Antenatal Care - Treatment

Gaps in Research

1.: Interventions are needed to sustain viral suppression and reduce loss to follow up once a woman has initiated Option B+, including affordable means of monitoring virological response and effective adherence counseling. Research is needed on how long is optimal to provide care within maternal health systems or when to transfer cART provision outside of maternal health systems.
2.: Interventions, including community based distribution of cART and/or funds for transport, are needed to reach pregnant women living with HIV who do not access ANC, postpartum care or cART.
3.: Promoting HIV testing for male and female adolescents prior to pregnancy or fatherhood may increase those on cART prior to pregnancy, thus decreasing viral load prior to pregnancy and increasing the likelihood of reduced risk of vertical transmission
4.: Interventions for pregnant women and their partners to stay HIV-negative or reduce HIV transmission are needed
5.: Mandating pregnant women to enroll in ART on the same day they test HIV positive may violate their human rights and may result in loss-to-follow up, increasing the risk of mortality, morbidity and drug resistance.
6.: Interventions are needed to reduce the higher attrition rate among pregnant adolescents living with HIV, including those perinatally infected, and provide needed support by parents and others.
7.: Strategies need to be identified to empower women to create demand for improved maternal health services and challenge violations of their rights in facility-based childbirth.
8.: Ongoing surveillance is needed to assess the impact of cART on infants (both HIV-negative and HIV-positive) exposed in utero and during breastfeeding.
9.: Monitoring for drug resistance in low- and middle-income countries is needed during Option B+ scale up.
10.: Efforts are needed to effectively implement Option B+ in non-prejudicial ways.
11.: Interventions are needed for male involvement that do not such reinforce harmful gender norms or increase risk for violence, stigma or discrimination.
12.: Additional support for pregnant women living with HIV who face violence is needed, including establishing proper mechanisms for seeking redress, along with more research on mental health and maternal morbidity among women living with HIV.
13.: Women and men need accurate information on vertical transmission, treatment adherence strategies, the importance of their viral load and the low risk of vertical transmission if virally suppressed.
14.: Strategies, including legal strategies, are needed to empower pregnant women living with HIV to ask questions, be properly informed and to challenge stigma, disrespect and abuse.
15.: More effective and timely translation of new PMTCT policy into standard practice is needed.
16.: Interventions are needed to provide pregnant and breastfeeding women with more food security in order to increase viral suppression.

1. Interventions are needed to sustain viral suppression and reduce loss to follow up once a woman has initiated Option B+, including affordable means of monitoring virological response and effective adherence counseling. Research is needed on how long is optimal to provide care within maternal health systems or when to transfer cART provision outside of maternal health systems. Compared to people who started cART for their own health, a study found that women who started cART while pregnant were 5 times less likely to return to the clinics after the initial visit. Women who started cART while breastfeeding were twice as likely to miss their first follow up appointment. On average, 17% of pregnant women who started ART under Option B+ dropped out of care in the first six months of ART and 22% dropped out within one year (Tenhathi et al., 2014). Systems are rarely in place to track mothers six weeks post-partum (Psaros et al., 2015; Waiswa, 2016). A survey found that ART retention was greatest in those facilities where newly diagnosed pregnant women living with HIV were referred from ANC to the ART clinic in the same facility for initiation and follow up or were referred to facilities serving as ART referral sites that did not provide ANC (van Lettow et al., 2014). A review noted that women found challenges in accessing cART either through maternal care systems, postpartum or through HIV care. Input from pregnant and postpartum women living with HIV is needed

Gap noted globally (Colvin et al., 2014; Nutman et al., 2013 cited in Kendall and Danel, 2014); and, for example in Zambia (Bengston et al., 2016, Ngoma et al., 2015); Brazil (de Andrade et al., 2016); Rwanda, Malawi, Kenya and Swaziland (Woelk et al., 2015); Zimbabwe (Dzangare et al., 2015); South Africa (Phillips et al., 2015; Clouse et al., 2015; Henegar et al., 2015; Clouse et al., 2013); Uganda (Psaros et al., 2015, Mugasha et al., 2014), Malawi (Tenthani et al., 2014; van Lettow et al., 2014; Tweya et al., 2014; Koole et al., 2014); Tanzania (Ngarina et al., 2014); and Kenya (Ayuo et al., 2013).

