Browsing by Author "Montgomery, Elizabeth T."

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    Acceptability and use of a dapivirine vaginal ring in a phase III trial
    (AIDS (London, England), 2017) Montgomery, Elizabeth T.; Straten, Ariane van der; Chitukuta, Miria; Reddy, Krishnaveni; Woeber, Kubashni; Atujuna, Millicent; Bekker, Linda-Gail; Etima, Juliane; Nakyanzi, Teopista; Mayo, Ashley J.; Katz, Ariana; Laborde, Nicole; Grossman, Cynthia I.; Soto-Torres, Lydia; Palanee-Phillips, Thesla; Baeten, Jared M.
    The MTN-020/ASPIRE trial evaluated the safety and effectiveness of the dapivirine vaginal ring for prevention of HIV-1 infection among African women. A nested qualitative component was conducted at six of 15 study sites in Uganda, Malawi, Zimbabwe and South Africa to evaluate acceptability of and adherence to the ring. Method—Qualitative study participants (n = 214) were interviewed with one of three modalities: single in-depth interview, up to three serial interviews or an exit Focus Group Discussion. Using semistructured guides administered in local languages, 280 interviews were audio-recorded, transcribed, translated, coded and analyzed. Results—We identified three key findings: first, despite initial fears about the ring's appearance and potential side effects, participants grew to like it and developed a sense of ownership of the ring once they had used it. Second, uptake and sustained adherence challenges were generally overcome with staff and peer support. Participants developed gradual familiarity with ring use through trial progression, and most reported that it was easy to use and integrate into their lives. Using the ring in ASPIRE was akin to joining a team and contributing to a broader, communal good. Third, the actual or perceived dynamics of participants' male partner relationship(s) were the most consistently described influence (which ranged from positive to negative) on participants' acceptability and use of the ring. Conclusion—It is critical that demonstration projects address challenges during the early adoption stages of ring diffusion to help achieve its potential public health impact as an effective, long-acting, female-initiated HIV prevention option addressing women's disproportionate HIV burden.
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    Impact of Male Partner Involvement on Women’s Adherence to the Dapivirine Vaginal Ring During a Phase III HIV Prevention Trial
    (AIDS and Behavior, 2020) Roberts, Sarah T.; Nair, Gonasagrie; Baeten, Jared M.; Palanee‑Philips, Thesla; Schwartz, Katie; Reddy, Krishnaveni; Kabwigu, Samuel; Matovu Kiweewa, Flavia; Govender, Vaneshree; Gaffoor, Zakir; Singh, Nishanta; Siva, Samantha; Naidoo, Kalendri; Montgomery, Elizabeth T.
    identified as one of the most significant factors impacting women’s willingness and ability to use them. As a result, research teams have sought to increase male partner involvement by encouraging disclosure of product use to male partners, promoting male partner engagement in the study through attendance at the study clinic, and helping women to garner male partner support for product use. This paper aims to assess the impact of these three elements of male partner involvement on women’s adherence to the dapivirine vaginal ring during MTN-020/ASPIRE, a phase III randomized placebo-controlled clinical trial involving 2629 women in Malawi, South Africa, Uganda, and Zimbabwe. During the study, 64–80% of participants reported disclosure of ring use at each quarterly visit, and 13% reported that their partners had attended the study clinic at some point during the study. At study exit, 66% reported that their partner was supportive, 18% unsupportive, and 17% were unsure. After adjusting for age, site and time in study, women were more likely to have low ring adherence if they had an unsupportive male partner (aRR 1.29, 95% CI 1.03–1.62). Neither disclosure nor clinic attendance directly predicted ring adherence, but disclosure increased the probability of having a supportive partner (aRRR 24.17, 95% CI 16.38–35.66) or an unsupportive partner (aRRR 4.10, 95% CI 2.70–6.24), relative to an unknown level of partner support. Women were also more likely to have a supportive partner if their partner had attended the clinic (aRRR 3.77, 95% CI 1.36–10.42). This study suggests that although the vaginal ring is relatively discreet, lack of support from male partners remains a relevant barrier to use. Though both disclosure and clinic attendance may increase partner support, disclosure may also increase partner opposition. Interventions to reduce male partner opposition are needed to maximize the potential impact of the ring and other PrEP products for HIV prevention.
