Browsing by Author "Reddy, Krishnaveni"
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Item 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.Item Ask the Way From Those Who Have Walked It Before – Grandmothers’ Roles in Health-related Decision Making and HIV Pre-exposure Prophylaxis (PrEP) Use Among Pregnant and Breastfeeding Women in Africa(Research Square, 2021) Reddy, Krishnaveni; Kemigisha, Doreen; Chitukuta, Miria; Dadabhai, Sufia; Mathebula, Florence; Tenza, Siyanda; Palanee-Phillips, Thesla; Ryan, Julia; van der Straten, Ariane; Musara, Petina; Macagna, Nicole; Ryan, JuliaHIV acquisition among pregnant and breastfeeding women in sub-Saharan Africa (SSA) and vertical transmission rates remain high despite established strategies for HIV prevention. Methods: We explored grandmothers’ (mothers/mothers-in-law) influence on pregnant and breastfeeding women’s health-related decisions and their potential to support use of HIV prevention products utilizing qualitative data collected from grandmothers, HIV-uninfected, currently/recently pregnant or breastfeeding women and male partners of currently/recently pregnant or breastfeeding women during the MTN-041/MAMMA study. Results: Grandmothers were described as important sources of information, playing both supportive and influencer roles, due to personal maternal experience and generational knowledge. Grandmothers expressed willingness to support pre-exposure prophylaxis (PrEP) use and agreed with other groups that this decision should be made by women themselves and/or with partners. Conclusion: With the right framing and approach, grandmothers’ supportive roles can optimise uptake and adherence to biomedical HIV prevention and reduce HIV acquisition among pregnant and breastfeeding women in these communities.Item Dapivirine vaginal ring use does not diminish the effectiveness of hormonal contraception(Journal of acquired immune deficiency syndromes, 2017) Balkus, Jennifer E.; Palanee-Phillips, Thesla; Reddy, Krishnaveni; Siva, Samantha; Harkoo, Ishana; Nakabiito, Clemensia; Kintu, Kenneth; Nair, Gonasangrie; Chappell, Catherine; Matovu Kiweewa, Flavia; Kabwigu, Samuel; Naidoo, Logashvari; Jeenarain, Nitesha; Marzinke, Mark; Soto-Torres, Lydia; Brown, Elizabeth R.; Baeten, Jared M.To evaluate the potential for a clinically relevant drug-drug interaction with concomitant use of a dapivirine vaginal ring, a novel antiretroviral-based HIV-1 prevention strategy, and hormonal contraception by examining contraceptive efficacies with and without dapivirine ring use. A secondary analysis of women participating in MTN-020/ASPIRE, a randomized, double-blind, placebo-controlled trial of the dapivirine vaginal ring for HIV-1 prevention. Methods: Use of a highly effective method of contraception was an eligibility criterion for study participation. Urine pregnancy tests were performed monthly. Pregnancy incidence by arm was calculated separately for each hormonal contraceptive method and compared using an Andersen-Gill proportional hazards model stratified by site and censored at HIV-1 infection. Of 2629 women enrolled, 2310 women returned for follow-up and reported using a hormonal contraceptive method at any point during study participation (1139 in the dapivirine arm, 1171 in the placebo arm). Pregnancy incidence in the dapivirine arm versus placebo among women using injectable depot medroxyprogesterone acetate was 0.43% vs. 0.54%, among women using injectable norethisterone enanthate was 1.15% vs. 0%, among women using hormonal implants was 0.22% vs. 0.69%, and among women using oral contraceptive pills was 32.26% vs. 28.01%. Pregnancy incidence did not differ by study arm for any of the hormonal contraceptive methods. Use of the dapivirine ring does not reduce the effectiveness of hormonal contraceptives for pregnancy prevention. Oral contraceptive pill use was associated with high pregnancy incidence, potentially due to poor pill adherence. Injectable and implantable methods were highly effective in preventing pregnancy.Item 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.Item 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 themselvesItem Negative rumors about a vaginal ring for HIV-1 prevention in sub-Saharan Africa(HHS Public Access, 