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Vaginal ring acceptability and related preferences among women in low- and middle-income countries: A systematic review and narrative synthesis


Autoři: Jennifer B. Griffin aff001;  Kathleen Ridgeway aff002;  Elizabeth Montgomery aff001;  Kristine Torjesen aff002;  Rachel Clark aff003;  Jill Peterson aff002;  Rachel Baggaley aff004;  Ariane van der Straten aff001
Působiště autorů: RTI International, Center for Global Health, Durham, NC, United States of America aff001;  FHI 360, Global Health Population and Nutrition, Durham, NC, United States of America aff002;  RTI International, Public Health Research Division, Durham, NC, United States of America aff003;  World Health Organization, Geneva, Switzerland aff004;  University of California, San Francisco, Department of Medicine, San Francisco, CA, United States of America aff005
Vyšlo v časopise: PLoS ONE 14(11)
Kategorie: Research Article
doi: https://doi.org/10.1371/journal.pone.0224898

Souhrn

The vaginal ring (VR) is a female-initiated drug-delivery platform used for different indications, including HIV pre-exposure prophylaxis (PrEP). We conducted a systematic review of VR acceptability, values and preferences among women in low- and middle-income countries (LMIC) to inform further investment and/or guidance on VR use for HIV prevention. Following PRISMA guidelines, we used structured methods to search, screen, and extract data from randomized controlled trials (RCTs) and observational studies reporting quantitative outcomes of acceptability of the VR for any indication published 1/1970-2/2019 (PROSPERO: CRD42019122220). Of 1,110 records identified, 68 met inclusion criteria. Studies included women 15–50+ years from 25 LMIC for indications including HIV prevention, contraception, abnormal bleeding, and menopause. Overall VR acceptability was high (71–98% across RCTs; 62–100% across observational studies), with 80–100% continuation rates in RCTs and favorable ease of insertion (greater than 85%) and removal 89–99%). Users reported concerns about the VR getting lost in the body (8–43%), although actual expulsions and adverse events were generally infrequent. Most women disclosed use to partners, with some worrying about partner anger/violence. The VR was not felt during intercourse by 70–92% of users and 48–97% of partners. Acceptability improved over time both within studies (as women gained VR experience and worries diminished), and over chronological time (as the device was popularized). Women expressed preferences for accessible, long-acting, partner-approved methods that prevent both HIV and pregnancy, can be used without partner knowledge, and have no impact on sex and few side effects. This review was limited by a lack of standardization of acceptability measures and study heterogeneity. This systematic review suggests that most LMIC women users have a positive view of the VR that increases with familiarity of use; and, that many would consider the VR an acceptable future delivery device for HIV prevention or other indications.

Klíčová slova:

Contraception – Female contraception – HIV prevention – Observational studies – Preventive medicine – Progesterone – Systematic reviews


Zdroje

1. Alexander NJ, Baker E, Kaptein M, Karck U, Miller L, Zampaglione E. Why consider vaginal drug administration? Fertil Steril. 2004;82(1):1–12. doi: 10.1016/j.fertnstert.2004.01.025 WOS:000222745600001. 15236978

2. van den Heuvel MW, van Bragt AJM, Alnabawy AKM, Kaptein MCJ. Comparison of ethinylestradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive. Contraception. 2005;72(3):168–74. doi: 10.1016/j.contraception.2005.03.005 WOS:000231654300002. 16102549

3. Roumen FJ, Apter D, Mulders TM, Dieben TO. Efficacy, tolerability and acceptability of a novel contraceptive vaginal ring releasing etonogestrel and ethinyl oestradiol. Human reproduction (Oxford, England). 2001;16(3):469–75. Epub 2001/03/03. doi: 10.1093/humrep/16.3.469 11228213.

4. Massai R, Miranda P, Valdes P, Lavin P, Zepeda A, Casado ME, et al. Preregistration study on the safety and contraceptive efficacy of a progesterone-releasing vaginal ring in Chilean nursing women. Contraception. 1999;60(1):9–14. Epub 1999/11/05. doi: 10.1016/s0010-7824(99)00057-8 10549447.

5. Rahn DD, Carberry C, Sanses TV, Mamik MM, Ward RM, Meriwether KV, et al. Vaginal estrogen for genitourinary syndrome of menopause: a systematic review. Obstetrics and gynecology. 2014;124(6):1147. doi: 10.1097/AOG.0000000000000526 25415166

6. Speroff L. Efficacy and tolerability of a novel estradiol vaginal ring for relief of menopausal symptoms. Obstet Gynecol. 2003;102(4):823–34. Epub 2003/10/11. doi: 10.1016/s0029-7844(03)00764-6 14551014.

7. Battaglia C, Mancini F, Fabbri R, Persico N, Busacchi P, Facchinetti F, et al. Polycystic ovary syndrome and cardiovascular risk in young patients treated with drospirenone-ethinylestradiol or contraceptive vaginal ring. A prospective, randomized, pilot study. Fertil Steril. 2010;94(4):1417–25. Epub 2009/07/14. doi: 10.1016/j.fertnstert.2009.05.044 19591981.

