AIDS Care Psychological and Socio-medical Aspects of AIDS/HIV ISSN: (Print) (Online) Journal homepage: www.tandfonline.com/journals/caic20 Acceptability of the dapivirine vaginal ring for HIV-1 prevention among women reporting engagement in transactional sex Erica N. Browne, Kristine Torjesen, Brenda Gati Mirembe, Thesla Palanee- Phillips, Nitesha Jeenarain, Miria Chitukuta, Marie C. D. Stoner, Leila E. Mansoor, Krishnaveni Reddy, Thelma T. Tauya, Logashvari Naidoo, Samantha Siva, Barbra Richardson, Sufia Dadabhai, Linly Seyama, Lydia Soto-Torres, Ariane van der Straten & on behalf of the MTN-020/ASPIRE Study Team To cite this article: Erica N. Browne, Kristine Torjesen, Brenda Gati Mirembe, Thesla Palanee- Phillips, Nitesha Jeenarain, Miria Chitukuta, Marie C. D. Stoner, Leila E. Mansoor, Krishnaveni Reddy, Thelma T. Tauya, Logashvari Naidoo, Samantha Siva, Barbra Richardson, Sufia Dadabhai, Linly Seyama, Lydia Soto-Torres, Ariane van der Straten & on behalf of the MTN-020/ ASPIRE Study Team (2024) Acceptability of the dapivirine vaginal ring for HIV-1 prevention among women reporting engagement in transactional sex, AIDS Care, 36:1, 80-86, DOI: 10.1080/09540121.2023.2198187 To link to this article: https://doi.org/10.1080/09540121.2023.2198187 Published online: 17 Apr 2023. 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Browne a, Kristine Torjesenb, Brenda Gati Mirembec, Thesla Palanee-Phillipsd, Nitesha Jeenaraine, Miria Chitukutaf, Marie C. D. Stoner a, Leila E. Mansoorg, Krishnaveni Reddyd, Thelma T. Tauyaf, Logashvari Naidooe, Samantha Sivae, Barbra Richardsonh, Sufia Dadabhaii, Linly Seyamai, Lydia Soto-Torresj and Ariane van der Straten on behalf of the MTN-020/ASPIRE Study Teamk,l aWomen’s Global Health Imperative, RTI International, Berkeley, CA, USA; bFHI 360, Durham, NC, USA; cMakerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda; dWits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; eSouth African Medical Research Council, Durban, South Africa; fUniversity of Zimbabwe Clinical Trials Research Centre, Harare, Zimbabwe; gCentre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu- Natal, Durban, South Africa; hDepartment of Biostatistics, University of Washington, Seattle, WA, USA; iCollege of Medicine-John Hopkins University Research Project, Blantyre, Malawi; jDivision of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Mental Health, and Eunice Shriver Kennedy, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA; kUniversity of California San Francisco, San Francisco, CA, USA; lASTRA Consulting, Kensington, PA, USA ABSTRACT We assessed if acceptability of the dapivirine vaginal ring for HIV prevention differed among the subgroup of women who reported engaging in transactional sex prior to enrollment in MTN- 020/ASPIRE (phase III trial in Malawi, South Africa, Uganda, and Zimbabwe, 2012-2015; n = 2629). Transactional sex was defined as receipt of money, goods, gifts, drugs, or shelter in exchange for sex in the past year. Dimensions of acceptability included: ease of use and physical sensation in situ, impacts on sex, partner’s opinion, and likelihood of future use. We used Poisson regression models with robust standard errors to compare risk of acceptability challenges by baseline history of transactional sex. At product discontinuation, women exchanging sex found the ring comfortable (90%), easy to insert (92%) and nearly all (96%) were likely to use the ring in the future. Women who had exchanged sex were more likely to report feeling the ring during sex (ARR 1.43, 95% CI: 1.09, 1.89; p = 0.01) and slightly more likely to mind wearing the ring during menses (ARR 1.22, 95% CI: 1.01, 1,46; p = 0.04) and during sex (ARR 1.22, 95% CI: 1.02, 1.45; p = 0.03). Messaging and counseling should include enhanced support for use during sex and menses to support optimal use. ARTICLE HISTORY Received 29 March 2022 Accepted 27 March 2023 KEYWORDS HIV prevention; acceptability; vaginal ring; sub-saharan Africa; transactional sex; women Introduction In eastern and southern Africa, women who exchange sex for money or material goods have a high incidence of HIV and are 13 times more likely to become infected with HIV than