2019) Chitukuta, Miria; Duby, Zoe; Katz, Ariana; Nakyanzi, Teopista; Reddy, Krishnaveni; Palanee-Phillips, Thesla; Tembo, Tchangani; Etima, Juliane; Musara, Petina; Mgodi, Nyaradzo M.; Straten, Ariane van derRumours may influence health-related behaviours, including uptake and adherence to HIV prevention products. This ASPIRE study assessed the safety and effectiveness of a vaginal ring delivering the antiretroviral dapivirine for HIV prevention in Africa. We explored negative rumours about study participation and the vaginal ring amongst study participants and their communities in Malawi, Uganda, South Africa and Zimbabwe. Two hundred and fourteen women participated in either single or serial in-depth interviews, or a focus group discussion. Three key findings emerged in the data. Firstly, rumours reflected fears concerning the ring and trial participation. Given the historical-political context of the countries in which the trial was conducted, the ring’s investigational nature and its foreign origin, ring use was rumoured to cause negative health outcomes such as cancer and infertility and was also associated with practices such as witchcraft or Satanism; salience of these rumours varied by country. Secondly, rumours reportedly affected participants’ adherence to the ring, and other women’s willingness to participate in the study. Finally, participants reported that participant engagement activities helped address rumours, resulting in enhanced trust and rapport between staff and participants.Item Pregnancy and Infant Outcomes Among Women Using the Dapivirine Vaginal Ring in Early Pregnancy(Journal of acquired immune deficiency syndromes, 2018) Makanani, Bonus; Balkus, Jennifer E.; Jiao, Yuqing; Noguchi, Lisa M.; Palanee-Phillips, Thesla; Mbilizi, Yamikani; Moodley, Jothi; Kintu, Kenneth; Reddy, Krishnaveni; Kabwigu, Samuel; Jeenariain, Nitesha; Harkoo, Ishana; Mgodi, Nyaradzo; Piper, Jeanna; Rees, Helen; Scheckter, Rachel; Beigi, Richard; Baeten, Jared M. ,Monthly use of the dapivirine vaginal ring has been shown to be safe and effective for HIV-1 prevention in nonpregnant reproductive-aged women. The impact of dapivirine on pregnancy outcomes and infant is not known. We compared pregnancy incidence and outcomes by study arm among HIV-1–uninfected women who became pregnant while participating in MTN-020/ASPIRE. ASPIRE was a randomized, double-blind, placebocontrolled phase III safety and effectiveness study of the dapivirinering for HIV-1 prevention. Sexually active women aged 18–45 years from Malawi, South Africa, Uganda, and Zimbabwe were enrolled. Urine pregnancy tests were performed monthly, and, if positive, study product was withheld during pregnancy and breastfeeding. Pregnancy-related outcomes included the following: pregnancy incidence, pregnancy outcomes (live birth, preterm birth, pregnancy loss, and congenital anomalies), and infant growth.Item Social harms in female-initiated HIV prevention method research: state of the evidence(AIDS (London, England), 2019) Montgomerya, Elizabeth T.; Robertsa, Sarah T.; Nelb, Annalene; Malherbeb, Mariette; Torjesenc, Kristine; Bunged, Katherine; Singhd, Devika; Baetene, Jared M.; Marrazzof, Jeanne; Chirenjeg, Z. Mike; Kabwigu, Samuel; Beigi, Richard; Riddler, Sharon A.; Gaffour, Zakir; Reddy, Krishnaveni; Mansoor, Leila E.; Nair, Gonasagrie; Woeberi, Kusbashni; Moodley, Jayajothi; Jeenaraini, Nitesha; Siva, Samantha; Naidoo, Logashvari; Govender, Vaneshree; Palanee-Phillips, TheslaAssessment of safety is an integral part of real-time monitoring in clinical trials. In HIV prevention research, safety of investigational products and trial participation has been expanded to include monitoring for ‘social harms’, generally defined as negative consequences of trial participation that may manifest in social, psychological, or physical ways. Further research on social harms within HIV prevention research is needed to understand the potential safety risks for women and advance the implementation of prevention methods in real-world contexts. Secondary analysis of quantitative data from three randomized, double-blind, placebo-controlled trials of microbicide candidates in sub-Saharan Africa was conducted. Additionally, we assessed data from two prospective cohort studies that included participants who became HIV-positive or pregnant during parent trials.