Worldwide, approximately 2.2 million women and 600,000 infants are infected with HIV each year. 1 Antiretroviral prophylaxis, obstetric interventions (cesarean section), and the avoidance of breast-feeding have dramatically reduced mother-infant HIV transmission in countries with adequate health care resources. 2,3 In developing countries, where the impact of HIV is greatest, however, implementation has been limited by the complexity and expense of these interventions. 4
The Caribbean is the region hardest hit by HIV/AIDS in the world outside sub-Saharan Africa. 5 Nine of the 12 countries with the highest HIV prevalence in the Americas are in the Caribbean basin. In the Dominican Republic, 1 adult in 40 is HIV infected. Sentinel site testing for HIV prevalence among pregnant women has been ongoing since 1991. 5 Data from these sources suggest that the prevalence of HIV among pregnant women ranges from <2% to >5% and that the epidemic is rapidly increasing among women of reproductive age. 5
Transmission of HIV in the Dominican Republic occurs primarily through heterosexual contact. Since the 1st pediatric AIDS case was documented in 1985, the number of infected children has increased markedly, and the health care for these children is becoming an increasing burden on the public health system. 5 In 2001, almost 500 cumulative HIV/AIDS pediatric cases were documented. 5
As part of a continuing strategy to prevent and contain the spread of HIV infection, the Ministry of Health (MOH) of the Dominican Republic recently established an integrated package of interventions, including voluntary counseling and testing, the administration of a single-dose of nevirapine to the mother at the onset of labor or 8 hours previous to the cesarean section, and to the neonate 8–72 hours postpartum, an elective cesarean section, and alternative method of breast-feeding to prevent HIV mother-to-child transmission (PMTCT).
Although the MOH has been conducting sentinel site voluntary counseling and testing (VCT) among pregnant women since 1991, very little experience in providing universal voluntary and counseling testing among this population has been reported. Most of the MOH hospitals do not routinely perform HIV pre- and posttest counseling or testing. The majority (98.5%) of women in the Dominican Republic receive prenatal care, however, suggesting that a program to screen women for HIV infection would cover most of the pregnant population and would be a sustainable activity. This report documents the 1st-year results of the Dominican PMTCT program, pointing out the strengths and limitations observed during this period.
Design and Implementation of the PMTCT Program
The implementation of the integrated package was formally initiated on May 15, 2,000, with a 3-year donation of nevirapine from the Government of La Rioja, Spain. The program was designed to be implemented in 3 phases. The 1st phase included 4 mother and child hospitals; the 2nd phase included 8 mother and child health institutions in Santo Domingo, the capital of the Dominican Republic, and 7 additional mother and child hospitals at sentinel sites. In the 3rd phase, all other remaining (12) mother and child health care institutions of the Dominican Republic will be included.
During the 1st year, phase 1 was conducted, and 4 of the hospitals in phase 2 were incorporated into the program. Counseling sessions were offered at all of the 8 hospitals included in the 1st year. Training was performed at the hospital level. Each of the 8 hospitals had 4 counselors for the pregnant women: 2 counselors worked at the hospital in the morning, and 2 were available for afternoon consultations. Counselors were paid by the MOH of the Dominican Republic. Standardized training protocols were implemented for both pre- and posttest counseling, as well as methods for bookkeeping, data collection, administration of nevirapine, and alternative methods of breast-feeding.
Although polymerase chain reaction testing, by the National AIDS Program, was available for the first 45 infants in the MTCT Program, general measures to monitor HIV infection such as antiretroviral treatment, CD4 cell count, and HIV viral load were not available in the Dominican Republic during the 1st phases of the intervention.
All HIV-positive pregnant women included in the program were to receive a 200-mg nevirapine tablet during labor or 8 hours previous to the cesarean section. Additionally, all children born from HIV-positive mothers were to receive a 0.6-mL of nevirapine suspension with a 1-mL tuberculin syringe. HIV-positive pregnant women would only be excluded from receiving nevirapine if they had symptomatic liver disease, as nevirapine can result in transient alanine aminotransferase elevations in some patients. The drug was stored at room temperature under lock and key in cabinets in the antenatal clinics. Nevirapine was dispensed by staff nurses at the MOH hospitals, who recorded all drugs issued in a dispensary log.
