Antenatal Care - Treatment

• Overview
• Evidence
• Gaps
• Using the Evidence

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"I was really in favour of early treatment and to have this Option B+. But now my worry is: are we being given this as an option or is this being pushed on us with no option?" -Woman living with HIV in Zimbabwe (ATHENA et al., 2015: 3).

Women Need Information, Support and Respect in Decision-Making About Antiretroviral Therapy

While WHO does not specify how quickly a pregnant woman should initiate cART upon an HIV-positive diagnosis, countries that are implementing Option B+ are interpreting the guidance to mean immediately. Yet initiating treatment upon diagnosis may be too challenging for some pregnant women. Women in South Africa noted that they faced a triple burden of transitioning into pregnancy, accepting a new HIV-positive serostatus and recognizing the need to start lifelong ART as soon as possible (Stinson and Myer, 2012). Notably, the INSIGHT START Study Group cautioned, "Patients may wish to consider and differently weigh multiple factors when making the decision to initiate lifelong anti-retroviral therapy" (The INSIGHT START Study Group, 2015: 804). And US 2015 guidance notes: "The decision about when to initiate ART should be carefully considered by health providers and their patients...women's choices after counseling to use or not use ARV drugs during pregnancy should be respected" (USHHS, 2015: c-26 and c-27).

Women living with HIV may choose to delay treatment for a variety of reasons despite the benefit of continuous ART for their health (Phillips et al., 2014; Kieffer et al., 2014), but will still need to be provided with ongoing monitoring and support. In a qualitative study in South Africa, the majority of women emphasized that accepting lifelong ART treatment was more difficult than accepting their positive HIV status. "...women may be insufficiently able to accept the full consequences of a positive HIV test and the need to start lifelong ART all at once" (van Lettow et al., 2014: p. 7). Scientists have recognized that when women decline to initiate ART, "no one should ever be pressured to initiate treatment" (Kellerman et al., 2013: p. 5).

Insufficient counseling or respect for womens decision-making time can drive women away from accessing treatment. A recent study in Ethiopia found that a key factor associated with loss to follow up on Option B+ was starting treatment on the same day as diagnosis: 28.1% of 418 pregnant women started on cART received cART only once and never returned to the health facility (Mitiku et al., 2016). However, in a different pilot program with intensive counseling, pregnant women living with HIV were willing to initiate within one to four days, with 97% of 100 women initiating ART prior to delivery (Myer et al., 2012). Common barriers to ART initiation included concern about side effects and the practicalities of ART, fear of stigma, partner abandonment and abuse after disclosing their status, and perceived lack of support from families and partners, and laws and policies that criminalize HIV. For example, in Uganda, it is mandatory for pregnant women to be tested for HIV, If she does not disclose her positive serostatus and/or practice safe sex with her male partner, she can be both fined and imprisoned for up to five years. Her male partner, however, is exempt from HIV testing if he so choses (Republic of Uganda, 2014).

"I think the (doctor) did not want me to become pregnant but it is my right to do so" -Pregnant women living with HIV in Thailand (Liamputtong and Haritaborn, 2014: 1169)

In interviews with women living with HIV in Malawi and Uganda, women warned "starting patients on treatment before they feel ready would not be conducive to adherence, retention or good health" (Matheson et al., 2015: p. 3). Women in Malawi and Uganda felt that Option B+ was a misnomer, that it is not an individual option but a government mandate that is potentially coercive. "Young women spoke of being pressured to start treatment before they were ready," negatively affecting their adherence (Hsieh, 2013: 25). Women reported wanting more counseling to make the momentous decision to start lifelong ART (Hsieh, 2013). Women were told by providers that they needed to start lifelong treatment the same day they tested HIV-positive, though some providers provided women with the chance to think about it overnight (Hsieh, 2013). Yet "rights to privacy and bodily integrity still require that people living with HIV control their own medical decisions...communities have no right to coerce people living with HIV into treatment" (Kavanagh et al., 2015: 83).

