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1.  Stigma and psychiatric morbidity among mothers of children with epilepsy in Zambia 
International Health  2013;5(4):288-294.
Background
Epilepsy-associated stigma contributes substantially to the social, medical, and economic burden of disease for people with epilepsy (PWE), but little is known about its impact on caregivers of PWE.
Methods
To better understand stigma experienced by caregivers of PWE, factors that influence caregiver stigma, and the effect of stigma on a caregiver's psychologic well being, we interviewed 100 caregivers of children with epilepsy in Zambia. Questions assessed maternal knowledge, attitudes, and practices related to epilepsy, maternal stigma, mother's proxy report of child stigma, and maternal psychiatric morbidity.
Results
Of 100 mothers, 39 (39%) indicated that their child was stigmatized because of his or her epilepsy. Maternal proxy report of child stigma was highly correlated with maternal stigma (OR: 5.4, p=0.04), seizure frequency (p=0.03) and seizure severity (p=0.01). One in five of 100 mothers (20%) reported feeling stigmatized because of their child's epilepsy. Higher maternal stigma was associated with lower familial and community support (ORs: 65.2 and 34.7, respectively; both p<0.0001) as well as higher psychiatric morbidity (OR: 1.2; p=0.002). Formal education and epilepsy knowledge were associated with decreased maternal stigma (ORs: 0.8 and 0.7, respectively; both p<0.001).
Conclusions
One in five mothers of PWE feel stigmatized because of their child's epilepsy. As maternal stigma is associated with psychiatric morbidity, educating caregivers about epilepsy and screening for anxiety and depression are warranted.
doi:10.1093/inthealth/iht028
PMCID: PMC3850361  PMID: 24214528
Affiliate stigma; Africa; Caregiver; Depression; Education; Felt stigma
2.  Dose of early intervention treatment during children’s first 36 months of life is associated with developmental outcomes: an observational cohort study in three low/low-middle income countries 
BMC Pediatrics  2014;14(1):281.
Background
The positive effects of early developmental intervention (EDI) on early child development have been reported in numerous controlled trials in a variety of countries. An important aspect to determining the efficacy of EDI is the degree to which dosage is linked to outcomes. However, few studies of EDI have conducted such analyses. This observational cohort study examined the association between treatment dose and children’s development when EDI was implemented in three low and low-middle income countries as well as demographic and child health factors associated with treatment dose.
Methods
Infants (78 males, 67 females) born in rural communities in India, Pakistan, and Zambia received a parent-implemented EDI delivered through biweekly home visits by trainers during the first 36 months of life. Outcome was measured at age 36 months with the Mental (MDI) and Psychomotor (PDI) Development Indices of the Bayley Scales of Infant Development-II. Treatment dose was measured by number of home visits completed and parent-reported implementation of assigned developmental stimulation activities between visits. Sociodemographic, prenatal, perinatal, and child health variables were measures as correlates.
Results
Average home visits dose exceeded 91% and mothers engaged the children in activities on average 62.5% of days. Higher home visits dose was significantly associated with higher MDI (mean for dose quintiles 1–2 combined = 97.8, quintiles 3–5 combined = 103.4, p = 0.0017). Higher treatment dose was also generally associated with greater mean PDI, but the relationships were non-linear. Location, sociodemographic, and child health variables were associated with treatment dose.
Conclusions
Receiving a higher dose of EDI during the first 36 months of life is generally associated with better developmental outcomes. The higher benefit appears when receiving ≥91% of biweekly home visits and program activities on ≥67% of days over 3 years. It is important to ensure that EDI is implemented with a sufficiently high dose to achieve desired effect. To this end groups at risk for receiving lower dose can be identified and may require special attention to ensure adequate effect.
doi:10.1186/1471-2431-14-281
PMCID: PMC4288653  PMID: 25344731
Treatment dose; Early developmental intervention; Neurodevelopmental disability; Birth asphyxia; Developing countries
4.  Contraceptive discontinuation and switching among couples receiving integrated HIV and family planning services in Lusaka, Zambia 
AIDS (London, England)  2013;27(0 1):S93-103.
