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Intrauterine Contraception Among Women Living With Human Immunodeficiency Virus: A Randomized Controlled Trial

Kakaire, Othman MD; Byamugisha, Josaphat Kayogoza MD, PhD; Tumwesigye, Nazarius Mbona BStat, PhD; Gemzell-Danielsson, Kristina MD, PhD

doi: 10.1097/AOG.0000000000001087
Contents: Long-Acting Reversible Contraception: Original Research
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OBJECTIVE: To compare discontinuation rates of the levonorgestrel and copper intrauterine devices (IUDs) among women with human immunodeficiency virus.

METHODS: A double-masked randomized trial was conducted at Mulago Hospital, Uganda. Women received either a copper or levonorgestrel IUD. The primary outcome was discontinuation of intrauterine contraception within 1 year of placement. The secondary outcomes were incidence of side effects and severe adverse events. To discern a difference of 10% from a copper IUD discontinuation rate of 18%, power of 80%, and 95% confidence interval (CI), a sample size of 351 per arm was estimated. Analysis of the primary outcome was by intension-to-treat principle.

RESULTS: From September 2013 to December 2014, 979 were screened and 703 randomized as follows: 349 to the copper group and 354 to the levonorgestrel group. In total, 8.6% (29/338) women in the copper group compared with 8.1% (27/334) in the levonorgestrel group discontinued intrauterine conception within 1 year of placement (incidence rate ratio 1.1 [95% CI 0.64–1.96]). Overall, the incidence of heavy bleeding was higher in the copper group (37% [125/338]) than in the levonorgestrel group (19.5% [65/334]). However, the incidence of amenorrhea, which occurred in 3.3% (11/338) of women, was lower in the copper group than the 19.8% (66/334) of women who reported amenorrhea in the levonorgestrel group.

CONCLUSION: There was no difference in discontinuation rates between the copper and levonorgestrel devices. Women in the levonorgestrel group had reduced incidence of heavy bleeding and a higher incidence of amenorrhea compared with those in the copper group.

CLINICAL TRIAL REGISTRATION: Pan African Clinical Trial Registry, www.pactr.org, PACTR 201308000561212.

LEVEL OF EVIDENCE: I

There is no difference in discontinuation rates between the levonorgestrel and copper intrauterine devices among women with human immunodeficiency virus.

Department of Obstetrics and Gynaecology and School of Public Health, Makerere University College of Health Sciences, Old Mulago Hill Kampala, Uganda; and the Division of Obstetrics and Gynaecology, Department of Women's and Children's Health, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.

Corresponding author: Othman Kakaire, MD, Department of Obstetrics and Gynaecology, Makerere University College of Health Sciences, PO Box 7072, Kampala, Uganda; e-mail: kakaireothman@hotmail.com.

Financial Disclosure The authors did not report any potential conflicts of interest.

This work was funded by Medical Education for Equitable Services to All Ugandans, a Medical Education Partnership Initiative grant number 5R24TW008886 from the Office of Global AIDS Coordinator and the U.S. Department of Health and Human Services, the Health Resources and Services Administration, and the National Institutes of Health. The Swedish International Development Agency, Swedish Research Council (SIDA/VR) provided additional support. The International Contraceptive Access (ICA) donated the levonorgestrel intrauterine systems used in this study. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of the funders.

© 2015 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.