Prevention for Women
Male and Female Condom Use
- Consistent use of male condoms can reduce the chances of HIV acquisition by more than 95%.
- Male and female condoms when used consistently and correctly, are comparable in effectiveness.
- Expanding distribution of female condoms may increase female condom use, thus increasing the number of protected sex acts and preventing HIV acquisition and transmission.
- Increasing couple communication about HIV risk can increase preventive behaviors, including condom use.
- Promoting the dual use of condoms as a contraceptive as well as for HIV prevention may make use more acceptable and easier to negotiate.
- Peer education for women can increase condom use.
- Promoting condoms, either in individual or group sessions, along with skills training, provision of condoms, and motivational education can increase condom use.
There are promising strategies and further discussion that you can read about by clicking on the button below.
There are currently no strategies for Partner Reduction that have been classified as "What Works".
There are promising strategies and further discussion that you can read about by clicking on the button below.
Voluntary Medical Male Circumcision
- Male circumcision reduces HIV acquisition for men and reduces the likelihood of transmission to HIV-negative women.
There are promising strategies and further discussion that you can read about by clicking on the button below.
Treating Sexually Transmitted Infections (STIs)
- STI counseling, diagnosis and treatment represent an important access point for women at high risk of HIV.
Treatment as Prevention
- ARV therapy can reduce (but does not eliminate) the risk of HIV transmission and is an additional prevention strategy.
- Providing antiretroviral treatment to people living with HIV can increase HIV prevention behaviors, including condom use.
In this era of great strides forward in treatment, it is important not to lose sight of the continued need to undertake a range of interventions to prevent HIV transmission. An estimated 2.7 million people newly acquired HIV infection in 2010, as they did for each of the years 2009, 2008 and 2007, down from 3.1 million people in 2002 (WHO et al., 2011b). However, even with all this encouraging news, for every one person initiated on ART, there were two new HIV infections in 2010 (Zachariah et al., 2011a). The goal of programs and national policies should be both to reduce the annual number of deaths by continued access to effective treatment and to reduce the annual number of new infections by effective HIV prevention (Over, 2011). Despite the many documented successes of prevention programs, in 2007 fewer than 10% of individuals at risk worldwide received key prevention services (Merson et al., 2008). With more than half of new infections among women, and the largest proportion among young women (WHO et al., 2011b), programs for women and girls must be at the forefront of expanding prevention efforts.
Prevention Efforts Can Succeed and Must Be Scaled Up
Encouragingly, "the discourse on HIV prevention now includes the possibility that the epidemic can be stopped" (Padian et al., 2011b: 269). In addition to the many successful prevention efforts over the past decade, greater access to treatment and breakthroughs in the role of treatment as a prevention strategy have the potential to change the course of the epidemic. At the same time, “HIV prevention is neither simple nor simplistic” (Coates et al., 2008: 670) and “no single, stand-alone HIV prevention intervention offers a ‘magic bullet’” (Kurth et al., 2011: 63). Furthermore, “no major multicomponent package of interventions has been launched in a full-scale, community-level randomized trial to assess impact on HIV seroincidence” (Kurth et al., 2011: 63). At the same time, “established methods such as condoms and behavioral change have never been scaled up to saturation level” (Katsidzira and Hakim, 2011: 1122) even though scaling up proven interventions is critical (Dieffenbach and Fauci, 2011). Even blood safety, long known as a critical component of HIV prevention, is insufficiently scaled up thirty years after the first HIV infections (WHO et al., 2011a; WHO et al., 2011b). Modeling has shown that prevention interventions have been more effective the sooner they are rolled out (Johnson and White, 2011). While prevention efforts can succeed, there is a “need to continually evaluate and update knowledge on HIV transmission and what works in prevention so as to better inform and reinforce policy making and implementation” (Wamai et al., 2011: 2).
