Cost estimation alongside a multi-regional, multi-country randomized trial of antenatal ultrasound in five low-and-middle-income countries.

BACKGROUND: Improving maternal health has been a primary goal of international health agencies for many years, with the aim of reducing maternal and child deaths and improving access to antenatal care (ANC) services, particularly in low-and-middle-income countries (LMICs). Health interventions with these aims have received more attention from a clinical effectiveness perspective than for cost impact and economic efficiency. METHODS: We collected data on resource use and costs as part of a large, multi-country study assessing the use of routine antenatal screening ultrasound (US) with the aim of considering the implications for economic efficiency. We assessed typical antenatal outpatient and hospital-based (facility) care for pregnant women, in general, with selective complication-related data collection in women participating in a large maternal health registry and clinical trial in five LMICs. We estimated average costs from a facility/health system perspective for outpatient and inpatient services. We converted all country-level currency cost estimates to 2015 United States dollars (USD). We compared average costs across countries for ANC visits, deliveries, higher-risk pregnancies, and complications, and conducted sensitivity analyses. RESULTS: Our study included sites in five countries representing different regions. Overall, the relative cost of individual ANC and delivery-related healthcare use was consistent among countries, generally corresponding to country-specific income levels. ANC outpatient visit cost estimates per patient among countries ranged from 15 to 30 USD, based on average counts for visits with and without US. Estimates for antenatal screening US visits were more costly than non-US visits. Costs associated with higher-risk pregnancies were influenced by rates of hospital delivery by cesarean section (mean per person delivery cost estimate range: 25-65 USD). CONCLUSIONS: Despite substantial differences among countries in infrastructures and health system capacity, there were similarities in resource allocation, delivery location, and country-level challenges. Overall, there was no clear suggestion that adding antenatal screening US would result in either major cost savings or major cost increases. However, antenatal screening US would have higher training and maintenance costs. Given the lack of clinical effectiveness evidence and greater resource constraints of LMICs, it is unlikely that introducing antenatal screening US would be economically efficient in these settings--on the demand side (i.e., patients) or supply side (i.e., healthcare providers). TRIAL REGISTRATION: Trial number: NCT01990625 (First posted: November 21, 2013 on https://clinicaltrials.gov ).

Association of haemoglobin levels in the first trimester and at 26-30 weeks with fetal and neonatal outcomes: a secondary analysis of the Global Network for Women's and Children's Health's ASPIRIN Trial.

OBJECTIVE: Limited data are available from low- and middle-income countries (LMICs) on the relationship of haemoglobin levels to adverse outcomes at different times during pregnancy. We evaluated the association of haemoglobin levels in nulliparous women at two times in pregnancy with pregnancy outcomes. DESIGN: ASPIRIN Trial data were used to study the association between haemoglobin levels measured at 6+0 -13+6  weeks and 26+0 -30+0  weeks of gestation with fetal and neonatal outcomes. SETTING: Obstetric care facilities in Pakistan, India, Kenya, Zambia, The Democratic Republic of the Congo and Guatemala. POPULATION: A total of 11 976 pregnant women. METHODS: Generalised linear models were used to obtain adjusted relative risks and 95% CI for adverse outcomes. MAIN OUTCOME MEASURES: Preterm birth, stillbirth, neonatal death, small for gestational age (SGA) and birthweight <2500 g. RESULTS: The mean haemoglobin levels at 6+0 -13+6  weeks and at 26-30 weeks of gestation were 116 g/l (SD 17) and 107 g/l (SD 15), respectively. In general, pregnancy outcomes were better with increasing haemoglobin. At 6+0 -13+6  weeks of gestation, stillbirth, SGA and birthweight <2500 g, were significantly associated with haemoglobin of 70-89 g/l compared with haemoglobin of 110-129 g/l The relationships of adverse pregnancy outcomes with various haemoglobin levels were more marked at 26-30 weeks of gestation. CONCLUSIONS: Both lower and some higher haemoglobin concentrations are associated with adverse fetal and neonatal outcomes at 6+0 -13+6  weeks and at 26-30 weeks of gestation, although the relationship with low haemoglobin levels appears more consistent and generally stronger. TWEETABLE ABSTRACT: Both lower and some higher haemoglobin concentrations were associated with adverse fetal and neonatal outcomes at 6-13 weeks and 26-30 weeks of gestation.

Routine antenatal ultrasound in low- and middle-income countries: first look - a cluster randomised trial.

