| | Site-specific interventions to improve prevention of mother-to-child transmission of human immunodeficiency virus programs in less developed settingsReceived 2 February 2006; received in revised form 8 March 2006; accepted 15 March 2006. This article reviews the experiences of programs designed to provide access to prevention of mother-to-child transmission services with the goal of improving services in resource-constrained settings. The article reports new data from the Elizabeth Glaser Pediatric AIDS Foundation’s prevention of mother-to-child transmission program in sub-Saharan Africa, which has provided human immunodeficiency virus testing to more than 1,300,000 pregnant women and antiretroviral prophylaxis to 134,000 human immunodeficiency virus–infected pregnant women and more than 78,000 human immunodeficiency virus–exposed infants. Review of qualitative program data highlights the practical innovations that sites are implementing to improve the uptake of prevention of mother-to-child transmission services. Recommendations discussed include opt-out counseling and testing, rapid human immunodeficiency virus testing in antenatal care, counseling and testing in maternity, and provision of antiretroviral prophylaxis for mother and infant at the time of human immunodeficiency virus testing. Successful programmatic innovations need to be disseminated widely as more aggressive prevention strategies must be implemented to increase access to more than 10% of pregnant women worldwide. Worldwide, 530,000 children became infected with the human immunodeficiency virus (HIV) in 2006, an estimated 90% as a result of mother-to-child transmission (MTCT).1 In 2001, the UN General Assembly set a target of reducing the proportion of infants infected with HIV by 20% by 2005 and 50% by 2010.2 This article explores the experiences of prevention of mother-to-child HIV transmission (PMTCT) programs designed to meet these targets in resource-constrained settings. The following sections highlight the various interventions used, with the successes and challenges faced along the way. The strategies described draw from the published literature and the last 6 years of experience with the Elizabeth Glaser Pediatric AIDS Foundation’s (EGPAF) PMTCT program, initially entitled “Call to Action.” The World Health Organization (WHO) recommendations for PMTCT (revised in 2006) include a 4-pronged comprehensive strategy.3 Although we acknowledge the critical role that all approaches play in reducing pediatric HIV infection, the focus of this article is on site-specific strategies that address the third prong: preventing HIV transmission from infected mothers to their infants. Programmatic experiences in sub-Saharan Africa are the primary focus here, but the lessons learned from these examples apply to other resource-constrained settings. Methods  EGPAF requires a quantitative progress report quarterly for US government-funded PMTCT sites and every 6 months for privately funded sites. Each site records patient data about counseling, testing, HIV status, antiretroviral (ARV) prophylaxis, and other indicators. A standardized form is submitted to the in-country technical advisor or the EGPAF program officer. Data are reviewed for inconsistencies, trends over time, site variability, and discussion of challenges and improvements. Queries are sent to in-country staff for appropriate corrections. All corrected data are entered in FileMakerPro 6 (Filemaker Inc, Santa Clara, CA). Qualitative data reports are submitted every 6 months and are reviewed alongside the quantitative data to provide context and explanation regarding site successes and challenges. Programmatic experience and innovations Despite many challenges, 6 years of EGPAF’s program experience with PMTCT service delivery in 13 African nations has shown that high uptake of HIV counseling, testing, and delivery of an intervention is possible in resource-poor settings (Figure 1). Statistical analyses on program data regarding uptake in HIV counseling, HIV testing, women receiving test results, and provision of ARV to mother and infant show significance in improvement over the years.4 PMTCT and maternal and child health services The defined minimum package for antenatal care (ANC) usually includes health education, a physical examination, urinalysis, laboratory blood tests, including syphilis screening, vitamin and iron supplementation, tetanus immunization, and malaria prophylaxis. However, the availability of supplies and staff to provide basic services is dependent on the economic reality of the country. The availability of test kits, drugs, and other commodities, essential to providing PMTCT services, is inevitably linked to procurement, distribution, and supply chain management capacity. These aspects of program management are fundamental for the entire continuum of HIV services and need strengthening in most countries. Sites benefit from technical assistance to develop a clear procurement system and from support to hire and train individuals with the responsibility for ordering and distributing essential commodities. Human capacity and space constraints PMTCT is part of the complete package of quality health care services that should be offered to mothers and infants. To ensure integration, PMTCT services should be provided by the regular