References
- Armstrong, M. D. (2017). The ANC’s medical trial run: The anti-apartheid medical service in exile, 1964–1990 (Unpublished doctoral dissertation). Carleton University, Ottawa, Ontario.
- Baeten, J. (2016, July 21). Update on the ECHO randomised trial on HIV acquisition among users of different hormonal contraceptive (HC) methods. (Slides). Code THSA0904. Paper presented at the AIDS 2016 conference in the panel, Hormonal Contraception and HIV: A Review of the Science and Research, and Their Implications for Research, Programme and Policy. Retrieved from http://programme.aids2016.org/Programme/Session/41
- Bank, D., & Buckman, R. (2002, May 17). Gates Foundation buys stakes in drug makers. The Wall Street Journal. Retrieved from https://www.wsj.com/articles/SB1021577629748680000
- Bayer. (n.d). 27 million contraceptive implants in six years. Retrieved from http://pharma.bayer.com/en/commitment-responsibility/family-planning/implant-initiative/
- Boozang, K. M., Coleman, C., Miller, T. E., Greenwood, K., Gutmann, V., Handler-Hutchinson, S., & Finizio, C. (2009). Conflicts of interest in clinical trial recruitment & enrollment: A call for increased oversight. Newark, NJ: The Center for Health & Pharmaceutical Law & Policy, Seton Hall University School of Law.
- Brown, J. G. (2000). Recruiting human subjects: Sample guidelines for practice. Boston, MA: Department of Health and Human Services, Office of Inspector General. Retrieved from https://oig.hhs.gov/oei/reports/oei-01-97-00196.pdf
- Butler, A. R., Smith, J. A., Polis, C. B., Gregson, S., Stanton, D., & Hallett, T. B. (2013). Modelling the global competing risks of a potential interaction between injectable hormonal contraception and HIV risk. Aids (London, England), 27(1), 105–113. doi: 10.1097/QAD.0b013e32835a5a52
- Cates, W., & for the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Consortium. (2014). Research on hormonal contraception and HIV. The Lancet, 383(9914), 303–304. doi: 10.1016/S0140-6736(14)60097-0
- ClinicalTrials.gov. (n.d.a). Disclaimer. Retrieved from https://clinicaltrials.gov/ct2/about-site/disclaimer
- ClinicalTrials.gov. (n.d.b). The evidence for contraceptive options and HIV outcomes trial (ECHO). Retrieved from https://clinicaltrials.gov/ct2/show/record/NCT02550067
- Council for International Organizations of Medical Sciences. (2016). International ethical guidelines for health-related research involving humans (4th ed). Geneva: Author.
- Deaton, A., & Cartwright, N. (2018). Understanding and misunderstanding randomized controlled trials. Social Science & Medicine, 210, 2–21. https://doi.org/10.1016/j.socscimed.2017.12.005
- ECHO Consortium. (2017, March 3). The Evidence for contraceptive options and HIV outcomes: Supplementary File 1: ECHO trial Protocol. Version 5.0.
- ECHO Consortium. (n.d.a). Study Design. Retrieved from http://echo-consortium.com/study-design/
- ECHO Consortium. (n.d.b). Retrieved from http://echo-consortium.com/wp-content/uploads/2018/09/map-of-sites-2018-1.png
- Edwards, S. J. L., Lilford, R. J., & Hewison, J. (1998). The ethics of randomised controlled trials from the perspectives of patients, the public, and healthcare professionals. British Medical Journal, 317(7167), 1209–1212. doi: 10.1136/bmj.317.7167.1209
- English Oxford Living Dictionaries. (n.d.). Retrieved from https://en.oxforddictionaries.com/definition/believe
- European Medicines Agency. (2004). ICH topic E 2 D: Post approval safety data management. Retrieved from https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-12.pdf
- Feldblum, P. J., Caraway, J., Bahamondes, L., El-Shafei, M., Quan, H. D., Morales, E., … Condon, S. (2005). Randomized assignment to copper IUD or depot-medroxyprogesterone acetate: Feasibility of enrollment, continuation and disease ascertainment. Contraception, 72, 187–191. doi: 10.1016/j.contraception.2005.03.006
- FHI 360 Study #523201. (2017a, 5 April). Echo template: enrolment informed consent Form V6.0.
