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

Abstract

To compare discontinuation rates of the levonorgestrel and copper intrauterine devices (IUDs) among women with human immunodeficiency virus. 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. 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. 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. Pan African Clinical Trial Registry, www.pactr.org, PACTR 201308000561212. I.