maternal and child health (MCH) staff, not by a separate cadre of health care providers. However, adding PMTCT services increases the time demands on staff, and additional personnel may be required to handle the workload. Equally important, all staff in the facility must be appropriately trained in PMTCT and involved in service delivery so that every mother has access to services, regardless of which provider she sees at the facility. The addition of counseling alters patient flow and creates a need for confidential space. National programs should incorporate PMTCT curricula into the preservice training of physicians, nurses, and clinical officers to ultimately diminish training needs of personnel providing services. Strategies that have been used include: •Paying trained staff to work overtime, as sites have done in Zambia.5 •Reapportioning the work and using staff of the highest skill level for tasks only they can perform. For example, nurses do not need to register patients when a clerk can do so. In Malawi and Zimbabwe, nurses provide rapid tests at the time of counseling. •Training new cadres of workers, such as lay counselors, as sites have done in Zimbabwe and South Africa. •Engaging community workers, such as traditional birth attendants (TBA), in the program, as sites have done in Tanzania and Cameroon.6, 7 The availability of sufficient space to provide services is often a challenge to already stretched health facilities. Adding the need to accommodate every woman in confidential space for counseling has changed facilities and patient flow. Where feasible, sites have constructed new buildings; when resources and property restrictions do not allow for a new building, sites have used other innovative strategies: In Kenya, sites have used partitions creatively within the existing facility and have brought in trucking containers modified with windows and air conditioning to serve as counseling rooms. In Zambia, counselors set up tents to provide space when PMTCT service initiation could not wait for new construction. In Uganda, the Ministry of Health (MOH) abandoned traditional ANC days and provided services to women five days a week to alleviate crowding on any given day. HIV counseling The initial presentation of PMTCT concepts to pregnant women is critically important in the uptake of services. Initially, many sites provided counseling and testing in an opt-in fashion, meaning clients elected to be counseled and tested for HIV. Discussion and testing for HIV were treated as a special service that mothers needed to actively accept. Many programs are now shifting to provide HIV counseling as a routine service. Women have the right to actively refuse or “opt out” of testing. The EGPAF/Cameroon Baptist Convention Health Board program has provided opt-out counseling and testing for 5 years.8 Through 2005, 100% (111,322) of eligible women have been counseled, and 91.6% of those counseled have accepted testing in more than 200 facilities. Pretest HIV counseling may be offered individually or to groups, with group counseling reducing the number of staff needed.9, 10 A Burkina Faso study comparing group and individual HIV counseling found that pregnant women receiving group counseling had higher posttest knowledge about HIV/AIDS in all but 1 topic area.11 In early 2005, the Malawi EGPAF/University of North Carolina PMTCT program shifted from an opt-in to an opt-out approach to HIV counseling and testing and initiated group pretest counseling. In 1 year the program increased counseling from 75-100%, whereas testing remained at 98% of those counseled. With a seroprevalence of 15% in a population of 20,100 pregnant women using ANC services, an estimated 96% of HIV-positive women were provided nevirapine.12 The national PMTCT program in Kenya also experienced a dramatic increase in uptake of HIV testing when MOH policy shifted from opt in to opt-out. Uptake of testing in the first 3 months of the new policy significantly improved, but testing rates declined with stock-outs of HIV test kits. Because policy and procurement were not coordinated, the dramatic increase in testing uptake rapidly depleted the supply of kits, undermining the uptake improvements within the first 6 months of the policy change (Figure 2) (D. Mbori-Ngacha, CDC/MOH, personal communication, 2006). HIV testing HIV tests are administered in accordance with national policy and there is considerable variability in approach among countries.13, 14 Most sites use rapid HIV testing by using a serial algorithm and deliver results to women on the same day that testing takes place. In the district of Hlabisa, South Africa, 14 rural MCH clinics seeing 7000 women over 21 months were able to give results to only 66% because blood was sent for enzyme-linked immunosorbent assay testing and same day results were not available. When rapid testing became available, 93% of women obtained their results over the ensuing 24 months. Programs should consider counseling and testing in labor and delivery to provide PMTCT services for women without ANC care or with unknown serostatus. A study in Kenya showed that a high percentage (79%) of women delivering in the maternity of a large tertiary facility had no prior ANC visits or attended ANC in facilities in which PMTCT services were not offered.15 The Rwanda EGPAF PMTCT sites