Objective
To describe predictors of contraceptive method discontinuation and switching behaviors among HIV positive couples receiving couples' voluntary HIV counseling and testing services in Lusaka, Zambia.
Design
Couples were randomized in a factorial design to two family planning educational intervention videos, received comprehensive family planning services, and were assessed every 3-months for contraceptive initiation, discontinuation and switching.
Methods
We modeled factors associated with contraceptive method upgrading and downgrading via multivariate Andersen-Gill models.
Results
Most women continued the initial method selected after randomization. The highest rates of discontinuation/switching were observed for injectable contraceptive and intrauterine device users. Time to discontinuing the more effective contraceptive methods or downgrading to oral contraceptives or condoms was associated with the women's younger age, desire for more children within the next year, heavy menstrual bleeding, bleeding between periods, and cystitis/dysuria. Health concerns among women about contraceptive implants and male partners not wanting more children were associated with upgrading from oral contraceptives or condoms. HIV status of the woman or the couple was not predictive of switching or stopping.
Conclusions
We found complicated patterns of contraceptive use. The predictors of contraception switching indicate that interventions targeted to younger couples that address common contraception-related misconceptions could improve effective family planning utilization. We recommend these findings be used to increase the uptake and continuation of contraception, especially long acting reversible contraceptive (LARC) methods, and that fertility-goal based, LARC-focused family planning be offered as an integral part of HIV prevention services.
doi:10.1097/QAD.0000000000000039
PMCID: PMC4070372  PMID: 24088689
Contraceptive discontinuation; couples' voluntary HIV counseling and testing; family planning; long-acting reversible contraception; Zambia
5.  Randomized Trial of Plastic Bags to Prevent Term Neonatal Hypothermia in a Resource-Poor Setting 
Pediatrics  2013;132(3):e656-e661.
OBJECTIVES:
Term infants in resource-poor settings frequently develop hypothermia during the first hours after birth. Plastic bags or wraps are a low-cost intervention for the prevention of hypothermia in preterm and low birth weight infants that may also be effective in term infants. Our objective was to test the hypothesis that placement of term neonates in plastic bags at birth reduces hypothermia at 1 hour after birth in a resource-poor hospital.
METHODS:
This parallel-group randomized controlled trial was conducted at University Teaching Hospital, the tertiary referral center in Zambia. Inborn neonates with both a gestational age ≥37 weeks and a birth weight ≥2500 g were randomized 1:1 to either a standard thermoregulation protocol or to a standard thermoregulation protocol with placement of the torso and lower extremities inside a plastic bag within 10 minutes after birth. The primary outcome was hypothermia (<36.5°C axillary temperature) at 1 hour after birth.
RESULTS:
Neonates randomized to plastic bag (n = 135) or to standard thermoregulation care (n = 136) had similar baseline characteristics (birth weight, gestational age, gender, and baseline temperature). Neonates in the plastic bag group had a lower rate of hypothermia (60% vs 73%, risk ratio 0.76, confidence interval 0.60–0.96, P = .026) and a higher axillary temperature (36.4 ± 0.5°C vs 36.2 ± 0.7°C, P < .001) at 1 hour after birth compared with infants receiving standard care.
CONCLUSIONS:
Placement in a plastic bag at birth reduced the incidence of hypothermia at 1 hour after birth in term neonates born in a resource-poor setting, but most neonates remained hypothermic.
doi:10.1542/peds.2013-0172
PMCID: PMC3876758  PMID: 23979082
infant, term; infant, newborn; infant, hypothermia/prevention and control; plastic bag; bedding and linens; body temperature, regulation; polyethylenes; delivery, obstetrics
6.  Plastic Bags for Prevention of Hypothermia in Preterm and Low Birth Weight Infants 
Pediatrics  2013;132(1):e128-e134.