Behavior Change is Possible
“A quarter of a century of AIDS responses has created a huge body of knowledge about HIV transmission and how to prevent it, yet every day, around the world, nearly 7,000 people become infected with the virus. Prevention work takes the longest time, is largely outside of health services, and has no ‘quick win.’ If not tackled, prevention work will also continue to undermine all the other gains” (Piot et al., 2008: 845, 857). There is “growing evidence that, across a wide range of settings, people can and do alter their sexual and drug-use practices in response to the spread of HIV” (Bingenheimer and Geronimus, 2009: 193). In Kenya, the prevalence has stabilized at about 7% from a high of 13.4% in 2000, less than ten years ago (Siringi, 2010). In Rwanda, HIV prevalence decreased from 13% in 2000 to 3% in 2007 (Pose and Samuels, 2011). Also in Rwanda, reported condom use has increased to nearly 75% among men; fewer than 11% of men and 2% of women had multiple partners; and boys have delayed sexual debut (UNAIDS, 2011b). In Thailand, the HIV incidence was 150,000 in 1991 and since then the number of newly acquired HIV cases has decreased. This decline was correlated with implementation of the national HIV/AIDS programs (Park et al., 2010). HIV prevalence declined substantially – to 1% in 2010 – following a decline in incidence in Zimbabwe (Hargrove et al., 2011), and it is likely that even in rural areas, the decline in HIV prevalence and incidence was due to HIV prevention activities (Gregson et al., 2011a) as the numbers of condoms distributed increased from 21.5 million in 1990 to 90 million by 2009. The proportion of condoms sold (rather than distributed at no cost) increased from 1% in 1990 to 70% in 2008 (Hargrove et al., 2011). In addition, the proportion of males aged 15 to 19 who reported having ever had sex declined from 33% in 1994 to 27% in 2005 and men’s reduction of nonregular partners went from 57% in 1999 to 47% in 2005. The percent of sexually experienced men who reported paying for sex in the past year fell from 7.2% in 1999 to 3.6% in 2005 (Gregson et al., 2010a).
In South Africa, the incidence rate among young women aged 15 to 24 had a statistically significant decline of 60% from 2002 to 2008; however 2.2% of HIV-negative young women aged 15 to 24 became HIV-positive during the last year (Rehle et al., 2010). Condom use increased significantly among both men and women between 2002 to 2008, from 31% to 65% (Rehle et al., 2010). Cuba has managed to maintain a low adult HIV prevalence of 0.1% in 2009 (WHO et al., 2011b). In Brazil, adult HIV prevalence never reached 1% due to a well-coordinated response, protection of human rights, and large evidence-informed programs focused on sex workers, MSM and PWID (WHO et al., 2011b). In Cambodia, the prevalence of HIV infection has declined from 2% among people aged 15 to 49 in 1998 to a projected 0.7% in 2010 (WHO et al., 2011b). Declines in HIV incidence exceeded what would be expected from natural saturation of infection, “suggesting that programmatic approaches may be having an effect” (AIDS2031 Consortium, 2010: 51).
A Range of Prevention Interventions Are Needed
Sexual behaviors and the sharing of injection equipment that cause most HIV infections worldwide occur due to a variety of motivations (e.g., reproduction, desire, peer pressure, desire to please, access to material goods, gender norms, coercion, etc.). Epidemiological studies have shown that multi-partner sex, paid sex and STIs are important risk factors in the AIDS epidemic, no matter what stage of the epidemic (Chen et al., 2007b). Sustaining behavioral change among individuals, couples, families, peer groups, networks, institutions and/or communities is no easy task, but can occur through educational, motivational, peer-group, skills-building or community normative approaches (Coates et al., 2008). “To be most effective, behavior change programs need to …both…[change] behaviors in HIV-negative partners to reduce their risk of HIV acquisition and [change] behaviors of HIV-positive partners to reduce their risk of onward transmission” (Ross, 2010: S5). [See Treatment as Prevention and Staying Healthy and Reducing Transmission]
It is critical to make explicit the interdependency of behavioral and biological mechanisms for HIV prevention (Bingenheimer and Geronimus, 2009). “The value of prevention with antiretroviral drugs for individuals with and without HIV has emphasized the overlap of treatment and prevention, and reinforces the need for integrated strategies for epidemic control. No longer is it acceptable to consider expenditures for treatment and prevention separately; the challenges for sustainably financing epidemic control apply equally to both” (Padian et al., 2011a: 274).
Prevention Efforts Must Be Tailored
Behavior change (e.g. condom use, partner reduction, use of clean needles) needs to be promoted through a variety of means, including structural changes, such as changes in legal and gender norms, and promoting girl’s education and employment opportunities. [See Strengthening the Enabling Environment] In countries in which 10–30% of the population is living with HIV, generalized interventions for women may be warranted. In other countries, specific key populations of women have much higher levels of HIV prevalence and need to be the focus of prevention efforts. [See Prevention for Key Affected Populations] However, HIV prevention programs for women who fall outside of “most-at-risk populations” are often lacking (Silverman, 2010). Young women require special attention. “…Our current ‘prevention toolbox’ is woefully inadequate for preventing HIV infection in young women who cannot negotiate monogamy and/or condom use with their sexual partner” (Abdool Karim and Humphries, 2010: 1). [See Prevention and Services for Adolescents and Young People]
Focusing on Key Affected Groups Can Leave Out Other Women Also at Risk for HIV Acquisition
“When HIV programmes largely focus on sex work, drug use and male-to-male sex, it contributes to low HIV risk perceptions in the general population. Intimate partners are often left out and there is [a] lack of couple communication about sexual matters” (UNAIDS, 2009e: 15). One study found very limited communication concerning sexual matters between married Indian couples, in part, because bedrooms are shared with other family members and women, in particular, had no one with whom they could discuss sex (Marlow et al., 2010). Married women may not realize or have any control over their partners’ extramarital sexual relationships [See also Partner Reduction] More prevention interventions are needed on a universal level so that everyone—including married women, for example, who may not realize their level of risk—can communicate with their partners and protect themselves.
