Comparison of Safety and Continuation of the Levonorgestrel Intrauterine System versus the Copper Intrauterine Device Among Women Living with HIV: A Randomised Controlled Trial

Abstract

Background: Hormonal contraceptives may increase genital tract HIV viral load (gVL) and risk for sexual transmission in women living with HIV (WLHIV). We compared detectable gVL and intrauterine contraceptive (IUC) continuation between levonorgestrel intrauterine system (LNG-IUS) versus copper intrauterine device (C-IUD) in Cape Town, South Africa. Methods: In this double-masked, randomised controlled trial, eligible WLHIV were: ages 18-40, not pregnant or desiring pregnancy within 30 months, and virologically-suppressed using antiretroviral therapy (ART) or with CD4+ lymphocyte count above treatment threshold at enrolment (non-ART). At enrolment, we randomised within ART groups and provided the allocated IUC to consenting women. At all visits, participants completed questionnaires and provided specimens for gVL, plasma VL, and pregnancy testing. We assessed gVL through six and 24 months controlling for baseline gVL, ART group, age, and reproductive tract infection. Results: We enrolled 67 non-ART (36 LNG-IUS, 31 C-IUD) and 132 ART-using (65 LNG-IUS, 67 C-IUD) women. Detectable gVL did not differ between LNGIUS compared to C-IUD across six (Adjusted Odds Ratio (AOR): 0·82, 95% Confidence Interval (CI): 0·46-1·47) and 24 months (AOR: 0·96, 95% CI: 0·63-1·45). Overall IUC continuation was 80%; C-IUD users experienced higher expulsion (8% vs 1%, p=0·02) and elective discontinuation (adjusted Hazard Ratio: 8·75, 95% CI: 3·08-24·8) rates. Interpretation: The LNG-IUS has no significant effect on gVL, and higher continuation rates when compared with the C-IUD, among WLHIV. Clinical Registration Number: NCT01721798. Funding Statement: Eunice Kennedy Shriver National Institute of Child Health and Human Development, U.S. National Institutes of Health (5R01HD071804); Preventive Technologies Agreement (No. GHO‑A‑00‑09‑00016-00), U.S. Agency for International Development. Declaration of Interests: The authors declare no competing interests. Ethics Approval Statement: The University of Cape Town and FHI 360 institutional review boards approved the study, and all participants provided written informed consent prior to trial participation.