adults in the general population (UNAIDS, 2018a). They also often face additional bar- riers to accessing HIV prevention services including stigma and discrimination (Hensen et al., 2021). Math- ematical modeling suggests that the unmet HIV preven- tion and treatment needs of women who sell sex will have an outsized contribution to HIV transmissions over the next decade, becoming increasingly important drivers in both concentrated and generalized epidemics (Mishra et al., 2016). “Transactional sex” is a term that has emerged to describe exchange practices beyond for- mal sex work, where women may describe their sex partners as lovers or boyfriends instead of as clients, but an implicit assumption exists within the relationship that sex will be exchanged for material benefit or status. Relationship power dynamics, along with social and economic aspects of gender inequality, are thought to explain the increased risk of HIV among women who practice transactional sex in sub-Saharan Africa (Wamoyi et al., 2016). Given their heightened risk of HIV acquisition, addressing the needs of women who engage in transactional sex is a critical component toward achieving the UNAIDS 95-95-95 goals for end- ing the global HIV epidemic, including by providing access to novel biomedical prevention technologies as they become available. The monthly dapivirine vaginal ring (i.e., the ring) is a monthly topical HIV prevention option that will pro- vide women with much needed choice for preventing HIV acquisition. The ring has been found to be well- © 2023 Informa UK Limited, trading as Taylor & Francis Group CONTACT Erica N. Browne ebrowne@rti.org 2150 Shattuck Avenue, Suite 800, Berkeley, CA 94704, USA AIDS CARE 2024, VOL. 36, NO. 1, 80–86 https://doi.org/10.1080/09540121.2023.2198187 http://crossmark.crossref.org/dialog/?doi=10.1080/09540121.2023.2198187&domain=pdf http://orcid.org/0000-0003-2069-6589 http://orcid.org/0000-0002-7189-8669 http://orcid.org/0000-0001-8536-648X mailto:ebrowne@rti.org http://www.tandfonline.com tolerated and acceptable to women and can reduce HIV risk by 27% (95% confidence interval [CI], 1–46%; Bae- ten et al., 2016; Brown et al., 2020; Montgomery et al., 2017; Nel et al., 2016). In 2020, the ring received a posi- tive opinion from the European Medicines Agency, and the World Health Organization issued a recommen- dation for the product in November 2020 (‘IPM’s dapi- virine ring for women’s HIV prevention receives WHO prequalification’, 2020). In July 2021, the WHO released updated consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring that included a recommendation for the ring as an additional prevention choice for women at substantial risk of HIV infection. The ring was approved for use by the Medicines Control Authority of Zimbabwe in July 2021 with regulatory reviews in other African countries underway (Gwarisa, 2021). To assist in informing rollout given the imminent introduction of the ring, we assessed whether attitudes about the ring differed among women who had engaged in transactional sex, as they are at higher risk for acquir- ing HIV and could benefit from ring access. While trials for the ring did not specifically target recruitment of women who engage in transactional sex, the MTN- 020/ASPIRE trial (conducted in Malawi, South Africa, Uganda, and Zimbabwe) asked participants about their recent history of exchanging sex for goods, money, or other services. Our objective was to describe the acceptability of the ring among women who engaged in transactional sex and to evaluate if ring acceptability differed among those who had or had not engaged in transactional sex. Materials and methods Study design and procedures The MTN-020/ASPIRE phase III randomized, double- blind, placebo-controlled clinical trial (NCT01617096) enrolled healthy women aged 18–45 across 15 sites in Malawi (2 sites), South Africa (9 sites), Uganda (1 site), and Zimbabwe (3 sites). Details of the trial design, recruitment, and results have been previously published (Baeten et al., 2016). In summary, women were randomized in a 1:1 ratio to use either a monthly silicone elastomer vaginal matrix ring containing 25 mg of dapivirine or a placebo