All women, and particularly women living with HIV, need accurate information about their pregnancies and their rights. They should know that they have the right to bear children and that pregnancy does not accelerate HIV disease progression (Westreich et al., 2013 cited in Kendall and Danel, 2014).Sterilization must never be presented to women living with HIV as an option to prevent vertical transmission. A community based research project from Mexico, Nicaragua, El Salvador and Honduras found that of 285 women living with HIV, 23% experienced pressure to sterilize post-diagnosis (Kendall and Albert, 2015). The People Living with HIV Stigma Index found high rates of stigma and discrimination in Uganda, but this was not disaggregated by pregnancy status. However, 365 of the sample (30%) reported that they were advised to not have children after being diagnosed as HIV-positive and 121 (11%) reported to have been forced to undergo sterilization because of their HIV-positive serostatus (Uganda AIDS Commission UNAIDS, 2013). Such practices impede women from accessing health facilities to seek services and are gross human rights violations.

The large majority of women globally will want to initiate cART during pregnancy, both for their own health and to prevent vertical transmission. However, for those women who only learn their HIV-positive serostatus in labor or who fear that initiating cART will subject them to violence (see below), infant prophylaxis immediately postpartum can reduce the risk of vertical transmission. Infant prophylaxis is the standard of care, according to WHO guidance, even if a woman is virally suppressed on cART. Provision of ART prophylaxis to infants will not prevent infants from acquiring HIV prior to labor and delivery, though. A study of 1,684 infants enrolled in a randomized controlled trial from Brazil, South Africa, Argentina and the US found that duo or triple therapy was more effective at preventing vertical transmission than monotherapy for formula feeding infants whose mothers had not received ART before labor. "Although our study identified improved prophylactic alternatives for infants born to late-presenting HIV-infected mothers, the present approach does not substitute for the prevention and early identification of HIV-1 infection in women, with prompt initiation of ART during pregnancy" (Nielsen-Saines et al., 2012: 2375). Infant prophylaxis should continue throughout breastfeeding if the mother is not on ART.

Fear of Disclosure, Violence Can Influence Treatment Initiation and Adherence

Pregnant women living with HIV still remain highly stigmatized in many countries. While "disclosure of one's HIV status can help to improve uptake and retention in prevention of mother-to-child transmission of HIV services..." (Tam et al., 2015: 436), some women are reluctant to disclose, particularly to their sexual partners (Croce-Galis et al., 2015). As one woman living with HIV, diagnosed during pregnancy, put it: "...I won't tell him, because I need him, because he helps me with money. I can't lose him now because I can't manage to have this baby if he doesn't support me" (Sewnunam and Modiba, 2015: 63). In some cases, disclosure may place a pregnant woman at risk. For example, pregnant women in Zimbabwe have faced violence for testing without their partner's consent (Shamu et al., 2014).

A systematic review of factors influencing initiation, adherence and retention on ART while pregnant or postpartum found that a significant barrier was "fear of domestic violence after disclosure" (Hodgson et al., 2014: Table 3). Another systematic review and meta-analysis of intimate partner violence (IPV) and engagement in HIV care and treatment among women found that IPV was associated with lower ART use, half the odds of self-reported ART adherence and significantly worsened viral suppression among women (Hatcher et al., 2015). Staying on ART is challenging, as some women find it difficult to take home ART medications for fear that their partners find it (Mugasha et al., 2014). A recent study of 1,951 pregnant women in Zimbabwe who disclosed their HIV status found that 32.8% reported interpersonal violence and abuse sometime between disclosure and delivery. The study found that male control of women's sexual decision-making was associated with interpersonal violence during pregnancy and with unequal gender power (Shamu et al., 2014; Shamu et al., 2012 cited in Shamu et al., 2014).