2. Interventions, including community based distribution of cART and/or funds for transport, are needed to reach pregnant women living with HIV who do not access ANC, postpartum care or cART. “Restrictions on women’s mobility and lack of access to transportation and financial resources may limit their ability to seek PMTCT services” (Ghanotakis et al., 2012: table 2).

Gap noted, for example in Kenya (Mason et al., 2015); Zimbabwe (Dzangare et al., 2015); McCoy et al., 2015a); Botswana (Dryden-Peterson et al., 2015); Tanzania (Gourlay et al., 2015); Malawi (Tweya et al., 2014); and Uganda (Mugasha et al., 2014; Lubega et al., 2013).

3. Promoting HIV testing for male and female adolescents prior to pregnancy or fatherhood may increase those on cART prior to pregnancy, thus decreasing viral load prior to pregnancy and increasing the likelihood of reduced risk of vertical transmission

Gap noted, for example in Tanzania (Goulray et al., 2015) and in South Africa (Fatti et al., 2014; Horwood et al., 2013).

4. Interventions for pregnant women and their partners to stay HIV-negative or reduce HIV transmission are needed . [See also HIV Testing and Counseling for Women and Treatment] Pregnancy is a time of high risk for HIV acquisition. Home-based partner education for couples with no reports of interpersonal violence may be more effective than clinic based interventions, especially when women can opt-out of disclosing their sero-status. A systematic review found that incident infection (i.e. recently acquired during pregnancy) resulted in up to a 15-fold higher risk of vertical transmission.

Gap noted globally (Croce-Galis et al., 2015; USHHS, 2015); and for example, in Africa, Asia, USA, Europe and Latin America (Drake et al., 2014); Mozambique (De Schacht et al., 2014); Kenya (Farquhar, 2016: CROI Abstract); South Africa (Dinh et al., 2015; Peltzer and Mlambo, 2013; Petlzer et al., 2013; Johnson et al., 2012); Mexico (Rivero and Kendall, 2015); Uganda (Saleem et al., 2014); and Mozambique (De Schact et al., 2014).

5. Mandating pregnant women to enroll in ART on the same day they test HIV positive may violate their human rights and may result in loss-to-follow up, increasing the risk of mortality, morbidity and drug resistance. Providing enough counseling and information to pregnant women found positive before being initiated on lifelong treatment helps in reducing cases of loss to follow up. Active tracing of women lost to follow up in a way that does not violate consent, confidentiality and human rights, may be warranted. An analysis of national facilities with over 20,000 women started on cART under Option B+ found that loss to follow up was highest in patients who began cART at large clinics on the day they were diagnosed with HIV. After controlling for age and facility type, Option B+ patients who started on ART on the same day of testing were almost twice as likely to never return to the clinic than other Option B+ patients. Note: WHO September 2015 guidelines do not specify when during pregnancy a woman living with HIV should be initiated on cART

Gap noted globally (Welbourn, 2014) and for example in Ethiopia (Mitiku et al., 2016); Zimbabwe (Dzangare et al., 2015); Sub-Saharan Africa (Bain et al., 2015); Kenya (Ferguson et al., 2014); Malawi (Tenthani et al., 2014).

6. Interventions are needed to reduce the higher attrition rate among pregnant adolescents living with HIV, including those perinatally infected, and provide needed support by parents and others. [See also Prevention and Services for Adolescents and Young People] Additional research may also be needed on how to best care for perinatally-infected pregnant women who have decreased virological suppression, increased risk of vertical transmission and increased challenges in remaining adherent. While currently noted in the United States, it is anticipated to be relevant to low- and middle-income countries as more perinatally-infected women give birth.

Gap noted, for example in Zimbabwe (Dzangare et al., 2015) and South Africa (Woldesenbet et al., 2015; Hill et al., 2015) and United States (Jao et al., 2015; Badell et al., 2013; Munjal et al., 2013 cited in USHHS, 2015).