ring. Participants were followed monthly for at least one year (maximum 33 months) between August 2012 and June 2015. At each monthly visit, participants received HIV-1 serolo- gic and pregnancy testing and safety monitoring. In addition, participants were counseled on how to insert and remove the ring, instructed to keep the ring inserted for the entire month and were provided individualized adherence counseling based on their ring use experi- ences. Audio computer-assisted self-interviews (ACA- SIs) at baseline, the Month-3 visit, and at the Product Use End visit (PUEV, the penultimate study visit when study product dispensing was permanently dis- continued) collected behavioral and acceptability data. All participants provided written informed consent; all procedures were approved by local IRBs. Measures We assessed if participants had engaged in transactional sex on the baseline self-administered ACASI using the following question: ‘in the past year, did you receive money, material goods, gifts, drugs, or shelter in exchange for vaginal or anal sex?’ Transactional sex was dichotomized (yes/no) defined by an affirmative response. Acceptability measures included in the ACASI were informed by the components of acceptability outlined by Mensch et al., 2012. Dimensions of acceptability included: ease of use and physical sensation in situ, impact on sex, partner’s opinion, and likelihood of future use if a similar vaginal ring that provided some protection against HIV became available. During each ACASI, participants were asked to reflect on their experiences using the ring in the prior 3 months. At PUEV, additional questions captured perceptions of the ring based on participants’ entire experience. A list of acceptability question text with response options are outlined in full in Mayo et al., 2021. Analysis Characteristics of the subsample of participants who reported engaging in transactional sex were summar- ized using descriptive statistics (e.g., frequencies, means). A Chi-square test was used to compare pro- portions of participants reporting exchanging sex by country. We used Poisson regression with robust stan- dard errors (binary outcomes) or linear regression (con- tinuous outcomes) models adjusting for country to compare characteristics of those who did and did not report engagement in transactional sex. Acceptability measures were summarized by study visit. To test for associations between recent history of transactional sex and acceptability, measures of acceptability were dichotomized. We used Poisson regression models with robust standard errors to compare risk of accept- ability challenges by baseline history of engaging in transactional sex, controlling for country, study arm, and months of follow-up. AIDS CARE 81 Results Among the 2629 women enrolled, 2614 (99%) com- pleted the baseline ACASI; 162 (6%) reported engaging in transactional sex in the year prior to enrollment. Table 1 describes the baseline characteristics of this sub- group of participants. The median age was 26 years (interquartile range [IQR] 22–30; max 43 years). Nearly all reported having a primary sex partner (97%), and 28% said that they had multiple sex partners in the past 3 months. Compared to those who did not report engaging in transactional sex, women who exchanged sex were more likely to have tested positive for an STI at screening (adjusted relative risk [ARR] 1.38, 95% CI 1.06, 1.80; p = 0.02), to report multiple sex partners in the past 3 months (ARR 1.36, 95% CI: 1.05, 1.77; p = 0.02), and to report excessive alcohol use (ARR 1.78, 95% CI: 1.19, 2.62; p = 0.004) at enrollment. More participants in Uganda (15%) said they had recently exchanged sex for money/goods compared to those in other countries (3–6%, p < 0.001). There was no difference in follow-up time between those who did and did not engage in transactional sex (median 21, IQR 14–30 months). A similar proportion of women with a history of transactional sex seroconverted during the study (5.6%, n = 9) compared to those who did not report engaging in transactional sex (6.5%, n = 159). Of the 162 women with a baseline history of transac- tional sex, 156 (96%) completed at least one follow-up ACASI; 153 