BACKGROUND AND OBJECTIVES:
Hypothermia contributes to neonatal mortality and morbidity, especially in preterm and low birth weight infants in developing countries. Plastic bags covering the trunk and extremities of very low birth weight infants reduces hypothermia. This technique has not been studied in larger infants or in many resource-limited settings. The objective was to determine if placing preterm and low birth weight infants inside a plastic bag at birth maintains normothermia.
METHODS:
Infants at 26 to 36 weeks’ gestational age and/or with a birth weight of 1000 to 2500 g born at the University Teaching Hospital in Lusaka, Zambia, were randomized by using a 1:1 allocation and parallel design to standard thermoregulation (blanket or radiant warmer) care or to standard thermoregulation care plus placement inside a plastic bag at birth. The primary outcome measure was axillary temperature in the World Health Organization–defined normal range (36.5–37.5°C) at 1 hour after birth.
RESULTS:
A total of 104 infants were randomized. At 1 hour after birth, infants randomized to plastic bag (n = 49) were more likely to have a temperature in the normal range as compared with infants in the standard thermoregulation care group (n = 55; 59.2% vs 32.7%; relative risk 1.81; 95% confidence interval 1.16–2.81; P = .007). The temperature at 1 hour after birth in the infants randomized to plastic bag was 36.5 ± 0.5°C compared with 36.1 ± 0.6°C in standard care infants (P < .001). Hyperthermia (>38.0°C) did not occur in any infant.
CONCLUSIONS:
Placement of preterm/low birth weight infants inside a plastic bag at birth compared with standard thermoregulation care reduced hypothermia without resulting in hyperthermia, and is a low-cost, low-technology tool for resource-limited settings.
doi:10.1542/peds.2012-2030
PMCID: PMC3691528  PMID: 23733796
hypothermia/prevention and control; infant newborn; infant premature; diseases/prevention and control; perinatal care/methods
7.  Syphilis Treatment Response Among HIV-Discordant Couples in Zambia and Rwanda 
In 2 large human immunodeficiency virus (HIV)–discordant couple cohorts in Africa, time to treatment response after penicillin therapy for a positive rapid plasma reagin test result was similar irrespective of HIV status. Despite effective therapy, serofast state and syphilis reinfection were common.
Background. Syphilis continues to be a common sexually transmitted infection, despite the availability of inexpensive and effective treatment. Infection in human immunodeficiency virus (HIV)–discordant couples is important because syphilis increases the risk of HIV acquisition. Current US treatment guidelines recommend 1 dose of benzathine penicillin for early syphilis, irrespective of HIV status, but data from coinfected patients are limited.
Methods. Retrospective analysis of 1321 individuals in 2 African HIV-discordant couple cohorts was performed. Cox proportional hazards analysis and multivariable modeling were used to assess predictors of serologic response to treatment at 180 days and 400 days. Modeling was performed for all episodes of positive rapid plasma reagin (RPR) test results and on a subset with higher RPR titers (≥1:4).
Results. A total of 1810 episodes of syphilis among 1321 individuals were treated with penicillin between 2002 and 2008. Although a positive RPR was more common in the HIV-infected partners, HIV infection did not impact the likelihood of serologic response to therapy (odds ratio [OR], 1.001; P = .995). By 400 days, 67% had responded to therapy, 27% were serofast, and 6.5% had documented reinfection. Prevalent infections were more likely to remain serofast than incident infections (33% vs 20% at 400 days).
Conclusions. In 2 HIV-serodiscordant couple cohorts in Africa, incident syphilis had a very good likelihood of response to penicillin therapy, irrespective of HIV infection. This supports current Centers for Disease Control and Prevention treatment guidelines. A high proportion of prevalent RPR-positive infections remain serofast despite treatment.
doi:10.1093/cid/cit146
PMCID: PMC3658364  PMID: 23487377
HIV/AIDS; syphilis; discordant couples; Zambia; Rwanda
8.  Impact of long-term contraceptive promotion on incident pregnancy: a randomized controlled trial among HIV positive couples in Lusaka, Zambia 
Objectives
To evaluate the impact of family planning promotion on incident pregnancy in a combined effort to address Prongs 1 and 2 of Prevention of Mother-to-Child Transmission of HIV.