Disclosure interventions must "protect women's rights, autonomy and safety" (Spangler et al., 2014: S235). "...In the absence of specific interventions to respond to violence or promote safety, women who are at risk of violence may be better off being supported in a decision not to disclose their status" (Kennedy et al., 2015: p. 7). Little evaluated work exists on disclosure by pregnant women to other family members besides sexual partners and how this could increase support for women (Busza et al., 2012). [See also Addressing Violence Against Women]

Gender-based violence has other harmful effects for safe motherhood for women living with HIV. A recent analysis found significantly higher odds of unintended pregnancies among women who faced intimate partner violence (Pallitto et al., 2013). Experience of intimate partner violence decreased the odds of skilled birth attendance in Kenya (Goo and Harlow, 2012) and, in a recent systematic and meta-analysis, was associated with a significant decrease in condom use (Maxwell et al., 2015). This presents particular challenges for pregnant women who want to remain HIV-negative as HIV acquisition by women during pregnancy greatly increases the risk of vertical transmission since acute infection leads to high viral loads prior to testing HIV-positive (Nesheim et al., 2013; Dinh et al., 2015). [See Treatment]

Addressing Gender Norms and Supporting Women May be Key to Eliminating Vertical Transmission

Women may face other gender related barriers to accessing health services (Croce-Galis et al., 2015), as one woman noted in Cote d'Ivoire, who said that her husband would not give her the funds to get transport to services (Schechter et al., 2014). Another study in Tanzania among postpartum women living with HIV who were not adherent noted "many were entirely dependent on their partner for financial support and with minimal negotiation power" (Ngarina et al., 2013: p. 5). A barrier to initiation, adherence and retention on ART for pregnant women living with HIV is that she may be required to ask permission to access services (Hodgson et al., 2014; Hlarlaithe et al., 2014). According to recent modeling, Option B+ is more effective in reducing heterosexual transmission (Khanna et al., 2015) but women living with HIV have stated that they feel burdened that they are the ones on treatment and who have to remain adherent, as opposed to their male partners. [See also Strengthening the Enabling Environment]

Key to gender transformative programming in Safe Motherhood and Prevention of Vertical Transmission is for women's lives to be valued not just to keep babies healthy. One qualitative study on why women do not remain adherent postpartum in South Africa found that women believed that their own health was less important and that once they accomplished having a healthy, HIV-negative baby, their own health postpartum did not matter (Clouse et al., 2014). As one woman put it: "When they see that their babies are well, they don't see a need to come to the clinic anymore" (Clouse et al., 2014: e14). Another woman stated: "Most of the pregnant women take their medication only to prevent passing on the virus to the baby and do not care about their health" (Clouse et al., 2014: e14). A study from Tanzania found that women who had a detectable viral load at 24 months postnatally did not acknowledge lack of adherence until confronted with the information on their viral load. Once they acknowledged that they had not been adherent, they expressed that once they had an HIV-negative child, they were ready to die: "Not that I forgot to take them. I thought it was okay if I died...After I stopped breastfeeding that is when I lost hope completely" (Ngarina et al., 2013: p. 4). A qualitative study of pregnant women living with HIV in South Africa also found that the primary motivation for initiating cART in pregnancy was the well being of their child, and women may be more adherent to cART if they understand how a healthy mother is key to a healthy child (Black et al., 2014). Women may also need additional psychological and peer support. [See also Adherence and Supportand Care and Support]

Community-based support programs for pregnant women living with HIV can be helpful. A recent study of implementation of community-based adherence clubs for stable ART patients, which provided ART to 2,133 patients, 71% female, with a strong emphasis on peer-based support and patient self management, found that one year later, only 6% of patients were lost to follow up and fewer than 2% of patients experienced viral load rebound (Grimsrud et al., 2015). How to link pregnant women postpartum to such community-based interventions remains a challenge (Onono et al., 2015). A recent review of maternal health globally found that community women's groups can have important effects on reducing mortality and morbidity (Prost et al., 2013 cited in Downe et al., 2016; Marcos et al., 2012). Community-based interventions for pregnant women living with HIV outside of the health facility have generally not been part of national scale up efforts (Ezeanolue et al., 2016). A randomized controlled trial is underway to assess whether clinic or community-based peer support programs improve health outcomes (Rosenberg et al., 2014). [See also Pre-Conceptionand Care and Support]

Additional Efforts are Needed to Better Engage Men in Supporting Safe Motherhood and Prevention of Vertical Transmission

