A randomized trial of the intrauterine contraceptive device vs hormonal contraception in women who are infected with the human immunodeficiency virus

Abstract

OBJECTIVE-The purpose of this study was to determine whether the intrauterine contraceptive device (IUD) is effective and safe among women who are infected with the human immunodeficiency virus (HIV).STUDY DESIGN-We randomly assigned 599 postpartum, HIV-infected women in Zambia to receive either a copper IUD or hormonal contraception and followed them for at least 2 years.RESULTS-Women who were assigned randomly to hormonal contraception were more likely to become pregnant than those who were assigned randomly to receive an IUD (rate, 4.6/100 vs 2.0/100 woman-years; hazards ratio, 2.4; 95% CI, 1.3-4.7). One woman who was assigned to the IUD experienced pelvic inflammatory disease (crude rate, 0.16/100 woman-years; 95% CI, 0.004-868); there was no pelvic inflammatory disease among those women who were assigned to hormonal contraception. Clinical disease progression (death or CD4+ lymphocyte count dropping below 200 cells/μL) was more common in women who were allocated to hormonal contraception (13.2/100 woman-years) than in women who were allocated to the IUD (8.6/100 woman-years; hazard ratio, 1.5; 95% CI, 1.04-2.1). CONCLUSION-TheIUD is effective and safe in HIV-infected women. The unexpected observation that hormonal contraception was associated with more rapid HIV disease progression requires urgent further study. Pregnancy and acquired immunodeficiency syndrome (AIDS) are among the most important health risks faced by sexually active women in sub-Saharan Africa. [1][2][3] In Zambia, as many as 1 in 5 pregnant women is infected with human immunodeficiency virus (HIV), 4 and a woman's lifetime risk of dying from a pregnancy complication exceeds 5% (nearly 100 times the risk faced by women in Europe and North America). 2 The provision of reliable contraception to HIV-infected women who desire it has been identified by the World Health Organization (WHO) as a primary strategy for the prevention of pediatric AIDS. 5 Thus, safe and effective contraception for HIV-infected women represents a critical component of reproductive health, with benefits that range from averting obstetric catastrophe to preventing pediatric AIDS.Even though there are approximately 18 million women living with HIV worldwide, 3 surprisingly little data are available on contraception options for this large population of women. Among immunocompetent women, the intra-uterine contraceptive device (IUD) is known to be highly effective and safe 6,7 and represents a particularly attractive choice in developing world settings, where inconsistent supply chains and imperfect patient follow-up can produce large discrepancies between "ideal effectiveness" and "user effectiveness" for hormonal methods.Historically, there has been confusion around the use of the IUDs in HIV-infected women. The International Planned Parenthood Federation and the WHO have recommended against its use in this population, although more recently the WHO recommendations have been modified with a stated caveat that there is "limited evidence" of its safety. 8 As a result...

A Qualitative Assessment of Decisions Affecting Contraceptive Utilization and Fertility Intentions among HIV-Positive Women in Soweto, South Africa

“…However, we also encountered misconceptions said to originate from providers that injectable contraceptives adversely affect HAART efficacy, which may unnecessarily discourage use of this method. It has been noted previously that peer and provider misinformation may dissuade HIV-positive women from using highly efficacious long-term methods, such as the IUD, whose use is generally considered safe in HIV-positive women but was not seen in our study at all (WHO 2004;Sinei et al 1998;Stringer et al 2007;Williams et al 1996).…”

“…Women receiving HAART are more likely to practice protected sex and to use contraception (Myer et al 2007b). A randomized trial comparing copper intrauterine devices (IUD) to systemic hormonal contraception among HIVpositive women in Zambia noted that 31% across both arms discontinued their originally allocated contraception; half the women discontinuing the hormonal contraceptive arm chose to terminate contraception altogether (Stringer et al 2007).…”

Influence of Culture on Contraceptive Utilization Among HIV-Positive Women in Brazil, Kenya, and South Africa

“…However, the effect of HIV on contraceptive use is not uniform between settings, where HIV-positive women may be less or equally as likely to use contraception as uninfected women [20,24]. In Zambia, contraceptive discontinuation rates among HIV-positive women were high regardless of assigned method or educational intervention [25,26]; desired fertility was a rarely stated reason for discontinuation. Given this data, a qualitative assessment for context of contraceptive method choice, discontinuation, and relative effect of HIV on these choices is indicated.…”

REVIEW ARTICLE: HIV Infection in the Female Genital Tract: Discrete Influence of the Local Mucosal Microenvironment

“…[62][63][64] A recent study further suggested that women who use progesterone-based contraceptives display accelerated HIV-1 disease progression and mortality, compared to women who do not. 65 Although the pathways involved in these outcomes are not clear, progesterone is known to regulate a number of immunological pathways, including the inhibition of CTLs and natural killer cells. [66][67][68] It also decreases the production and alters glycosylation of IgG and IgA antibodies, modulates cytokine production and upregulates HIV-1 receptor expression on CD4 + T cells.…”