Alcohol Use Puts Women and Men at Higher Risk for HIV Acquisition
Alcohol use inhibits judgment and can lead to unprotected sex and violence. A review of 73 articles representing research conducted in 19 different sub-Saharan countries published between 1992 and 2008 found that HIV seropositivity and high-risk sexual behavior was correlated with alcohol use, with the odds for HIV infection between 1.5 and three times higher for individuals who consume alcohol and for women who have male partners who consume alcohol (Woolf-King and Maisto, 2011). Others have also found an association between HIV and alcohol consumption (Baliunas et al., 2010; Thomas and Lungu, 2010; Singh et al., 2011). Among girls 15 to 19 years of age, the riskiest sexual behaviors in one study in Zimbabwe found took place at venues affiliated with alcohol, and therefore should be the target of HIV prevention efforts (Singh et al., 2010). “Women are at risk of alcohol-related sexual risk behavior in multiple ways” (Fritz et al., 2010). A study of 12 focus group discussions in rural Uganda in 2002 found that both men and women viewed men’s alcohol use as related to rape; agreeing with the assumption that women who accept alcohol from men will agree to have sex (Wolff et al., 2006). Men are more likely than women to consume alcohol and to consume alcohol in sexual situations and women whose partners regularly consume alcohol are more likely to be HIV-positive (Woolf-King and Maisto, 2011).
A review of peer-reviewed literature from 1980 to 2008 found inconsistent associations between alcohol use by female sex workers with HIV (Li et al., 2010b). Studies in Indonesia, China and Mexico found alcohol use common prior to sexual intercourse by female sex workers, as well as by clients, and associated with unprotected sex (Safika et al., 2011; Wang et al., 2010a; de la Torre et al., 2010). However, female sex workers in a study in India have stated that they avoid alcohol prior to sex in order to reduce the risk of violence, but male migrant workers used alcohol to “be bold enough” to go to sex workers. As one male migrant worker put it: “if I don’t drink nothing works out” (Rodriguez et al., 2010: S139.). Another study in India also found no association between alcohol and condom use by HIV-positive female sex workers, but did find an association between HIV-positive male clients, alcohol use and inconsistent condom use (Samet et al., 2010).
A cross-sectional study of 2,920 patients in West Africa found that antiretroviral adherence was reduced for those who had high levels of hazardous alcohol consumption (6.1% of men and 1.6% of women), recommending programs to address alcoholism (Jaquet et al., 2010). “Numerous studies have examined the intersection between alcohol and other drug use and HIV risk behaviors… and have shown that alcohol and other drug use is related to sexual risk behaviors… However, there is a paucity of recent literature examining existing HIV interventions that focus specifically on this relationship” (Browne and Wechsberg, 2010: 207-208). A study in Thailand found that health care costs were associated with alcohol consumption in 42 diseases, including HIV, as alcohol consumption is associated with unsafe sex (Nerampititagkul et al., 2009). Alcohol use also impacts adherence to antiretroviral therapy (Altice et al., 2010) and is associated with HIV disease progression (Shuper et al., 2010).
Anal Intercourse Poses High Risks for Women and Men
Within a serodiscordant relationship, certain sexual behavior is inherently more risky for women. Anal sex increases risk of HIV acquisition and is practiced by heterosexual couples as well as MSM. A study in South Africa found that 14% of men and 10% of women reported anal intercourse (Kalichman et al., 2009 cited in Boily et al., 2009b). “Anal intercourse within heterosexual relationships is not an uncommon practice but is often underreported” (Baggaley et al., 2010: 1049). Most studies of heterosexual couples have found an increased male-to-female transmission risk among couples practicing anal intercourse, even if only occasionally. A systematic review and meta-analysis found no significant difference between per act risk of acquiring HIV through unprotected anal intercourse for heterosexuals and MSM. A woman who has unprotected receptive anal intercourse is 35 times more likely to acquire HIV than through oral-genital intercourse. Anal intercourse “may substantially increase HIV transmission risk even if the infected partner is receiving HAART” (Baggaley et al., 2010: 1048).