In the Dominican Republic, breast-feeding is not universal, indicating that mothers who choose an alternative method of feeding will not necessarily be identified as HIV positive. Only 28% of infants <4 months of age are exclusively breast-fed and the median age of introduction of solid foods is 0.9 months. Reports from DHS-1996 6 indicate that more than half (56%) of infants <1 month of age have been bottle fed in the previous 24 hours. Among infants 2–4 months old, this proportion increases to 80%. Therefore, formula feeding was recommended as part of the PMTCT program strategies, since it is unlikely that the confidentiality of HIV-positive mothers who choose an alternative method of breast-feeding would be compromised.
At each hospital, all women enrolled in the program were recorded, along with the number of counseling sessions attended. The number of rapid tests performed was documented along with the percentage of pregnant women tested. At each hospital, the number of cesarean section and vaginal deliveries was recorded, and the number of women and children who received nevirapine was documented.
The number of infected children was calculated using RNA-HIV-1 (Quantiplex bDNA Analyzer, Bayer-Chiron), and the number of children who received alternative methods of breast-feeding was recorded. An infant was considered HIV infected if blood obtained after 6 weeks of nevirapine administration tested positive for the virus (RNA HIV-1).
Frequency, proportions, and 95% CIs were calculated using EPI-INFO 6.04d statistical package (Centers for Disease Control, Atlanta, GA). Fisher exact test was used to compare proportions of MTCT of HIV between nevirapine-treated mother-child pairs and children-only treated with nevirapine. Alpha error was set at 0.05.
Prenatal Care in the Dominican Republic
In the year 2000, according to the data provided by the MOH of the Dominican Republic, 133,715 births were registered in MOH hospitals. An estimated number of HIV-positive pregnant woman in each province was calculated; assuming an HIV prevalence of 2%, a total of 2735 pregnant women were estimated to be HIV positive and therefore at risk of passing the virus to their infants.
Most or 98.5% of all pregnant women reported receiving prenatal care. 6 Of the women who receive prenatal care, almost all (98%) are cared for by a physician. Over half (55%) receive care from an obstetrician and the remainder (43%) are followed by a general physician. Prenatal care is started early, prior to the 6th month of pregnancy for 93% of women; 88% report ≥4 visits. Almost all births (96%) take place in health institutions. A total of 75% occur in public institutions and 25% occur in private institutions. 6
First Year of Implementation
As of July 2001, the program supported by the MOH has been implemented at 8 hospitals in the Dominican Republic. This activity was conducted in collaboration with a wide range of community efforts, including the Rotary Club, HIV/AIDS NGO Coalition, along with the military and the Departments of Reproductive Health and Nutrition. The number of women who attended prenatal care services in the 1st year of implementation was 42,666 (Table 1). Each hospital provided pre- and posttest counseling sessions and performed HIV rapid tests.
From the 42,666 women who attended prenatal care services, 6528 (28%) women participated in pretest counseling sessions, and 3467 (15%) in posttest counseling sessions (Table 1). The percentage of counseling sessions performed among the 12 hospitals included in the 1st year of the PMTCT program varied greatly. Some hospitals, such as the Military Armed Forces Hospital and Centro Sanitario de Puerto Plata, reported 100% attendance at pre- and posttest counseling sessions for women who attended the prenatal care services of those health care institutions (Table 1). In the remaining hospitals, however, the percentage of pre- and posttest counseling sessions performed ranged from 0–79% (Table 1).
HIV Rapid Tests
As part of the PMTCT program, HIV rapid tests were offered at all of the 8 sites. More than half (54% = 23,067/42,666) of the pregnant women were tested for HIV. In some of the hospitals, tests were not available to perform HIV testing in all of the women, and in some cases, the HIV rapid test was not performed because the physician did not prescribe HIV testing. From the 23,067 pregnant women tested, 581 (2.5%) were HIV positive (Table 1).
Antiretroviral Treatment and Cesarean Section
A total of 185 women delivered in the 1st year of the PMTCT program. Antiretroviral treatment (nevirapine) was administered at onset of labor to 164 (89%) of 185 HIV-positive pregnant women and to 183 (98%) of 186 children (Table 2). Women who arrived at the hospital in labor (11%) did not receive the nevirapine. None of the women was excluded for presenting symptomatic liver disease.
