{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,3,4]],"date-time":"2025-03-04T05:28:10Z","timestamp":1741066090075,"version":"3.38.0"},"reference-count":36,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2025,3,3]],"date-time":"2025-03-03T00:00:00Z","timestamp":1740960000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill & Melinda Gates Foundation","doi-asserted-by":"crossref","award":["[INV-046476]"],"award-info":[{"award-number":["[INV-046476]"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["gatesopenresearch.org"],"crossmark-restriction":false},"short-container-title":["Gates Open Res"],"abstract":"<ns4:p>BackgroundExpanding contraceptive options could better meet users\u2019 diverse needs and preferences. Annovera <ns4:sup>\u00ae<\/ns4:sup> is a contraceptive vaginal ring that provides a year of pregnancy prevention while remaining under user control and allowing for regular menstrual cycles. This method may also help to reduce burdens on some health care and supply chain systems. However, knowledge gaps exist regarding initial and ongoing acceptability of contraceptive vaginal rings in African settings.MethodsWe will undertake an open-label, non-randomized, two-arm, parallel clinical acceptability study with an embedded qualitative component, based in clinics providing contraceptive services in Kenya and Zimbabwe. Women aged 18-45 interested in newly initiating or switching contraception will choose from among all available contraceptive options, including Annovera. We aim to enroll 200 participants selecting Annovera and 200 participants selecting either contraceptive injectables or pills. We will compare method uptake, continuation, and satisfaction over one year. Participants will complete questionnaires administered by study staff during two in-person visits (a screening\/enrollment visit, and an end of study visit after 52 weeks of method use or at discontinuation) and four phone appointments (at 4, 12, 24, and 36 weeks of use). We will evaluate used rings for discoloration and residual drug levels. The qualitative component involve in-depth interviews with women in the clinical study, their sexual partners, and their service providers, to further examine drivers of and barriers to interest in and use of contraceptive vaginal rings.DiscussionThis study will explore acceptability of contraceptive vaginal rings in \u2018real-world\u2019 contraceptive service settings in two African countries. Findings will be based on actual ring use and contextualized via comparison to two other commonly available methods. As vaginal rings are being considered for multiple reproductive health indications, this work can fill key knowledge gaps and empower decision-makers with information needed to inform future investments in reproductive health.<\/ns4:p>","DOI":"10.12688\/gatesopenres.16315.1","type":"journal-article","created":{"date-parts":[[2025,3,3]],"date-time":"2025-03-03T08:20:07Z","timestamp":1740990007000},"page":"5","update-policy":"https:\/\/doi.org\/10.12688\/gatesopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["A comparison of acceptability of contraceptive vaginal rings, pills, and injectables among cisgender women in Kenya and Zimbabwe: protocol for a mixed-methods study"],"prefix":"10.12688","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1031-7074","authenticated-orcid":false,"given":"Chelsea B.","family":"Polis","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francis O.","family":"Obare","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Irene V.","family":"Bruce","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cynthia","family":"Banda","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lisa B.","family":"Haddad","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antwanette","family":"Heyns","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Petros","family":"Isaakidis","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mercy","family":"Kamupira","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Terrance","family":"Kufakunesu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zachary A.","family":"Kwena","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Farai","family":"Machinga","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Regina F.","family":"Magore","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aleck","family":"Mapangire","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3370-9318","authenticated-orcid":false,"given":"Mercy","family":"Marimirofa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matheus","family":"Mathipa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sanyukta","family":"Mathur","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mary","family":"Mudavanhu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tatenda