8. Nel A, Kapiga S, Bekker LG, Devlin B, Borremans M, Rosenberg Z. Safety and efficacy of dapivirine vaginal ring for HIV-1 prevention in African women. Topics in Antiviral Medicine. 2016;24(E-1):45.

9. Baeten JM, Palanee-Phillips T, Brown ER, Schwartz K, Soto-Torres LE, Govender V, et al. Use of a vaginal ring containing dapivirine for HIV-1 prevention in women. New England Journal of Medicine. 2016;375(22):2121–32. doi: 10.1056/NEJMoa1506110 26900902

10. Thurman AR, Clark MR, Hurlburt JA, Doncel GF. Intravaginal rings as delivery systems for microbicides and multipurpose prevention technologies. International journal of women's health. 2013;5:695–708. Epub 2013/11/01. doi: 10.2147/IJWH.S34030 24174884; PubMed Central PMCID: PMC3808127.

11. Achilles SL, Hendrix CW, Poloyac SM, Hoesley CJ, Peda M, Gundacker H, et al., editors. Safety and Pharmacokinetics of Dapivirine and Levonorgestrel Vaginal Rings for Multipurpose Prevention of HIV and Pregnancy. AIDS research and human retroviruses; 2018: MARY ANN LIEBERT, INC 140 HUGUENOT STREET, 3RD FL, NEW ROCHELLE, NY 10801 USA.

12. Murphy DJ, Desjardins D, Dereuddre-Bosquet N, Brochard P, Perrot L, Pruvost A, et al. Pre-clinical development of a combination microbicide vaginal ring containing dapivirine and darunavir. The Journal of antimicrobial chemotherapy. 2014;69(9):2477–88. Epub 2014/05/28. doi: 10.1093/jac/dku160 24862093.

13. Vincent KL, Moss JA, Marzinke MA, Hendrix CW, Anton PA, Pyles RB, et al. Safety and pharmacokinetics of single, dual, and triple antiretroviral drug formulations delivered by pod-intravaginal rings designed for HIV-1 prevention: A Phase I trial. PLoS medicine. 2018;15(9):e1002655. Epub 2018/09/29. doi: 10.1371/journal.pmed.1002655 30265679; PubMed Central PMCID: PMC6161852 following competing interests: During part of the time of the study, IB, SAC, and JMC were employees of Auritec and participated in manufacturing the vaginal rings; they were no longer employees at the time of sample collection, data analysis, and manuscript preparation. Prior to August 2016, MG was a 50% shared employee of Auritec and participated in the residual drug measurements and coordinating sample distribution. JAM and MMB are co-inventors on patent applications that include aspects of the intravaginal ring device that was used in the clinical trial described in this manuscript and have received funding for preclinical research relevant to HIV (but not vaginal rings) from ViiV/GSK. They also have received funding from the International Partnership for Microbicides, CONRAD, and the Population Council. JAM, MMB, and MG are co-inventors on the following patent applications relevant to HIV: https://patents.google.com/patent/WO2016149561A1/en and https://patents.google.com/patent/WO2017161136A1/en. KLV and RBP are paid consultants to ABL, Inc. CWH has received funding for clinical research from ViiV/GSK managed via Johns Hopkins University and was a consultant for 1–2 days in 2017 to ViiV/GSK.

14. Lusti‐Narasimhan M, Merialdi M, Holt B. Multipurpose prevention technologies: maximising positive synergies. BJOG: An International Journal of Obstetrics & Gynaecology. 2014;121(3):251–.

15. Madden T, Secura GM, Nease RF, Politi MC, Peipert JF. The role of contraceptive attributes in women's contraceptive decision making. American journal of obstetrics and gynecology. 2015;213(1):46.e1–.e6. Epub 01/30. doi: 10.1016/j.ajog.2015.01.051 25644443.

16. Ross J, Stover J. Use of modern contraception increases when more methods become available: analysis of evidence from 1982–2009. Global Health: Science and Practice. 2013:ghs1300010.

17. Delany-Moretlwe S, Mullick S, Eakle R, Rees H. Planning for HIV preexposure prophylaxis introduction: lessons learned from contraception. Current opinion in HIV and AIDS. 2016;11(1):87–93. doi: 10.1097/COH.0000000000000221 26575146

18. World Health Organization. WHO handbook for guideline development: World Health Organization; 2014.

19. Moher D, Liberati A, Tetzlaff J, Altman DG, Group P. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS medicine. 2009;6(7):e1000097. doi: 10.1371/journal.pmed.1000097 19621072

20. Mensch BS, van der Straten A, Katzen LL. Acceptability in microbicide and PrEP trials: current status and a reconceptualization. Curr Opin HIV AIDS. 2012;7(6):534–41. Epub 2012/10/04. doi: 10.1097/COH.0b013e3283590632 23032737; PubMed Central PMCID: PMC4026162.

21. Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017;17(1):88. Epub 2017/01/28. doi: 10.1186/s12913-017-2031-8 28126032; PubMed Central PMCID: PMC5267473.

