WHO World Health Organization Reviews Contraception in light of 3 recent studies published: 'Condoms Best Protection'....Dual Protection Recommended
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WHO: "Consistent and correct use of condoms, male or female, is critical for prevention of HIV transmission to non-infected sexual partners......The group noted the importance of hormonal contraceptives and of HIV prevention for public health and emphasized the need for individuals living with or at risk of HIV to also always use condoms, male or female, as hormonal contraceptives are not protective against HIV transmission or acquisition......Some studies suggest that women using progestogen-only injectable contraception may be at increased risk of HIV acquisition, other studies do not show this association......Some studies suggest that women using progestogen-only injectable contraception may be at increased risk of HIV acquisition, other studies do not show this association. A WHO expert group reviewed all the available evidence and agreed that the data were not sufficiently conclusive to change current guidance. However, because of the inconclusive nature of the body of evidence on possible increased risk of HIV acquisition, women using progestogen-only injectable contraception should be strongly advised to also always use condoms, male or female, and other HIV preventive measures."
"Three systematic reviews of the epidemiological evidence were conducted: hormonal contraception and acquisition in HIV-negative women; hormonal contraception and transmission from HIV-positive women to HIV-negative men; and hormonal contraception and disease progression in HIV-positive women.PubMed and EMBASE databases were searched for studies published in any language in a peer-reviewed journal up to 15 December 2011. The three systematic reviews were peer-reviewed by an Advisory Committee prior to the meeting and final drafts provided to all meeting participants several weeks prior to the meeting. Particular attention was paid to studies published since the last meeting to update the MEC, held in 2008. The systematic reviews, along with presentations given on possible biological mechanisms for any epidemiological associations, and on balancing risks and benefits for women using hormonal contraceptives in different parts of the world, served as the basis for the group's deliberations during the meeting."
WHO: Contraceptive Advice Not Changed-Dual Protection Urged
Author: Mark Mascolini
19 February 2012
After reviewing all recent data on HIV transmission risk with hormonal contraceptives, the World Health Organization (WHO) maintained its advice not to restrict use of hormonal contraceptives to avoid unintended pregnancies.
Women using progestogen-only injectable contraceptives, WHO says, should also use condoms or other measures to prevent HIV infection.
A Partners in Prevention study of 3790 heterosexual HIV-discordant couples (one partner positive and one negative) in Africa found that hormonal contraceptive use doubled the risk of HIV acquisition in women and doubled the risk of HIV transmission from positive women to negative men (Heffron R, et al, for the Partners in Prevention HSV/HIV Transmission Study Team. Lancet Infect Dis. 2012; 12: 19-26).
Oral or injectable hormonal contraceptives did not raise the risk of HIV acquisition in a separate study of 5500 South African women, though the investigators cautioned that "the effect estimate does not rule out a moderate increase in HIV risk associated with DMPA use found in some other recent studies" (Morrison CS, et al. AIDS. 2012; 26: 497-504).
"After careful review of all available evidence," stakeholders at the WHO meeting "found that the data were not sufficiently conclusive to change current guidance," a UNAIDS press release states.
WHO noted that "only condoms, male and female, provide dual protection by stopping HIV transmission and preventing unintended pregnancies." The WHO panel stressed that "this information must be communicated to sexually active women and girls by health workers pro-actively."
Among 1.18 billion 15-to-49-year-old women worldwide, WHO estimates that 11% have unmet family planning needs. Among 128 million married or partnered women that age in sub-Saharan Africa, 25% have unmet family planning needs.
Reflecting the recent evidence on HIV acquisition and transmission risk in women using hormonal contraceptives, WHO added this clarification to its recommendations:
"Some studies suggest that women using progestogen-only injectable contraception may be at increased risk of HIV acquisition, other studies do not show this association. A WHO expert group reviewed all the available evidence and agreed that the data were not sufficiently conclusive to change current guidance. However, because of the inconclusive nature of the body of evidence on possible increased risk of HIV acquisition, women using progestogen-only injectable contraception should be strongly advised to also always use condoms, male or female, and other HIV preventive measures. Expansion of contraceptive method mix and further research on the relationship between hormonal contraception and HIV infection is essential."
The Partners in Prevention researchers (Heffron et al) believe "women should be counselled about potentially increased risk of HIV-1 acquisition and transmission with hormonal contraception, especially injectable methods, and about the importance of dual protection with condoms to decrease HIV-1 risk. Non-hormonal or low-dose hormonal contraceptive methods should be considered for women with or at-risk for HIV-1."
