{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T22:24:48Z","timestamp":1788560688456,"version":"build-2803163510"},"reference-count":38,"publisher":"BMJ","issue":"11","license":[{"start":{"date-parts":[[2020,11,19]],"date-time":"2020-11-19T00:00:00Z","timestamp":1605744000000},"content-version":"unspecified","delay-in-days":18,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000008","name":"The David and Lucile Packard Foundation","doi-asserted-by":"crossref","award":["2018-67537"],"award-info":[{"award-number":["2018-67537"]}],"id":[{"id":"10.13039\/100000008","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2020,10,19]]},"published-print":{"date-parts":[[2020,11]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>A range of barriers deter or prevent people from accessing facility-based abortion care. As a result, people are obtaining and using abortifacient medications to end their pregnancies outside of the formal healthcare system, without clinical supervision. One model of self-managed abortion has come to be known as the \u2018accompaniment\u2019 model, in which grassroots organisations provide pregnant people with evidence-based counselling and support through the medication abortion process. Data are needed to understand the safety and effectiveness of this increasingly common model of abortion care.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This is a large, prospective, observational study in Argentina and Nigeria. All people who contact one of two accompaniment groups seeking information for their own self-managed medication abortion, are ages 13 years and older, have no contraindications for medication abortion, are within the gestational range supported by the group (up to 12 weeks\u2019 gestation for the primary outcome) and are willing to be contacted for follow-up will be recruited. Participants will respond to an interviewer-administered baseline survey at enrolment, and 1\u20134 additional surveys over 6\u2009weeks to ascertain whether they obtain medications for abortion, dosing and route of administration of medications, physical and emotional experience of medication abortion self-management, and effectiveness and safety outcomes. Analyses will include estimates of the primary outcome: the proportion of participants that report a complete abortion without surgical intervention at last recorded follow-up; as well as secondary outcomes including a pseudo-experimental test of non-inferiority of the effectiveness of self-managed medication abortion as compared with clinical medication abortion.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>We describe the ethical considerations and protections for this study, as well the creation of a study-specific Data Monitoring and Oversight Committee. We describe dissemination plans to ensure that study results are shared widely with all relevant audiences, particularly researchers, advocates, policymakers and clinicians.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"ISRCTN95769543\">ISRCTN95769543<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-036800","type":"journal-article","created":{"date-parts":[[2020,11,20]],"date-time":"2020-11-20T03:12:04Z","timestamp":1605841924000},"page":"e036800","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":18,"title":["Studying Accompaniment model Feasibility and Effectiveness (SAFE) Study: study protocol for a prospective observational cohort study of the effectiveness of self-managed medication abortion"],"prefix":"10.1136","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2488-2429","authenticated-orcid":false,"given":"Heidi","family":"Moseson","sequence":"first","affiliation":[{"name":"Ibis Reproductive Health, Oakland, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brianna","family":"Keefe-Oates","sequence":"additional","affiliation":[{"name":"Ibis Reproductive Health, Cambridge, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruvani T","family":"Jayaweera","sequence":"additional","affiliation":[{"name":"Ibis Reproductive Health, Oakland, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sofia","family":"Filippa","sequence":"additional","affiliation":[{"name":"Rollins School of Public Health, Emory University, Atlanta, Georgia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Relebohile","family":"Motana","sequence":"additional","affiliation":[{"name":"Ibis Reproductive Health, Johannesburg, Gauteng, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Bercu","sequence":"additional","affiliation":[{"name":"Ibis Reproductive Health, Oakland, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ijeoma","family":"Egwuatu","sequence":"additional","affiliation":[{"name":"Generation Initiative for Women and Youth Nigeria, Lagos, Nigeria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Belen","family":"Grosso","sequence":"additional","affiliation":[{"name":"Colectiva Feminista La Revuelta, Neuquen, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ika Ayu","family":"Kristianingrum","sequence":"additional","affiliation":[{"name":"Samsara, Yogyakarta, Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sybil","family":"Nmezi","sequence":"additional","affiliation":[{"name":"Generation Initiative for Women and Youth Nigeria, Lagos, Nigeria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruth","family":"Zurbriggen","sequence":"additional","affiliation":[{"name":"Colectiva Feminista La Revuelta, Neuquen, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmeline","family":"Friedman","sequence":"additional","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai, New York, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caitlin","family":"Gerdts","sequence":"additional","affiliation":[{"name":"Ibis Reproductive Health, Oakland, California, 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