P.","family":"Mujuru","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Prisca","family":"Mutero","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Betty","family":"Njoroge","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Collen","family":"Nyatsambo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah","family":"Okumu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Leah","family":"Omondi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tevyne","family":"Omondi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marlena G.","family":"Plagianos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Greshon","family":"Rota","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Samuel","family":"Sithole","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bruce","family":"Variano","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J. Brady","family":"Burnett-Zieman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Petina","family":"Musara","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"George","family":"Odwe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerald","family":"Hangaika","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Serah","family":"Gitome","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizabeth A.","family":"Bukusi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kuziwa","family":"Kuwenyi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2560","published-online":{"date-parts":[[2025,3,3]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"e1152-e1161","DOI":"10.1016\/S2214-109X(20)30315-6","article-title":"Unintended pregnancy and abortion by income, region, and the legal status of abortion: estimates from a comprehensive model for 1990\u20132019.","volume":"8","author":"J Bearak","year":"2020","journal-title":"Lancet Glob Health."},{"key":"ref3","doi-asserted-by":"publisher","first-page":"203-212","DOI":"10.9745\/GHSP-D-13-00010","article-title":"Use of modern contraception increases when more methods become available: analysis of evidence from 1982\u20132009.","volume":"1","author":"J Ross","year":"2013","journal-title":"Glob Health Sci Pract."},{"key":"ref4","doi-asserted-by":"publisher","first-page":"34-55","DOI":"10.9745\/GHSP-D-14-00199","article-title":"Trends in the contraceptive method mix in low- and middle-income countries: analysis using a new \u201caverage deviation\u201d measure.","volume":"3","author":"J Ross","year":"2015","journal-title":"Glob Health Sci Pract."},{"key":"ref5","doi-asserted-by":"publisher","first-page":"1707","DOI":"10.1186\/s12889-019-8080-7","article-title":"Expanding choice and access in contraception: an assessment of intrauterine contraception policies in low and middle-income countries.","volume":"19","author":"M Ali","year":"2019","journal-title":"BMC Public Health."},{"key":"ref6","doi-asserted-by":"publisher","first-page":"e2300070","DOI":"10.9745\/GHSP-D-23-00070","article-title":"Inequities in Family Planning in Low- and Middle-Income Countries.","volume":"11","author":"J Ross","year":"2023","journal-title":"Glob Health Sci Pract."},{"key":"ref7","doi-asserted-by":"publisher","first-page":"100154","DOI":"10.1016\/j.ssmqr.2022.100154","article-title":"\u201cShe told me no, that you cannot change\u201d: Understanding provider refusal to remove contraceptive implants.","volume":"2","author":"L Senderowicz","year":"2022","journal-title":"SSM Qual Res Health."},{"key":"ref8","doi-asserted-by":"publisher","first-page":"100132","DOI":"10.1016\/j.xagr.2022.100132","article-title":"Facility readiness to remove subdermal contraceptive implants in 6 sub-Saharan African countries.","volume":"2","author":"L Senderowicz","year":"2022","journal-title":"AJOG Glob Rep."},{"key":"ref9","doi-asserted-by":"publisher","first-page":"110302","DOI":"10.1016\/j.contraception.2023.110302","article-title":"Perceptions of access to long-acting reversible contraception removal among women in Burkina Faso.","volume":"129","author":"N Sokol","year":"2024","journal-title":"Contraception."},{"key":"ref10","doi-asserted-by":"publisher","first-page":"114","DOI":"10.1186\/s12978-018-0561-0","article-title":"There might be blood: a scoping review on women\u2019s responses to contraceptive-induced menstrual bleeding changes.","volume":"15","author":"C Polis","year":"2018","journal-title":"Reprod Health."},{"key":"ref12","doi-asserted-by":"publisher","first-page":"2098557","DOI":"10.1080\/26410397.2022.2098557","article-title":"Impacts of COVID-19 on contraceptive and abortion services in low- and middle-income countries: a scoping review.","volume":"30","author":"C Polis","year":"2022","journal-title":"Sex Reprod Health Matters."