A prospective cohort study conducted from 2004 to 2010 demonstrated an increased risk of HIV acquisition and transmission among sero-discordant couples using hormonal injectable contraception.  The study followed a population of nearly 4,000 heterosexual HIV sero-discordant couples from seven African countries for up to 24 months.  The study concluded that women using hormonal contraceptives, particularly injectable contraception, are at a greater risk both of acquiring HIV themselves and of passing it on to a male sexual partner. 

According to this study, the relative risk is as follows:  Among 1,314 couples in which the HIV-1 seronegative partner was female, HIV-1 acquisition rates were 6.61 and 3.78 per 100 person-years in women currently using and not using hormonal contraception (adjusted hazard ratio [HR] 1.98, 95% confidence interval [CI] 1.06-3.68, p=0.03). Among 2476 couples in which the HIV-1 seronegative partner was male, HIV-1 transmission rates from women to men were 2.61 and 1.51 per 100 person-years in those whose partners currently used versus did not use hormonal contraception (adjusted HR 1.97, 95% CI 1.12-3.45, p=0.02).] The authors concluded that strategies are needed to improve access to and uptake of lower-dose contraceptives and non-hormonal methods – such as IUDs, implants, patches or combination injectables.  

While the results of this study are significant statistically and noteworthy from a public health perspective, there is a need for additional research to confirm and better understand the study’s findings and address key outstanding issues and questions.  

IPPF is consulting with partners in both the family planning and HIV & AIDS communities to fully understand the implications of the study’s findings and how this may affect family planning clients and services.  Currently, IPPF considers that this study should not be used to draw conclusions on hormonal contraceptive use overall and its potential role in increasing users risk of HIV acquisition or transmission. There were not enough women using oral contraceptives (OC) in this study to find statistically significant results on the links between use of OC and HIV. Women using Contraceptive Implants or IUDs containing hormonal contraception were not included in this study. The study’s findings can therefore only really highlight important considerations for injectable contraceptives. Available information we have from the study thus far does not indicate which injectables were used – DMPA vs. Net-EN, nor the duration of use - factors which could affect the level of risk. In addition, the findings in relation to OC (slightly increased risk of both transmission and acquisition, but not statistically significant) do not address different types of OC and/or their duration of use. Without more information it is difficult to determine the biological model implicit in these relationships, the mechanisms of action of diverse hormones on HIV acquisition and transmission or the plausible alternative explanations for this observed effect e.g.  multiple sexual partners, circumcision practices, other.

This study involved women and men at high risk of HIV acquisition, in particular sero-discordant couples. How the findings might translate to the general population of sexually active men and women, even in HIV-endemic countries, is not known. The risks associated with pregnancy and unsafe abortion are well documented in many countries.  It is therefore imperative that women everywhere must have access to the information and choices in services they need to make informed decisions based on weighing these relative risks in the context of their lives when selecting a contraceptive method.  Men should be prepared to better support these decisions and also engage in sexual relationships in a way that fosters improved health for themselves and their partners.   Public health entities and communities too have a role in ensuring that information, products and services are available for all those that need them, without stigma, discrimination or inequities due to age, gender, religion or ethnicity.

From a public health and ethical perspective, this study highlights the need for additional research on the dynamics and implications of the interaction between selected hormones and HIV acquisition and transmission. From a human rights perspective it showcases the importance of the need to more adequately understand, address and respond to the sexual and reproductive health and rights of HIV positive people. It also highlights the urgent need for a re-invigoration of contraceptive research and development to ensure that we are able to meet the needs of all women and men ( including those living with HIV) with a wide range of appropriate and affordable contraceptive options that protect their health and ensure their right to decide on the number and timing of their children.