- FHI 360 Study #523201. (2017b, 5 April). Echo template: screening informed consent Form V6.0.
- Forder, P. M., Gebski, V. J., & Keech, A. C. (2005). Allocation concealment and blinding: When ignorance is bliss. The Medical Journal of Australia, 182(2), 87–89. https://doi.org/10.5694/j.1326-5377.2005.tb06584.x
- Hapgood, J. P., Kaushic, C., & Hel, Z. (2018). Hormonal contraception and HIV-1 acquisition: Biological mechanisms. Endocrine Reviews, 39(1), 36–78. doi: 10.1210/er.2017-00103
- Hickey, M., Marino, J. L., & Tachedjian, G. (2016). Critical review: Mechanisms of HIV transmission in depo-provera users: The likely role of hypoestrogenism. Journal of Acquired Immune Deficiency Syndromes, 71(1), 1–7. doi:10.1097/QAI.0000000000000805.
- Hofmeyr, G. J., Morrison, C. S., Baeten, J. M., Chipato, T., Donnell, D., Gichangi, P., … Taylor, D. (2018). Rationale and design of a multi-center, open-label, randomised clinical trial comparing HIV incidence and contraceptive benefits in women using three commonly-used contraceptive methods (the ECHO study) [version2; referees 2 approved]. Gates Open Research, 1, 17. doi: 10.12688/gatesopenres.12775.2
- Human Reproduction Programme. (2018). The evidence for contraceptive options and HIV outcomes (ECHO) Trial: current project brief. Retrieved from http://www.who.int/reproductivehealth/projects/ECHO.pdf
- Jain, A. K. (2012). Hormonal contraception and HIV acquisition risk: Implications for individual users and public policies. Contraception, 86(6), 645–652. doi: 10.1016/j.contraception.2012.03.008
- Jepson, M., Elliott, D., Conefrey, C., Wade, J., Rooshenas, L., Wilson, C., … Stallard, N. (2018). An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment. Journal of Clinical Epidemiology, 99, 75–83. doi: 10.1016/j.jclinepi.2018.02.018
- Kahan, B. C., Rehal, S., & Cro, S. (2015). Risk of selection bias in randomised trials. Trials, 16, 405. doi: 10.1186/s13063-015-0920-x
- Karlberg, J. P. E., & Speers, M. A. (Eds.). (2010). Reviewing clinical trials: A guide for the ethics committee. Hong Kong: Karlberg, Johan Petter Einar.
- Martin, H. L., Nyange, P. M., Richardson, B. A., Lavreys, L., Mandaliya, K., Jackson, D. J., … Kreiss, J. (1998). Hormonal contraception, sexually transmitted diseases, and risk of heterosexual transmission of human immunodeficiency virus type 1. The Journal of Infectious Diseases, 178(4), 1053–1059. doi:10.1086/515654.