have achieved high coverage of the intervention, including counseling and testing in ANC and in maternity settings. By including PMTCT services in maternity hospitals, the program identified 1983 (27.7%) of a program total of 7150 HIV-positive pregnant women through December 2005; these women would not have been counseled and tested if the intervention was limited to the ANC setting. Likewise, 15% of 40,204 women in Kenya, 28% of 10,645 women in Swaziland, and 11% of 94,633 women in Tanzania accessed services in maternity. Counseling and testing should become a routine service at each contact point in MCH clinics, including ANC, maternity, well-child, family planning, and postnatal clinics. The personnel are often the same as in ANC and trained in the provision of these services. Provision of ARV prophylaxis to HIV-positive mothers and HIV-exposed infants The choice of prophylactic regimen is determined by the MOH within each country. Generally, countries have opted for the most feasible effective regimen that can be administered on a large scale. To date, that often means single-dose nevirapine (SD-NVP). SD-NVP dispensing practices have been modified over time to maximize the number of HIV-infected women who receive ARV prophylaxis.8 In most locations, HIV-infected women are encouraged to deliver in a maternity setting where they may be observed ingesting the NVP tablet. Initially, NVP was dispensed only in maternity when women arrived for delivery. However, sites in Uganda, Zimbabwe, and elsewhere recognized that women might not deliver in facilities or might arrive too late to receive the NVP tablet because delivery is imminent or they deliver before reaching the facility. As a result, policies evolved toward dispensing NVP for the mother to take home during ANC at a fixed point in gestation, such as 28 weeks. However, women do not always return to ANC to receive NVP late in gestation. In Kericho, a tea estate region in Western Kenya, 72.5% of 1600 HIV-positive women received their dose of NVP after 28 weeks’ gestation. This improved to 94.4% of 1100 HIV-positive women when the policy was changed to providing the NVP dose when women tested HIV positive. Similarly, in Cameroon 40.8% of 7171 HIV-positive women received NVP in delivery but subsequent to a policy change, 87.4% of 1735 women received NVP at the time of testing HIV positive. Thus, many sites now give SD-NVP to the mother during the antenatal visit at time of diagnosis, advising her to take it at the onset of active labor. Sites have acknowledged the difficulty of delivering the infant dose when a high proportion of mothers deliver at home and it is often impossible to bring their infants for NVP dosing within 1 week of birth. Transportation and cultural barriers are particular impediments. Note in Figure 1 that only 43.6% of HIV-exposed infants received ARV prophylaxis. An increasing number of sites have started to dispense NVP doses for both infant and mother simultaneously, with instructions to the mother about dosing her infant. The infant dose is not yet available in single-dose packaging so it is dispensed in an oral syringe. Stability of NVP has been demonstrated for 2 months in the donated Baxa syringe.16 In Kericho, Kenya (Figure 3), the PMTCT program has started to provide infant prophylaxis in ANC at the time of the mother’s HIV test. The NVP-filled, capped syringes are wrapped in foil and placed in a black plastic bag for mothers to take home with their NVP tablet; mothers are instructed to give the syrup to their infant within 3 days of birth. The program began with 2 sites toward the end of 2003 and with more sites dispensing NVP-filled syringes by the end of 2004. By mid-2005, the majority of 52 sites were providing NVP-filled syringes. From April to December 2005, 76.5% of the infants of identified HIV positive mothers received ARV prophylaxis. In July 2005, Kericho District rapidly increased the number of new sites providing PMTCT services. These new sites received conflicting information regarding when to dispense NVP and some of the health care workers were not confident enough to dispense the infant NVP for the mothers to take home. During this quarter, the percentage of infants receiving NVP decreased to 54.6%, but as procedures were clarified, the infant NVP uptake increased to 82.0% the following quarter. The NVP doses provided in ANC are not directly observed being swallowed and there is no guarantee that all will take their medication. However, women and infants must have access to the medication in order to take it. AZT and combined regimens As many countries scale-up ART programs, additional infrastructure and staffing are being put into place. Providing HAART to treatment-eligible persons has enhanced the possibility of providing more complex and effective prophylactic regimens. Countries in sub-Saharan Africa have reviewed and revised policies for PMTCT and started to selectively pilot administration of AZT/NVP prophylactic regimens and screen and provide HAART for eligible women. However, the experience of delivering complex regimens in these settings remains limited. Research is needed to determine how best to operationalize delivery of complex prophylactic regimens.17, 18 Some concerns expressed by sites that must be addressed include the need for training, appropriate