UNAIDS. Press statement. Women need access to dual protection-effective contraceptives and HIV prevention options. 16 February 2012.
World Health Organization. Hormonal contraception and HIV: Technical statement. WHO/RHR/12.08. February 2012.
WHO press statement
Women need access to dual protection-effective contraceptives and HIV prevention options
WHO recommendations related to use of hormonal contraceptives remain unchanged. The use of condoms-male and female-is a reliable method of HIV prevention.
GENEVA, 16 February 2012-A stakeholder consultation convened by the World Health Organization (WHO) in Geneva has reviewed recent epidemiological studies related to HIV transmission and acquisition by women using hormonal contraceptives. After careful review of all available evidence, the stakeholders found that the data were not sufficiently conclusive to change current guidance.
In light of this review, WHO today announced that its current recommendation---no restrictions on the use of hormonal contraceptives to avoid unintended pregnancies-remains unchanged. They also recommend that women using progestogen-only injectable contraceptives also use condoms or other measures to prevent HIV infection. This information must be communicated to sexually active women and girls by health workers pro-actively.
About half of the 34 million people living with HIV are women. In sub-Saharan Africa, the region most affected by the epidemic, nearly 60% of all new HIV infections occur in women.
The level of unmet family planning need among the 1.18 billion women aged 15-49 worldwide is estimated to be 11%. Among the 128 million women (married or in a union) aged 15-49 in sub-Saharan Africa, the estimated unmet need for family planning is more than twice as high, at 25%. This highlights the urgency of finding innovative solutions that address the dual needs of women in preventing HIV and stopping unintended pregnancies.
While a range of contraceptives protect against unintended pregnancies, only condoms, male and female, provide dual protection by stopping HIV transmission and preventing unintended pregnancies.
The Joint United Nations Programme on HIV/AIDS (UNAIDS) recommends that people who are sexually active-particularly women and girls-have full access to information and counselling to make evidence informed choices about their sexual and reproductive health needs. Women and girls must also have access to the widest range of contraceptive and HIV prevention options. Such services must be provided in an integrated manner by health workers.
The lack of female controlled methods of HIV prevention and low levels of condom use place women and girls at increased vulnerability to HIV infection. "Women need safe contraceptive and HIV prevention options that they can own and manage," said Michel Sidibˇ, Executive Director of UNAIDS. "New investments into research for female controlled HIV prevention options and safe contraceptive methods are essential."
WHO Executive Summary Technical Statement Excerpts
Following new findings from recently published epidemiological studies, the World Health Organization (WHO) convened a technical consultation regarding hormonal contraception and HIV acquisition, progression and transmission. It was recognized that this issue was likely to be of particular concern in countries where women have a high lifetime risk of acquiring HIV, where hormonal contraceptives (especially progestogen-only injectable methods) constitute a large proportion of all modern methods used and where maternal mortality rates remain high. The meeting was held in Geneva between 31 January and 1 February 2012, and involved 75 individuals representing a wide range of stakeholders. Specifically, the group considered whether the guideline Medical eligibility criteria for contraceptive use, Fourth edition 2009 (MEC) should be changed in light of the accumulating evidence.
After detailed, prolonged deliberation, informed by systematic reviews of the available evidence and presentations on biological and animal data, GRADE profile summaries on the strength of the epidemiological evidence, and analysis of risks and benefits to country programmes, the group concluded that the World Health Organization should continue to recommend that there are no restrictions (MEC Category 1) on the use of any hormonal contraceptive method for women living with HIV or at high risk of HIV. However, the group recommended that a new clarification (under Category 1) be added to the MEC for women using progestogen-only injectable contraception at high risk of HIV as follows:
Some studies suggest that women using progestogen-only injectable contraception may be at increased risk of HIV acquisition, other studies do not show this association. A WHO expert group reviewed all the available evidence and agreed that the data were not sufficiently conclusive to change current guidance. However, because of the inconclusive nature of the body of evidence on possible increased risk of HIV acquisition, women using progestogen-only injectable contraception should be strongly advised to also always use condoms, male or female, and other HIV preventive measures. Expansion of contraceptive method mix and further research on the relationship between hormonal contraception and HIV infection is essential. These recommendations will be continually reviewed in light of new evidence.
The group further wished to draw the attention of policy-makers and programme managers to the potential seriousness of the issue and the complex balance of risks and benefits. The group noted the importance of hormonal contraceptives and of HIV prevention for public health and emphasized the need for individuals living with or at risk of HIV to also always use condoms, male or female, as hormonal contraceptives are not protective against HIV transmission or acquisition.
