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Protocol
Studying Accompaniment model Feasibility and Effectiveness (SAFE) Study: study protocol for a prospective observational cohort study of the effectiveness of self-managed medication abortion
  1. Heidi Moseson1,
  2. Brianna Keefe-Oates2,
  3. Ruvani T Jayaweera1,
  4. Sofia Filippa3,
  5. Relebohile Motana4,
  6. Chiara Bercu1,
  7. Ijeoma Egwuatu5,
  8. Belen Grosso6,
  9. Ika Ayu Kristianingrum7,
  10. Sybil Nmezi5,
  11. Ruth Zurbriggen6,
  12. Emmeline Friedman8,
  13. Caitlin Gerdts1
  1. 1Ibis Reproductive Health, Oakland, California, USA
  2. 2Ibis Reproductive Health, Cambridge, Massachusetts, USA
  3. 3Rollins School of Public Health, Emory University, Atlanta, Georgia, USA
  4. 4Ibis Reproductive Health, Johannesburg, Gauteng, South Africa
  5. 5Generation Initiative for Women and Youth Nigeria, Lagos, Nigeria
  6. 6Colectiva Feminista La Revuelta, Neuquen, Argentina
  7. 7Samsara, Yogyakarta, Indonesia
  8. 8Icahn School of Medicine at Mount Sinai, New York, New York, USA
  1. Correspondence to Dr Heidi Moseson; hmoseson{at}ibisreproductivehealth.org

Abstract

Introduction 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 ‘accompaniment’ 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.

Methods and analysis 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’ 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 1–4 additional surveys over 6 weeks 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.

Ethics and dissemination 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.

Trial registration number ISRCTN95769543.

  • accompaniment
  • abortion
  • medication abortion
  • misoprostol
  • mifepristone
  • self-managed abortion
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Footnotes

  • Contributors BK-O, CG, HM and RTJ conceived the initial study idea and obtained funding for the research. All authors (BK-O, CG, HM, RTJ, RM, CB, IE, BG, IAK, SN, RZ and EF) then collaborated to finalise the study conceptualisation, and to determine details and practicalities of study design and procedures that formed this study protocol. HM, BK-O, SF and RTJ drafted the initial study protocol, and all authors (BK-O, CG, HM, RTJ, RM, CB, IE, BG, IAK, SN, RZ and EF) then critically reviewed, edited and approved the final version to be published. All authors agree to be accountable for all aspects of the submitted work.

  • Funding A grant from the David and Lucille Packard Foundation funds the Studying Accompaniment model Feasibility and Effectiveness (SAFE) Study.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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