Strengthening medical abortion in South Africa By Deborah Constant CNSDEB001 n B.Sc (Phys), B.Sc Hons (Anat), M.Sc (Anat), MPH w o T e p Thesis presented for thea degree of C Doctor of Philosophy f in the School of Public oHealth and Family Medicine Facultyy of Health Sciences t i UNsIVERSITY OF CAPE TOWN r e v August 2016 i n U Main Supervisor: Co-supervisor: Associate Professor Jane Harries Professor Landon Myer School of Public Health and Family Medicine School of Public Health and Family Medicine University of Cape Town University of Cape Town i n w The copyright of this thesis vests in the author. No o T quotation from it or information derived from it is to be published without full acknowledgeement of the source. p The thesis is to be used for private study or non- a C commercial research purposes only. f o Published by the Universit y of Cape Town (UCT) in terms y t of the non-exclusive license granted to UCT by the author. i s r e v i n U DECLARATION I, Deborah Constant, hereby declare that the work on which this thesis is based is original research and that neither the whole work nor any part of it has been, is being, or is to be submitted for another degree in this or any other university. The contents of this thesis are entirely the work of the candidate, or, in the case of multi- authored published papers and manuscripts prepared for publication, constitutes work for which the candidate was the lead author. The contribution of the candidate to multi- authored works is outlined in the preface to the thesis and in the introduction to each included paper and manuscript. I empower the university to reproduce for the purpose of research either the whole or any portion of the contents in any manner whatsoever. Deborah Ann Constant Date: August 2016 ii ABSTRACT Access to safe, legal abortion services is an important public health measure to address morbidity and mortality from unsafe abortion. To expand access and strengthen medical abortion provision in South Africa, evidence is needed on the safety, effectiveness, feasibility and acceptability of task sharing strategies and the implementation of evidence- based regimens. This research aims to: (a) evaluate the safety and acceptability of task sharing gestational age estimation for women seeking abortion, (b) determine the effectiveness and acceptability of text messaging on mobile phones to support women self-managing medical abortion, (c) evaluate the feasibility, safety and acceptability of self-assessment of medical abortion completion using mobile phones alone or in combination with a low-sensitivity pregnancy test, and (d) document clinical outcomes and women’s experiences following the introduction of mifepristone into second trimester medical abortion services. Published or submitted papers included in this thesis are from four prospective studies evaluating interventions and interviewing women and health care workers in South African public sector and non-governmental clinics between 2011 and 2015. The first paper establishes that last menstrual period is sufficiently accurate to estimate gestational age in selected women (97%) and has potential to be task shared with community health workers or women themselves. The second paper reports reduced anxiety (p=0.013) and better preparedness (p=0.016) for self-managing abortion symptoms among women receiving automated text messages (compared to those receiving standard care). The third and fourth papers show that mobile phones are a feasible modality for self-assessment for most women (86%), but that clinical history needs to be combined with an appropriate pregnancy test to detect incomplete or failed procedures. Self-assessment using a low-sensitivity pregnancy test is preferred by most women (98%) to in-clinic follow-up, and providing a guided demonstration on the use of a low-sensitivity pregnancy test does not significantly impact on the accuracy of self-assessed abortion outcome compared to simple verbal instructions (88% vs. 85% accuracy; p=0.449). The fifth paper documents successful self- administration of mifepristone, a higher 24-hour abortion rate (93% vs 77%; p<0.001), and iii greater acceptability following the introduction of mifepristone into second trimester abortion care, compared to historic cohorts receiving misoprostol only. The thesis concludes that supported self-management and task sharing can strengthen medical abortion provision in South Africa. Research evaluating task sharing of medical abortion care has potential to inform similar approaches for other health care services. iv ACKNOWLEDGMENTS I would like to thank the following persons and organizations for their contributions to this thesis: My supervisors Associate Professor Jane Harries and co-supervisor Professor Landon Myer for mentorship, support and guidance throughout the PhD process PhD mentor, Dr. Anna Strebel for guidance, assistance with editing and unfailing positive support. Prof. Daniel Grossman, Department of