22. Tricco AC, Antony J, Soobiah C, Kastner M, MacDonald H, Cogo E, et al. Knowledge synthesis methods for integrating qualitative and quantitative data: a scoping review reveals poor operationalization of the methodological steps. Journal of Clinical Epidemiology. 2016;73:29–35. doi: 10.1016/j.jclinepi.2015.12.011 26891948

23. Higgins J, Sterne J, Savović J, Page M, Hróbjartsson A, Boutron I, et al. A revised tool for assessing risk of bias in randomized trials. The Cochrane database of systematic reviews. 2016;10(Suppl 1):29–31.

24. Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. Bmj. 2011;343:d5928. doi: 10.1136/bmj.d5928 22008217

25. Sterne JA, Hernán MA, Reeves BC, Savović J, Berkman ND, Viswanathan M, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. Bmj. 2016;355:i4919. doi: 10.1136/bmj.i4919 27733354

26. Buckshee K, Kumar S, Saraya L. Contraceptive vaginal ring—a rising star on the contraceptive horizon. Advances in contraception: the official journal of the Society for the Advancement of Contraception. 1990;6(3):177–83. Epub 1990/09/01. doi: 10.1007/bf01849492 2123369.

27. Chen JH, Wu SC, Shao WQ, Zou MH, Hu J, Cong L, et al. The comparative trial of TCu 380A IUD and progesterone-releasing vaginal ring used by lactating women. Contraception. 1998;57(6):371–9. Epub 1998/08/07. doi: 10.1016/s0010-7824(98)00043-2 9693396.

28. Dahiya P, Dalal M, Yadav A, Dahiya K, Jain S, Silan V. Efficacy of combined hormonal vaginal ring in comparison to combined hormonal pills in heavy menstrual bleeding. European journal of obstetrics, gynecology, and reproductive biology. 2016;203:147–51. Epub 2016/06/11. doi: 10.1016/j.ejogrb.2016.05.009 27285306.

29. Das S, Sanyal A, Roy R, Mistri P, Vernekar M, Naskar TK. Combined contraceptive vaginal ring- its acceptability in Indian women. Indian Journal of Public Health Research and Development. 2016;7(1):57–63. doi: 10.5958/0976-5506.2016.00012.7

30. Fan GS, Ren M, Di W, Su P, Chang Q, Wu S, et al. Efficacy and safety of the contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive in Chinese women: a 1-year randomised trial. European Journal of Contraception and Reproductive Health Care. 2016;21(4):303–9. doi: 10.1080/13625187.2016.1186269 27339759

31. Gupta AN, Dhaliwal LK, Gulati K. Clinical performance with contraceptive vaginal rings containing levonorgestrel. The Indian journal of medical research. 1986;84:321–5. Epub 1986/09/01. 3102365.

32. Jain S, Vaid NB, Narang Y, Suneja A, Guleria K. A Randomised Controlled Trial Comparing the Efficacy and Side-Effects of Intravaginal Ring (Nuvaring((R))) With Combined Oral Hormonal Preparation in Dysfunctional Uterine Bleeding. Journal of clinical and diagnostic research: JCDR. 2016;10(3):Qc21–4. Epub 2016/05/03. doi: 10.7860/JCDR/2016/16545.7516 27134949; PubMed Central PMCID: PMC4843334.

33. Madhavan Nair K, Sivakumar B, Prema K, Narasinga Rao BS. Bioavailability of levonorgestrel from intravaginal rings in women of low income groups. Contraception. 1986;33(3):307–22. Epub 1986/03/01. doi: 10.1016/0010-7824(86)90022-3 3087697.

34. Mehta S, Joshi UM, Sankolli GM, Adatia A, Donde UM, Saxena BN. Clinical performance and endocrine profiles with contraceptive vaginal rings containing a combination of estradiol and D-norgestrel. Contraception. 1981;23(3):241–50. Epub 1981/03/01. doi: 10.1016/0010-7824(81)90046-9 7238044.

35. Merkatz R, Roy M, Plagianos M, Hazra A, Vieira CS, Sitruk-Ware R. Reports of acceptability by women using novel contraceptive vaginal rings in diverse settings. European Journal of Contraception and Reproductive Health Care. 2018;23:105–6. doi: 10.1080/13625187.2018.1449823

36. Pandit SN, Chauhan AR, Anagani M, Reddy S, Birla A, Ray SK. Multicenter Study of Contraceptive Vaginal Ring (NuvaRing((R))) in Normal Daily Practice in Indian Women. Journal of obstetrics and gynaecology of India. 2014;64(6):409–16. Epub 2014/12/10. doi: 10.1007/s13224-014-0559-7 25489144; PubMed Central PMCID: PMC4257921.

37. Priya K, Rajaram S, Goel N. Comparison of combined hormonal vaginal ring and low dose combined oral hormonal pill for the treatment of idiopathic chronic pelvic pain: a randomised trial. European journal of obstetrics, gynecology, and reproductive biology. 2016;207:141–6. Epub 2016/11/20. doi: 10.1016/j.ejogrb.2016.10.026 27863271.