},{"key":"ref13","doi-asserted-by":"publisher","first-page":"377-379","DOI":"10.1016\/j.contraception.2021.03.023","article-title":"Addressing contraceptive needs exacerbated by COVID-19: A call for increasing choice and access to self-managed methods.","volume":"103","author":"L Haddad","year":"2021","journal-title":"Contraception."},{"key":"ref15","doi-asserted-by":"publisher","first-page":"323-328","DOI":"10.1016\/j.contraception.2019.02.001","article-title":"Segesterone acetate\/ethinyl estradiol 12-month contraceptive vaginal system safety evaluation.","volume":"99","author":"K Gemzell-Danielsson","year":"2019","journal-title":"Contraception."},{"key":"ref16","doi-asserted-by":"publisher","first-page":"e1054-e1064","DOI":"10.1016\/S2214-109X(19)30265-7","article-title":"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.","volume":"7","author":"D Archer","year":"2019","journal-title":"Lancet Glob Health."},{"key":"ref17","doi-asserted-by":"publisher","first-page":"1-12","DOI":"10.1016\/j.fertnstert.2004.01.025","article-title":"Why consider vaginal drug administration?","volume":"82","author":"N Alexander","year":"2004","journal-title":"Fertil Steril."},{"key":"ref18","doi-asserted-by":"publisher","first-page":"789-806","DOI":"10.1055\/a-1369-9395","article-title":"Development of Hormonal Intravaginal Rings: Technology and Challenges.","volume":"81","author":"F Rafiei","year":"2021","journal-title":"Geburtshilfe Frauenheilkd."},{"key":"ref21","doi-asserted-by":"publisher","first-page":"71-80","DOI":"10.1363\/psrh.12103","article-title":"A Qualitative Systematic Review of Women\u2019s Experiences Using Contraceptive Vaginal Rings: Implications for New Technologies.","volume":"51","author":"S Vargas","year":"2019","journal-title":"Perspect Sex Repro H."},{"key":"ref22","doi-asserted-by":"publisher","first-page":"e0224898","DOI":"10.1371\/journal.pone.0224898","article-title":"Vaginal ring acceptability and related preferences among women in low- and middle-income countries: A systematic review and narrative synthesis.","volume":"14","author":"J Griffin","year":"2019","journal-title":"PLoS One."},{"key":"ref23","doi-asserted-by":"publisher","first-page":"16-33","DOI":"10.1016\/j.contraception.2021.10.001","article-title":"Vaginal ring acceptability: A systematic review and meta-analysis of vaginal ring experiences from around the world.","volume":"106","author":"K Ridgeway","year":"2022","journal-title":"Contraception."},{"key":"ref24","doi-asserted-by":"publisher","first-page":"455-490","DOI":"10.1111\/sifp.12209","article-title":"Barriers and Enablers Influencing Women\u2019s Adoption and Continuation of Vaginally Inserted Contraceptive Methods: A Literature Review.","volume":"53","author":"D Harris","year":"2022","journal-title":"Stud Fam Plan."},{"key":"ref25","doi-asserted-by":"publisher","first-page":"2662-2673","DOI":"10.1007\/s10461-018-2078-5","article-title":"Young Women\u2019s Ratings of Three Placebo Multipurpose Prevention Technologies for HIV and Pregnancy Prevention in a Randomized, Cross-Over Study in Kenya and South Africa.","volume":"22","author":"A Minnis","year":"2018","journal-title":"AIDS Behav."},{"key":"ref26","doi-asserted-by":"publisher","first-page":"e7586-e7586","DOI":"10.1136\/bmj.e7586","article-title":"SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.","volume":"346","author":"A Chan","year":"2013","journal-title":"BMJ."},{"key":"ref27","doi-asserted-by":"publisher","first-page":"88","DOI":"10.1186\/s12913-017-2031-8","article-title":"Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework.","volume":"17","author":"M Sekhon","year":"2017","journal-title":"BMC Health Serv. Res."},{"key":"ref28","doi-asserted-by":"publisher","first-page":"514-521","DOI":"10.1016\/j.contraception.2014.05.015","article-title":"Acceptability of the nestorone\n                        \u00ae\/ethinyl estradiol contraceptive vaginal ring: development of a model; implications for introduction.","volume":"90","author":"R Merkatz","year":"2014","journal-title":"Contraception."},{"key":"ref29","doi-asserted-by":"publisher","first-page":"71-86","DOI":"10.1111\/sifp.12046","article-title":"Do Women Find the Progesterone Vaginal Ring Acceptable? Findings from Kenya, Nigeria, and Senegal: Do Women Find the Progesterone Vaginal Ring Acceptable?","volume":"49","author":"S RamaRao","year":"2018","journal-title":"Stud Fam Plan."},{"key":"ref30","doi-asserted-by":"publisher","first-page":"e0199096","DOI":"10.1371\/journal.pone.0199096","article-title":"High acceptability of a contraceptive vaginal ring among women in Kigali, Rwanda.","volume":"13","author":"E Kestelyn","year":"2018","journal-title":"PLoS One."