Design
We conducted a factorial randomized controlled trial of two video-based interventions.
Methods
“Methods-focused” and “Motivational” messages promoted long-term contraceptive use among 1060 couples with HIV in Lusaka, Zambia.
Results
Among couples not using contraception prior to randomization (N=782), the video interventions had no impact on incident pregnancy. Among baseline contraceptive users, viewing the “Methods” video which focused on the IUD and contraceptive implant was associated with a significantly lower pregnancy incidence (HR=0.38; 95%CI:0.19–0.75) relative to those viewing control and/or motivational videos. The effect was strongest in concordant positive couples (HR=0.22; 95%CI:0.08–0.58) and couples with HIV+ women (HR=0.23; 95%CI:0.09–0.55).
Conclusions
The “Methods video” intervention was previously shown to increase uptake of longer-acting contraception and to prompt a shift from daily oral contraceptives to quarterly injectables and long-acting methods such as the IUD and implant. Follow-up confirms sustained intervention impact on pregnancy incidence among baseline contraceptive users, in particular couples with HIV positive women. Further work is needed to identify effective interventions to promote long-acting contraception among couples who have not yet adopted modern methods.
doi:10.1097/QAI.0b013e31827ee19c
PMCID: PMC3625483  PMID: 23202814
Couples’ voluntary HIV counseling and testing; family planning; long-term contraception; randomized controlled trial; Zambia
9.  Randomized Trial of Early Developmental Intervention on Outcomes in Children after Birth Asphyxia in Developing Countries 
The Journal of pediatrics  2012;162(4):705-712.e3.
Objective
To determine if early developmental intervention (EDI) improves developmental abilities in resuscitated children.
Study design
This was a parallel group, randomized controlled trial of infants unresponsive to stimulation who received bag and mask ventilation as part of their resuscitation at birth and infants who did not require any resuscitation born in rural communities in India, Pakistan, and Zambia. Intervention infants received a parent-implemented EDI delivered with home visits by parent trainers every other week for 3 years started the first month after birth. Parents in both intervention and control groups received health and safety counseling during home visits on the same schedule. The main outcome measure was the Mental Development Index (MDI) of the Bayley Scales of Infant Development, 2nd edition, assessed at 36 months by evaluators unaware of treatment group and resuscitation history.
Results
MDI was higher in the EDI (102.6±9.8) compared with the control resuscitated children (98.0±14.6, one-sided p=0.0202) but there was no difference between groups in the non-resuscitated children (100.1±10.7 vs. 97.7±10.4, p=0.1392). The Psychomotor Development Index (PDI) was higher in the EDI group for both the resuscitated (p=0.0430) and non-resuscitated children (p=0.0164).
Conclusions
This trial of home-based, parent provided EDI in children resuscitated at birth provides evidence of treatment benefits on cognitive and psychomotor outcomes. MDI and PDI scores of both non-resuscitated and resuscitated infants were within normal range, independent of early intervention.
doi:10.1016/j.jpeds.2012.09.052
PMCID: PMC3582821  PMID: 23164311
Early intervention; resuscitation; intellectual disability; low and middle income countries; neonatal mortality; infant mortality; developmental outcome
10.  Peer Support Groups as an Intervention to Decrease Epilepsy-Associated Stigma 
Epilepsy & behavior : E&B  2013;27(1):188-192.