More Research is Needed on the Risk of HIV Acquisition and Transmission During Menstruation
In addition, some articles have suggested that sex during menses may increase the risk for both HIV acquisition and HIV transmission (Lurie and Rosenthal, 2010; Royce et al., 1997) and it is surprising that not enough research has been conducted on this issue 30 years later to provide a definitive answer.
Timely Access to Post-Exposure Prophylaxis (PEP) is Needed
“HIV is seen as a woman’s disease in our community” – Member of a breastfeeding support group, Kenya (Fleischman, 2011)There is significant evidence from animal transmission models, perinatal HIV transmission studies, observational studies, studies of post-exposure prophylaxis (PEP) in health care workers, and meta-analyses indicating that PEP is effective in reducing HIV transmission (CDC, 1998b; Bell, 1997; Young et al., 2007 cited in Siika et al., 2009). Health providers who have an occupational exposure to HIV need access to PEP. Gender-based violence increases the risk of HIV and rape survivors also need timely access to PEP. [See Addressing Violence Against Women]. Although the efficacy of post-rape antiretroviral prophylaxis has not been determined, zidovudine reduces the transmission of HIV after needle stick injury by 81% (Cardo et al., 1997; Petra Study Team, 2002 cited in Carries et al., 2007). “As such, there is current consensus that HIV prophylaxis should be provided immediately after an exposure where there is judged to be risk of HIV acquisition” (Siika et al., 2009: 48). In observational nonrandomized studies of zidovudine/lamivudine in 480 initially seronegative cases of heterosexual rape in South Africa, there was one seroconversion, and that occurred in an individual who did not initiate PEP until 96 hours after exposure, instead of the required 72 hours (Christofides et al., 2006; Bryant et al., 2009 cited in Weber et al., 2010). Because PEP is now the standard of care, it would be unethical to conduct a randomized clinical trial and it is highly unlikely such a trial would ever be conducted (Weber et al., 2010). For PEP, triple antiretroviral therapy is recommended for 28 days to be used in an HIV-negative person after high risk HIV exposure so that should prophylaxis fail and the person acquires HIV, there will be only a negligible risk of antiretroviral resistance developing (Weber et al., 2010).
Some Women Are Overlooked in Prevention Programming
Older women and women with disabilities also need attention in HIV prevention programming but are often neglected (Rohleder et al., 2010). Additional research is necessary to discern the major risks facing these women and to evaluate interventions addressing those risks.
Women Over the Age of 50
“Grandmothers are too often and incorrectly assumed to be sexually inactive…” (Sepulveda et al., 2007).Women past the age of childbearing are often ignored in HIV prevention (Conde et al., 2009). In parts of southern Africa, older adults in heterosexual relationships account for a large share of new infections, but few programs address their needs (UNAIDS, 2011a). In sub-Saharan Africa in 2007, an estimated three million people over the age of 50 were living with HIV, accounting for approximately 14% of infections (Atun and Bataringaya, 2011; Negin and Cumming, 2010). HIV prevention and education efforts are needed for people over the age of 50. A WHO review of HIV in developing countries found that “sexual activity of older individuals in the developing world is barely researched. Many older individuals everywhere are sexually active” (Schmid et al., 2009: 162). A study in hospital of 706 cataract surgery patients over age 50 in Ethiopia found an HIV seroprevalence of 5% (35 out of 706) (Kassu et al., 2004). In Brazil, of 51,255 AIDS cases reported from 1982 to 2006, 2,668 AIDS cases were among those ages 50 or older. A study in South Africa found that of 100 women aged 50 to 80 years of age, few had adequate knowledge of how HIV is transmitted (Rauf et al., 2010). “Elderly grandmothers…appear to be forgotten in terms of their need for HIV/AIDS prevention information and education” (Sepulveda et al., 2007). Due to ARV therapy, more HIV-positive women are reaching menopause. Interventions for post-menopausal HIV-negative women, such as evaluation of cardiovascular risk, osteoporosis, etc. are also believed to benefit women living with HIV (Conde et al., 2009).
Women With Disabilities
WHO estimates that one in ten people in the world lives with some kind of disability (WHO cited in Hanass-Hancock and Nixon, 2009). As of 2011, approximately 110 million people globally experience very significant disability and these people are at equal or higher risk of HIV acquisition. Women and girls with disabilities are often at increased risk of HIV acquisition (IDDC, 2012). Women with disabilities are also at risk for HIV but are often overlooked in HIV prevention strategies. “…The field of HIV and disability remains largely overlooked” (Heidari and Kippax, 2009: para 1). A systematic review of 36 studies in Cameroon, Ethiopia, Lesotho, Rwanda, Mozambique, Malawi, Swaziland, Uganda, Kenya, Nigeria, Zimbabwe and South Africa concerning disability and HIV/AIDS found that people with disabilities lacked access to information, testing and treatment and despite popular misconceptions, are sexually active and therefore there is a real need for disability specific HIV prevention programs (Hanass-Hancock, 2009).