of 156 (98%) reported using the ring during at least one three-month period prior to an ACASI and responded to questions of acceptability. A summary of acceptability measures collected at the Month-3 visit and at the PUEV is presented in Table 2. At both visits, most women who reported engaging in transactional sex indicated that the ring was “usually comfortable” (n = 121, 85%; n = 106, 90%), that they were unaware of the ring in situ during normal activities (n = 106, 75%; n = 90, 76%), and that they found removal (n = 111, 82%; n = 84, 85%) and insertion (n = 118, 83%; n = 109, 92%) easy. At the PUEV, more than a third minded wearing the ring during sex (37%) or during menses (39%) and felt it during sex most or some of the time (34%). Nearly all (96%) reported being likely Table 1. Baseline characteristics of participants in the MTN-020/ASPIRE Trial (Aug 2012–Jun 2015), by report of engaging in transactional sexa in the year prior to enrollment. Engaged in transactional sexa Yes No Total N (%) N (%) N (%) Total 162 (100) 2452 (100) 2614e (100) Sociodemographic characteristics Age, years – mean median (IQR) 26.5, 26 (22–30) 27.2, 26 (22–31) 27.2, 26 (22–31) Younger, aged 18–21 32 (20) 488 (20) 520 (20) Secondary education completed 56 (35) 1136 (46) 1192 (46) Earns income 90 (56) 1090 (44) 1180 (45) Has primary sex partner 157 (97) 2405 (98) 2562 (98) Married 52 (32) 1020 (42) 1072 (41) Parous 148 (91) 2244 (92) 2392 (92) Risk behavior & history Excessive alcohol useb 26 (16) 156 (6) 182 (7) Multiple sex partners in past 3 months 46 (28) 390 (16) 436 (17) Condomless sexc 66 (41) 1050 (43) 1116 (43) Positive for sexually transmitted infectiond 45 (28) 475 (19) 520 (20) Contraceptive method and vaginal practices Current contraceptive method Injectable 91 (56) 1347 (55) 1438 (55) Implant 33 (20) 468 (19) 501 (19) Copper intrauterine device (IUD) 16 (10) 308 (13) 324 (12) Oral contraceptive 21 (13) 266 (11) 287 (11) Sterilization 1 (1) 77 (3) 78 (3) Menstruation in past 3 months 118 (73) 1903 (78) 2021 (77) Vaginal practices: tissue/toilet paper/cloth inside the vagina prior 3 months 56 (35) 543 (23) 599 (23) Enrollment location Malawi 16 (10) 256 (10) 272 (10) South Africa 87 (54) 1325 (54) 1412 (54) Uganda 38 (24) 214 (9) 252 (10) Zimbabwe 21 (13) 657 (27) 678 (26) aReceived money, goods, gifts, drugs, or shelter in exchange for sex in past year. bDefined by 7 or more alcoholic drinks per week or drinking alcohol 2 or more times per week. cLast vaginal sex act without use of a male or female condom. dPositive for Chlamydia, Gonorrhea, and/or Trichomoniasis prior to enrollment. e2629 women were enrolled but 15 did not complete the baseline ACASI and therefore are missing data on recent history of transactional sex. 82 E. N. BROWNE ET AL. to use the ring in the future, with two-thirds (66%) say- ing that they were “very likely” to wear a ring in the future. When asked about the ring’s effect on sexual pleasure, 40% reported it increased pleasure, 57% reported that it did not change pleasure and, 4% said it decreased pleasure, although reasons behind these responses were not captured. At the PUEV, women who had exchanged sex were more likely to report feeling the ring during sex (adjusted predicted percentage [PP] 33% versus 23%; ARR 1.43, 95% CI: 1.09, 1.89; p = 0.01) and slightly more likely to mind wearing the ring during menses (PP 22% vs 18%; ARR 1.22, 95% CI: 1.01, 1,46; p = 0.04) and during sex (PP 22% vs 18%; ARR 1.22, 95% CI: 1.02, 1.45; p = 0.03) compared to women who had not reported exchanging sex prior to enrollment (Figure 1). They were also more likely to report having multiple sex partners in the 3 months prior to the Table 2. Dapivirine vaginal ring acceptability among those who reported engaging in transactional sex prior to enrollment (n = 162), collected via ACASI at Month-3 and Product Use End Visit (PUEV). Month-3 PUEV N (%) N (%) Total completed visit 155 148 Total completed ACASI 152 131b Total who used ring in past 3 monthsa 142 (93) 118 (90) Use attributes: Ease and comfort of use Difficulty with insertion at last insertion Not difficult at all 118 (83) 109 (92) Very/somewhat difficult 23 (16) 8 (7) Never inserted ring in