In general, most available epidemiological evidence has assessed COCs or progestogen-only injectable contraceptives (including DMPA and NET-EN); little evidence is available on the potential relationship between HIV risks and other hormonal contraceptive methods such as implants, vaginal rings, patches, or intrauterine devices.
1. Acquisition in HIV-negative women
In total, 20 prospective studies assessed the risk of HIV acquisition among HIV-negative women using different hormonal contraceptives; the group focused largely upon a subset of studies considered to be of higher methodological quality.
Most higher-quality studies found no statistically significant association between oral contraceptive pill use and HIV acquisition, although point estimates varied and several had limited statistical power (indicated by wide 95% confidence intervals). No currently available studies report a statistically significant association between use of NET-EN and HIV-acquisition risk. Evidence on injectables was mixed; some higher quality observational studies reported a significant increase in risk (ranging from a 48% to 100%) of HIV acquisition, other higher-quality observational studies did not report such an association.
All studies had limitations that affected data interpretation. Inconsistencies between point estimates related to injectable contraception were not explained by differences in overall HIV incidence in the study population, primary study objective, study size, number of seroconverters, or the statistical methods used. Other methodological factors, including manner of controlling for potential differences in condom use, length of time between
study visits, and analysis of serodiscordant couples could explain part, if not all, of the differences in results from the various studies.
These factors merit additional consideration in future analyses. Owing to serious limitations and inconsistency in the data, the quality of the body of evidence on hormonal contraception and HIV acquisition in women was given a GRADE rating of "low".
2. Transmission from HIV-positive women to HIV-negative men
One recent observational study provided direct evidence on the relationship between oral contraceptive pills or injectable contraception and female-to-male HIV transmission. It suggested a two to three-fold increased risk (depending on statistical method) with use of injectable contraceptives, but not for oral contraceptive pills. This study had several strengths, including statistical adjustment for multiple potential confounders, low loss to follow-up and frequent follow-up visits, large size of the population studied, genetic linkage of HIV transmissions, and measurement of genital viral shedding. However, limitations included the potential for residual confounding in observational data, uncertainty regarding whether the genital shedding data bolster the main findings, and the limited statistical power given small numbers of new HIV infections in men.
Indirect evidence on two possible mechanisms by which hormonal contraception may impact female-to-male HIV transmission, namely increased genital HIV viral shedding or altered plasma viral load, was also assessed. Findings from studies assessing hormonal contraceptive use and genital HIV viral shedding were inconsistent, but studies assessing hormonal contraceptive use and plasma viral load or viral load setpoint largely indicated no adverse effects. Owing to serious limitations of the data and serious imprecision in the study results, the GRADE rating for the quality of the body of evidence on injectable contraception and female-to-male HIV transmission was "low" and the rating for oral contraceptives and female-to-male transmission was "very low".
3. Disease progression in HIV-positive women
None of the 10 observational studies examining use of various hormonal contraceptives and HIV disease progression (as measured by mortality, time to CD4+ cell count below 200 cells/mm3, initiation of antiretroviral therapy (ART), increased HIV-RNA viral load, or decreased CD4+ cell count) found a statistically significant association. An increased risk of a combined outcome of progression to AIDS, ART initiation or death was reported in one randomized controlled trial that compared hormonal contraceptive users with copper intrauterine device users; however, interpretation of this association is difficult due to high rates of method
switching and loss to follow-up. Due to serious limitations of the data and the imprecision of study results, the GRADE rating for the quality of the body of evidence on hormonal contraception and HIV disease progression was "low".
Contraceptives and HIV
Can barrier methods help reduce the risk of both pregnancy and HIV infection?
Observational studies show that, if used consistently and correctly, male latex condoms provide protection against HIV, gonorrhea and unintended pregnancy. Consistent use has been found to reduce HIV incidence by at least 80 percent and perhaps as much as 97 percent depending on the meta-analysis or model used in the study. For protection against unintended pregnancy, male latex condoms are 86 percent to 97 percent effective, depending on whether they are used "typically" or "perfectly." Most of the HIV and other sexually transmitted infections (STIs) or unplanned pregnancies that occur result from inconsistent or incorrect use. Scientific evidence to support these conclusions is strong and consistent enough to produce the solid public health recommendation that condoms are effective. The challenge is to increase their correct and consistent use during risky sexual contacts.
The female condom, like the male condom, has been found to be impermeable to various STIs, including HIV, in the laboratory. In theory, the device should protect against STIs in people as well, but more research is needed to confirm its effectiveness.