Studies have also shown that adolescents with disabilities are also sexually active (Groce et al., 2003 cited in Hanass-Hancock and Nixon, 2009). LVCT (formerly Liverpool VCT) in Kenya has launched a program to provide HIV services to deaf people (Taegtmeyer et al., 2009 cited in Hanass-Hancock and Nixon, 2009). Another study in Cameroon found that those who were hearing impaired had rates of HIV similar to the general population, as well as risk factors such as early sexual debut and low condom use but with no HIV prevention activities tailored to their needs (Touko et al., 2010). A study in Uganda found that women with disabilities reported difficulties in accessing HIV/AIDS services (Chireshe et al., 2010). Those with disabilities also experience stigma and a lack of recognition of their sexual activity. People living with HIV also experience disability and HAART can cause disabling side-effects (Elliott et al., 2009), and therefore people living with HIV need protection against discrimination. A resource library - HEARD (Health Economics and HIV/AIDS Research Division) - in South Africa with a list of good practices on disability and HIV can be found at: http://www.heard.org.za/african-leadership/disability/good-practice-overview.
Overall, very little evidence is available regarding what works specifically for women over the age of fifty and disabled women and much more research and evaluated programming is necessary.
Critical Prevention Approaches Under Development
Scientists are working to develop “new, potent biomedical prevention tools that can be integrated with – and enhance – currently available prevention approaches” (Dieffenbach and Fauci, 2011: 1). A number of biomedical prevention technologies are currently in clinical trials to assess their safety and effectiveness. These include vaccines, microbicides and the use of ART as prophylaxis, also referred to as pre-exposure prophylaxis or PrEP. While results from vaccine studies and microbicides “suggest the possibility of the eventual development of new prevention technologies, much work will be required before these early results can be translated into widely used products” (IOM, 2011: 25). The goal of developing PrEP, microbicides and a vaccine will be to expand the range of prevention options (AVAC, 2010).
Vaccine Development Continues to be a Priority
“It is still possible to have a vaccine within 12 years, but it will take some luck and better planning.” –Bill Gates (Gates, 2012: 13)Substantial reductions in incidence of over 50% will only occur with the introduction of a vaccine or curative treatment (Hecht et al., 2010: 1256). “The development of a safe and effective vaccine has long been a major goal of prevention research. If developed, a vaccine would be a cornerstone of an integrated HIV prevention strategy” (Dieffenbach and Fauci, 2011: 4). An ideal vaccine would be feasible for widespread use in low-income settings, confer lifelong immunity, protect against all routes of HIV transmission and work against diverse strains; however, the limited efficacy of early HIV vaccines means that they would, once developed and available for use, need to be used as a complementary tool with existing prevention strategies (AIDS2031 Consortium, 2010). “It is, however, widely accepted, that a fully efficacious vaccine providing durable (years) protection against HIV would have the biggest impact on HIV incidence” (Shattock et al., 2011: 42). “A vaccine would be a great equalizer, presumably protecting men and women indistinguishably” (Padian et al., 2011b: 275).
While recent trials have been promising, an HIV vaccine is yet to be licensed. A vaccine can have special benefits for women. An effective vaccine would provide women autonomy to protect themselves against HIV acquisition. A trial of an HIV vaccine with 16,402 healthy men and women ages 18 to 30 in Thailand found a vaccine efficacy of 31.2 percent, a modest efficacy, with less HIV acquisition among women than men among those on the vaccine as compared to placebo. The vaccine efficacy may have been greater in persons at lower risk of HIV acquisition. “…After the exclusion of the subjects who were infected with HIV-1 before vaccination, the modified intention-to-treat analysis showed a significant, though modest, reduction in the rate of HIV-1 infection, as compared with placebo” (Rerks-Ngarm et al., 2009: 8-9). Additional efforts are underway to assess effects of additional doses and to determine whether this vaccine could be effective in Africa (UNAIDS, 2011b). Others have argued that the results from the trial (Rerks-Ngarm et al., 2009) do not represent significance, as “the low HIV incidence among this sample of the general population limited study power sufficiently so that both the strict intent-to-treat and per protocol analyses yielded a nonsignficant 26% reduction in HIV incidence and even the significant efficacy documented in the modified intent-to-treat analysis had such a wide confidence interval that questions have been raised about the interpretability of the results” (Padian et al., 2010: 624). Others have argued that even a vaccine with 30% efficacy (Rerks-Ngarm et al., 2009) could avert 44% of all HIV infections over the next 20 years in Thailand and 35% of all HIV infections in South Africa (Kaldor and Wilson, 2010) and have a significant public health benefit (Abbas, 2011). Even a vaccine with rapidly waning protection covering 60% of the population in South Africa could prevent three million new infections between 2020 and 2030, or about 36% of expected infection and require only 39 people to be vaccinated for every infection averted (Andersson and Stover, 2011).