OBJECTIVE: Ultrasound is widely regarded as an important adjunct to antenatal care (ANC) to guide practice and reduce perinatal mortality. We assessed the impact of ANC ultrasound use at health centres in resource-limited countries. DESIGN: Cluster randomised trial. SETTING: Clusters within five countries (Democratic Republic of Congo, Guatemala, Kenya, Pakistan, and Zambia) METHODS: Clusters were randomised to standard ANC or standard care plus two ultrasounds and referral for complications. The study trained providers in intervention clusters to perform basic obstetric ultrasounds. MAIN OUTCOME MEASURES: The primary outcome was a composite of maternal mortality, maternal near-miss mortality, stillbirth, and neonatal mortality. RESULTS: During the 24-month trial, 28 intervention and 28 control clusters had 24 263 and 23 160 births, respectively; 78% in the intervention clusters received at least one study ultrasound; 60% received two. The prevalence of conditions noted including twins, placenta previa, and abnormal lie was within expected ranges. 9% were referred for an ultrasound-diagnosed condition, and 71% attended the referral. The ANC (RR 1.0 95% CI 1.00, 1.01) and hospital delivery rates for complicated pregnancies (RR 1.03 95% CI 0.89, 1.20) did not differ between intervention and control clusters nor did the composite outcome (RR 1.09 95% CI 0.97, 1.23) or its individual components. CONCLUSIONS: Despite availability of ultrasound at ANC in the intervention clusters, neither ANC nor hospital delivery for complicated pregnancies increased. The composite outcome and the individual components were not reduced. TWEETABLE ABSTRACT: Antenatal care ultrasound did not improve a composite outcome that included maternal, fetal, and neonatal mortality.

A prospective cause of death classification system for maternal deaths in low and middle-income countries: results from the Global Network Maternal Newborn Health Registry.

OBJECTIVE: To describe the causes of maternal death in a population-based cohort in six low- and middle-income countries using a standardised, hierarchical, algorithmic cause of death (COD) methodology. DESIGN: A population-based, prospective observational study. SETTING: Seven sites in six low- to middle-income countries including the Democratic Republic of the Congo (DRC), Guatemala, India (two sites), Kenya, Pakistan and Zambia. POPULATION: All deaths among pregnant women resident in the study sites from 2014 to December 2016. METHODS: For women who died, we used a standardised questionnaire to collect clinical data regarding maternal conditions present during pregnancy and delivery. These data were analysed using a computer-based algorithm to assign cause of maternal death based on the International Classification of Disease-Maternal Mortality system (trauma, termination of pregnancy-related, eclampsia, haemorrhage, pregnancy-related infection and medical conditions). We also compared the COD results to healthcare-provider-assigned maternal COD. MAIN OUTCOME MEASURES: Assigned causes of maternal mortality. RESULTS: Among 158 205 women, there were 221 maternal deaths. The most common algorithm-assigned maternal COD were obstetric haemorrhage (38.6%), pregnancy-related infection (26.4%) and pre-eclampsia/eclampsia (18.2%). Agreement between algorithm-assigned COD and COD assigned by healthcare providers ranged from 75% for haemorrhage to 25% for medical causes coincident to pregnancy. CONCLUSIONS: The major maternal COD in the Global Network sites were haemorrhage, pregnancy-related infection and pre-eclampsia/eclampsia. This system could allow public health programmes in low- and middle-income countries to generate transparent and comparable data for maternal COD across time or regions. TWEETABLE ABSTRACT: An algorithmic system for determining maternal cause of death in low-resource settings is described.

Global Network for Women's and Children's Health Research: probable causes of stillbirth in low- and middle-income countries using a prospectively defined classification system.