Eighty percent of people with epilepsy (PWE) reside in low-income countries where stigma contributes substantially to social and medical morbidity. Peer support groups (PSGs) are thought to be beneficial for people with stigmatized conditions, but little data exists regarding PSG effectiveness. We facilitated monthly PSG meetings for men, women, and youth from three Zambian clinics for one year. Pre- and post-intervention assessments measured internalized stigma, psychiatric morbidity, medication adherence, socioeconomic status, and community disclosure. Of 103 participants (39 men, 30 women, 34 youth), 80 PWE (78%) attended ≥6 meetings. There were no significant demographic differences between PWE that attended ≥6 vs. <6 meetings. Among youth attending ≥6 meetings, internalized stigma decreased (p<0.02). Among adults, there was a non-significant stigma decrease. No differences were detected in medication use, adherence, or psychiatric morbidity. PSGs effectively reduce stigma for youth and may offer a low-cost approach to addressing epilepsy-associated stigma in resource-poor settings.
doi:10.1016/j.yebeh.2013.01.005
PMCID: PMC3602129  PMID: 23454914
Africa; rural; urban; men; women; youth; psychiatric morbidity; medication use; community disclosure; medication adherence
11.  First look: a cluster-randomized trial of ultrasound to improve pregnancy outcomes in low income country settings 
Background
In high-resource settings, obstetric ultrasound is a standard component of prenatal care used to identify pregnancy complications and to establish an accurate gestational age in order to improve obstetric care. Whether or not ultrasound use will improve care and ultimately pregnancy outcomes in low-resource settings is unknown.
Methods/Design
This multi-country cluster randomized trial will assess the impact of antenatal ultrasound screening performed by health care staff on a composite outcome consisting of maternal mortality and maternal near-miss, stillbirth and neonatal mortality in low-resource community settings. The trial will utilize an existing research infrastructure, the Global Network for Women’s and Children’s Health Research with sites in Pakistan, Kenya, Zambia, Democratic Republic of Congo and Guatemala. A maternal and newborn health registry in defined geographic areas which documents all pregnancies and their outcomes to 6 weeks post-delivery will provide population-based rates of maternal mortality and morbidity, stillbirth, neonatal mortality and morbidity, and health care utilization for study clusters. A total of 58 study clusters each with a health center and about 500 births per year will be randomized (29 intervention and 29 control). The intervention includes training of health workers (e.g., nurses, midwives, clinical officers) to perform ultrasound examinations during antenatal care, generally at 18–22 and at 32–36 weeks for each subject. Women who are identified as having a complication of pregnancy will be referred to a hospital for appropriate care. Finally, the intervention includes community sensitization activities to inform women and their families of the availability of ultrasound at the antenatal care clinic and training in emergency obstetric and neonatal care at referral facilities.
Discussion
In summary, our trial will evaluate whether introduction of ultrasound during antenatal care improves pregnancy outcomes in rural, low-resource settings. The intervention includes training for ultrasound-naïve providers in basic obstetric ultrasonography and then enabling these trainees to use ultrasound to screen for pregnancy complications in primary antenatal care clinics and to refer appropriately.
Trial registration
Clinicaltrials.gov (NCT # 01990625)
doi:10.1186/1471-2393-14-73
PMCID: PMC3996090  PMID: 24533878
Maternal mortality; Maternal near miss; Perinatal mortality; Obstetric ultrasound; Low-income countries
12.  High Mortality Rates for Very Low Birth Weight Infants in Developing Countries Despite Training 
Pediatrics  2010;126(5):e1072-e1080.
OBJECTIVE
The goal was to determine the effect of training in newborn care and resuscitation on 7-day (early) neonatal mortality rates for very low birth weight (VLBW) infants. The study was designed to test the hypothesis that these training programs would reduce neonatal mortality rates for VLBW infants.
METHODS
Local instructors trained birth attendants from 96 rural communities in 6 developing countries in protocol and data collection, the World Health Organization Essential Newborn Care (ENC) course, and a modified version of the American Academy of Pediatrics Neonatal Resuscitation Program (NRP), by using a train-the-trainer model. To test the impact of ENC training, data on infants of 500 to 1499 g were collected by using a before/after, active baseline, controlled study design. A cluster-randomized, controlled trial design was used to test the impact of the NRP.