As some vaccine experts note, however: “It is misleading to say that a vaccine is the solution” as even once a vaccine is invented …in five to ten years hence, “the AIDS epidemic will be with us for many years.” It is unlikely that the first generation of vaccines will be 100 percent effective. “We remain cautiously optimistic that a substantial increase in our understanding of HIV infection and disease will lead to creative ideas about how to design an effective vaccine” (Johnston and Fauci, 2008: 890). However, “scientists agree that with no prospect of an effective vaccine to curb the HIV/AIDS pandemic in the foreseeable future, expanding the repertoire of prevention tools is all the more important” (Stephenson, 2008: 1529). Once developed and distributed, partially effective vaccines could be combined with all existing HIV technologies plus microbicides and PrEP (Excler et al., 2011; Shattock et al., 2011).
PReP or Oral Pre-exposure Prophylaxis is a Promising Potential Strategy
“Promising results from recent trials of oral and topical pre-exposure prophylaxis (PrEP) have bolstered hopes that antiretroviral (ARV) based methods will be a cornerstone of HIV prevention efforts in the future. Nevertheless, it is clear that in the near term, there will be no HIV prevention panacea” (Padian et al., 2011c: 1). A randomized controlled study with 4,758 HIV serodiscordant couples in Kenya and Uganda showed that when used as pre-exposure prophylaxis (PrEP) by the HIV-negative partner, daily tenofovir (TDF, or brand name Viread), an antiretroviral drug, was 67% effective and daily TDF combined with emtricitabine (FTC) (or TDF/FTC, brand name with Truvada (another antiretroviral drug) was 75% effective in preventing HIV acquisition. “Both study medications significantly reduced HIV risk in both men and women” (Baeten et al., 2012). A PrEP with TDF/FTC study in Botswana with 1,200 men and women, of whom 45% were women, had an efficacy rate of 63%, with no increased adverse or safety for those on PrEP compared to placebo (Birnkrant, 2011). However, another PrEP trial with TDF/FTC and another with oral TDF among women in a number of African countries were stopped as roughly equivalent numbers of women acquired HIV among those receiving PrEP as those that did not. It is not yet understood why PrEP has worked in some populations and not others, although drug adherence may have been an issue where PrEP has not been shown to be effective (Van Damme et al., 2012; Microbicides Trial Network, 2012 cited in Cohen et al., 2012). In May 2012, the United States’ Food and Drug Administration’s Antiviral Drugs Advisory Committee (ADAC) voted by a large majority in favor of recommending Truvada as PrEP (pre-exposure prophylaxis) for men who have sex with men, and for an approval for use by the HIV-negative partner in serodiscordant couples (www.FDA.gov/advisorycommittees). The FDA is expected to decide by September of 2012. Trials are also underway to assess PrEP in key affected populations in resource-limited settings and further research is awaited.
The use of PrEP is not without concern. Questions remain: Will people take more risks with PrEP if they think they are protected? Would those on PrEP who seroconvert and become HIV-positive have their treatment options limited by antiretroviral resistance? What about drug resistance if PrEP is given to someone who is HIV-positive but not yet diagnosed as HIV-positive (Wainberg, 2011)? “Concerns remain that using the same ARV drugs for treatment and prophylaxis may exacerbate circulating drug resistance if efficacy is only partial” (Shattock et al., 2011: 43), though studies to date have not shown increased resistance (Warren, 2012) as long as PrEP is initiated after confirmed HIV negative status (Warren, 2012). Some of these same hypothetical concerns have also been raised with male circumcision, microbicides and vaccines – especially risk compensation/behavioral disinhibition (Baeten, 2012).