OBJECTIVE: We sought to classify causes of stillbirth for six low-middle-income countries using a prospectively defined algorithm. DESIGN: Prospective, observational study. SETTING: Communities in India, Pakistan, Guatemala, Democratic Republic of Congo, Zambia and Kenya. POPULATION: Pregnant women residing in defined study regions. METHODS: Basic data regarding conditions present during pregnancy and delivery were collected. Using these data, a computer-based hierarchal algorithm assigned cause of stillbirth. Causes included birth trauma, congenital anomaly, infection, asphyxia, and preterm birth, based on existing cause of death classifications and included contributing maternal conditions. MAIN OUTCOME MEASURES: Primary cause of stillbirth. RESULTS: Of 109 911 women who were enrolled and delivered (99% of those screened in pregnancy), 2847 had a stillbirth (a rate of 27.2 per 1000 births). Asphyxia was the cause of 46.6% of the stillbirths, followed by infection (20.8%), congenital anomalies (8.4%) and prematurity (6.6%). Among those caused by asphyxia, 38% had prolonged or obstructed labour, 19% antepartum haemorrhage and 18% pre-eclampsia/eclampsia. About two-thirds (67.4%) of the stillbirths did not have signs of maceration. CONCLUSIONS: Our algorithm determined cause of stillbirth from basic data obtained from lay-health providers. The major cause of stillbirth was fetal asphyxia associated with prolonged or obstructed labour, pre-eclampsia and antepartum haemorrhage. In the African sites, infection also was an important contributor to stillbirth. Using this algorithm, we documented cause of stillbirth and its trends to inform public health programs, using consistency, transparency, and comparability across time or regions with minimal burden on the healthcare system. TWEETABLE ABSTRACT: Major causes of stillbirth are asphyxia, pre-eclampsia and haemorrhage. Infections are important in Africa.

Birth attendants as perinatal verbal autopsy respondents in low- and middle-income countries: a viable alternative?

OBJECTIVE: To assess the feasibility of using birth attendants instead of bereaved mothers as perinatal verbal autopsy respondents. METHODS: Verbal autopsy interviews for early neonatal deaths and stillbirths were conducted separately among mothers (reference standard) and birth attendants in 38 communities in four developing countries. Concordance between maternal and attendant responses was calculated for all questions, for categories of questions and for individual questions. The sensitivity and specificity of individual questions with the birth attendant as respondent were assessed. FINDINGS: For early neonatal deaths, concordance across all questions was 94%. Concordance was at least 95% for more than half the questions on maternal medical history, birth attendance and neonate characteristics. Concordance on any given question was never less than 80%. Sensitivity and specificity varied across individual questions, more than 80% of which had a sensitivity of at least 80% and a specificity of at least 90%. For stillbirths, concordance across all questions was 93%. Concordance was 95% or greater more than half the time for questions on birth attendance, site of delivery and stillborn characteristics. Sensitivity and specificity varied across individual questions. Over 60% of the questions had a sensitivity of at least 80% and over 80% of them had a specificity of at least 90%. Overall, the causes of death established through verbal autopsy were similar, regardless of respondent. CONCLUSION: Birth attendants can substitute for bereaved mothers as verbal autopsy respondents. The questions in existing harmonized verbal autopsy questionnaires need further refinement, as their sensitivity and specificity differ widely.

Causes of community stillbirths and early neonatal deaths in low-income countries using verbal autopsy: an International, Multicenter Study.

OBJECTIVE: Six million stillbirths (SB) and early neonatal deaths (END) occur annually worldwide, mostly in rural settings distant from health facilities. We used verbal autopsy (VA), to understand causes of non-hospital, community-based SB and END from four low-income countries. STUDY DESIGN: This prospective observational study utilized the train-the-trainer method. VA interviewers conducted standardized interviews; in each country data were reviewed by two local physicians who assigned an underlying causes of deaths (COD). RESULT: There were 252 perinatal deaths (118 END; 134 SB) studied from pooled data. Almost half (45%) the END occurred on postnatal day 1, 19% on the second day and 16% the third day. Major early neonatal COD were infections (49%), birth asphyxia (26%), prematurity (17%) and congenital malformations (3%). Major causes of SB were infection (37%), prolonged labor (11%), antepartum hemorrhage (10%), preterm delivery (7%), cord complications (6%) and accidents (5%). CONCLUSION: Many of these SB and END were from easily preventable causes. Over 80% of END occurred during the first 3 days of postnatal life, and >90% were due to infection, birth asphyxia and prematurity. The causes of SB were more varied, and maternal infections were the most common cause. Increased attention should be targeting at interventions that reduce maternal and neonatal infections and prevent END, particularly during the first 3 days of life.

An alternative strategy for perinatal verbal autopsy coding: single versus multiple coders.