past 3 months 1 (1) 1 (1) Difficulty with removal at last removal Not difficult at all 111 (78) 84 (71) Very/somewhat difficult 20 (14) 19 (16) Never took out ring in past 3 months 11 (8) 15 (13) Use attributes: Physical sensation in situ In past 3 months, comfort with wearing ring every day Usually comfortable 121 (85) 106 (90) Sometimes/usually uncomfortable 21 (15) 12 (10) In past 3 months, frequency of awareness during normal daily activities Never 106 (75) 90 (76) Most/some of the time 36 (25) 28 (24) Effects on sex In past 3 months, frequency felt ring during sex Never 90 (63) 75 (64) Most/some of the time 49 (35) 39 (33) Did not have sex in past 3 months 3 (2) 4 (3) In past 3 months, any partners felt ring during sex No 83 (58) 67 (57) Yes 33 (23) 23 (19) Don’t know 23 (16) 24 (20) Did not have sex in past 3 months 3 (2) 4 (3) Overall impressions of the ring (PUEV only, N = 131) Minded wearing ring during menses No Na 71 (54) Yes Na 44 (34) Did not have menses during the study Na 14 (11) Did not wear ring during menses Na 2 (2) Ring’s effect on sexual pleasure Increases sexual pleasure Na 52 (40) Does not change pleasure Na 74 (57) Decreases sexual pleasure Na 5 (4) Minded wearing ring during sex No Na 82 (63) Yes Na 48 (37) Ring acceptable to primary partner Yes Na 88 (67) No Na 21 (16) Don’t know Na 22 (17) Likelihood of future use Very likely Na 87 (66) Likely Na 39 (30) Unlikely Na 0 (0) Very unlikely Na 5 (4) aParticipants may have been on a product hold for pregnancy, adverse experience, or another reason. b148 (91%) completed the PUEV ACASI, but because of electronic transmission errors, ACASI responses are missing for n = 17. Na: Not applicable; question was not asked. AIDS CARE 83 PUEV (PP 16% versus 10%; ARR 1.64, 95% CI: 1.18, 2.30; p = 0.004) and had more vaginal sex acts in the past week (mean 4.1 times versus 2.4 times; adjusted mean difference = 1.8, 95% CI: 0.99, 2.60; p < 0.001). They were as likely to have reported any anal sex in the past 3 months (9%, ARR 1.08, 95% CI: 0.62, 1.88; p = 0.78). Women who said they had exchanged sex were not more likely to report that their partner(s) had felt the ring during sex (ARR 1.10, 95% CI 0.75, 1.62), and they were not significantly more likely to note that their partner found the ring unacceptable (ARR 1.17, 95% CI 0.76, 1.78). Though difficulty with ring removal was reported by few women who had engaged in transactional sex (n = 19), they were more likely to note difficulty at last removal (PP 18% vs 10%; ARR 1.75, 95% CI: 1.12, 2.71; p = 0.01). Despite some differences in acceptability, women who had engaged in transactional sex were equally as willing to use the ring in the future (“very likely” ARR 0.98; 95% CI: 0.87, 1.11; p = 0.78). Discussion Overall, acceptability of the monthly dapivirine vaginal ring for HIV prevention was high among women who reported transactional sex in the year prior to enrollment, with these women perceiving the ring to be easy to use, comfortable and most reporting an interest in using the ring in the future when it is available for HIV prevention. Ring acceptability did not differ by reported engagement in transactional sex and findings are similar to prior research showing acceptability of the ring to prevent HIV among a larger population of healthy, HIV unin- fected women and to prevent pregnancy (Griffin et al., 2019; Montgomery et al., 2017). Further, women who reported transactional sex were more vulnerable to HIV than women who did not report transactional sex; they had more STIs, were more likely to have multiple partners and more vaginal sex acts in the past week. Given their greater risk of HIV as well as the high accept- ability of the ring, women who engage in transactional sex are an important population to be offered the ring when it becomes available. Since the ring only protects against infection from vaginal sex, other prevention methods such as oral pre-exposure prophylaxis should be encouraged for anyone engaging in anal sex. The avail- ability of multiple PrEP products allows women to find the one that best fits their needs and preferences, and the ring provides women with a long-acting, user-con- trolled, immediately reversible