RESULTS
A total of 1096 VLBW (500–1499 g) infants were enrolled, and 98.5% of live-born infants were monitored to 7 days. All-cause, 7-day neonatal mortality, stillbirth, and perinatal mortality rates were not affected by ENC or NRP training.
CONCLUSIONS
Neither ENC nor NRP training of birth attendants decreased 7-day neonatal, stillbirth, or perinatal mortality rates for VLBW infants born at home or at first-level facilities. Encouragement of delivery in a facility where a higher level of care is available may be preferable when delivery of a VLBW infant is expected.
doi:10.1542/peds.2010-1183
PMCID: PMC3918943  PMID: 20937655
neonatal mortality; perinatal mortality; stillbirth; developing countries; health care systems; very low birth weight; prematurity
13.  Meat consumption is associated with less stunting among toddlers in four diverse low-income settings 
Food and nutrition bulletin  2011;32(3):185-191.
Background
Early growth faltering is common but is difficult to reverse after the first 2 years of life.
Objective
To describe feeding practices and growth in infants and young children in diverse low-income settings prior to undertaking a complementary feeding trial.
Methods
This cross-sectional study was conducted through the Global Network for Women’s and Children’s Health Research in Guatemala, Democratic Republic of Congo, Zambia, and Pakistan. Feeding questionnaires were administered to convenience samples of mothers of 5- to 9-month old infants and 12- to 24-month-old toddlers. After standardized training, anthropometric measurements were obtained from the toddlers. Following the 2006 World Health Organization Growth Standards, stunting was defined as length-for-age < −2SD, and wasting as weight-for-length < −2SD. Logistic regression was applied to evaluate relationships between stunting and wasting and consumption of meat (including chicken and liver and not including fish).
Results
Data were obtained from 1,500 infants with a mean (± SD) age of 6.9 ± 1.4 months and 1,658 toddlers with a mean age of 17.2 ± 3.5 months. The majority of the subjects in both age groups were breastfed. Less than 25% of the infants received meat regularly, whereas 62% of toddlers consumed these foods regularly, although the rates varied widely among sites. Stunting rate ranged from 44% to 66% among sites; wasting prevalence was less than 10% at all sites. After controlling for covariates, consumption of meat was associated with a reduced likelihood of stunting (OR = 0.64; 95% CI, 0.46 to 0.90).
Conclusions
The strikingly high stunting rates in these toddlers and the protective effect of meat consumption against stunting emphasize the need for interventions to improve complementary feeding practices, beginning in infancy.
PMCID: PMC3918945  PMID: 22073791
Complementary feeding; infant growth; infant nutrition; stunting
14.  Tobacco Use and Secondhand Smoke Exposure During Pregnancy in Two African Countries: Zambia and the Democratic Republic of the Congo 
Acta obstetricia et gynecologica Scandinavica  2010;89(4):10.3109/00016341003605693.
Objective
To study pregnant women’s knowledge, attitudes and behaviors towards tobacco use and secondhand smoke (SHS) exposure, and exposure to advertising for and against tobacco products in Zambia and the Democratic Republic of the Congo (DRC).
Design
Prospective cross-sectional survey between November 2004 and September 2005.
Setting
Antenatal care clinics in Lusaka, Zambia and Kinshasa, DRC.
Population
Pregnant women in Zambia (909) and the DRC (847).
Methods
Research staff administered a structured questionnaire to pregnant women attending antenatal care clinics.
Main Outcome Measures
Pregnant women’s use of tobacco, exposure to SHS, knowledge of the harms of tobacco, and exposure to advertising for and against tobacco products.