OBJECTIVE: To determine the comparability between cause of death (COD) by a single physician coder and a two-physician panel, using verbal autopsy. METHODS: The study was conducted between May 2007 and June 2008. Within a week of a perinatal death in 38 rural remote communities in Guatemala, the Democratic Republic of Congo, Zambia and Pakistan, VA questionnaires were completed. Two independent physicians, unaware of the others decisions, assigned an underlying COD, in accordance with the causes listed in the chapter headings of the International classification diseases and related health problems, 10th revision (ICD-10). Cohen's kappa statistic was used to assess level of agreement between physician coders. RESULTS: There were 9461 births during the study period; 252 deaths met study enrolment criteria and underwent verbal autopsy. Physicians assigned the same COD for 75% of stillbirths (SB) (K = 0.69; 95% confidence interval: 0.61-0.78) and 82% early neonatal deaths (END) (K = 0.75; 95% confidence interval: 0.65-0.84). The patterns and proportion of SBs and ENDs determined by the physician coders were very similar compared to causes individually assigned by each physician. Similarly, rank order of the top five causes of SB and END was identical for each physician. CONCLUSION: This study raises important questions about the utility of a system of multiple coders that is currently widely accepted and speculates that a single physician coder may be an effective and economical alternative to VA programmes that use traditional two-physician panels to assign COD.

Using verbal autopsy to ascertain perinatal cause of death: are trained non-physicians adequate?

OBJECTIVES: To develop a standardized verbal autopsy (VA) training program and evaluate whether its implementation resulted in comparable knowledge required to classify perinatal cause of death (COD) by physicians and non-physicians. METHODS: Training materials, case studies, and written and mock scenarios for this VA program were developed using conventional VA and ICD-10 guidelines. This program was used to instruct physicians and non-physicians in VA methodology using a train-the-trainer model. Written tests of cognitive and applied knowledge required to classify perinatal COD were administered before and after training to evaluate the effect of the VA training program. RESULTS: Fifty-three physicians and non-physicians (nurse-midwives/nurses and Community Health Workers [CHW]) from Pakistan, Zambia, the Democratic Republic of Congo, and Guatemala were trained. Cognitive and applied knowledge mean scores among all trainees improved significantly (12.8 and 28.8% respectively, P < 0.001). Cognitive and applied knowledge post-training test scores of nurse-midwives/nurses were comparable to those of physicians. CHW (high-school graduates with 15 months or less formal health/nursing training) had the largest improvements in post-training applied knowledge with scores comparable to those of physicians and nurse-midwives/nurses. However, CHW cognitive knowledge post-training scores were significantly lower than those of physicians and nurses. CONCLUSIONS: With appropriate training in VA, cognitive and applied knowledge required to determine perinatal COD is similar for physicians and nurses-midwives/nurses. This suggests that midwives and nurses may play a useful role in determining COD at the community level, which may be a practical way to improve the accuracy of COD data in rural, remote, geographic areas.

Birth asphyxia survivors in a developing country.

OBJECTIVE: Determine the baseline incidence of birth asphyxia in neonatal intensive care unit (NICU) survivors in a developing country and the early neurodevelopmental outcomes of such infants. STUDY DESIGN: This cross-sectional, prospective study collected diagnostic and examination findings on all infants seen in the University of Zambia NICU follow-up clinic over a 4-week period. RESULT: Of the 182 infants, 42 (23%) had a clinical diagnosis of birth asphyxia. Of 42 infants with birth asphyxia, 13 (31%) had an abnormal neurologic examination during the clinic visit; in contrast, 13 of 141 infants without birth asphyxia (9%) had an abnormal examination (odds ratio 4.4, 95% confidence interval: 1.8, 10.4). CONCLUSION: Birth asphyxia survivors account for almost a quarter of NICU survivors in a developing country and half of those with an abnormal neurologic examination. Studies are necessary to determine the percent of birth asphyxia survivors who have permanent motor and cognitive disabilities.

The impact of project closure on HIV incidence and mortality in a cohort of couples in Lusaka, Zambia.

The objective of this study was to assess the impact of temporary closure of an HIV research clinic on the health of study participants. Primary data were collected quarterly from couples enrolled in research studies at an established HIV study site. There were 632 participating couples enrolled when the project closed, 475 of whom returned when it re-opened six months later. HIV sero-incidence, mortality rates and risk-taking behaviours were compared before and during the closure. Perceived impact of the closure was measured in returning participants. Demographic data collected at the last pre-closure study visit were used to look at the differences between returning and non-returning study participants. Serologic data from those who returned were compared pre- and post-closure to examine changes in HIV incidence. Mortality rates were estimated from reported deaths, and were compared pre- and during project closure. Perceptions of the impact of the closure among returning participants were examined through an interviewer administered questionnaire. It was found that couples who returned were not demographically different from couples who did not return. Most participants reported no problems with finding alternate sources of condoms and the incidence of HIV did not change significantly during the closure. Eighty-four percent respondents reported that the closure had a negative impact on them, 87% of whom rated loss of medical care as the main impact. The mortality rate among HIV-positive participants doubled from 6.7/100 person years to 12.4/100 person years during the closure (p=0.01). Results indicate that couples voluntary counselling and testing (CVCT) established durable risk-reduction behaviours that persisted during project closure. ThIn ae loss of healthcare was perceived as the most negative impact on participants, reflected in increased mortality rates. Research projects should make transition plans and budget for mechanisms to reduce the negative impact on participants of project closures.