- Moodley, K., Pather, M., & Myer, L. (2005). Informed consent and participant perceptions of influenza vaccine trials in South Africa. Journal of Medical Ethics, 31(12), 727–732. doi: 10.1136/jme.2004.009910
- Mosher, H. I., Moorthi, G., Li, J., & Weeks, M. R. (2015). A qualitative analysis of peer recruitment pressures in respondent driven sampling: Are risks above the ethical limit? International Journal of Drug Policy, 26(9), 832–842. doi: 10.1016/j.drugpo.2015.05.027
- Mostad, S. B., Overbaugh, J., DeVange, D. M., Welch, M. J., Chohan, B., Mandaliya, K., … Kreiss, J. K. (1997). Hormonal contraception, vitamin A deficiency, and other risk factors for shedding of HIV-1 infected cells from the cervix and vagina’. The Lancet, 350(9082), 922–927. doi: 10.1016/S0140-6736(97)04240-2
- MRC Clinical Trials Unit. (n.d.). What is a randomised clinical trial? Retrieved from https://www.ctu.mrc.ac.uk/patients-public/about-clinical-trials/what-is-a-randomised-clinical-trial/
- Multinational Monitor. (1985). The Case against Depo-Provera: problems in the US. 6 (2&3). Retrieved from https://www.multinationalmonitor.org/hyper/issues/1985/02/problems-us.html
- Nardini, C. (2014). Ethics of clinical trial. Ecancer Medical Science, 8, 387. https://doi.org/10.3332/ecancer.2014.387
- Office of the Human Research Protection Program. (2019). Guidance and procedure: Recruitment and screening methods and materials. Los Angeles, CA: University of California, (UCLA). Retrieved from http://ora.research.ucla.edu/OHRPP/Documents/Policy/5/Recruitment.pdf
- Parliament of India. (2013). Alleged irregularities in the conduct of studies using human papilloma virus (HPV) vaccine by Path in India. Seventy second report. New Delhi: Rajya Sabha Secretariat. Retrieved from http://164.100.47.5/newcommittee/reports/EnglishCommittees/Committee%20on%20Health%20and%20Family%20Welfare/72.pdf
- Pettifor, A. E. (n.d.). Curriculum vitae. Retrieved from http://www.cpc.unc.edu/people/cv/apettif.pdf
- Pfizer. (2014, 13 November). Novel agreement expands access to Pfizer’s contraceptive, Sayana® Press, for women most in need in the world’s poorest countries. Retrieved from https://www.pfizer.com/news/press-release/press-release-detail/novel_agreement_expands_access_to_pfizer_s_contraceptive_sayana_press_for_women_most_in_need_in_the_world_s_poorest_countries
- Pfizer. (2016, 19 October). Pfizer awarded grant to evaluate vaccine to protect newborns against Group B streptococcus infection. Retrieved from https://www.pfizer.com/news/press-release/press-release-detail/pfizer_awarded_grant_to_evaluate_vaccine_to_protect_newborns_against_group_b_streptococcus_infection-0 detail/pfizer_awarded_grant_to_evaluate_vaccine_to_protect_newborns_against_group_b_streptococcus_infection-0
- Pfizer Canada Inc. (2018). Product monograph, including patient medication information: DEPO-PROVERA. Quebec: Pfizer Canada Inc. Retrieved from https://www.pfizer.ca/sites/g/files/g10050796/f/201803/DEPO-PROVERA_PM_E_210121_13Feb2018.pdf
- Polis, C. B., Curtis, K. M., Hannaford, P. C., Phillips, S. J., Chipato, T., Kiarie, J. N., … Steyn, P. S. (2016). An updated systematic review of epidemiological evidence on hormonal contraceptive methods and HIV acquisition in women. Aids (London, England), 30(17), 2665–2683. doi: 10.1097/QAD.0000000000001228
- Potts, M., & Paxman, J. M. (1984). Depo-Provera–ethical issues in its testing and distribution. Journal of Medical Ethics, 10(1), 9–20. doi: 10.1136/jme.10.1.9
- Ralph, L. J., McCoy, S. I., Hallett, T., & Padian, N. (2013). Next steps for research on hormonal contraception and HIV. The Lancet, 382(9903), 1467–1469. https://doi.org/10.1016/S0140-6736(13)61420-8
- Ralph, L. J., McCoy, S. I., Shiu, K., & Padian, N. S. (2015). Hormonal contraceptive use and women’s risk of HIV acquisition: A meta-analysis of observational studies. The Lancet Infectious Diseases, 15(2), 181–189. https://doi.org/10.1016/S1473-3099(14)71052-7
- Rees, H., & ECHO Consortium. (2014). DMPA and HIV: Why we need a trial. Contraception, 90(4), 354–356. doi: 10.1016/j.contraception.2014.08.007
- Rivera, R., & Borasky, D. (2009). Research ethics training curriculum (2nd ed.). Research Triangle Park, NC: Family Health International.