},{"key":"ref31","article-title":"Development and validation of a multidimensional Intravaginal Ring Acceptability Scale among US women and their male partners.","author":"A Gottert","year":"n.d"},{"key":"ref32","doi-asserted-by":"publisher","first-page":"23","DOI":"10.1002\/jia2.25626","article-title":"An open-label, randomized crossover study to evaluate the acceptability and preference for contraceptive options in female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose).","volume":"23","author":"K Gill","year":"2020","journal-title":"J Intern AIDS Soc."},{"key":"ref33","doi-asserted-by":"publisher","first-page":"507-520","DOI":"10.1016\/j.jsxm.2021.12.007","article-title":"Measuring the Sexual Acceptability of Contraception: Psychometric Examination and Development of a Valid and Reliable Prospective Instrument.","volume":"19","author":"J Sanders","year":"2022","journal-title":"J Sex Med."},{"key":"ref34","doi-asserted-by":"publisher","first-page":"2104680","DOI":"10.1080\/26410397.2022.2104680","article-title":"Husbands\u2019 concerns and experiences with the progesterone vaginal ring in three sub-Saharan African countries: a mixed methods study.","volume":"29","author":"F Obare","year":"2022","journal-title":"Sex Reprod Health Matters."},{"key":"ref35","doi-asserted-by":"publisher","first-page":"1761-1770","DOI":"10.2147\/PPA.S265503","article-title":"Choosing and Using the Progesterone Vaginal Ring: Women\u2019s Lived Experiences in Three African Cities.","volume":"14","author":"C Undie","year":"2020","journal-title":"PPA."},{"key":"ref36","doi-asserted-by":"publisher","DOI":"10.15761\/FWH.1000122","article-title":"Contraceptive vaginal ring experiences among women and men in Kisumu, Kenya: A qualitative study.","volume":"2","author":"E McLellan-Lemal","year":"2017","journal-title":"Front. Womens Health."},{"key":"ref37","doi-asserted-by":"publisher","first-page":"377-381","DOI":"10.1016\/j.jbi.2008.08.010","article-title":"Research electronic data capture (REDCap)\u2014A metadata-driven methodology and workflow process for providing translational research informatics support.","volume":"42","author":"P Harris","year":"2009","journal-title":"J Biomed Inform."},{"key":"ref38","doi-asserted-by":"publisher","first-page":"103208","DOI":"10.1016\/j.jbi.2019.103208","article-title":"The REDCap consortium: Building an international community of software platform partners.","volume":"95","author":"P Harris","year":"2019","journal-title":"J Biomed Inform."},{"key":"ref39","doi-asserted-by":"publisher","first-page":"241-246","DOI":"10.1016\/j.contraception.2019.06.013","article-title":"Post-use ring weight and residual drug content as potential objective measures of user adherence to a contraceptive progesterone vaginal ring.","volume":"100","author":"D Murphy","year":"2019","journal-title":"Contraception."},{"key":"ref40","doi-asserted-by":"publisher","first-page":"59-82","DOI":"10.1177\/1525822X05279903","article-title":"How Many Interviews Are Enough?: An Experiment with Data Saturation and Variability.","volume":"18","author":"G Guest","year":"2006","journal-title":"Field Methods."},{"key":"ref41","doi-asserted-by":"publisher","DOI":"10.7910\/DVN\/ZFJZ2D","article-title":"A comparison of acceptability of contraceptive vaginal rings, pills, and injectables among cisgender women in Kenya and Zimbabwe: protocol for a mixed-methods study (SPIRIT Checklist-Protocol Paper).","volume":"V1","author":"C Polis","year":"2024","journal-title":"Harvard Dataverse."}],"container-title":["Gates Open Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/gatesopenresearch.org\/articles\/9-5\/v1\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/gatesopenresearch.org\/articles\/9-5\/v1\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/gatesopenresearch.org\/articles\/9-5\/v1\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,3]],"date-time":"2025-03-03T08:20:23Z","timestamp":1740990023000},"score":1,"resource":{"primary":{"URL":"https:\/\/gatesopenresearch.org\/articles\/9-5\/v1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,3,3]]},"references-count":36,"URL":"https:\/\/doi.org\/10.12688\/gatesopenres.16315.1","relation":{"has-preprint":[{"id-type":"doi","id":"10.12688\/verixiv.471.1","asserted-by":"subject"}]},"ISSN":["2572-4754"],"issn-type":[{"value":"2572-4754","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,3,3]]},"assertion":[{"value":"Awaiting Peer Review","URL":"https:\/\/gatesopenresearch.org\/articles\/9-5\/v1#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"This work was supported, in whole or in part, by the Bill & Melinda Gates Foundation [INV-046476]. Additionally, in-kind support is provided by MSF in Zimbabwe in the form of salaries for the MSF staff who contributed to the study; MSF site did not receive funding for this study from the abovementioned grant. Supplies of Annovera used in this study were donated by the Population Council in cooperation with Mayne Pharma. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":0,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}