Anita V. Shankar

Extended-dose nevirapine to 6 weeks of age for infants to prevent HIV transmission via breastfeeding in Ethiopia, India, and Uganda: an analysis of three randomised controlled trials.

BACKGROUND UNICEF/WHO recommends that infants born to HIV-infected mothers who do not have access to acceptable, feasible, affordable, sustainable, and safe replacement feeding should be exclusively breastfed for at least 6 months. The aim of three trials in Ethiopia, India, and Uganda was to assess whether daily nevirapine given to breastfed infants through 6 weeks of age can decrease HIV transmission via breastfeeding. METHODS HIV-infected women breastfeeding their infants were eligible for participation. Participants were randomly assigned to receive either single-dose nevirapine (nevirapine 200 mg to women in labour and nevirapine 2 mg/kg to newborns after birth) or 6 week extended-dose nevirapine (nevirapine 200 mg to women in labour and nevirapine 2 mg/kg to newborn babies after birth plus nevirapine 5 mg daily from days 8-42 for the infant). The randomisation sequences were generated by computer at a central data coordinating centre. The primary endpoint was HIV infection at 6 months of age in infants who were HIV PCR negative at birth. Analyses were by modified intention to treat, excluding infants with missing specimens and those with indeterminate or confirmed HIV infection at birth. These studies are registered with ClinicalTrials.gov, numbers NCT00074399, NCT00061321, and NCT00639938. FINDINGS 2024 liveborn infants randomised in the study had at least one specimen tested before 6 months of age (1047 infants in the single-dose group and 977 infants in the extended-dose group). The modified intention-to-treat population included 986 infants in the single-dose group and 901 in the extended-dose group. At 6 months, 87 children in the single-dose group and 62 in the extended-dose group were infected with HIV (relative risk 0.80, 95% CI 0.58-1.10; p=0.16). At 6 weeks of age, 54 children in the single-dose group and 25 in the extended-dose group were HIV positive (0.54, 0.34-0.85; p=0.009). 393 infants in the single-dose group and 346 in the extended-dose group experienced grade 3 or 4 serious adverse events during the study (p=0.54). INTERPRETATION Although a 6-week regimen of daily nevirapine might be associated with a reduction in the risk of HIV transmission at 6 weeks of age, the lack of a significant reduction in the primary endpoint-risk of HIV transmission at 6 months-suggests that a longer course of daily infant nevirapine to prevent HIV transmission via breast milk might be more effective where access to affordable and safe replacement feeding is not yet available and where the risks of replacement feeding are high. FUNDING US National Institutes of Health; US National Institute of Allergy and Infectious Diseases; Fogarty International Center.

Effect of maternal multiple micronutrient supplementation on fetal loss and infant death in Indonesia: a double-blind cluster-randomised trial.