As part of the PMTCT program, elective cesarean section was offered to increase the probability of reduction of MTCT HIV transmission in all HIV-positive pregnant women included in the program. At the end of the 1st year of implementation, cesarean section was performed in 67% (124/185) of the HIV-positive pregnant women (Table 2). The remaining women (33%) who did not receive cesarean section were admitted for delivery from the emergency department.
Postpartum Feeding Practices
Formula feeding counseling was administered to all HIV-positive mothers at hospital discharge. Infant formula was dispensed to 47% (87/186) of all cases (Table 2). Only 1% (3/186) of the children was breastfed. In 52% (96/186), information regarding postpartum feeding practices was not assessed. Infant formula was not available for distribution to low-income women.
For the diagnosis of HIV infection, RNA-HIV-1 testing was offered to all infants (of HIV-positive mothers) at 6 weeks of age. Due to the limited polymerase chain reaction testing by the National AIDS Program for the MTCT program, only the first 45 infants were tested. By the end of the 1st year of implementation, HIV-1 RNA viral load levels were nondetectable in 78% (35/45) of the children who were tested at 6 weeks of age. When mother-child pairs treated with nevirapine were compared with only children-treated, the likelihood of HIV vertical transmission was lower in the former group (odds ratio = 0.09; CI 95%: 0.01,0.85, P < 0.05) than in the children-treated group (Table 3).
This report demonstrates the feasibility of implementing a large-scale program to prevent mother-infant HIV transmission in a developing country. A major strength of the program implementation was the wide acceptance among hospitals and support of the community and the MOH. An additional strength involved the integration of different sectors of the Dominican Republic, interested in collaborating with the program, such as the Rotary Club, the coalition of NGO working in HIV and AIDS, as well as the military forces, reproductive health department, nutrition department, and international agencies, among others. Together, these efforts support the sustainability of the program.
Based on this 1-year project evaluation, we estimate that implementation of the PMTCT program in the Dominican Republic, using the nevirapine regimen (HIVNET012), 7 could reduce the average risk for MTCT by 50%, preventing approximately 1000 infant HIV infections each year. As reported by Kanshana and Simonds, 8 to achieve and maintain this prevention effect, national monitoring and evaluation data should be reviewed frequently to identify areas where the program can be improved.
Although aspects of the Dominican Republic health care infrastructure, such as high level of coverage for prenatal care, and an HIV epidemic with a relatively low HIV prevalence, may not be generalized to areas devastated by HIV/AIDS, several lessons learned from this pilot program evaluation may be useful for other developing countries. The PMTCT program provided the opportunity to train counselors in voluntary counseling and testing and to integrate other health topics (tuberculosis, vaccine, reproductive health) at the counseling sessions. Of concern, and a limitation highlighted by the program, was the low number of voluntary counseling and testing sessions. This appears to be due to a combination of factors such as scarce human resources and inadequate infrastructure. Hospitals such as the military forces, however, represent an effective approach that may reflect more authoritative directions to the health care counseling workers.
It is recognized that counseling is the cornerstone of the PMTC program and provides critical information to pregnant women about HIV testing and prevention. Counseling is also necessary to help HIV-infected women to adjust to their diagnosis and reduce transmission to their children. Thus, training in counseling can enhance not only the possibility of reducing HIV vertical transmission but also the quality of antenatal care and other health services in addition to the prevention of HIV MTCT.
It is important to note that patient consent for HIV testing is mandatory in the Dominican Republic. Thus, the low number of voluntary pretest counseling sessions may reflect lack of knowledge regarding the legal aspect of HIV testing in the country. Monitoring the process of HIV counseling in prenatal care health facilities where the PMTCT program is implemented is essential.
The identification of HIV-positive pregnant women is the focal point of the prevention strategies. Of concern was the inadequate number of rapid tests, which could provide a feasible way to extend the provision of testing to all centers. This unavailability, along with the lack of orders for HIV testing, were the major factors associated with the large number of women who did not receive testing. To address these limitations, the PMTCT program needs to develop a standardized approach to the issue of universal antenatal testing and promote prescriptions for HIV testing by the medical team. The conduct of a rapid assessment process will permit specific algorithms for rapid versus standard testing to be evaluated in relationship to the benefits of education and prevention. Additionally, designated funds will be necessary to provide HIV rapid testing resources at all hospitals.