staffing, feasible prescribing policy and reliable logistics systems. In 2006, WHO revised its recommendations for ARVs for PMTCT in resource-limited settings. (See WHO’s revised guidelines for regimen recommendations.3) Infant feeding practices Addressing infant feeding options for mothers is as important as ARV prophylaxis because one-third to one-half of all MTCT occurs postnatally through breastfeeding.19 WHO recommends avoiding all breastfeeding from birth only if replacement feeding is “AFASS” (acceptable, feasible, affordable, sustainable, and safe) and has recently released a consensus statement supporting breastfeeding where AFASS conditions are not met.20 Many national guidelines continue to recommend exclusive breastfeeding because the majority of women in their countries do not meet AFASS requirements. A recommendation for early weaning at 6 months is also dependent on the AFASS criteria, requiring availability of supplementary foods and mother’s appropriate knowledge of nutritional needs for the infant. Understanding and assessing the AFASS conditions for individual mothers has proven to be very challenging for many health care workers. An infant feeding algorithm to help health providers counsel individual women has been developed.21 All feeding choices for HIV-infected mothers carry some risk. Although breastfeeding exposes infants to HIV, replacement feeding carries the risks of increased morbidity and mortality.22, 23 In a Botswana study that included free formula for participants, there was increased mortality in the first 7 months of life for nonbreastfed infants, and HIV-free survival was the same at 18 months of age.24 The provision of formula reduced HIV infections but added risk for other morbidity and mortality in infants who were not HIV infected. Longitudinal care Introducing the concept and practice of longitudinal care to both health care providers and clients is critical to bridging the gap between PMTCT services and continued follow-up and appropriate HIV care and treatment. Integrated family services would involve coordination of ANC and long-term care of the mother, infant, and additional family members. Follow-up of HIV-exposed children is best performed in the MCH setting, where they normally return for immunizations and well-child care. Knowing which infants have been HIV exposed (born to HIV positive women) is essential to providing optimal care so that cotrimoxazole can be administered as recommended, the infant’s infection status can be assessed, and ART can be provided when available. A system for sharing this knowledge is not often a part of well-child care. However, some countries, including Zimbabwe and Tanzania, are including the mother’s serostatus routinely on the infant health card. Capacity of the staff in MCH clinics in facilities providing ARV should be developed so that HIV care can be provided in MCH during pregnancy, the early postnatal period, and for infants. Involving men There has been little or no male involvement at most sites. This is related to deep-seated sex imbalances, as well as institutional factors within health system delivery. Some women believe they need partner consent before agreeing to HIV testing, and perceptions about the husband’s approval have been shown in a rural Ugandan context to be a strong predictor of their willingness to be tested.25 Some sites have introduced “male-friendly” interventions with varying success. Efforts include: •Allowing pregnant mothers to go to the front of the line in ANC if they bring their male partners. •Offering testing to men at evening or weekend clinics, when they are most likely to be available. •Sending an invitation home with the partner with a direct request that the man attend ANC with his partner. •Coordinating with local companies to provide paid leave for male partners who accompany their wives to the antenatal clinic. •Providing couples testing and counseling. Community involvement Local leadership is required to ensure PMTCT services are acceptable to the community. Lessons learned from the first 18 months of a rural PMTCT program in Zimbabwe suggest the importance of community education to raise awareness of HIV in general, as well as of specific PMTCT services, and to lessen the stigma surrounding HIV. The community activities were designed to prepare mothers for HIV counseling and testing in ANC and include informational meetings and the development of materials for multiple community targets, such as pregnant women, community leaders, and men and women of childbearing age.26 Conclusion PMTCT was initially viewed as an independent service unrelated to continued care for mothers, their infants and other children, and their partners. With the global rollout of HIV services, PMTCT services need to become an integral part of the continuum of care. The pregnant women who are diagnosed as HIV infected can serve as an entry point for families, promoting early diagnosis, particularly of women and young infants who have not yet become ill, and linking them into long-term care. PMTCT is the single most effective program available to prevent HIV transmission, and preventing new infections is essential if the course of the epidemic is to be altered. The outcomes of the interventions discussed are very encouraging and need continued attention and improvement. The Table outlines key future directions and recommendations for PMTCT programming. Expanding access to interventions that effectively prevent MTCT is an urgent priority and one that must be maintained and strengthened in parallel with increasing availability of ARV treatment.  | •PMTCT services should be integrated into all facilities with ARV programs. •Continue expansion of the simplest intervention (SD-NVP) to increase access for all mothers. •Provide routine, opt-out HIV testing in ANC, delivery, and postpartum settings. •Provide improved infant feeding counseling to all women. •Tailor infant feeding counseling after HIV status has been ascertained. •Strengthen family planning services in MCH and HIV care clinics. •Train MCH staff to screen and stage HIV-positive women and increase access to CD4 testing in MCH settings. •Strengthen postnatal/longitudinal follow-up for mothers and infants, starting with knowledge of the mother’s HIV status. •Measure the effectiveness of both simple and more complex PMTCT regimens in program and community settings. •Encourage, support, educate, and fund more efficacious ARV prophylactic regimens to provide more complete treatment options. •Improve early diagnostic capacity for infants. •Provide cotrimoxazole to all HIV-exposed infants. •Treat symptomatic infants in accord with guidelines. | | | | |
Acknowledgment We would like to acknowledge the tireless efforts of the PMTCT partners in all 22 countries whose work made this article possible. Ellen Piwoz of AED provided substantial technical input to the infant feeding section. We thank the following reviewers and their helpful comments: Chuck Hoblitzelle of EGPAF, Peter Savosnick of EGPAF, Heather Bergmann of EGPAF, Lucy Alcala of EGPAF, Charlotte Colvin of EGPAF, Nathan Shaffer of CDC, Rabia Mathai of CMMB, and Chewe Luo of UNICEF. EGPAF’s PMTCT program appreciates the generous financial support of the US Agency for International Development, Johnson & Johnson, Boehringer Ingelheim, Jeweler’s Charity Fund, the Bill and Melinda Gate’s Foundation, Oprah Winfrey Foundation, and Ronald McDonald House Charities. References 1. 1UNAIDS. UNAIDS/WHO AIDS epidemic update: December 2006. Geneva: UNAIDS; 2005;. 2. 2United Nations General Assembly. Final declaration of commitment on HIV/AIDS. New York: United Nations; 2001;. 3. 3World Health Organization. Antiretroviral drugs for treating pregnant women and preventing HIV infections in infants in resource-limited settings: toward universal access. 2006;. 4. 4Spensley A, Wilfert C, Flynn K, . International AIDS Society Conference; August 13-18, 2006; Toronto, Canada. Abstract TUPE0338. 5. 5Chi BH, Sinkala M, Stringer EM, et al. Employment of off-duty staff: a strategy to meet the human resource needs for a large PMTCT program in Zambia. JAIDS. 2005;40:381–382. 6. 6Bulterys M, Fowler MG, Shaffer N, et al. Role of traditional birth attendants in preventing perinatal HIV transmission of HIV. BMJ. 2002;324:222–224. 7. 7Msaky H, Kironde S, Shuma J, Nzima M, Mlay V, Reeler A. Scaling the frontier: Traditional birth attendant involvement in PMTCT service delivery in Hai and Kilombero Districts of Tanzania. In: Bangkok, Thailand: International AIDS Society Conference; 2004;. 8. 8Welty TK, Bulterys M, Welty ER, et al. Integrating prevention of mother-to-child HIV transmission into routine antenatal care: the key to program expansion in Cameroon. J Acquir Immune Defic Syndr. 2005;40:486–493. MEDLINE |
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23. 23Iliff J, Piwoz EG, Tavengwa NV, et al.ZVITAMBO study group Early exclusive breastfeeding reduces the risk of postnatal HIV-1 trasmission and increases HIV-free survival. AIDS. 2005;19:699–708. MEDLINE 24. 24Thior I, Lockman S, Smeaton L, et al. Breastfeeding plus infant zidovudine prophylaxis for 6 months vs formula feeding plus infant zidovudine for 1 month to reduce mother to child HIV transmission in Botswana: a randomized trial: the Mashi study. JAMA. 2006;296:794–805.
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25. 25Bajunirwe F, Muzoora M. Barriers to the implementation of programs for the prevention of mother-to-child transmission of HIV: a cross-sectional survey in rural and urban Uganda. AIDS Res Ther. 2005;2:10. 26. 26Perez F, Mukotekwa T, Miller A, et al. Implementing a rural programme of prevention of mother-to-child transmission of HIV in Zimbabwe: first 18 months of experience. Trop Med Inter Health. 2004;9:774–783. 1 Elizabeth Glaser Pediatric AIDS Foundation, Washington, DC 2 University of Witwatersrand, Johannesburg, South Africa 3 Family Health International, Arlington, VA 4 Walter Reed, Washington, DC 5 Baylor College of Medicine, Houston, TX. Support was provided from the Global Bureau’s Center for Population, Health, and Nutrition of the United States Agency for International Development under the terms of Cooperative Agreement no. GPH-A-00-02-00011-00 (Call To Action Project) with the Elizabeth Glaser Pediatric AIDS Foundation. The opinions expressed herein are those of the authors and do not necessarily reflect the views of the US Agency for International Development. Reprints not available from the authors. PII: S0002-9378(07)00435-8 doi:10.1016/j.ajog.2007.03.069 © 2007 Mosby, Inc. All rights reserved. | |
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