Background Maternal nutrient supplementation in developing countries is generally restricted to provision of iron and folic acid (IFA). Change in practice toward supplementation with multiple micronutrients (MMN) has been hindered by little evidence of the eff ects of MMN on fetal loss and infant death. We assessed the eff ect of maternal supplementation with MMN, compared with IFA, on fetal loss and infant death in the setting of routine prenatal care services.BACKGROUND Maternal nutrient supplementation in developing countries is generally restricted to provision of iron and folic acid (IFA). Change in practice toward supplementation with multiple micronutrients (MMN) has been hindered by little evidence of the effects of MMN on fetal loss and infant death. We assessed the effect of maternal supplementation with MMN, compared with IFA, on fetal loss and infant death in the setting of routine prenatal care services. METHODS In a double-blind cluster-randomised trial in Lombok, Indonesia, we randomly assigned 262 midwives to distribute IFA (n=15 ,86) or MMN (n=15,804) supplements to 31 290 pregnant women through government prenatal care services that were strengthened by training and community-based advocacy. Women obtained supplements, to be taken daily, every month from enrolment to 90 days post partum. The primary outcome was early infant mortality (deaths until 90 days post partum). Secondary outcomes were neonatal mortality, fetal loss (abortions and stillbirths), and low birthweight. Analysis was by intention to treat. The study is registered as an International Standard Randomised Controlled Trial, number ISRCTN34151616. FINDINGS Infants of women consuming MMN supplements had an 18% reduction in early infant mortality compared with those of women given IFA (35.5 deaths per 1000 livebirths vs 43 per 1000; relative risk [RR] 0.82, 95% CI 0.70-0.95, p=0.010). Infants whose mothers were undernourished (mid upper arm circumference <23.5 cm) or anaemic (haemoglobin <110 g/L) at enrolment had a reduction in early infant mortality of 25% (RR 0.75, 0.62-0.90, p=0.0021) and 38% (RR 0.62, 0.49-0.78, p<0.0001), respectively. Combined fetal loss and neonatal deaths were reduced by 11% (RR 0.89, 0.81-1.00, p=0.045), with significant effects in undernourished (RR 0.85, 0.73-0.98, p=0.022) or anaemic (RR 0.71, 0.58-0.87, p=0.0010) women. A cohort of 11 101 infants weighed within 1 h of birth showed a 14% (RR 0.86, 0.73-1.01, p=0.060) decreased risk of low birthweight for those in the MMN group, with a 33% (RR 0.67, 0.51-0.89, p=0.0062) decrease for infants of women anaemic at enrolment. INTERPRETATION Maternal MMN supplementation, as compared with IFA, can reduce early infant mortality, especially in undernourished and anaemic women. Maternal MMN supplementation might therefore be an important part of overall strengthening of prenatal-care programmes.

Reproductive Decision Making and the HIV/AIDS Epidemic in Zimbabwe

The fertility-stimulating effect of high rates of child mortality on reproductive decision making (RDM) is a central tenet of population studies, yet the effects of the HIV/AIDS epidemic on RDM have not been thoroughly explored in the literature. This paper investigates how RDM is articulated in the context of high HIV/AIDS prevalence in Zimbabwe. Using qualitative methods (35 focus groups and 46 in-depth interviews), we found that childbearing is extremely important in the lives of adult Zimbabweans and that children are needed to cement the couples relationship, whether it is the first or subsequent marriage. Most respondents said that rates of both adult and child mortality were greatly increasing due to the AIDS epidemic. However, contrary to expectations based upon the insurance strategy, most respondents said that they would have fewer children as a result of the perceived increase in child mortality. They were also hesitant to continue childbearing after a child death, indicating only weak replacement motivation. Instead, many respondents expressed the desire to limit family size due to concerns about their own mortality and its negative effects on their children. Furthermore, new reproductive strategies seem to be emerging, which focus upon the health of parents and child and are based upon perceptions of 100 per cent maternal-infant HIV transmission. Adult HIV status is linked to child survival as respondents explained that having a healthy child who survives to age five indicates that the parents are also free of the virus and, at this point, they can safely continue childbearing. Additionally, couples who have experienced the death of a child are hesitant to give birth again because they believe future children would die. Finally, there was some talk of having children early in an attempt to avoid contracting HIV. This study presents evidence that Zimbabweans are altering their reproductive strategies in order to protect both parents and children from the threat of AIDS.