Little work has been done to explain vertical transmission to male partners and how men can support pregnant partners living with HIV (Auvinen et al., 2014b). While in some studies, PMTCT uptake is associated with male support, other studies have found that women without any partner involvement were more likely to complete the PMTCT cascade (Kim et al., 2012). PEPFAR's Gender Strategy notes the importance of not "penalizing women who are not accompanied by men" (PEPFAR, 2013: 14). Interviews with male partners of pregnant women living with HIV in South Africa found that men felt responsible for their children, but that long clinic lines and the view that clinics for maternal health care are women-only spaces reduced the likelihood that men will access services through antenatal care (Koo et al., 2013a). However, many younger fathers admitted that they had felt unprepared for the responsibilities of fatherhood and would have been enthusiastic about receiving information about fatherhood, with HIV as a part of this (Koo et al., 2013a). A card inviting men to be a great partner, love their partner, love their baby and love themselves was seen as the most welcoming of several potential invitations (Koo et al., 2013b). Remarkably little is known about couples and their relationships in the context of HIV and how to improve couple communication about sensitive topics around risk, sex and transmission (Ramirez-Ferrero and Lusti-Narasimhan, 2012).

"Because we are seeing Option B+ they are giving the medicine to only a woman who is pregnant. Men will say 'Its me who made that woman pregnant. Why am I not started on treatment too?'"-Woman living with HIV in Uganda or Malawi (Hsieh, 2013).

More nuanced efforts are needed to engage men in prevention of vertical transmission. Mandating men to attend antenatal care may be counterproductive and prejudice women without partners. Preparing men and women to be parents and have healthy educated children, is key to the well being of future generations. "Sometimes the labor pain may begin when you are with your spouse and you tell him to accompany you to the hospital since you can't walk on foot. He will respond that he is busy and moreover he doesn't have money to take you to the hospital" (Mason et al., 2015: p. 5).Yet many men in another qualitative study noted that while they are excluded from maternal health services, they felt a sense of duty to care for their pregnant wives - but providers did not approach men who waited for their wives during ANC or childbirth (Villar-Loubet et al., 2013).

Men are important to both maternal and child health, yet men are unlikely to attend the birth of their child - and are relegated to remain outside the room where a woman gives birth or even to the parking lot of the health facility - despite women's wishes for support from their male partner during childbirth and delivery (Levtov et al., 2015). While cultural beliefs or fear of violence may lead women to want to exclude men from delivery and childbirth, it is often the health facility - and the infrastructure of the health facility - that makes men unwelcome at the birth of their child.

In a qualitative study of married men in Uganda, men noted that they would not disclose an HIV-positive serostatus to their pregnant wives, fearing abandonment also: "I can't tell her, she will run away and leave me with the children" (Duff et al., 2012:230). Women living with HIV may fear disclosing to a partner if he cannot access treatment also. But in some countries the increased access by pregnant women to cART may prejudice access by men. A recent abstract at the 2016 Conference on Retroviruses and Opportunistic Infections (CROI) found that Option B+ has widened the gap between male and female cART coverage in Malawi (Jahn, 2016b). A review of gender inequality through male involvement in maternal health found 13 studies which showed that men were viewed mostly as gatekeepers for women's health and used men to facilitate health seeking behavior by female partners; as instruments rather than people with their own needs in terms of the birth of their child (Comrie-Thomson et al., 2015). Wide adoption of 'Test and Start' policies could improve availability of treatment for men.

Progress Has Been Made in Improving Maternal Health But More Is Needed

Significant progress in maternal health has been made globally: maternal deaths have been reduced from 376,000 in 1990 to an estimated 292,982 maternal deaths in 2013 (Kassebaum et al., 2014). A significant increase has also been seen in the number of women with skilled birth attendants from 56% in 1990 to 74% in 2015 (van den Broek, 2016) - another key marker of maternal health. But though progress on maternal health has been achieved, only 16 countries (seven of which were developing countries) met the Millennium Development Goal related to reducing maternal mortality (Kassebaum et al., 2014), which was to reduce maternal mortality by three quarters by 2015. Instead, maternal mortality was reduced by 44% (WHO, 2015l).