38. Santibenchakul S, Jaisamrarn U. Acceptability, tolerability, and satisfaction of a contraceptive vaginal ring (the NuvaRing) among Thai women. Asian Biomedicine. 2016;10(3):235–41. doi: 10.5372/1905-7415.1003.485

39. Sharma R, Kapur A, Fotedar S. Comparison of efficacy, compliance, acceptability and tolerability of hormonal contraceptive vaginal ring (NuvaRing) versus combined oral contraceptives (COCs)—a prospective randomized controlled study in a district level hospital in East Delhi. International Journal of Scientific Research. 2018;7(1).

40. Sheriar N, Joshi R, Mukherjee B, Pal B, Birla A, Ray SK. Impact of structured counseling on the selection of hormonal contraceptive methods: results of a multi-centric, observational study in India. Journal of obstetrics and gynaecology of India. 2014;64(4):241–50. Epub 2014/08/20. doi: 10.1007/s13224-014-0560-1 25136168; PubMed Central PMCID: PMC4126937.

41. Siraj HH, Thandayathany V, Tamil A. Nurses and contraceptive vaginal ring: To use or not to use? International Journal of Gynecology and Obstetrics. 2015;131:E385.

42. Soni A, Garg S, Bangar R. Efficacy, user acceptability, tolerability, and cycle control of a combined contraceptive vaginal ring: the Indian perspective. Journal of obstetrics and gynaecology of India. 2013;63(5):337–41. Epub 2014/01/17. doi: 10.1007/s13224-013-0391-5 24431671; PubMed Central PMCID: PMC3798445.

43. Vijayaletchumi T, Siraj HH, Azmi MT, Jamil MA. Acceptablity of contraceptive vaginal ring (NuvaRing®) amongst nurses in a Malaysian Teaching Hospital. BJOG: An International Journal of Obstetrics and Gynaecology. 2012;119:147. doi: 10.1111/j.1471-0528.2012.03378.x

44. Abu Hashim H, Alsherbini W, Bazeed M. Contraceptive vaginal ring treatment of heavy menstrual bleeding: a randomized controlled trial with norethisterone. Contraception. 2012;85(3):246–52. Epub 2011/11/10. doi: 10.1016/j.contraception.2011.07.012 22067765.

45. Browne E, Mayo AJ, Montgomery E, Torjesen K, Palanee-Philips T, Jeenarain N, et al. Acceptability of and Adherence to the Dapivirine Vaginal Ring for HIV-1 Prevention. Adherence; Miami, FL2019.

46. Browne E, Montgomery E, Van der Straten A, Boeri M, Mange B, Beksinska M, et al. What Do Women Prefer in a Vaginal HIV Prevention Product? Findings from a Discrete Choice Experiment in Southern Africa. HIV Research for Prevention; Madrid, Spain2018.

47. Duby Z, Katz AW, Browne EN, Mutero P, Etima J, Zimba CC, et al. Hygiene, Blood Flow, and Vaginal Overload: Why Women Removed an HIV Prevention Vaginal Ring During Menstruation in Malawi, South Africa, Uganda and Zimbabwe. AIDS and behavior. 2019:1–12.

48. Healthcare I. Summary Booklet: Assessing the Potential of MPTs in South Africa, Uganda, and Nigeria.

49. Healthcare I. Assessing the potential of MPTs in South Africa, Uganda and Nigeria. Bill and Melinda Gates Foundation; 2014.

50. Progesterone Vaginal Ring: Results of an Acceptability Study in Nigeria [Internet]. Population Council. 2015.

51. Kestelyn E, Agaba S, Van Nuil JI, Uwineza M, Umulisa MM, Mwambarangwe L, et al. A randomised trial of a contraceptive vaginal ring in women at risk of HIV infection in Rwanda: Safety of intermittent and continuous use. PloS one. 2018;13(6):e0197572. Epub 2018/06/02. doi: 10.1371/journal.pone.0197572 29856848; PubMed Central PMCID: PMC5983532.

52. Kestelyn E, Van Nuil JI, Umulisa MM, Umutoni G, Uwingabire A, Mwambarangwe L, et al. High acceptability of a contraceptive vaginal ring among women in Kigali, Rwanda. PloS one. 2018;13(6):e0199096. Epub 2018/06/19. doi: 10.1371/journal.pone.0199096 29912906; PubMed Central PMCID: PMC6005526.

53. Kuteesa MO, Quaife M, Biraro S, Katumba KR, Seeley J, Kamali A, et al. Acceptability and Predictors of Uptake of Anti-retroviral Pre-exposure Prophylaxis (PrEP) Among Fishing Communities in Uganda: A Cross-Sectional Discrete Choice Experiment Survey. AIDS and behavior. 2019;2019 Feb 8. doi: 10.1007/s10461-019-02418-7 [Epub ahead of print]. Epub 2019/02/09. 30734882.