Sensitivity and specificity of rapid HIV testing of pregnant women in India

OBJECTIVE Efforts to prevent HIV transmission from mother to infants in settings like India may benefit from the availability of reliable methods for rapid and simple HIV screening. Data from India on the reliability of rapid HIV test kits are limited and there are no data on the use of rapid HIV tests for screening of pregnant women. METHODS Pregnant women attending an antenatal clinic and delivery room in Pune agreed to participate in an evaluation of five rapid HIV tests, including (a) a saliva brush test (Oraquick HIV-1/2, Orasure Technologies Inc.), (b) a rapid plasma test (Oraquick HIV-1/2) and (c) three rapid finger prick tests (Oraquick HIV-1/2; HIV-1/2 Determine, Abbott; NEVA HIV-1/2 Cadila). Results of the rapid tests were compared with three commercial plasma enzyme immunoassay (EIA) tests (Innotest HIV AB EIA, Lab systems/ELISCAN HIV AB EIA, UBI HIV Ab EIA). RESULTS Between September 2000 and October 1, 2001, 1258 pregnant women were screened for HIV using these rapid tests. Forty-four (3.49%) of the specimens were HIV-antibody-positive by at least two plasma EIA tests. All of the rapid HIV tests demonstrated excellent specificity (96-100%). The sensitivity of the rapid tests ranged from 75-94%. The combined sensitivity and specificity of a two-step algorithm for rapid HIV testing was excellent for a number of combinations of the five rapid finger stick tests. CONCLUSION In this relatively low HIV prevalence population of pregnant women in India, the sensitivity of the rapid HIV tests varied, when compared to a dual EIA algorithm. In general, the specificity of all the rapid tests was excellent, with very few false positive HIV tests. Based upon these data, two different rapid HIV tests for screening pregnant women in India would be highly sensitive, with excellent specificity to reliably prevent inappropriate use of antiretroviral therapy for prevention of vertical HIV transmission.

Awareness of HIV/AIDS and household environment of pregnant women in Pune, India

Our objective was to determine the level of HIV/AIDS knowledge of pregnant women in India. In a sub-sample of these women, we documented the extent to which they experienced adverse social and physical difficulties within their home. The study was performed at an urban antenatal hospital clinic in Maharastra, India. From April to September 2001, structured interviews were conducted on 707 randomly selected antenatal clinic patients related to HIV/AIDS knowledge. Of these, 283 were further interviewed to document any social or physical difficulties they experienced. Over 75% of women displayed knowledge of primary transmission routes. Nearly 70% of women demonstrated knowledge of maternal to child transmission, however, only 8% knew of any methods of prevention. TV and written material were more strongly related to knowledge than access to radio messages or conversations with individuals. Thirty per cent of the women experienced physical or mental abuse or their spouses alcohol and/or drug problems. Women reporting such abuse were more than twice as likely to have adequate HIV/AIDS knowledge compared with women reporting no such abuse. We found no relationship between reported household abuse and educational level of woman, husband, occupation of either partner, language or religion. We found no relationship between HIV status and knowledge of HIV and no relationship between HIV status and risk of abuse in the household. However, the total number of HIV patients in our sample was very small.

Determinants of low birthweight, small‐for‐gestational‐age and preterm birth in Lombok, Indonesia: analyses of the birthweight cohort of the SUMMIT trial

Objective  To examine the determinants of low birthweight (LBW), small‐for‐gestation (SGA) and preterm births in Lombok, Indonesia, an area of high infant mortality.

Women's acceptability and husband's support of rapid HIV testing of pregnant women in India

This study examined acceptability among pregnant women and their husbands for HIV testing within the antenatal clinic (ANC) and delivery room (DR) of a government hospital in Pune, India from September 2000 to November 2001. Acceptance of HIV counselling and testing was high with 83% of eligible women in the antenatal clinic (851 of 1025) and 68% of eligible women in the delivery room (417 of 613) getting tested on the same day. Structured interviews were conducted on 94 pregnant women in the ANC 50 women in the DR, and 100 husbands who accompanied their wives in the ANC. These data indicated that the majority of women agreed to be tested independently without the need for further consultation with family members, a view that was strongly supported in this sub-sample of accompanying husbands. For delivering women who were not progressing in their labour, counselling in the DR allowed for individual attention to questions and concerns thereby making counselling in the DR feasible.

Infant feeding practices reflect antecedent risk of xerophthalmia in Nepali children.