Perinatal care is critically important to maternal health, yet almost 40% of pregnant women do not have the recommended four antenatal visits and 27% of pregnant women did not have skilled attendants at birth in 2013 (WHO, 2015l; Kearns et al., 2015). Women are more likely to initiate treatment when they have access to maternal health care facilities and services. For example, a study of 220 women living with HIV in Ethiopia found that mothers who delivered at a health facility, compared to delivering at home, were 18 times more likely to receive services for safe motherhood and prevention of vertical transmission (Lerebo et al., 2014). Similarly, in Kenya, of 247 women living with HIV who delivered in the last year and participated in a community-based survey, those women with more ANC visits were more likely to access cART (Kohler et al., 2014). Antenatal care in pregnancy can also be protective against STIs, particularly with lab-based screening and treatment (Adachi et al., 2015). This is vital given that STIs, such as syphilis, may increase the risks of vertical transmission, as well as negatively impact the health of the mother and her sexual partner(s). [See also Preventing, Detecting and Treating Critical Co-Infections]

Once women give birth, postnatal care is often lacking: based on data in 17 resource-poor countries, only an estimated 40% of mothers receive postnatal care within 48 hours (Darmstadt et al., 2014). In addition, 2.2 million women in low- and middle-income countries between 2005 and 2015 gave birth alone, including in some countries with significant numbers of pregnant women living with HIV, such as Nigeria, India, Ethiopia, Uganda and Kenya. Those pregnant women who are poorest and with the most need are the least likely to access skilled attendants at birth (WHO, 2015f) and therefore will not have had any interventions related to safe motherhood for women living with HIV (Orobaton et al., 2016). Women and their families need information on why antenatal care is important for maternal and child health and what they can expect to receive as part of antenatal care, without high costs as a barrier or long waits to access care (Mason et al., 2015).

The true numbers of pregnant women living with HIV are likely underestimated, as "...empirical data about how the HIV epidemic has affected maternal mortality in Africa are few..." (Myer, 2013: 1700). Separate funding silos for maternal health from HIV programs may hinder needed collaboration in preventing maternal deaths, including from HIV. Importantly, the Global Fund supports funding synergistic maternal/newborn/child health (MNCH) interventions that impact HIV (Hope et al., 2014). But structures to monitor and evaluate maternal health remain separate from HIV (Hope et al., 2014). Pregnant women living with HIV will need to access care outside of maternal health services after the postpartum period. Key questions to address are: How are women transferred in and out of adult ART services before and after pregnancy? What support is needed for women who are not ready to initiate ART? What will support women to remain adherent during pregnancy, postpartum and for the remainder of their lives? (Colvin et al., 2014).

It IS Possible to Eliminate Vertical Transmission

"Eliminating mother-to-child HIV transmission (MTCT) is now considered a realistic public health goal for resource limited settings"(Woldesenbet et al., 2015: para 1)Between 2009 and 2015, there has been a 46% decline in the number of AIDS-related deaths among women of reproductive age in the 21 priority countries (UNAIDS, 2016), a remarkable achievement.

Some countries have achieved the global criteria for the elimination of vertical transmission or rates of transmission similar to resource-rich countries. An evaluation in South Africa found that at infant immunization clinics, the rates of transmission at six weeks postpartum was 3.5% (Goga et al., 2015). In June 2015, Cuba became the first country to be validated as having met the global criteria for eliminating vertical transmission as a public health problem, that is, in 2014, fewer than 50 new infections in 100,000 live births; a rate of under 5% in breastfeeding women and less than 2% among women who do not breastfeed (WHO, 2015a, cited in UNAIDS, 2015; Gulland, 2015). Even where countries have not met the criteria for elimination of vertical transmission, many countries have made large strides: for example, in Botswana, the percentage of infants who are born to women living with HIV declined from 21% in 2003 to a transmission rate of 2.6% in 2015 (UNAIDS, 2016).

This progress demonstrates that with sustained resources and attention, it will be possible to eliminate vertical transmission.