Juliane Etima MTN-041 Investigator of Record MUJHU

1. Different views about pregnant and breastfeeding women using PrEP and the ring: What we have learned from MTN-041 Juliane Etima MTN-041 Investigator of Record MUJHU Ensuring Safe HIV Prevention Methods for Pregnant and Breastfeeding Women Kampala, Uganda, 18 June 2019

2. Why MTN-041/MAMMA? • Different groups of people might have different attitudes and views about using oral PrEP or the dapivirine vaginal ring during pregnancy and breastfeeding • Groups include: • These perspectives could influence whether or not a pregnant or breastfeeding women will use PrEP or the ring during this time We wanted to understand whether these groups are willing to use or recommend use of these products during pregnancy and breastfeeding before conducting the DELIVER and B-PROTECTED studies at the same sites

3. Other questions we want to answer through MTN-041: • Do different groups prefer the vaginal ring or oral PrEP during pregnancy and breastfeeding? • What do different groups think and feel about sexual activity during pregnancy or breastfeeding? • Would a vaginal ring or oral PrEP affect sexual activity? • Do they feel women are at risk of HIV during pregnancy or breastfeeding? • What community beliefs or practices may be taboo or encouraged during pregnancy or breastfeeding? Would these affect use of the vaginal ring or oral PrEP?

4. Study Design & Sites Focus group discussions and in-depth interviews were conducted in order to understand or answer these questions • Uganda - 68 • Kampala (MU-JHU) • Malawi - 51 • Blantyre (JHU-CTU) • Zimbabwe - 60 • Zengeza (UZCHS-CTRC) • South Africa - 53 • Johannesburg (Wits RHI) 232 MAMMA participants

5. What is a focus group discussion and why do we do it? • A conversation about a particular topic involving about 4-12 people who share certain characteristics (ex: women of a certain age) • A facilitator to lead the conversation and a note-taker • Discussions are recorded with permission • Length of discussion ranged from 2 to 4 and a half hours • We conduct focus group discussions because: • Group dialogue triggers the sharing of ideas • Exposes diverse opinions and ideas as well as identifies where there is group consensus

6. Focus group discussions were conducted with three different groups of people • Pregnant and Breastfeeding Women : HIV-uninfected women, ages 18-40, currently pregnant or breastfeeding or had been within the previous two years • Male Partners : Aged 18 or older with a partner who was currently pregnant or breastfeeding or had been within the previous two years • Grandmothers: With a daughter/daughter- in-law currently pregnant or breastfeeding or had been within the previous two years

7. What is an in-depth interviewand why do we do it? • Face-to-face conversation between a researcher and a study participant • Semi-structured guide (questions) • Open-ended questions • Participants answers in their own words (cannot be answered with “yes” or “no”) • Recorded with permission • Length of interview ranged from 1 to 2 and half hours • We conduct in-depth interviews to: • To understand an individual’s feelings, opinions, and experiences about a particular topic • To address sensitive topics that a person might not want to share in group settings

8. In-Depth Interviews were conducted with “Key Informants” • 10 in-depth interviews were conducted at MU-JHU with: • Midwives (3) • Religious leaders (3) • Traditional care providers (2) • A clinical doctor • A local leader • 7 Female, 3 male • Median age was 48

9. The information on the following slides is specific to Uganda MUJHU

10. Awareness of HIV Prevention Methods MUJHU

11. Male Partner Focus Group Discussions • 2 focus groups were conducted, one with 9 men and one with 10 men • Average age: 31 • Most men: • Were married or living with partner (84%) • Had partners who were currently not pregnant (58%) • Earned an income of their own (90%) MUJHU

12. Grandmother Focus Group Discussions • Two focus groups took place, one with 9 participants and one with 12 participants • Median age: 44 • Most grandmothers: • Lived with their children (86%) • Earned an income of their own (91%) • Had not completed secondary education (71%) MUJHU

13. Pregnant & Breastfeeding Women Focus Group Discussions • Two focus groups were conducted, each with 9 women • Median age: 27 • Most women: • Were Christian (94%) • Were currently pregnant (65%) • Earned an income of their own (70%) • Had not completed secondary education (78%) • Lived in a household with a mobile telephone (100%) • Of note: • Over a quarter worried about not having enough food more than 3 times in past 4 weeks (40%) MUJHU

14. Pregnant & Breastfeeding Women • When asked about their previous use of HIV prevention methods: • Most had used male condoms (89%) • None had ever used female condoms, oral PrEP, vaginal gel or vaginal ring • These prevention methods are still under research so mostly women who have participated in these researches would have used them MUJHU