Objective: To determine the relationship between infant feeding history and risk of xerophthalmia due to vitamin A deficiency (VAD) in early childhood. Design: A case-control study of previously xerophthalmic and non-xerophthalmic children. Setting: Rural lowland region of Nepal. Subjects: One hundred and fifty-six children (aged 1–6 y old), half of whom previously had xerophthalmia due to vitamin A-deficiency, the other half matched by locale, age and the presence and age of a younger sibling (n=102). Methods: Xerophthalmia was determined by trained ophthalmic assistants on the basis of current Bitot’s spots, corneal xerosis or report of night blindness. Infant feeding history was collected through a diet history method obtained from the mother of the focus child. Exploratory factor analysis was conducted to determine the presence of underlying patterns in infant feeding practices. Conditional logistic regression was used to estimate odds ratios. Results: Mothers of control children tended to have a higher level of education (P<0.10) and to have fewer children who had died (P<0.10) than mothers of case children. Feeding of meat (OR=0.09, CI=0.01–0.70) or fish (OR=0.41, CI=0.17–0.99) with liver, eggs (OR=0.11, CI=0.01–0.88) and mango (OR=0.28, CI=0.13–0.60) were protective in association with xerophthalmia in early childhood. Factor analysis uncovered several distinct patterns in infant feeding, which varied by age of the infant. Only the ‘animal flesh’ feeding pattern (factor), practiced in the second year of life, proved significantly protective from xerophthalmia (OR=0.43, CI=0.20–0.94). Feeding patterns of younger children closely paralleled those of their older siblings with and without VAD. Conclusions: The study supports the hypothesis that infant dietary practices can influence subsequent risk for VAD. Our findings emphasize the importance of introducing vitamin A-rich foods during weaning to reduce the risk of VAD-associated xerophthalmia in the later preschool years. Sponsorship: The project is funded through Cooperative Agreement No. DAN 0045-A-00-5094-00 between the Center for Human Nutrition/Dana Center for Preventive Ophthalmology, The Johns Hopkins University and The Office of Health and Nutrition, US Agency for International Development, with additional support from Task Force Sight and Life (Roche, Basel), and NIH shared instrument grant No. S10-RR 04060.

Maximizing the benefits of improved cookstoves: moving from acquisition to correct and consistent use.

The adoption of clean cooking technologies goes beyond mere product acquisition and requires attention to issues of cooking traditions, user engagement, gender dynamics, culture, and religion to effect correct and consistent use. The adoption of clean cooking technologies goes beyond mere product acquisition and requires attention to issues of cooking traditions, user engagement, gender dynamics, culture, and religion to effect correct and consistent use.

Child feeding and care behaviors are associated with xerophthalmia in rural Nepalese households

The study examined caregiver-child interactions, intrahousehold food allocation and general child care behaviors and their effect on childrens xerophthalmia status in the rural Terai region of Nepal. Seventy-eight households with a child having a history of xerophthalmia (cases) were matched with 78 households with a child of the same age having no history of xerophthalmia (controls). Seven day-long continuous monitoring observations were performed in each household (over 15 months) by trained Nepali observers, focusing on feeding and care of a focus child and his/her younger sibling. Nineteen different behavioral variables were operationalized, including serving method, second helpings, serving refusals, encouragement to eat, request intensity, meal serving order, food channeling, food sharing, positive social behaviors, negative social behaviors, and positive health behaviors. Automatic serving and request intensity were strongly negatively correlated, especially among younger siblings. Children who serve themselves receive less encouragement to eat. Those children who are refused in their requests for food tend to ask for food more frequently, for a longer time, and be less likely to self-serve. Children who eat from a shared plate are less likely to interact with a food server and more likely to self-serve. Negative social behavior towards children is associated with the child having to request food more frequently and a greater likelihood of being refused food. Children who receive positive health care from their caregivers are also more frequently asked if they would like food by the server and are encouraged to eat. Several caregiver child feeding behaviors were related to a childs risk of having past vitamin A deficiency. Controls were much more likely to be served food automatically. Cases were more likely to serve themselves food and have multiple servings of food. Cases were nearly two times more likely than controls to be treated with neglect or harshly, and much less likely than controls to have their health needs receive attention. Examining intrahousehold behavior is critical for understanding the causes of vitamin A deficiency in rural Nepalese children, and has great potential for identifying and improving interventions to improve childrens diets and care.