following PrEP stop. More education about how ART prevents HIV transmission to uninfected partners after PrEP discontinuation may help to dispel fears. A greater emphasis in counseling on helping serodiscordant couples develop confidence in ART for prevention may reduce reluctance to discontinue PrEP.

20. Acknowledgements Kampala, Uganda data collection team: –Vicent Kaciita –Grace Kakoola –Brenda Kamusiimwe –Florence Nambi National Institutes of Health (R01 MH101027) Serodiscordant couples who participated in the study

21. The Partners Demonstration Project is made possible by the United States National Institutes of Health, the Bill and Melinda Gates Foundation, and the generous support of the American people through the United States Agency for International Development. The contents are the responsibility of the University of Washington and study partners and do not necessarily reflect the views of any of the study sponsors or the United States Government. Investigators –University of Washington Coordinating Center: Jared Baeten (protocol chair), Connie Celum (protocol co-chair), Renee Heffron (project director), Deborah Donnell (protocol statistician), Ruanne Barnabas, ICRC Operations, Data and Administration teams –Kabwohe, Uganda (KCRC): Stephen Asiimwe, Edna Tindimwebwa –Kampala, Uganda (Makerere University): Elly Katabira, Nulu Bulya –Kisumu, Kenya (KEMRI): Elizabeth Bukusi, Josephine Odoyo –Thika, Kenya (KEMRI): Nelly Mugo, Kenneth Ngure –MGH/Harvard: Jessica Haberer, Norma Ware –Johns Hopkins: Craig Hendrix, Mark Marzinke –DF/Net Research (data management) Funders –US National Institutes of Health (grants R01 MH095507, R01 MH100940, R01 MH101027, R21 AI104449, K99 HD076679, R00 HD076679) –Bill & Melinda Gates Foundation (grants OPP47674, OPP1056051) –US Agency for International Development (contract AID-OAA-A-12-00023) Research participants Partners Demonstration Project Team