Key issues arising from the study

There are a number of key issues that this study highlights, particularly in relation to the provision of services for people with or at high risk of acquiring HIV:
 

1. Dual Protection:  Globally, this study highlights the importance of dual protection with condoms (both male and female condoms) to decrease the risk of HIV acquisition.   Continued research and development of new dual protection methods such as microbicides combined with contraceptive products is also needed.
2. The Condom Gap:  Despite their proven effectiveness for dual protection, there is a substantial discrepancy between the number of male and female condoms needed and the number available. This global condom gap – of several billion condoms – is still a pressing concern and one that donors have not addressed with the priority it clearly deserves.
3. The SRH needs of HIV positive people:  Addressing the SRH of women and men living with HIV requires a more nuanced response to the way in which service providers meet their family planning (FP) needs.  This should include explicit counselling for women during FP, VCT and PNC consultations on the potential increased risk  of both acquiring (if HIV negative) and transmitting (if HIV positive) when using injectable contraception’. 
4. Increased impact on women living with HIV:  Another potential danger that this study highlights is that - in the policy environment where HIV transmission is increasingly criminalised -  that women living with HIV who are using hormonal contraception could be further stigmatised and seen as ‘responsible’ for HIV infection. (IPPF’s ‘Criminalise hate, not HIV’ campaign has drawn attention to the impact of these punitive laws on young women and girls.)
5. Treatment for Prevention:  The value of earlier diagnosis and treatment for men and women living with HIV (particularly from countries with high HIV prevalence rates) confirms that ‘treatment as prevention’ needs to be scaled up as a matter of urgency. Early treatment of HIV-positive people with Anti-Retroviral Therapy (ARTs) reduces the risk of HIV transmission to their partners. (Treatment for prevention needs to be used in combination with other HIV prevention options. These include correct and consistent use of male and female condoms, delaying sexual debut, partner reduction strategies, and male circumcision.) The significance of the findings indicates that ‘Treatment for Prevention’ should as an essential part of a package of services. It is worth noting that HIV positive partners in this study were not eligible for ART based on national guidelines so none were receiving treatment and the data from participants was no longer included if they started ART.
6. Alternative family planning strategies:  In countries with generalised HIV epidemics, IUDs and other long–acting contraceptive methods with lower doses of exogenous hormones should increasingly be promoted as part of a united FP approach.  Further, investments in the training and placement of skilled providers of both counselling and services for these long-acting methods should be a priority not only as a result of this study but more significantly as a result of the well documented association between effective contraceptive use and the reduced risk of maternal mortality and morbidity. HIV positive women have historically been denied much choice when it comes to contraceptive methods. They have been pushed away from OCPs due to the real or misunderstood interactions with ART, pushed away from IUDs due to the misperceived risks of pelvic infection and implants are not realistically available in many parts of the world. Therefore, their only choice other than condoms has been injectables and in some cases anecdotal evidence has shown healthcare providers requiring women to accept an injectable contraceptive before they are given ART or as a condition for abortion. However, the World Health Organisation (WHO) Medical Eligibility Criteria for Contraceptive Use  states that for women at high risk of HIV acquisition or women with HIV or AIDS who are stable on ART, the benefits of IUD use (both copper and LNG-IUS) outweigh the risks (Category 2). The only situation in which the risks outweigh the benefits is for initiation of IUD with women who have AIDS who are not well on ART.

Further information

Due to the importance of this research and the questions that still remain, we need additional high quality evidence to answer the crucial public health questions.  Ideally, a randomised controlled trial of DMPA versus a non-hormonal, highly effective method of contraception on HIV acquisition should be conducted.
 
Until conclusive findings are available, the World Health Organization (WHO) guidance is the best available guide for programmatic decisions that affect most women.  The WHO has addressed this issue in the context of Medical Eligibility Criteria for Contraceptive Use and concluded that hormonal contraception remains a safe option for women at high risk of and living with HIV.

Download a PDF of the WHO Statement on the Heffron et al study on the safety of using hormonal contraceptives for women at risk of HIV infection, October 2011.

View the WHO recommendations on the use of hormonal contraceptive methods for women living with HIV.