54. Luecke EH, Cheng H, Woeber K, Nakyanzi T, Mudekunye-Mahaka IC, van der Straten A. Stated product formulation preferences for HIV pre-exposure prophylaxis among women in the VOICE-D (MTN-003D) study. Journal of the International AIDS Society. 2016;19(1):20875. Epub 2016/06/02. doi: 10.7448/IAS.19.1.20875 27247202; PubMed Central PMCID: PMC4887458.

55. McLellan-Lemal E, Gvetadze R, Desai MA, Makanga EM, Pan Y, Haaland RE, et al. Non-adherence among women enrolled in a contraceptive vaginal ring use study in Kisumu, Kenya, 2014–2015. Journal of Global Health Reports. 2018;2.

56. Mensch BS, Richardson BA, Husnik M, Brown ER, Kiweewa FM, Mayo AJ, et al. Vaginal Ring Use in a Phase 3 Microbicide Trial: A Comparison of Objective Measures and Self-reports of Non-adherence in ASPIRE. AIDS and behavior. 2018;2018 Sep 14. doi: 10.1007/s10461-018-2261-8 [Epub ahead of print]. Epub 2018/09/16. 30218318.

57. Minnis AM, Browne EN, Boeri M, Agot K, van der Straten A, Ahmed K, et al. Young Women's Stated Preferences for Biomedical HIV Prevention: Results of a Discrete Choice Experiment in Kenya and South Africa. Journal of acquired immune deficiency syndromes (1999). 2019;80(4):394–403. Epub 2019/01/12. doi: 10.1097/qai.0000000000001945 30633040.

58. Minnis AM, Roberts ST, Agot K, Weinrib R, Ahmed K, Manenzhe K, et al. Young Women's Ratings of Three Placebo Multipurpose Prevention Technologies for HIV and Pregnancy Prevention in a Randomized, Cross-Over Study in Kenya and South Africa. AIDS and behavior. 2018;22(8):2662–73. Epub 2018/03/22. doi: 10.1007/s10461-018-2078-5 29560570; PubMed Central PMCID: PMC6097726.

59. Mohamed AMM, El-Sherbiny WSM, Mostafa WAI. Combined contraceptive ring versus combined oral contraceptive (30-mu g ethinylestradiol and 3-mg drospirenone). Int J Gynecol Obstet. 2011;114(2):145–8. doi: 10.1016/j.ijgo.2011.03.008 WOS:000293316600013. 21669426

60. Montgomery ET, Beksinska M, Mgodi N, Schwartz J, Weinrib R, Browne EN, et al. End‐user preference for and choice of four vaginally delivered HIV prevention methods among young women in South Africa and Zimbabwe: the Quatro Clinical Crossover Study. Journal of the International AIDS Society. 2019;22(5):e25283. doi: 10.1002/jia2.25283 31069957

61. Montgomery ET, van der Straten A, Cheng H, Wegner L, Masenga G, von Mollendorf C, et al. Vaginal ring adherence in sub-Saharan Africa: expulsion, removal, and perfect use. AIDS Behav. 2012;16(7):1787–98. Epub 2012/07/14. doi: 10.1007/s10461-012-0248-4 22790902.

62. Nassuuna I, Bayigga J, Masawi S, Onyango M, Kusemererwa S. Empowering trial participants to use the dapivirine vaginal ring: Experience from an open label extension trial in South Western Uganda. AIDS research and human retroviruses. 2018;34:367. doi: 10.1089/aid.2018.5000.abstracts

63. Ndagire AK, Onyango M, Bayigga J, Aling E, Kusemererwa S. Examining the relationship between multiple sexual partners and adherence to the dapivirine vaginal ring in a trial in South Western Uganda. AIDS research and human retroviruses. 2018;34:200. doi: 10.1089/aid.2018.5000.abstracts

64. Nel A, Bekker LG, Bukusi E, Hellstrm E, Kotze P, Louw C, et al. Safety, Acceptability and Adherence of Dapivirine Vaginal Ring in a Microbicide Clinical Trial Conducted in Multiple Countries in Sub-Saharan Africa. PloS one. 2016;11(3):e0147743. Epub 2016/03/11. doi: 10.1371/journal.pone.0147743 26963505; PubMed Central PMCID: PMC4786336.

65. Nel A, Martins J, Bekker LG, Ramjee G, Masenga G, Rees H, et al. Safety of a silicone elastomer vaginal ring as potential microbicide delivery method in African women: A Phase 1 randomized trial. PloS one. 2018;13(5):e0196904. Epub 2018/05/31. doi: 10.1371/journal.pone.0196904 29813074; PubMed Central PMCID: PMC5973569 Retroviruses and Opportunistic Infections (CROI) 2011, Boston, USA, 27 Feb to 02 March 2011; and at the SA AIDS conference, Durban, SA, 07 to 10 June 2011. This trial was funded by International Partnership for Microbicides (IPM) (a not-for-profit public-private partnership). The role of the funder in the trial is as follows: IPM was responsible for trial design, implementation and data interpretation, the trial project management and oversight, site coordination, and trial monitoring. IPM was also responsible for in-house preparation of the clinical study report and manuscript. IPM provided the silicone elastomer vaginal rings used in this trial. Dr. Annalene Nel, Ms. Neliette van Niekerk and Dr. Janine Martins are employees of IPM. With the exception of the above disclosure, the authors declare no further conflicts of interest. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

66. Palanee-Phillips T, Roberts ST, Reddy K, Govender V, Naidoo L, Siva S, et al. Impact of Partner-Related Social Harms on Women's Adherence to the Dapivirine Vaginal Ring During a Phase III Trial. Journal of acquired immune deficiency syndromes (1999). 2018;79(5):580–9. Epub 2018/09/22. doi: 10.1097/qai.0000000000001866 30239426; PubMed Central PMCID: PMC6231955.