- Saez, C. (2017, 29 January). Is Gates Foundation, WHO’s biggest funder, ineligible to Join WHO? Intellectual Property Watch. Retrieved from https://www.ip-watch.org/2017/01/29/gates-foundation-whos-biggest-private-funder-ineligible-join/
- Sathyamala, C. (1998). Hazardous contraceptives and the right to life. Journal of the Indian Law Institute, 40(1/4), 174–199. Retrieved from http://www.jstor.org/stable/43953316
- Sathyamala, C. (2000). An epidemiological review of the injectable contraceptive, Depo-Provera. Pune: Medico Friend Circle; and Mumbai: Forum for Women’s Health. Retrieved from http://www.mfcindia.org/main/Publications/Sathyamala_Epidemiological_review_depo_provera.pdf
- Simon, C., & Mosavel, M. (2010). Community members as recruiters of human subjects: Ethical considerations. The American Journal of Bioethics, 10(3), 3–11. doi: 10.1080/15265160903585578
- Tsui, A. O., Brown, W., & Li, Q. (2017). Contraceptive practice in Sub-Saharan Africa. Population and Development Review, 43(Suppl 1), 166–191. doi: 10.1111/padr.12051
- UNFPA. (2017). UNFPA supplies annual report 2017. New York: UNFPA Commodity Security Branch. Retrieved from https://www.unfpa.org/unfpa-supplies-annual-report-2017
- Ungchusak, K., Rehle, T., Thammapornpilap, P., Spiegelman, D., Brinkmann, U., & Siraprapasiri, T. (1996). Determinants of HIV infection among female commercial sex workers in northeastern Thailand: Results from a longitudinal study. Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology, 12(5), 500–507. doi: 10.1097/00042560-199608150-00010
- U.S. Agency for International Development (USAID). (2017). Overview of contraceptive and condom shipments, FY 2016. Washington, D.C.: John Snow, Inc. for USAID. Retrieved from https://www.usaid.gov/sites/default/files/documents/1864/C-C_FY16.pdf
- US Department of Health and Human Services [Office for Human Research Protections]. (n.d.). Informed Consent FAQs: what is informed consent and when, why, and how must it be obtained? Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.html
- US Food and Drug Administration. (2018). Title 21—Food and Drugs. Chapter I—Food and Drug Administration, Department of Health and Human Services. Subchapter D—Drugs for human use. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.32
- Vermund, S. H. (2015, February). Curriculum vitae. Retrieved from https://www.vumc.org/health-policy/files/health-policy/cv/Vermund_CV20032015.pdf
- Wemos. (2017). Clinical trials in Africa: The cases of Egypt, Kenya, Zimbabwe and South Africa. Amsterdam: Wemos Foundation. Retrieved from https://www.wemos.nl/wp-content/uploads/2017/07/JH_Wemos_Clinical-Trials_v5_def.pdf
- WHO Regional Office for Africa. (2012). Addressing the challenge of women’s health in Africa. A summary of the report of the commission on women’s health in the African region. Brazzaville: Author. Retrieved from https://www.afro.who.int/sites/default/files/2017-06/report-of-the-commission-on-womens-health-in-the-african-region-who_acsummary-comp.pdf
- WHO Regional Office for Africa. (2018). The state of health in the WHO African region: An analysis of the status of health, health services and health systems in the context of the sustainable development goals. Brazzaville: Author. Retrieved from https://www.afro.who.int/sites/default/files/sessions/documents/State%20of%20health%20in%20the%20African%20Region.pdf
- World Health Organization. (2012). Hormonal contraception and HIV; technical statement. WHO/RHR/12.08. Geneva: Author. Retrieved from https://www.who.int/reproductivehealth/topics/family_planning/Hormonal_contraception_and_HIV.pdf
- World Health Organization. (2017a). Hormonal contraceptive eligibility for women at high risk of HIV: Guidance statement. Geneva: Author. Retrieved from https://apps.who.int/iris/bitstream/handle/10665/254662/WHO-RHR-17.04-eng.pdf;jsessionid=A5F016A0FA6B1E5D264E8115FC65C82B?sequence=1
- World Health Organization. (2017b, February). Hormonal contraceptive eligibility for women at high risk of HIV: Frequently asked questions. Retrieved from http://www.who.int/reproductivehealth/faqs-hormonal-contraceptive-hiv/en/
- World Medical Association. (1964). WMA declaration of Helsinki –Ethical principles for medical research involving human subjects. Amended 64th WMA General Assembly, Fortaleza, Brazil, October 2013. Retrieved from https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/