In countries where those who meet national and international guidelines for access to treatment have difficulty accessing treatment, concerns have been raised as to the use of antiretroviral drugs for PrEP instead of for treatment. Experts have advised “the global community should adopt as its first priority extending life for the greatest number of people” (AIDS2031 Consortium, 2010: xiv). But modeling has shown that pre-exposure prophylaxis could avert as many as 30% of new infections in targeted age groups of women at highest risk of infection in South Africa, however, once access to antiretroviral therapy has been scaled up, cost-effectiveness of PrEP would decrease rapidly (Pretorius et al., 2010). Scaling up antiretroviral therapy is preferable as ARVs are both a treatment and a prevention strategy. It would be critical to counsel continued condom use for those on PrEP. [See also Treatment]
Frequent HIV testing is needed for those using PrEP (Cohen, 2011a). “PrEP involves dosing…uninfected individuals with costly medications …success…also [depends] on levels of risk compensation” (Leibowitz et al., 2011: 984). Clearly, PrEP is not for all populations and all settings (Leibowitz et al., 2011). Willingness of an HIV-negative person who feels at risk to access and use PrEP is also a question. A study posed a hypothetical question to 181 HIV-discordant couples in Kenya. HIV-positive partners were more likely to want to access ARVs for prevention and HIV-negative partners were more likely to want to access PrEP, with participants tending to choose “the prevention option they would control” (Heffron et al., 2012b). Modeling in Zambia and South Africa found that treatment of those who are HIV-positive was more cost-effective than providing PrEP. However, PrEP could be cost-saving if accessed by those at greatest risk of HIV acquisition (Alistar et al., 2012; Nichols et al., 2012). Programmatic and resource decisions on treatment and prevention will need to be strategically designed and optimized for local conditions.
Microbicides or Topical Pre-exposure Prophylaxis Are Not Yet Ready for Roll-Out
“Available HIV prevention strategies provide few options for young women who are at high risk of infection, but who are unable to convince their partner to be faithful or use condoms, underscoring the urgent need for a women-initiated HIV prevention technology” (Abdool Karim et al., 2011a: 279). Microbicides, a female-controlled technology, refer to a variety of topically applied products and hold great promise for women to be able to protect themselves from HIV, other STIs (Global Campaign for Microbicides, 2007), and unwanted pregnancy. While women have expressed a need for methods that can be used without the knowledge and consent of their male partners (Mantell et al., 2008a), in most clinical trials of microbicides, male involvement was the desired norm among female participants. Building on the experience observed in clinical trials and in female condom programs, focusing on sexual pleasure may increase future use. Microbicides for anal use are also under development.
The first generation of microbicides is expected to be less than 100 percent effective and will ideally need to be used with a condom. However, even if used alone, a partially effective microbicide could have a significant impact on HIV incidence (assuming risk taking does not increase with the use of this method). “A deeper understanding of the female genital tract and mucosal immunity is key to guiding the development of strategic and targeted products most suitable for combating HIV infection in women” (Abdool Karim et al., 2010a: S123). The impact of vaginal practices motivated by views of sexuality common in many parts of the world, such as washing intravaginally, will need to be assessed as microbicides are developed (van der Straten et al., 2010). Currently there are more than fifty candidate microbicides in preclinical development and eleven products are being tested in 21 ongoing trials. “…Microbicides provide real potential to influence the course of the HIV epidemic and are likely to be available and accessible sooner than HIV vaccines and will fill an important gap for women-initiated prevention methods” (Abdool Karim et al., 2010a: S126).
But while not ready for roll out yet, a landmark study demonstrating proof of concept that a microbicide could reduce HIV acquisition was released in July 2010. A double-blind, randomized, controlled trial (CAPRISA 004) in South Africa compared tenofovir gel (445 HIV-negative women) and a placebo gel (444 women) and showed that in women who followed the instructions closely – i.e. insert the gel 12 hours before sex and 12 hours following sex, had a 54% reduced risk of acquiring HIV among those who were highly adherent. Among women who were less adherent, the reduced risk of acquiring HIV was between 28% and 38% (Abdool Karim et al., 2011c). The results of CAPRISA 044 were statistically significant with no serious side effects (Cohen, 2010a).
If a tenofovir gel with the effectiveness of CAPRISA 004 were used by women in 80% or more of sexual encounters, it could avert 2.33 million new infections and save 1.3 million lives. If used in 25% of sexual encounters it could avert approximately 500,000 new infections and save approximately 300,000 million lives over the next twenty years, which would be highly cost-effective (Williams et al., 2011b). However, once a microbicide is developed, “neither the elegance of the science nor the strength of the effect will predict the ease of implementation” (Stanton cited in Stanton and Ferris, 2011). Questions remain concerning access, cost, which populations, clinical monitoring, resistance and resources. Antiretrovirals are not over the counter products and will require frequent contact with health systems for HIV testing and monitoring for side effects (Stanton and Ferris, 2011). Further research to develop an effective microbicide is needed to provide women with additional prevention options.