7. Strategies need to be identified to empower women to create demand for improved maternal health services and challenge violations of their rights in facility-based childbirth. This is a particularly acute need for women living with HIV. Studies show that HIV-related stigma may reduce the likelihood of delivering in a health facility

Gap noted globally (Vogel et al., 2015); and for example in South Africa (Schnippel et al., 2015; Clouse et al., 2014; Gross et al., 2012); Tanzania (Gill et al., 2015; Wabiri et al., 2013; Gross et al., 2012); Kenya (Turan et al., 2012 cited in Turan and Nyblade, 2013); and South Africa, Kenya, Tanzania, Zambia, Botswana, Ivory Coast (Ferguson et al., 2012).

8. Ongoing surveillance is needed to assess the impact of cART on infants (both HIV-negative and HIV-positive) exposed in utero and during breastfeeding. A recent US study had encouraging results that among ARV-exposed uninfected children, no learning issues were noted (Nozyce et al., 2014) and another US-based study found no increased risk for infants exposed to ART (Phiri et al., 2014). A pilot ART registry in Africa has been launched

Gap noted globally (Luzuriaga and Mofenson, 2016; Williams et al., 2015; de Martino et al., 2015; WHO, 2015a; Bulterys et al., 2014; Mofenson and Watts, 2014; Ahmed et al., 2013); and for example, Zambia (Nicholson et al., 2015; Liu et al., 2014); South Africa (Liu et al., 2014); India (Sangeeta et al., 2014); Italy (Floridia et al., 2013); Botswana (Chen et al., 2012); and Côte d’Ivoire, South Africa, Thailand (Ford et al., 2011).

9. Monitoring for drug resistance in low- and middle-income countries is needed during Option B+ scale up. Studies are finding drug resistance among women who are initiating cART or who have initiated cART

Gap noted globally (Paredes et al., 2013; Ahmed et al., 2013); and, for example in Tanzania (Ngarina et al., 2014); Brazil (Teixeira et al., 2014; Pilotto et al., 2013); Malawi (Palombi et al., 2015; Palombi et al., 2014; Mancinelli et al., 2015); Gabon (Caron et al., 2012); and Zambia (Kuhn et al., 2009b).

10. Efforts are needed to effectively implement Option B+ in non-prejudicial ways. Women who were sex workers reported being denied care until delivery. Women who were not accompanied by husbands were denied any health services during pregnancy. A sign on health centers read: “Notice: all pregnant women are supposed to come with their husbands/partners at their first visit. You will not be given services without implementing this” (Beckham et al., 2015: 66).

Gap noted globally (Turan and Nyblade, 2013), and for example, in Kenya, Nigeria and Namibia (ICW+ and GNP+, 2015); South Africa (Sewnunan and Modiba, 2015); Côte d’Ivoire (Schwartz et al., 2015a); Burkina Faso (Papworth et al., 2015); Tanzania (Beckham et al., 2015; Ngarina et al., 2014); Uganda (Mugasha et al., 2014); Cameroon, Nigeria and Zambia (Haerizadeh et al., 2014); and Senegal (Sow, 2014).

11. Interventions are needed for male involvement that do not such reinforce harmful gender norms or increase risk for violence, stigma or discrimination. “Evidence for effectiveness of male involvement in PMTCT programs is scant” (Beckham et al., 2015: 67). One study only evaluated male involvement as accompanying their pregnant partner to ANC care with no HIV related outcomes listed and tasking the woman to require her male partner to come to ANC (Nyondo et al., 2015). Most approaches only reach men through their pregnant spouse, with no services for men beyond HIV testing and use men as an instrument solely to increase access to services by women. Men have been denied involvement in antenatal care, birth and delivery even if the couple so chooses.