Other important variables for targeted intervention programs to reduce HIV perinatal transmission include antiretroviral administration, cesarean section performance, and postpartum feeding practices. The 2-dose nevirapine regimen has been reported to be effective in lowering the risk of HIV perinatal transmission and is considered one of the few deliverable and sustainable strategies for the prevention of this route of transmission. 9 Use of elective cesarean section in combination with antiretroviral treatment can decrease perinatal HIV transmission by 87%. 5 During this 1-year pilot project, elective cesarean section was performed in 67% of the HIV-positive pregnant women, 85% of 39 mother-child pairs treated with nevirapine were HIV negative, and only 33% of 6 only-child treated with nevirapine were HIV negative.
Elective cesarean section was performed less frequently than expected during the early stage of the program implementation, primarily due to the refusal of some obstetricians to perform the procedure. To reduce the possibility of stigmatization of HIV-positive pregnant women, and fears related with HIV transmission, several workshops were conducted, leading to a considerable increase in the number of elective cesarean deliveries by the end of the 1st year of implementation.
Theoretically, neonatal prophylaxis has the potential to prevent the risk of maternal-infant HIV transmission if exposure occurs primarily at the time of delivery. Nevertheless, any labor regimen if shown to be efficacious in preventing vertical transmission will be more effective if women take the nevirapine at the onset of labor pains, and the child is given nevirapine within 72 hours of birth. It is important to note, however, that the lack of testing for CD4 and HIV viral load, in both mother and child, by the end of their 1st year of implementation, limited the analysis of these factors on HIV vertical transmission rates. Additional efforts to increase HIV testing for mothers with unknown HIV status at the time of delivery are recommended, along with the administration of nevirapine to both mother and child.
A major aspect of the PMTCT program includes the provision of alternative methods of breast-feeding. Even in the absence of replacement feeding to prevent postnatal HIV transmission through breast-feeding, 57% of the children received formula feeding in the 1st year. Nevertheless, lack of information in 43% of the children in postpartum feeding practices is of critical concern. Available data suggest that there is a 14% additional risk of postnatal transmission from breast-feeding for women with prevalent infections and a 29% risk for women with incident infection postpartum. 10 A high proportion (one third to one half) of perinatal HIV infections in African settings, due to breast-feeding, has been reported. 10–13 To decrease the probability of HIV postpartum infection, the MOH of the Dominican Republic needs to allocate funds to purchase infant formula for children born from HIV-positive mothers, as well as develop a system of formula delivery, according to the specific needs and concerns at the province level. We suggest that at the local level, infant formula be delivered at the pharmacy hospital. The formula needs for infants of HIV-positive women at the hospital will be minimal, because of the short length of maternity stays. The purchase and use of formula in medically indicated cases, such as maternal HIV infection, are permitted under both the International Code of Marketing of Breastmilk Substitutes and the Baby Friendly Hospital Initiative.
Upon hospital discharge, HIV-positive mothers will need to receive a prescription and coupon for an adequate quantity of infant formula to meet the nutritional requirements of their infant until the 1st scheduled well-baby visit. Rigorous steps should be taken to ensure the confidentiality of HIV-positive women both with respect to their own and their infant's treatment within the health system and also within the community. It is also recommended that the evaluation of replacement feeding and early weaning practices be conducted, to assess their impact on survival and disease in infants, especially diarrheal and respiratory disease as well as nutritional status, and on local breast-feeding norms, birth spacing, and maternal health.
The results of this 1-year evaluation demonstrate the feasibility of implementing a large-scale PMTCT program in a country that has begun important efforts for the prevention of MTCT of HIV. To move toward a nationwide implementation, relevant decisions of the MOH of the Dominican Republic will need to be based on the best available scientific data. Policies and practices need to be reviewed to ensure that pretest counseling requirements are not barriers to diagnosing HIV infection in women and preventing transmission to their children. Prenatal counseling and testing must be simplified as much as possible and offered routinely while remaining voluntary, confidential, and supportive of HIV and AIDS prevention in women and their partners. These efforts are essential to maintain and further decrease the reduction in HIV vertical transmission observed during the 1st year of this program.
