Felix G Mhlanga1, Jennifer E Balkus2, Devika Singh3, Catherine Chappell4, Betty Kamira5, Ishana Harkoo6, Daniel Szydlo7, Shorai Mukaka8, Jeanna Piper9, Sharon L Hillier10. 1. Senior Lecturer, University of Zimbabwe College of Health Sciences Clinical Trials Unit, Harare, Zimbabwe, fmhlanga@uzchs-ctrc.org. 2. Assistant Professor, Department of Epidemiology and Department of Global Health, University of Washington, Seattle, WA, USA. 3. Safety Researcher at the Microbicide Trials Network, Seattle, WA, USA. 4. Assistant Professor, Obstetrics, Gynecology and Reproductive Services, Magee-Women's Research Institute and Foundation, Pittsburgh, PA, USA. 5. Medical Officer, Makerere University-John Hopkins University, Kampala, Uganda. 6. Medical Officer, Centre for AIDS Programme of Research in South Africa, Durban, South Africa. 7. Statistical Research Associate, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. 8. Medical Officer, University of Zimbabwe College of Health Sciences Clinical Trials Unit, Harare, Zimbabwe. 9. Senior Officer, Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA. 10. Richard Sweet Professor of Reproductive Infectious Disease, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Abstract
CONTEXT: The copper IUD is safe and effective, but underutilized in Sub-Saharan Africa, in part because of a lack of trained providers. The World Health Organization recommends training mid-level providers-including nurses and midwives-to insert IUDs; however, the safety of such task shifting has not been evaluated in Sub-Saharan Africa. METHODS: Data were drawn from baseline surveys and study charts of 535 sexually active women aged 18-45 who used a copper IUD while participating in an HIV-prevention clinical trial conducted from August 2012 through June 2015 in Malawi, South Africa, Uganda and Zimbabwe. IUDs were inserted by study physicians, nurses and midwives trained as part of the trial, and by local nonstudy providers. Chi-square and Fisher's exact tests were used to compare women's experiences of adverse events-such as irregular bleeding, pelvic pain or device expulsion-by provider type. RESULTS: Half (54%) of women reported experiencing an adverse event; the most common were irregular bleeding and pelvic pain (45% and 25%, respectively). Compared with women who had received an IUD from a study physician or study nurse, greater proportions of women who had received one from a nonstudy provider reported any adverse event (76% vs. 49% and 51%, respectively), irregular bleeding (57% vs. 41% and 45%) and pelvic pain (35% vs. 15% and 32%); the difference between study physicians and nurses was significant only for pelvic pain. Expulsion rates were comparable for study nurses and nonstudy providers (12.3 and 11.9 per 100 woman-years, respectively), but lower for study physicians (7.3 per 100 woman-years). CONCLUSIONS: The findings support task shifting of IUD insertion to mid-level providers to improve IUD access in Sub-Saharan Africa.
CONTEXT: The copper IUD is safe and effective, but underutilized in Sub-Saharan Africa, in part because of a lack of trained providers. The World Health Organization recommends training mid-level providers-including nurses and midwives-to insert IUDs; however, the safety of such task shifting has not been evaluated in Sub-Saharan Africa. METHODS: Data were drawn from baseline surveys and study charts of 535 sexually active women aged 18-45 who used a copper IUD while participating in an HIV-prevention clinical trial conducted from August 2012 through June 2015 in Malawi, South Africa, Uganda and Zimbabwe. IUDs were inserted by study physicians, nurses and midwives trained as part of the trial, and by local nonstudy providers. Chi-square and Fisher's exact tests were used to compare women's experiences of adverse events-such as irregular bleeding, pelvic pain or device expulsion-by provider type. RESULTS: Half (54%) of women reported experiencing an adverse event; the most common were irregular bleeding and pelvic pain (45% and 25%, respectively). Compared with women who had received an IUD from a study physician or study nurse, greater proportions of women who had received one from a nonstudy provider reported any adverse event (76% vs. 49% and 51%, respectively), irregular bleeding (57% vs. 41% and 45%) and pelvic pain (35% vs. 15% and 32%); the difference between study physicians and nurses was significant only for pelvic pain. Expulsion rates were comparable for study nurses and nonstudy providers (12.3 and 11.9 per 100 woman-years, respectively), but lower for study physicians (7.3 per 100 woman-years). CONCLUSIONS: The findings support task shifting of IUD insertion to mid-level providers to improve IUD access in Sub-Saharan Africa.
Authors: Jared M Baeten; Thesla Palanee-Phillips; Elizabeth R Brown; Katie Schwartz; Lydia E Soto-Torres; Vaneshree Govender; Nyaradzo M Mgodi; Flavia Matovu Kiweewa; Gonasagrie Nair; Felix Mhlanga; Samantha Siva; Linda-Gail Bekker; Nitesha Jeenarain; Zakir Gaffoor; Francis Martinson; Bonus Makanani; Arendevi Pather; Logashvari Naidoo; Marla Husnik; Barbra A Richardson; Urvi M Parikh; John W Mellors; Mark A Marzinke; Craig W Hendrix; Ariane van der Straten; Gita Ramjee; Zvavahera M Chirenje; Clemensia Nakabiito; Taha E Taha; Judith Jones; Ashley Mayo; Rachel Scheckter; Jennifer Berthiaume; Edward Livant; Cindy Jacobson; Patrick Ndase; Rhonda White; Karen Patterson; Donna Germuga; Beth Galaska; Katherine Bunge; Devika Singh; Daniel W Szydlo; Elizabeth T Montgomery; Barbara S Mensch; Kristine Torjesen; Cynthia I Grossman; Nahida Chakhtoura; Annalene Nel; Zeda Rosenberg; Ian McGowan; Sharon Hillier Journal: N Engl J Med Date: 2016-02-22 Impact factor: 91.245