option. In terms of challenges with the ring, women exchan- ging sex prior to enrollment were more likely to note difficulty at last removal than those who did not report exchanging sex. These findings suggest the need for an added emphasis on counseling and training on proper insertion/removal of the ring in this population as part of adherence related support and education during roll-out. Additionally, women who had exchanged sex were more likely to report feeling the ring during sex and slightly more likely to mind wearing the ring during menses and during sex. Messaging and discussion of the effect and noticeability of the ring during sex and menses may be an important when counseling on use of the vaginal ring versus other HIV prevention options. Although vaginal rings can be noticed during sex, a recent systematic review indicated that generally sex partners don’t mind having sex with a ring in situ, even if they feel it (Ridgeway et al., 2022). Figure 1. Comparing acceptability challenges reported at PUEV among women who reported engaging in transactional sex in year prior to enrollment to those who had not. Each model adjusted for country, treatment arm, and months of follow-up (N = 2219). 84 E. N. BROWNE ET AL. Data in our study are from a randomized phase III trial, and there may be some social desirability bias in answers about ring preferences or acceptability whereby users may respond in a more favorable manner. Accept- ability of the ring was assessed independent of its efficacy. As the availability of PrEP products continues to increase, the acceptability of the ring may change in context of choice among highly effective products. Nonetheless, a vaginal ring as a PrEP delivery mechan- ism was found to be a highly acceptable. Additionally, we measured self-reported transactional sex and were unable to differentiate acceptability by transactional sex versus women engaged in formal sex work. Sexual exchange occurs along a spectrum, and the motivations underlying formal sex work versus transactional sex may vary, leading to differences in perceived HIV risk and differences in preferences for HIV prevention pro- ducts (Kilburn et al., 2018; UNAIDS, 2018b; Wamoyi et al., 2016). Women who engage in transactional sex may be less likely to access HIV and other health ser- vices, and may therefore be a population in particular need of targeted services (Hensen et al., 2019). Differing recruitment strategies across sites resulted in over rep- resentation of women exchanging sex from Uganda; however, modeling results adjusted for country to adjust for geographic and cultural differences. Lastly, detailed information from casual partners was not collected and partners are known to have an important influence on product use (Mayo et al., 2021; Montgomery et al., 2017; Roberts et al., 2020). This study provides evidence showing high accept- ability of the dapivirine vaginal ring to prevent HIV among women who engaged in transactional sex. Chal- lenges using the ring among this population were related to use during sex and menses. Messaging and counseling should emphasize how to use the ring during sex and menses to encourage persistent use. And, more broadly, as the choice of PrEP products continues to increase, counseling should focus on helping women select an HIV prevention method that will be most acceptable for them. Acknowledgements The authors would like to recognize Dr. Bonus Makanani for his contributions to the development of this manuscript. The authors would also like to acknowledge the full MTN-020/ ASPIRE study team and ASPIRE study participants, without which this work would not have been possible. Data manage- ment was provided by the Women’s Global Health Imperative Program (RTI International, San Francisco, CA) and the Stat- istical Center for HIV/AIDS Research & Prevention (Fred Hutchinson Cancer Research Center, Seattle, WA). ACASI build up was provided by Barbara Mensch and Stan Mierzwa (Population Council, New York City, New York). Site labora- tory oversight was provided by the Microbicide Trials Net- work Laboratory Center (Pittsburgh, PA). Study Team Leadership: Jared Baeten, University of Washington (Protocol