Obstetrics, Gynecology & Reproductive Sciences Director, Advancing New Standards in Reproductive Health (ANSIRH). Prof. Kristina Gemzell-Danielsson, Chair of Obstetrics and Gynaecology and Director of the WHO collaboration centre for Research in Human Reproduction, Karolinska Institutet, Sweden. Kristen Daskilewicz, Ntombomzi Macanjana, Ntuthuzela Mvana, Nomfundu Cishe and Mariette Momberg in the School of Public Health and Family Medicine, UCT. Katherine de Tolly, Senior Project Manager, Vital Wave, South Africa. Facility staff at all clinics where projects where conducted. Dr. Bela Ganatra and Dr. Garret Mehl at the World Health Organization, Geneva, Switzerland for technical advice with the projects and assistance with funding processes. The Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland for funding the research projects. The Safe Abortion Action Fund (SAAF) for support and funding for funding this research. The Research Office of the University of Cape Town for funding over 3 years to top-up the project as well as a contribution to funding time off work to complete the PhD write-up process The Harry Crossley Foundation for awarding two fellowships, in 2013 and 2015 to allow for time off to write the proposal for this PhD and to compete the dissertation write-up in v 2015/2016. The National Research Foundation of South Africa for the grant award in 2015/2016, which co-funded time off to write up this dissertation. The Medical Research Council of South Africa for funding the research projects and for bursary supplementation. My family for their support and encouragement over the years for this project of mine. vi PREFACE This thesis includes published papers, manuscripts submitted for publication, and manuscripts prepared for submission as per general provision 6.7 in the General Rules for the Degree of Doctor of Philosophy (PhD) of the University of Cape Town, and with the approval in July 2016 of the University Doctoral Degrees Board. The analyses and drafting of all papers was conducted by the candidate during the period of doctoral degree registration. The following five papers and manuscripts are included as part of the thesis. 1. Accuracy of gestational age estimation from last menstrual period among women seeking abortion in South Africa, with a view to task sharing: a mixed methods study. Submitted for publication to Reproductive Health (August 2016). 2. Mobile phone messages to provide support to women during the home phase of medical abortion in South Africa: a randomised controlled trial. Contraception 2014; Sep;90(3)226-33. 3. Self-assessment of medical abortion completion using a text questionnaire on mobile phones among South African women. Reproductive Health Matters 2015;22(44) Suppl 1:83-93. 4. Self-assessment of medical abortion outcome in South Africa: A non-inferiority, randomized controlled trial. Prepared for submission to Obstetrics and Gynecology (August 2016). 5. Clinical outcomes and women’s experiences before and after the introduction of mifepristone into second-trimester medical abortion services in South Africa. PLoS One 2016;Sep 1;11(9):e0161843 The contribution of the candidate is outlined in the introduction to each of the papers vii (Chapters 3, 4, 5, 6 and 7). The candidate was the lead author for all the papers and manuscripts. She was responsible for study design in Studies 2 and 3, and contributed to study design in Studies 1 and 4. The candidate prepared all the data sets for analysis, conducted all the analyses and drafted all versions of the manuscripts under the supervision of her doctoral advisors. All co-authors critically reviewed and approved the submitted manuscripts and the candidate was responsible for incorporating co-author’s comments as appropriate. viii LIST OF ACRONYMS AND ABBREVIATIONS ANC African National Congress CEDAW Convention on the Elimination of All Forms of Discrimination against Women CHW Community health worker CL Checklist CI Confidence interval CTOPA Choice on Termination of Pregnancy Act D&E Dilation and evacuation (abortion technique) DOH Department of Health EDL Essential Drug List FDA Food and Drug Administration FU Follow-up GA Gestational age hCG Human chorionic gonadotrophin HCP Health-care professional HCW Health-care worker HIV Human immunodeficiency virus HSUPT High-sensitivity urine pregnancy test HR Hazard ratio IDI In-depth interview ICPD International Conference on Population and Development ITT Intention to treat KZN KwaZulu-Natal LARC Long-acting, reversible contraception LMIC Low- and middle-income countries LMP Last menstrual period LSUPT Low-sensitivity urine pregnancy test LTF Loss to follow-up MA Medical abortion MCC Medicines Control Council MDGs Millennium Development Goals MLUPT Multi-level urine pregnancy test MNCH Maternal, new-born and child health MVA Manual vacuum aspiration (abortion technique) NDOH National Department of Health NGO Non-governmental organization NPV Negative predictive value OBGYN Obstetrician gynecologist ix