The demographic profile of sero-discordant couples enrolled in clinical research in Rwanda and Zambia.

This paper examines the demographic profile of two cohorts of sero-discordant couples enrolled in research activities at two clinical research sites in Kigali, Rwanda and Lusaka, Zambia and compares their background characteristics by country, gender and sero-status. Differences between the two cohorts represent economic and cultural differences between the two countries. Recruitment procedures appear to be successful in reaching the intended audience - couples from poor urban communities - and we suggest that similar recruitment strategies could be adopted to reach other population groups in other settings. The profiles of sero-discordant couples highlight several potential intervention points, and call for attention to be focused towards prevention efforts aimed at young women and their male partners.

The influence of motivational messages on future planning behaviors among HIV concordant positive and discordant couples in Lusaka, Zambia.

In Zambia the HIV/AIDS epidemic has resulted in many single female-headed households. Strong patriarchal laws and customs prevent widows and children from maintaining economic assets. This study examines the impact of a video-based motivational intervention promoting future planning in 1,504 HIV-infected couples in Lusaka, Zambia. Following a group video session, couples randomized to the motivational arm could choose to write a will, identify a guardian for their children and make financial plans. Desirable behaviours modelled in the motivational video were measured at quarterly intervals for a year and compared in intervention and control arms. Demographic measures including age, income and educational status were not associated with planning behaviours. Participation in the intervention was associated with will writing (23% versus 5%) and naming a guardian (32% versus 17%) but not with other planning behaviours. The study demonstrates the ability of motivational messages integrated into HIV VCT to encourage future planning behaviour and points to the need to expand existing HIV and VCT services to meet other non-health needs of those living with HIV.

Evaluation of the educational impact of the WHO Essential Newborn Care course in Zambia.

OBJECTIVES: To evaluate the effectiveness of the World Health Organization (WHO) Essential Newborn Care (ENC) course in improving knowledge and skills of nurse midwives in low-risk delivery clinics in a developing country. METHODS: The investigators identified the content specifications of the training material, developed both written and performance evaluations and administered the evaluations both before and after training clinical nurse midwives in Zambia. FINDINGS: Based on these evaluations, both the knowledge and skills of the nurse midwives improved significantly following the course (from a mean of 65% correct pretraining to 84% correct post-training and from 65% to 77% correct on the performance and written evaluations, respectively). The ENC course written evaluation was validated and both tools allowed evaluation of the ENC course training. CONCLUSIONS: We found significant improvements in trainees' knowledge and skills in essential newborn care following the WHO ENC course; however, lack of basic resources may have limited the application of the ENC guidelines. Implementation of the ENC course should be undertaken in consideration with the local conditions available for newborn care.

Property grabbing and will writing in Lusaka, Zambia: an examination of wills of HIV-infected cohabiting couples.

High rates of HIV and poverty place women in a precarious economic situation in Lusaka, Zambia. Mortality from HIV infection is high, leaving many households single headed and creating almost a half a million orphans. One of the most prevalent forms of gender violence that creates poverty in women is when the male's family claims the property of the deceased from the widow and the children. The Zambia-Emory HIV Research Project collected 184 wills from individuals in monogamous unions where one or both of the individuals were HIV-positive. Despite the fact that many wills specifically stated that their extended family was not allowed to tamper with their possessions in the event of death, property grabbing proved to be a prevalent and difficult issue in Lusaka. In order to improve the lives of widowed women in Lusaka, the government and other civic and non-governmental organisations must inform women of their rights to own and protect their land and other assets in the event of their husbands' death, an issue of increasing importance in the area of HIV/AIDS.

Knowledge, attitudes, behaviors, and practices regarding epilepsy among Zambian clerics.