67. Quaife M. Divergent stated preferences for new antiretroviral-based HIV prevention products across adults, adolescents and female sex workers in South Africa. International Health Economics Congress 2017; Boston, MA2017.

68. Quaife M, Cabrera M, Eakle R, Vickerman P, Delany-Moretlwe S, Terris-Prestholt F. Divergent stated preferences for new multipurpose prevention products across adults, adolescents and female sex workers in South Africa. AIDS Research and Human Retroviruses. 2016;32:158. doi: 10.1089/aid.2016.5000.abstracts

69. RamaRao S, Clark H, Rajamani D, Ishaku S, Mane B, Obare F, et al. Progesterone vaginal ring: Results of a three-country acceptability study. New York: Population Council, 2015.

70. RamaRao S, Obare F, Ishaku S, Mane B, Clark H, Liambila W, et al. Do Women Find the Progesterone Vaginal Ring Acceptable? Findings from Kenya, Nigeria, and Senegal. Studies in family planning. 2018;49(1):71–86. Epub 2018/02/03. doi: 10.1111/sifp.12046 29393513.

71. Routes2Results. Understanding Consumer Preferences for Prevention Products. 2017.

72. van der Straten A, Agot K, Ahmed K, Weinrib R, Browne EN, Manenzhe K, et al. The Tablets, Ring, Injections as Options (TRIO) study: what young African women chose and used for future HIV and pregnancy prevention. Journal of the International AIDS Society. 2018;21(3):e25094. Epub 2018/03/31. doi: 10.1002/jia2.25094 29600595; PubMed Central PMCID: PMC5876496.

73. van der Straten A, Browne EN, Shapley-Quinn MK, Brown ER, Reddy K, Scheckter R, et al. First Impressions Matter: How Initial Worries Influence Adherence to the Dapivirine Vaginal Ring. JAIDS Journal of Acquired Immune Deficiency Syndromes. 2019.

74. van der Straten A, Montgomery ET, Cheng H, Wegner L, Masenga G, von Mollendorf C, et al. High acceptability of a vaginal ring intended as a microbicide delivery method for HIV prevention in African women. AIDS Behav. 2012;16(7):1775–86. Epub 2012/05/31. doi: 10.1007/s10461-012-0215-0 22644068.

75. Weinrib R, Minnis A, Agot K, Ahmed K, Owino F, Manenzhe K, et al. End-Users' Product Preference Across Three Multipurpose Prevention Technology Delivery Forms: Baseline Results from Young Women in Kenya and South Africa. AIDS Behav. 2018;22(1):133–45. Epub 2017/10/21. doi: 10.1007/s10461-017-1911-6 29052018; PubMed Central PMCID: PMC5758675.

76. Barreiros FA, Guazzelli CAF, de Araújo FF, Barbosa R. Bleeding patterns of women using extended regimens of the contraceptive vaginal ring. Contraception. 2007;75(3):204–8. doi: 10.1016/j.contraception.2006.10.009 17303490

77. Faundes A, Hardy E, Reyes C, Pastene L, Portes-Carrasco R. Acceptability of the contraceptive vaginal ring by rural and urban population in two Latin American countries. Contraception. 1981;24(4):393–414. Epub 1981/10/01. doi: 10.1016/0010-7824(81)90006-8 7318435.

78. Guazzelli CA, Barreiros FA, Barbosa R, de Araujo FF, Moron AF. Extended regimens of the vaginal contraceptive ring: cycle control. Contraception. 2009;80(5):430–5. Epub 2009/10/20. doi: 10.1016/j.contraception.2009.05.004 19835716.

79. Hardy E, Hebling EM, Sousa MH, Almeida AF, Amaral E. Delivery of microbicides to the vagina: difficulties reported with the use of three devices, adherence to use and preferences. Contraception. 2007;76(2):126–31. Epub 2007/07/28. doi: 10.1016/j.contraception.2007.04.013 17656182.

80. Hardy EE, Reyes Q, Gomez F, Portes-Carrasco R, Faundes A. User's perception of the contraceptive vaginal ring: a field study in Brazil and the Dominican Republic. Studies in family planning. 1983;14(11):284–90. Epub 1983/11/01. 6417842.