Most other female barrier methods such as the diaphragm, cervical cap or contraceptive sponge involve the use of a spermicidal product, commonly one containing nonoxynol-9 (N-9). Spermicides containing N-9 are in themselves a moderately effective contraceptive option. Based on extensive research, however, technical experts have concluded that N-9 spermicides increase the risk of HIV infection when used frequently by women at high risk of infection. These spermicides should not, therefore, be used for HIV or STI prevention. Using a male condom pre-lubricated with N-9 is better than using no condom at all, but the technical experts have recommended against promoting condoms lubricated with N-9. No evidence suggests that such condoms are more effective in preventing pregnancy or infection than condoms lubricated with silicone. (Whether N-9 adds contraceptive protection to barrier methods other than condoms is unknown; nonetheless, spermicide use with the diaphragm continues to be recommended.)
A large, randomized controlled trial published in 2007 found that the use of a diaphragm (with a lubricant gel) did not decrease the risk of HIV infection compared to a gel-only group. Current evidence does not support the use of the diaphragm (alone) to prevent HIV infection. The question of whether a diaphragm and a microbicide used together may be more effective will be addressed in further research.
What is the relationship between the use of nonbarrier methods such as oral contraceptives, injectables and intrauterine devices (IUDs) and the acquisition of HIV?
Several prospective studies have examined whether hormonal contraceptives notably combined oral contraceptives (COCs) and progestin-only injectables such as depot-medroxyprogesterone acetate (DMPA) influence the risk of acquiring HIV. Many of these studies have found no relationship between the use of hormonal contraceptives and HIV, but a few studies, including three of the strongest, found an increased risk of HIV acquisition associated with the use of one or more of these methods, particularly injectables.
The first of these studies, conducted by scientists at the University of Washington, reported in 2007 that the use of oral contraceptive pills and DMPA were both associated with an increased risk of HIV infection among more than 1,200 female sex workers in Mombasa, Kenya.
The second study and the only large study specifically designed to study this issue was conducted by scientists at FHI 360 and their colleagues. This study included more than 4,400 HIV-uninfected women in Uganda and Zimbabwe. In 2010, the scientists reported that DMPA, but not COCs, was associated with an increased risk of acquiring HIV. The scientists also found that young women (between 18 and 24) who used either DMPA or COCs had an increased risk of acquiring HIV, but older women did not.
The third large study, conducted also by scientists at the University of Washington, involved nearly 3,800 heterosexual HIV-serodiscordant couples (in which one partner is HIV positive) from seven African countries. In October 2011, the scientists reported that using an injectable contraceptive (primarily DMPA) doubled the women's chances of acquiring HIV. Moreover, women who were HIV positive at the beginning of the study and were using an injectable contraceptive were twice as likely to transmit HIV to their uninfected partners, compared to women who were not using a hormonal contraceptive. The investigators were unable to draw conclusions about women who used oral contraceptives because of the small number of oral contraceptive users and the few occurrences of HIV infections in this group.
Because all of these studies were observational (not randomized) in design, they may be biased by self-selection or some other unexplained variables. In addition, users of hormonal contraceptives may differ in important ways from nonusers. For example, women using hormonal contraceptives may have higher coital frequency and lower condom use. As a result, these types of studies are usually not considered conclusive.
Many scientists believe that priority should be given to initiating a randomized controlled trial often considered the gold standard of medical research to provide a more definitive answer to this important public health issue. Such a trial might compare users of DMPA to users of highly effective nonhormonal methods (such as copper IUDs) or highly effective low dose hormonal methods (such as implants or levonorgestrel IUDs).
The other nonbarrier method considered here is the copper IUD. According to the World Health Organization, the benefits of copper IUDs outweigh the risks for women at high risk of HIV infection and for HIV-infected women currently using an IUD.
What are the current family planning guidelines with respect to HIV prevention?
Family planning and HIV service providers and educators should continue to counsel women and couples about the importance of family planning and the consistent use of condoms in conjunction with hormonal and nonhormonal contraceptives for preventing HIV and unintended pregnancies. In addition, strategies to improve accessibility to highly effective, lower dose hormonal methods (implants) and nonhormonal contraceptive methods (IUDs, sterilization) should be a high priority.
In summary, of all available contraceptives, only male latex condoms have been shown to help protect against HIV, STIs and unplanned pregnancies. Condoms may not be suitable for all users, but consistent and correct use of this method can give excellent protection against both pregnancy and STIs.