Vaccines, microbicides, PrEP and other female-controlled technologies are needed for primary prevention for women. Once these prevention modalities are rolled out, they have the potential to greatly reduce the risk of acquiring and transmitting HIV to reduce the vulnerability of women and could have a profound impact on the pandemic (Stanton and Ferris, 2011). But further progress in these areas is urgently needed. “For the foreseeable future…[these] strategies [are] unlikely to serve as a stand-alone prevention strategy. We therefore need ongoing research to identify the most effective combination of interventions for each population and setting” (Burns et al., 2010: 727) Scientists do not expect the first generation of these biomedical prevention modalities to be 100% effective, so programming for “combination prevention” where all effective prevention methods are used and tailored to the epidemiological and cultural context is critically important. Women will need access to both contraceptive and non-contraceptive microbicides, because some women will want to prevent HIV, STIs, and pregnancy, while other women will want to conceive without the risk of disease transmission. “No single, stand-alone HIV prevention intervention offers a ‘magic bullet’…Combining several partially protective strategies might have additive or synergistic effects in reducing HIV incidence on a population level…there is a growing recognition that combination HIV prevention strategies might optimize HIV prevention impact potentially enough to reduce transmission below the reproductive rate necessary to sustain HIV epidemics around the globe” (Kurth et al., 2011: 62).
“…There is an ethical responsibility to educate women about HIV infection and offer accurate prevention and risk reduction even in the absence of clear data on effectiveness. Yet how to incorporate behavioral change programs into HIV prevention packages is unclear” (McCoy et al., 2010). NIH and PEPFAR have launched a research initiative to fund combination HIV prevention studies, scheduled to start in December 2012 and 50 studies are in development (Cohen et al., 2012). The US National Institutes of Health (NIH) has recently funded research on gender specific combination HIV prevention in high burden settings, with results anticipated in 2015. For updates on biomedical HIV prevention research, please refer to: www.avac.org.
Also underway as prevention approaches is are the launch of an ARV-containing vaginal ring (http://www.ipmglobal.org/the-ring-study), and a long-acting injectable ARV.
What Works in Prevention for Women and Girls
A number of prevention strategies already work to help women prevent new HIV infections in women. These include male and female condom use, partner reduction, delay of marriage, completing secondary education, and seeking treatment for some sexually transmitted infections. In addition, voluntary medical male circumcision works for men and will, in the long run, also protect women. Additionally, increasing access to ART for all PLHIV will greatly reduce girls’ women’s risk of acquiring HIV infection by reducing the transmissibility of HIV by male sexual partners. Each of these areas has substantial evidence to justify their use in public health programming. Little evidence exists for how people can be encouraged to reduce the numbers of concurrent sexual partners, both as adults and adolescents. Each of these topics is discussed in more depth in the following sections. Preventions efforts must be informed by “what works to support women and girls,” particularly to strengthen the enabling environment by transforming gender and legal norms; addressing violence against women, legal capacity, inheritance and property rights; increasing opportunities for employment and income, reducing stigma and discrimination, and promoting women’s leadership. [See Strengthening the Enabling Environment] Women have multiple types of sexual partnerships: some women have only one sexual partner but are still at high risk for HIV acquisition from their sexual partner; some women have multiple sexual partnerships to survive economically [See Prevention for Key Affected Populations]; some women are young and are engaged in cross-generational sex, placing them at high risk [See Prevention and Services for Adolescents and Young People and Orphans and Vulnerable Children]. HIV prevention efforts will need to be tailored to a wide spectrum of risks for women. Women, themselves, have been leaders in HIV prevention efforts and creating awareness of the epidemic both at grassroots community levels as well as at the highest levels of government in fighting for prevention efforts to meet their varied needs. These efforts must be encouraged and promoted. “…A growing number of interventions have shown promise in partially protecting against HIV transmission and acquisition, including knowledge of HIV serostatus, behavioral risk reduction, condoms, male circumcision, needle exchange, treatment of sexually transmitted infections and use of systemic and topical antiretroviral medication by both HIV-infected and uninfected persons. Designing the optimal package of interventions that matches the epidemiological profile of the target population, delivering that package at the population level, and evaluating safety, acceptability, coverage and effectiveness all involve methodological challenges” (Kurth et al., 2011: 62). The prevention strategies in this section are applicable for all women; however certain groups of women and girls have particular prevention needs. Therefore, while this section presents what works for generally for all women, other sections, particularly Prevention for Key Affected Populations and Prevention and Services for Adolescents and Young People provide additional considerations and strategies for groups such as sex workers, female drug users, women and girls in complex emergencies, young people, etc. The three sections should be viewed together as a whole to identify what works in prevention for women and girls. For additional information, summaries for all WHO HIV/AIDS priority intervention recommendations (WHO, 2011h) are available at: http://www.who.int/hiv/pub/guidelines/9789241500234/en/index.html
 Attributing prevention efforts as a direct cause of HIV prevalence decline is speculative. If HIV prevention programs are implemented when HIV epidemics are at or near their peak, the subsequent decrease in prevalence might be incorrectly attributed to prevention programs (Chin and Bennett, 2007).