81. Nash HA, Brache V, Alvarez-Sanchez F, Jackanicz TM, Harmon TM. Estradiol delivery by vaginal rings: potential for hormone replacement therapy. Maturitas. 1997;26(1):27–33. Epub 1997/01/01. doi: 10.1016/s0378-5122(96)01072-9 9032744.

82. Plascencia-Nieto ES, Lira-Plascencia J, Gonzalez Habib R, Célis-Gonzalez C, Guarneros-Valdovinos R, Rosas-Balam A. The impact of contraceptive counselling in the prescription of combined hormonal contraceptives. European Journal of Contraception and Reproductive Health Care. 2016;21:107–8. doi: 10.3109/13625187.2015.1135897

83. Thurman AR, Schwartz JL, Brache V, Clark MR, McCormick T, Chandra N, et al. Randomized, placebo controlled phase I trial of safety, pharmacokinetics, pharmacodynamics and acceptability of tenofovir and tenofovir plus levonorgestrel vaginal rings in women. PloS one. 2018;13(6):e0199778. Epub 2018/06/29. doi: 10.1371/journal.pone.0199778 29953547; PubMed Central PMCID: PMC6023238.

84. Weisberg E, Fraser IS, Lacarra M, Mishell DR Jr., Alvarez F, Brache V, et al. Efficacy, bleeding patterns, and side effects of a 1-year contraceptive vaginal ring. Contraception. 1999;59(5):311–8. Epub 1999/09/24. doi: 10.1016/s0010-7824(99)00035-9 10494485.

85. Bitzer J, Cupanik V, Fait T, Gemzell-Danielsson K, Grob P, Oddens BJ, et al. Factors influencing women's selection of combined hormonal contraceptive methods after counselling in 11 countries: Results from a subanalysis of the CHOICE study. European Journal of Contraception and Reproductive Health Care. 2013;18(5):372–80. doi: 10.3109/13625187.2013.819077 WOS:000324618100007. 23941311

86. Bitzer J, Gemzell-Danielsson K, Roumen F, Marintcheva-Petrova M, van Bakel B, Oddens BJ. The CHOICE study: effect of counselling on the selection of combined hormonal contraceptive methods in 11 countries. The European journal of contraception & reproductive health care: the official journal of the European Society of Contraception. 2012;17(1):65–78. Epub 2012/01/14. doi: 10.3109/13625187.2011.637586 22239264.

87. Dakhly DMR, Bassiouny YA, Bayoumi YA, Gouda HM, Hassan AA, Hassan MA, et al. Current contraceptive trends among married Egyptian women: a cross-sectional survey. The European journal of contraception & reproductive health care: the official journal of the European Society of Contraception. 2018;23(5):351–6. Epub 2018/10/30. doi: 10.1080/13625187.2018.1532074 30372641.

88. Egarter C, Tirri BF, Bitzer J, Kaminskyy V, Oddens BJ, Prilepskaya V, et al. Women's perceptions and reasons for choosing the pill, patch, or ring in the CHOICE study: a cross-sectional survey of contraceptive method selection after counseling. BMC Womens Health. 2013;13:14. doi: 10.1186/1472-6874-13-14 WOS:000316730500001.

89. Shaaban MM. Contraception with progestogens and progesterone during lactation. The Journal of steroid biochemistry and molecular biology. 1991;40(4–6):705–10. Epub 1991/01/01. doi: 10.1016/0960-0760(91)90294-f 1835650.

90. Koetsawang S, Ji G, Krishna U, Cuadros A, Dhall GI, Wyss R, et al. Microdose intravaginal levonorgestrel contraception: a multicentre clinical trial. I. Contraceptive efficacy and side effects. World Health Organization. Task Force on Long-Acting Systemic Agents for Fertility Regulation. Contraception. 1990;41(2):105–24. Epub 1990/02/01. doi: 10.1016/0010-7824(90)90141-h 2107054.

91. Prilepskaya V, Nazarova N, Letunovskaya A. The role of contraceptive choice among counselled women (according to the project CHOICE in Russia). European Journal of Contraception and Reproductive Health Care. 2012;17:S34–S5. doi: 10.3109/13625187.2012.673962

92. Sivin I, Mishell DR Jr., Victor A, Diaz S, Alvarez-Sanchez F, Nielsen NC, et al. A multicenter study of levonorgestrel-estradiol contraceptive vaginal rings. I-Use effectiveness. An international comparative trial. Contraception. 1981;24(4):341–58. Epub 1981/10/01. doi: 10.1016/0010-7824(81)90003-2 6459208.