Gap noted globally (Ghanotakis et al., 2015; Colvin et al., 2014; Sherr and Croome, 2012; Brusamento et al., 2012 cited in Kendall and Danel, 2014; Ramirez-Ferrero and Lusti-Narasimhan, 20112); and for example, Zambia (Auvinen et al., 2014a and b); South Africa (Brittain et al., 2015); Malawi (Nyondo et al., 2015); Kenya, Namibia and Nigeria (ICW and GNP+, 2015) Tanzania (Sui et al., 2014 cited in Beckham et al., 2015; Auvinen et al., 2013 and Brusamento et al.,2011); and Sub-Saharan Africa (Kalembo et al., 2012).

12. Additional support for pregnant women living with HIV who face violence is needed, including establishing proper mechanisms for seeking redress, along with more research on mental health and maternal morbidity among women living with HIV.

Gap noted globally (Kendall et al., 2014a; Kendall et al., 2014b; Langer, 2016); and for example, in Nigeria (Iheanacho et al., 2015); Africa, Asia, Europe and USA (Kapetanovic et al., 2014); and Sub-Saharan Africa (Stringer et al., 2014); Zimbabwe (Shamu et al., 2014); and South Africa (Groves et al., 2014).

13. Women and men need accurate information on vertical transmission, treatment adherence strategies, the importance of their viral load and the low risk of vertical transmission if virally suppressed. Adherence has been challenging for women living with HIV postpartum, even for those initiating ART during pregnancy at CD4 counts under 350, with adequate adherence dropping from 75.7% during pregnancy to 53% postpartum globally (Nachega et al., 2012 cited in Coutsoudis et al., 2013). Knowledge of HIV and vertical transmission has shown to be correlated with increased initiation, adherence and retention for pregnant women living with HIV.

Gap noted globally (Ozra et al., 2015; Kendall and Danel, 2014); and for example, in Zambia (Wall et al., 2016); Malawi (Hoffman et al., 2016 – Abstract, CROI; Jahn et al., 2016a: CROI abstract; Kawale et al., 2015; Tenthani et al., 2014 cited in Clouse et al., 2014); Swaziland (Church et al., 2015); Sub-Saharan Africa (Tam et al., 2015; Gourlay et al., 2013);Mexico, El Salvador, Cameroon (Awungafac et al. 2015); Honduras and Nicaragua (Kendall and Albert, 2015); Uganda and South Africa (Wagman et al., 2015 cited in Kennedy et al., 2015; Maman et al., 2014); Ukraine (Bailey et al., 2014); South Africa (Nachega et al., 2012 cited in Kendall and Danel, 2014; Coutsoudis et al., 2013); Uganda (Duff et al., 2012); and Sub-Saharan Africa, Asia, Latin America, Europe and United States (Hodgson et al., 2014).

14. Strategies, including legal strategies, are needed to empower pregnant women living with HIV to ask questions, be properly informed and to challenge stigma, disrespect and abuse. [See also Reducing Stigma and Discrimination] Consequences for violating patient confidentiality, redress for women with HIV facing discrimination in facilities, and stigma reduction efforts are needed to increase adherence to cART, prior to, during and post pregnancy, including training for providers.

Gap noted globally (Khosla et al., 2015; Turan and Nyblade, 2013 cited in Kendall and Danel, 2014; Kendall et al., 2014b; Freedman et al., 2014; Busza et al., 2012); and for example, in India (Panditrao et al., 2015); Kenya, Nigeria and Namibia (ICW and GNP+, 2015); Cameroon, Nigeria and Zambia (Hawrizadeh et al., 2014); Sub-Saharan Africa (Gourlay et al., 2013); Kenya, Burkina Faso, Malawi and Uganda (Hardon et al., 2012); and Tanzania (Gourlay et al., 2014; Sando et al., 2014; Watson-Jones et al., 2012).

15. More effective and timely translation of new PMTCT policy into standard practice is needed.

Gap noted for example, in South Africa (Goga et al., 2015).

16. Interventions are needed to provide pregnant and breastfeeding women with more food security in order to increase viral suppression. A study found that food insecurity was associated with lower odds of sustained virological suppression.

Gap noted, for example, in Zimbabwe (McCoy et al., 2015b); Uganda (Koss et al., 2016; Young et al., 2012); and Tanzania (Ngarina et al., 2013).