The authors thank Anna Pilarte and Noaris Rodriguez for technical support. The authors also want to acknowledge the essential contribution of Antonio D' Moya (COPRESIDA), Ernesto Guerrero (UNAIDS), Ilsa Nina (UNICEF), and Maria Castillo (USAID) to the PMTCT program of the Dominican Republic and Marcos Espinal (WHO) for his research guidance.
Appendix: PMTCT GROUP
Felipa Garcia (Red Dominicana de Personas Viviendo con el VIH/SIDA-REDOVIH+), Dulce Almonte, (REDOVIH+), Jose Shower (Hospital Materno Infantil Nuestra Senora de Los Mina, Santo Domingo), Luis Rivera (Hospital Nuestra Senora de La Altagracia, Santo Domingo), Imma Mendoza (Grupo Clara, Puerto Plata), Deyanira Marmolejos (Hospital Jaime Mota, Barahona), Lovelys Nina (Hospital Central de Las Fuerzas Armadas, Santo Domingo), Benjamin Reyes (Hospital Ricardo Limardo, Puerto Plata), Josefina Coen (Comision Nacional de Lactancia Materna), Ramon Acosta Luciano (Hospital Alejandro Cabral de San Juan de La Maguana, Hospital Rosa Duarte de Elias Pina), Dionis Batista (Hospital Alejandro Cabral de San Juan de La Maguana y Hospital Rosa Duarte de Elias Pina), Ismael Alvarez (Hospital Nuestra Senora de Regla, Provincia Peravia).
1. UNAIDS. UNAIDS epidemic update. December 2000. Available at: http://www.unaids.org/wac/2000/wad00/files/WAD_epidemic_report.htm
. Accessed June 20, 2002.
2. Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. N Engl J Med. 1994; 331:1173–1180.
3. Cooper ER, Carurat M, Burns DN, et al. Trends in antiretroviral therapy and mother-infant transmission of HIV: the Women and Infants Transmission Study Group. J Acquir Immune Defic Syndr. 2000; 24:45–47.
4. De Cock KM, Fowler MG, Mercier E, et al. Prevention of mother-to-child HIV transmission in resource-poor countries: translating research into policy and practice. JAMA. 2000; 283:1175–1182.
5. Perez-Then E. Monitoreo de las Estrategias de Reducción de la Transmisión Vertical del VIH en Republica Dominicana. Mayo 2000–Julio 2001.
Santo Domingo: CENISMI; 2002. Serie de Publicaciones Tecnicas I.
6. CESDEM/PROFAMILIA. Encuesta Demográfica de Salud.
Santo Domingo, the Dominican Republic
: Demographic Health Survey, 1996. 1997.
7. Guay LA, Musoke P, Fleming T, et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet. 1999; 354:795–802.
8. Kanshana S, Simonds RJ. National Program for preventing mother-to-child HIV transmission in Thailand: successful implementation and lessons learned. AIDS. 2002; 16:953–959.
9. Musoke P, Guay LA, Bagenda D, et al. A phase I/II study of the safety and pharmacokinetics of nevirapine in HIV-I infected pregnant Ugandan women and their neonates (HIVNET 006). AIDS. 1999; 3:479–486.
10. Dunn DT, Newell ML, Ades AE, et al. Risk of human immunodeficiency virus type 1 transmission through breastfeeding. Lancet. 1992; 340:585–588.
11. Wiktor SZ, Ekpini E, Nduati RW. Prevention of mother-to-child transmission of HIV-1 in Africa. AIDS 1997; 11(suppl B):S79–S87.
12. Miotti PG, Taha TE, Kumwenda NL, et al. HIV transmission through breastfeeding: a study in Malawi. JAMA. 1999; 282:744–749.
13. Nduati R, John G, Mbori-Ngacha D, et al. Effect of breastfeeding and formula feeding on transmission of HIV-1: a randomized clinical trial. JAMA. 2000; 283:1167–1174.