15. Pregnant & Breastfeeding WomenWho they live with… Spouse/partner: 83% Children: 61% Mother and/or father: 6% Sibling(s): 6% Note: Numbers add up to more than 100% because this was a ‘Check all that apply’ question MUJHU

16. Who makes decisions about a woman’s antenatal care and HIV testing? • Less than half of pregnant and breastfeeding women said they make joint decisions about a woman’s antenatal care and HIV testing (44%), while a majority of male partners reported joint decision making on this topic (63%) • Note: The male partners in the study were not the partners of the pregnant and breastfeeding women MUJHU

17. Who makes decisions about a woman’s medication and vitamin use during pregnancy? • Over half of pregnant and breastfeeding women said the woman herself makes decisions around medication and vitamin use (61%), while a majority of men said decisions were made jointly (58%) • Women and men agreed that male partners do not make decisions alone on this topic (only 1 man reported that he decides) MUJHU

18. Who do women listen to most during pregnancy? Pregnant & breastfeeding women said: MUJHU

19. (1) Is there a belief that pregnant women are at risk for HIV? YES Across all groups, it was recognized that pregnancy is a period of high risk. Some of the reasons they cited were: • Biological factors: • Weak immune system • Behavioral factors: • Women’s engagement in sex work for “survival” (e.g. meet basic needs, support pregnancy/family) • Women’s increase in multiple partners because they are no longer trying to avoid pregnancy • Women’s inability to negotiate condom use • Women’s increased/decreased desire for sex • Women’s risk for rape MUJHU

20. (2) Is there a belief that pregnant women are at risk for HIV? • AdditionalBehavioral factors: • Men avoid HIV testing and assume their status is the same as their partner’s • Men dislike using condoms with married partners • Other men’s attractiveness to pregnant women (may lead women to have multiple partners) • Belief that their vaginas are more enjoyable • Men’s lack of attraction to or interest in pregnant partner (leads them to seek other sexual partners) • Women’s hormonal changes can result in decreased sex drive and negative attitudes toward male partners (driving men to find sex elsewhere) • Concern about hurting baby when having sex (particularly later in pregnancy) • Periods of time without sex due to cultural beliefs (stopping sex around the 6 0r 7th month of pregnancy) MUJHU

21. HIV Prevention Products • A 6-minute video which described the two HIV prevention products was shown to participants • Participants were also shown sample products at this time (oral PrEP pills and vaginal ring)

22. Motivations for Product Use: Perspectives from all study groups • Protection of woman and baby • Including healthy pregnancy outcome • Emphasis on staying healthy as a person AND as a family • “If I am HIV positive and my wife is HIV negative and we have children in the home, …we want our children to have good life, I can allow the wife to take these tablets (Oral PrEP tablets). Even if I die, the wife can stay alive and take care of the children.” • (Papa, Male Partner) • Recognition in several focus group discussions that preference for pills vs. ring is a matter of personal preference MUJHU

23. What do people like about PrEP that would help in using it? • Familiarity with daily pills • For couples in which one partner has HIV, protection for HIV-negative partner • Can be taken without partner's knowledge • Women see PrEP as an option if their partner refuses HIV testing • Dissolves and does not stay as a foreign object in body • Protection of mother and baby • Peace of mind • Perception that pills are: • “tested,” “approved,” “supported around the world,” “have no side effects” • Endorsement by health care providers would be important • “I would think that my daughter is okay since she has started using pills as a method of HIV prevention even if her husband has other sexual partners she is protected and I would feel happy.” • (Jenifer, Grandmother) MUJHU

24. What did groups say were potential barriers to using oral PrEP? • Lack of male partner support • Lack of education/not “understanding” • Rumors related to HIV stigma in the community • Lack of leadership support (e.g. government, health care providers, family, etc.) • Religious beliefs/practices • Some religions do not allow uptake of drugs MUJHU

25. (2) What did groups say were product-specific barriers to using oral PrEP? • Big size, perceived bitter taste • Dosing regimen related: • Concerns about forgetting • Particularly for young mothers • Concern that accumulation of pills in the body may cause harm over time • Pill burden (e.g. tedious and demanding) Why take a daily pill if you’re not sick? • Interaction with other drugs (e.g. blood pressure) • Stigma: packaging, color, similarities to ART • Not familiar with using pills as a way to prevent HIV • Fear pregnant women or male partners will become more promiscuous • May increase women’s HIV risk • Side effects in general: weight loss/gain, hunger patterns, bleeding “Some women fear taking daily tablets…and her partner might ask “Why are you taking that tablet?” he might think that “This woman got infected and she never told me.” You know you can’t hide something forever to a partner you stay with at home, he might get to know about it and it brings trouble to you.” (Carol, Female) MUJHU