Chair); Thesla Palanee-Phillips, Wits Reproductive Health and HIV Institute (Protocol Co-chair); Elizabeth Brown, Fred Hutchinson Cancer Research Center (Protocol Statis- tician); Lydia Soto-Torres, US National Institute of Allergy and Infectious Diseases (Medical Officer); Katie Schwartz, FHI 360 (Clinical Research Manager). Study sites and site Investigators of Record: Malawi, Blantyre site (Johns Hopkins University, Queen Elizabeth Hospital): Bonus Makanani; Malawi, Lilongwe site (University of North Carolina, Chapel Hill): Francis Martinson; South Africa, Cape Town site (University of Cape Town): Linda-Gail Bekker; South Africa, Durban – Botha’s Hill, Chatsworth, Isipingo, Tongaat, Umkomaas, Verulam sites (South African Medical Research Council): Vaneshree Govender, Samantha Siva, Zakir Gaffoor, Logashvari Naidoo, Arendevi Pather, and Nitesha Jeenarain; South Africa, Durban, eThekwini site (Center for the AIDS Programme for Research in South Africa): Gonasa- grie Nair; South Africa, Johannesburg site (Wits RHI): Thesla Palanee-Phillips; Uganda, Kampala site (John Hopkins Uni- versity, Makerere University): Flavia Matovu; Zimbabwe, Chitungwiza, Seke South and Zengeza sites (University of Zimbabwe College of Health Sciences Clinical Trials Unit): Nyaradzo Mgodi; Zimbabwe, Harare, Spilhaus site (Univer- sity of Zimbabwe College of Health Sciences Clinical Trials Unit): Felix Mhlanga. The vaginal rings used in this study were developed and supplied by the International Partnership for Microbicides (IPM). Disclosure statement No potential conflict of interest was reported by the author(s). Funding The ASPIRE study was designed and implemented by the Microbicide Trials Network (MTN) and 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 (NIH). The content is solely the responsibility of the authors and does not necessarily rep- resent the official views of the NIH. ORCID Erica N. Browne http://orcid.org/0000-0003-2069-6589 Marie C. D. Stoner http://orcid.org/0000-0002-7189-8669 Ariane van der Straten http://orcid.org/0000-0001-8536- 648X References Baeten, J. M., Palanee-Phillips, T., Brown, E. 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BROWNE ET AL. https://doi.org/10.1056/NEJMoa1506110 https://doi.org/10.1056/NEJMoa1506110 https://doi.org/10.1002/jia2.25634 https://doi.org/10.1371/journal.pone.0224898 https://healthtimes.co.zw/2021/07/14/breaking-dapivirine-vaginal-ring-approved-for-use-in-zimbabwe/ https://healthtimes.co.zw/2021/07/14/breaking-dapivirine-vaginal-ring-approved-for-use-in-zimbabwe/ https://healthtimes.co.zw/2021/07/14/breaking-dapivirine-vaginal-ring-approved-for-use-in-zimbabwe/ https://doi.org/10.1002/jia2.25410 https://doi.org/10.1002/jia2.25410 https://doi.org/10.1097/QAI.0000000000002733 https://doi.org/10.1097/QAI.0000000000002733 https://doi.org/10.1097/QAD.0000000000001866 https://doi.org/10.1097/QAD.0000000000001866 https://doi.org/10.1007/s10461-021-03205-z https://doi.org/10.1007/s10461-021-03205-z https://doi.org/10.1097/COH.0b013e3283590632 https://doi.org/10.1097/COH.0b013e3283590632 https://doi.org/10.1016/j.annepidem.2016.06.004 https://doi.org/10.1097/QAD.0000000000001452 https://doi.org/10.1097/QAD.0000000000001452 https://doi.org/10.1056/NEJMoa1602046 https://doi.org/10.1056/NEJMoa1602046 https://doi.org/10.1016/j.contraception.2021.10.001 https://doi.org/10.1016/j.contraception.2021.10.001 https://doi.org/10.1007/s10461-019-02707-1 https://doi.org/10.1007/s10461-019-02707-1 https://www.unaids.org/sites/default/files/media_asset/miles-to-go_en.pdf https://www.unaids.org/sites/default/files/media_asset/miles-to-go_en.pdf https://doi.org/10.7448/IAS.19.1.20992 Abstract Introduction Materials and methods Study design and procedures Measures Analysis Results Discussion Acknowledgements Disclosure statement ORCID References << /ASCII85EncodePages false /AllowTransparency false /AutoPositionEPSFiles false /AutoRotatePages /PageByPage /Binding /Left /CalGrayProfile () /CalRGBProfile (Adobe RGB \0501998\051) /CalCMYKProfile (U.S. Web Coated \050SWOP\051 v2) /sRGBProfile (sRGB IEC61966-2.1) /CannotEmbedFontPolicy /Error /CompatibilityLevel 1.5 /CompressObjects 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