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    Impact of the Dapivirine Vaginal Ring on Sexual Experiences and Intimate Partnerships of Women in an HIV Prevention Clinical Trial: Managing Ring Detection and Hot Sex
    (AIDS and Behavior, 2018) Laborde, Nicole D.; Pleasants, Elizabeth; Reddy, Krishnaveni; Atujuna, Millicent; Nakyanzi, Teopista; Chitukuta, Miria; Naidoo, Sarita; Palanee-Phillips, Thesla; Baeten, Jared M.; Montgomery, Elizabeth T.
    Vaginally-inserted HIV prevention methods have been reported to impact the sexual experience for women and their partners, and hence impacts acceptability of and adherence to the method. We analyzed in-depth interviews and focus group discussions about participants’ sexual experiences while wearing the ring, collected during the MTN-020/ASPIRE phase 3 safety and effectiveness trial of a dapivirine vaginal ring for HIV prevention in Malawi, South Africa, Uganda, and Zimbabwe. Most women reported that partners did not feel the ring during sex, however, women felt they had to manage their partners’ interaction with or reaction to the ring. In maintaining positive relationships, women were concerned about partners’ discovering ring use and about ensuring that partners had a good sexual experience with them. Finally women were concerned about how they themselves experienced sex with the ring. Some found that the ring made the vaginal environment more desirable for their partners and themselves
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    Implementation of gender-based violence screening guidelines in public HIV treatment programs: A mixed methods evaluation in Uganda
    (Public Library of Science, 2024-05) Thomas, Dorothy; Nalumansi, Alisaati; Reichman, Mira; Metitiri, Mine; Nambi, Florence; Kibuuka, Joseph; Nakabugo, Lylianne; Kamusiime, Brenda; Kasiita, Vicent; Nalukwago, Grace K.; Muwonge, Timothy R; Simoni, Jane; Montgomery, Elizabeth T.; Mujugira, Andrew; Heffron, Renee
    Background HIV and gender-based violence (GBV) intersect to threaten population health. The Uganda Ministry of Health recommends routine GBV screening alongside HIV care but evidence detailing its implementation in HIV care settings is limited. We evaluated screening practices in public HIV clinics to generate evidence supporting GBV screening optimization. Methods To evaluate GBV screening implementation in antiretroviral therapy (ART) clinics, we extracted client data from GBV registers at 12 public ART clinics in Uganda (January 2019-December 2021). We concurrently evaluated perceptions of GBV screening/referral practices by conducting in-depth qualitative interviews with providers (N = 30) and referral partners (N = 10). We contextualized quantitative findings with interview data which were analyzed using a thematic analysis approach. Results During the evaluation period, >90% of providers in participating health facilities implemented GBV screening. Among 107,767 clients served in public ART clinics, providers identified 9,290 (8.6%) clients who experienced past-year physical, sexual and/or emotional GBV of whom 86% received counseling and 19% were referred to support services—most commonly to legal services. Key factors influencing GBV screening implementation included awareness of screening guidelines; client volume; and client’s level of engagement in HIV care. Providers and referral partners identified important benefits to clients (e.g., pursuit of justice and removal from violent environments) when referrals were successful. Key factors influencing referrals included financial constraints that limited referral partners’ ability to provide services at no cost to clients and socio-cultural norms that inhibited client willingness to pursue support services. Conclusions GBV screening implementation in ART clinics supports identification and referral of clients exposed to violence. The effectiveness of GBV screening may be limited by socio-cultural factors that inhibit client capacity to pursue referrals and fragmented and resource-constrained referral networks. Providers and referral partners identified allocating funds to support referrals and collaborative networking meetings as important opportunities for strengthening GBV referrals.