26. What about using oral PrEP during pregnancy? Concerns about: • Fetal health: • Association with miscarriage • Adverse pregnancy outcomes (e.g. deformities) • Belief that fetus is particularly vulnerable “early on” (2-4 mo.) • Worsening of pregnancy side effects (e.g. fatigue, vomiting, dizziness, headache) • “I heard that when you take those pills you get a miscarriage. Now, how sure am I that when I take it I will not get a miscarriage. I have seen someone before who started taking it and got a miscarriage. She was about three months pregnant and she got a miscarriage.” • (Samantha, Female) • “…what if she takes the pill and it affects the baby? Sometimes some of these pills are acidic so they may burn the baby which is inside so there is that effect, the baby may be born with some of the body parts burnt or soft or deformed which is not good.” • (Traditional Birth Attendant) MUJHU

27. What do people like about the vaginal ring that would help in using it? • Monthly dosing regimen and discreetness • Peace of mind (low stress) • Easier to remember • Hidden from male partners and others • Avoid gossip/rumors • Drug is only in the vagina • Protection for women at risk for sexual violence/rape • Endorsement by health care providers would be important “If the woman has that vaginal ring as you said that it is inserted for a month, it means that the woman moves while protected and if she finds a man who rapes her, she is protected from HIV. It is not that I support rape but to be able to protect herself from things that can happen to her, she is better off having the ring inserted. (Karim, Male Partner) MUJHU

28. What did groups say were potential barriers to using a vaginal ring ? • Lack of male partner support • Lack of familiarity with method (vaginal insertion) • Mistrust in clinical trials • Community level barriers: • Lack of education • Potential for the ring to introduce mistrust in relationships “You will definitely get infected because you told us that when you are inserting it you have to make sure it is in shape of number eight yet when you are inserting it you can’t tell whether it is in shape of number eight. How will you tell that it is in shape of eight or not?”(Maureen, Female) MUJHU

29. What did groups say were potential product-specific barriers to using a vaginal ring ? • Big, hard, “scary” • Discomfort/fear of inserting wrongly • Concern it will tighten/enlarge the vagina • Interference with sex: • Impact on sexual desire • Male partner may feel it • Penis may go through ring • Interference with menstrual cycle • Stays inside for one month • Not hygienic • Notion that VR would cause possible vaginal infection or reproductive cancer • Concern that ring will move out of place or get lost in body • Concern about women hurting themselves when removing the ring (e.g. scratching herself) MUJHU

30. What about using the vaginal ring during pregnancy? Concerns: • May add to the physical discomfort of pregnancy • Related to vaginal insertion and placement of ring in the vagina • Fear/taboo of inserting products vaginally during pregnancy • may lead to questions about attempted abortion • Concern about the impact on development of baby • Concern about delivery if vaginal ring is not removed • e.g. strangling, hurting or blocking the baby MUJHU

31. Who has the most influence on a woman’s decisions during pregnancy? Perspectives from all groups • What about their male partners? • Differing opinions among pregnant and breastfeeding women about how involved a male partner be in a decision to use either product • Men desire involvement • Who are the most important voices in the community? • Health care providers • Seen to be more knowledgeable • Mothers/elders • Advise daughters on care seeking (e.g. biomedical/traditional) • Mostly involved in decision making for first pregnancies and for young mothers, especially in remote areas with limited access to care • Provide financial and nutritional support • Who are other trusted voices in the community? • Community/religious leaders • Traditional counselors, traditional birth attendants, healers, and practitioners MUJHU

32. Would women use these products during pregnancy? • Across all groups, pregnancy is perceived as a high-risk period and participants were willing to use/recommend use of products if: • Guaranteed safe for woman and baby • Health care provider prescribed and endorsed • Thorough education is provided NOT just to pregnant and breastfeeding women but also to: • Male partners • Health care providers • Community members/family • Religious leaders • Traditional health care providers MUJHU

33. Practical Recommendations: • Product education: • Explain what we know and don’t know (e.g. safety for non-pregnant women, address “tested/approved” belief) • Explain product mechanism of action, side effects • Product use ambassadors • Power of testimonials from real users and pregnant and breastfeeding women MUJHU

34. Practical Recommendations: Oral PrEP • Clarify flexibility of time for dosing for oral PrEP • Consider strategies to address HIV stigma in the community • Give details on side effects MUJHU

35. Practical Recommendations: Vaginal Ring • Need for more product information • Pregnancy-specific anatomy education to address: • Insertion/removal process • Location of vaginal ring in body • Explanation of side effects MUJHU

36. Practical Recommendations about Male Partners • Education efforts targeted to male partners • Men offer support as long as they are fully informed and involved in decision making “from the beginning” • Counseling on male partner disclosure (tailored to participant circumstance) MUJHU

37. Discussion