BACKGROUND: Epilepsy carries a high burden of social morbidity. An understanding of who propagates stigma and the determinants of stigmatizing attitudes is needed to develop effective interventions. Clerics represent an especially influential social group in Africa. Therefore, we conducted a survey of the knowledge, attitudes, behavior, and practices of Zambian clerics with respect to epilepsy. METHODS: We studied clerics in one large rural region as well as in the capital city. The rural survey was conducted door-to-door. In the urban areas, central administration for multiple denominations assisted in survey delivery. The survey, adapted from previously published instruments, included cleric-specific questions and demographic data. Composite scores for knowledge and tolerance were developed. Determinants of higher knowledge and tolerance were assessed. RESULTS: Almost all Zambian clerics know someone with epilepsy and have witnessed a seizure. More than 40% report having a family member with epilepsy. Unfortunately, this familiarity is not associated with more knowledge or tolerance for the condition. Younger clerics, urban dwellers, those with fewer children, and those with more years of formal education were significantly more tolerant. More knowledgeable clerics are more likely to recommend that a person with epilepsy seek care from a physician rather than a traditional healer. Formal education was the most important factor in determining tolerance toward epilepsy. CONCLUSIONS: Zambian clerics are very familiar with epilepsy, yet have relatively little knowledge of the etiology. Many view traditional healers as the appropriate care provider for epilepsy. To decrease stigma and improve the quality of advice offered by clerics to their congregations, educational programs focusing on the biomedical nature of the disorder are needed, particularly in rural regions.

HIV-1 and immunological changes during pregnancy: a comparison between HIV-1-seropositive and HIV-1-seronegative women in Nairobi, Kenya.

OBJECTIVE: To assess changes in the proportion of CD4 and CD8 T-lymphocyte profiles during pregnancy, at delivery and postpartum, and to determine whether HIV-1 infection affects the normal profile. DESIGN AND METHODS: A total of 416 pregnant HIV-1-infected women and an age and parity-matched HIV-seronegative group of 407 pregnant women were enrolled into a prospective study on the impact of HIV-1 infection on pregnancy. Maternal blood was obtained for lymphocyte subset determination at enrollment, delivery and 6 weeks postpartum. Whole blood sample drawn in EDTA-containing tubes were used to determine T-helper/inducer (CD4) and T-suppressor/cytotoxic (CD8) cells by direct immunofluorescence using monoclonal antibodies. RESULTS: No relationship was found between gestational age and any immunological variable. The CD4 percentage was lower postpartum than antenatally, in both HIV-1-seropositive and seronegative women, but this was not true for absolute CD4 counts. CD8 absolute counts and percentages were significantly higher postpartum than antenatally. The differences between HIV-1-seropositive and seronegative women in changes over pregnancy in CD4 and CD8 cells and their ratio, were not statistically significant. CONCLUSION: Our findings do not support a short-term synergistic effect of HIV-1 and pregnancy on the immune function as determined by T-lymphocyte subsets.

PIP: The impact of HIV-1 on pregnancy was investigated in a prospective case-control study of 416 pregnant HIV-infected women and 407 age- and parity-matched pregnant HIV-seronegative women from Nairobi, Kenya. No relationship existed between gestational age (14-30 weeks) and any hematologic or immunologic variable studied. In both cases and controls, the CD4 percentage (but not absolute count) was lower postpartum than during pregnancy, while CD8 absolute counts and percentages were significantly higher in the postpartum period. The differences between HIV-positive and HIV-negative women in changes during pregnancy in CD4 and CD8 cells and their ratio were not statistically significant. These findings fail to provide support for a synergistic effect of HIV-1 and pregnancy on immune function. Further studies are needed, however, to assess the long-term effects of pregnancy in HIV-infected women, to determine the impact of pregnancy at different stages of HIV disease, and to establish normal and HIV-1-related T-lymphocyte subset profiles during the entire course of pregnancy in African women.

Detection of human immunodeficiency virus type 1 (HIV-1) in heel prick blood on filter paper from children born to HIV-1-seropositive mothers.

The human immunodeficiency virus type 1 (HIV-1) DNA PCR results of 94 dried blood spot (DBS) samples on filter paper and corresponding venous blood in EDTA obtained from infants born to HIV-1-seropositive mothers were compared. In addition, the results of HIV-1 DNA PCR on DBS and the HIV-1 RNA PCR from plasma of 70 paired samples were compared. A 100% specificity and a 95% sensitivity for HIV-1 DNA PCR on DBS compared with results for venous blood were observed for the 94 paired samples. The results of the DBS HIV-1 DNA PCR and HIV-1 RNA PCR of 70 corresponding plasma samples correlated perfectly (100%). The DBS HIV-1 DNA PCR method proved reliable for HIV-1 detection.