93. Palanee-Phillips T, Roberts S, Montgomery E, Reddy K, Govender V, Naidoo L, et al. Frequency of partner-related social harms and their impact on adherence to the dapivirine vaginal ring during the MTN020/ aspire HIV prevention trial. AIDS Research and Human Retroviruses. 2016;32:94. doi: 10.1089/aid.2016.5000.abstracts

94. Abu Hashim H. Medical treatment of idiopathic heavy menstrual bleeding. What is new? An evidence based approach. Archives of Gynecology and Obstetrics. 2013;287(2):251–60. doi: 10.1007/s00404-012-2605-y 23117248

95. Thurman A, Schwartz J, Yousefieh N, Anderson S, Marzinke M, Gajer P, et al. Vaginal microbiota and mucosal pharmacokinetics of tenofovir in healthy women using placebo, tenofovir and tenofovir/levonorgestrel vaginal rings. AIDS Research and Human Retroviruses. 2018;34:295. doi: 10.1089/aid.2018.5000.abstracts

96. Nel A, van Niekerk N, Kapiga S, Bekker LG, Gama C, Gill K, et al. Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women. New England Journal of Medicine. 2016;375(22):2133–43. doi: 10.1056/NEJMoa1602046 WOS:000389030400005. 27959766

97. Bitzer J, Cupanik V, Fait T, Gemzell-Danielsson K, Grob P, Oddens BJ, et al. Factors influencing women's selection of contraceptive methods during counselling. European Journal of Contraception and Reproductive Health Care. 2012;17:S85–S6. doi: 10.3109/13625187.2012.673963

98. Egarter C, Grimm C, Nouri K, Ahrendt HJ, Bitzer J, Cermak C. Contraceptive counselling and factors affecting women's contraceptive choices: results of the CHOICE study in Austria. Reproductive biomedicine online. 2012;24(7):692–7. Epub 2012/01/31. doi: 10.1016/j.rbmo.2011.12.003 22285247.

99. Novak A, de la Loge C, Abetz L, van der Meulen EA. The combined contraceptive vaginal ring, NuvaRing: an international study of user acceptability. Contraception. 2003;67(3):187–94. Epub 2003/03/06. doi: 10.1016/s0010-7824(02)00514-0 12618252.

100. Tepe M, Mestad R, Secura G, Allsworth JE, Madden T, Peipert JF. Association between tampon use and choosing the contraceptive vaginal ring. Obstetrics and gynecology. 2010;115(4):735–9. Epub 2010/03/24. doi: 10.1097/AOG.0b013e3181d41c4a 20308832; PubMed Central PMCID: PMC3119479.

101. Mack N, Crawford TJ, Guise JM, Chen M, Grey TW, Feldblum PJ, et al. Strategies to improve adherence and continuation of shorter‐term hormonal methods of contraception. Cochrane Database Syst Rev. 2019;(4).

102. Montgomery ET, van der Straten A, Chitukuta M, Reddy K, Woeber K, Atujuna M, et al. Acceptability and use of a dapivirine vaginal ring in a phase III trial. AIDS (London, England). 2017;31(8):1159–67. Epub 2017/04/26. doi: 10.1097/qad.0000000000001452 28441175; PubMed Central PMCID: PMC5557083.

103. Montgomery ET, Stadler J, Naidoo S, Katz AWK, Laborde N, Garcia M, et al. Reasons for nonadherence to the dapivirine vaginal ring: narrative explanations of objective drug-level results. AIDS (London, England). 2018;32(11):1517–25. Epub 2018/06/30. doi: 10.1097/qad.0000000000001868 29957723; PubMed Central PMCID: PMC6230508.

104. Raine TR, Epstein LB, Harper CC, Brown BA, Boyer CB. Attitudes toward the vaginal ring and transdermal patch among adolescents and young women. Journal of Adolescent Health. 2009;45(3):262–7. doi: 10.1016/j.jadohealth.2009.02.007 19699422

105. Latka M. Female-initiated barrier methods for the prevention of STI/HIV: where are we now? Where should we go? Journal of urban health. 2001;78(4):571–80. doi: 10.1093/jurban/78.4.571 11796804

106. Archer DF, Merkatz RB, Bahamondes L, Westhoff CL, Darney P, Apter D, et al. Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system: results of two multicentre, open-label, single-arm, phase 3 trials. The Lancet Global Health. 2019.

107. Shapley-Quinn MK, Manenzhe KN, Agot K, Minnis AM, van der Straten A. "We are not the same": African women's view of multipurpose prevention products in the TRIO clinical study. International journal of women's health. 2019;11:97–107. Epub 2019/02/26. doi: 10.2147/IJWH.S185712 30799959; PubMed Central PMCID: PMC6369839.

108. Brady M, Manning J. Lessons from reproductive health to inform multipurpose prevention technologies: don't reinvent the wheel. Antiviral research. 2013;100 Suppl:S25–31. Epub 2013/11/06. doi: 10.1016/j.antiviral.2013.09.019 24188700.

109. Snow R, Garcia S, Kureshy N, Sadana R, Singh S, Becerra-Valdivia M, et al. Attributes of contraceptive technology: womens preferences in seven countries. 1997.

110. Kruk ME, Schwalbe N. The relation between intermittent dosing and adherence: preliminary insights. Clinical therapeutics. 2006;28(12):1989–95. doi: 10.1016/j.clinthera.2006.12.011 17296456

111. Rothrock NE, Kaiser K, Cella D. Developing a valid patient‐reported outcome measure. Clin Pharmacol Ther. 2011;90(5):737–42. doi: 10.1038/clpt.2011.195 21975345


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