Results
Only about 10% of pregnant women reported having ever tried cigarettes (6.6% Zambia; 14.1% DRC). However, in the DRC, 41.8% of pregnant women had ever tried other forms of tobacco, primarily snuff. About 10% of pregnant women and young children were frequently or always exposed to SHS. Pregnant women’s knowledge of the hazards of smoking and SHS exposure was extremely limited. About 13% of pregnant women had seen or heard advertising for tobacco products in the last 30 days.
Conclusions
Tobacco use and SHS exposure pose serious threats to the health of women, infants, and children. In many African countries, maternal and infant health outcomes are often poor and will likely worsen if maternal tobacco use increases. Our findings suggest that a “window of opportunity” exists to prevent increased tobacco use and SHS exposure of pregnant women in Zambia and the DRC.
doi:10.3109/00016341003605693
PMCID: PMC3875167  PMID: 20230310
15.  EVALUATION OF MEAT AS A FIRST COMPLEMENTARY FOOD FOR BREASTFED INFANTS: IMPACT ON IRON INTAKE & GROWTH 
Nutrition reviews  2011;69(0 1):10.1111/j.1753-4887.2011.00434.x.
The rationale is considered for promoting the availability of local, affordable, non-fortified food sources of bioavailable iron in developing countries. Intakes of iron from the regular consumption of meat from the age of six months are evaluated with respect to physiological requirements. The paper includes a description of two major randomized controlled trials of meat as a first and regular complementary food that are currently in progress. These trials involve poor communities in Guatemala, Pakistan, Zambia, Democratic Republic of the Congo and China.
doi:10.1111/j.1753-4887.2011.00434.x
PMCID: PMC3875190  PMID: 22043884
iron; meat; complementary feeding
16.  A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: a Global Network cluster randomized trial 
BMC Medicine  2013;11:215.
Background
Fetal and neonatal mortality rates in low-income countries are at least 10-fold greater than in high-income countries. These differences have been related to poor access to and poor quality of obstetric and neonatal care.
Methods
This trial tested the hypothesis that teams of health care providers, administrators and local residents can address the problem of limited access to quality obstetric and neonatal care and lead to a reduction in perinatal mortality in intervention compared to control locations. In seven geographic areas in five low-income and one middle-income country, most with high perinatal mortality rates and substantial numbers of home deliveries, we performed a cluster randomized non-masked trial of a package of interventions that included community mobilization focusing on birth planning and hospital transport, community birth attendant training in problem recognition, and facility staff training in the management of obstetric and neonatal emergencies. The primary outcome was perinatal mortality at ≥28 weeks gestation or birth weight ≥1000 g.
Results
Despite extensive effort in all sites in each of the three intervention areas, no differences emerged in the primary or any secondary outcome between the intervention and control clusters. In both groups, the mean perinatal mortality was 40.1/1,000 births (P = 0.9996). Neither were there differences between the two groups in outcomes in the last six months of the project, in the year following intervention cessation, nor in the clusters that best implemented the intervention.
Conclusions
This cluster randomized comprehensive, large-scale, multi-sector intervention did not result in detectable impact on the proposed outcomes. While this does not negate the importance of these interventions, we expect that achieving improvement in pregnancy outcomes in these settings will require substantially more obstetric and neonatal care infrastructure than was available at the sites during this trial, and without them provider training and community mobilization will not be sufficient. Our results highlight the critical importance of evaluating outcomes in randomized trials, as interventions that should be effective may not be.
Trial registration
ClinicalTrials.gov NCT01073488
doi:10.1186/1741-7015-11-215
PMCID: PMC3853358  PMID: 24090370
Stillbirth; Neonatal mortality; Maternal mortality; Emergency obstetric care
17.  Assessment of Obstetric and Neonatal Health Services in Developing Country Health Facilities 
American journal of perinatology  2013;30(9):787-794.
Objective
To describe the staffing and availability of medical equipment and medications and the performance of procedures at health facilities providing maternal and neonatal care at African, Asian, and Latin American sites participating in a multicenter trial to improve emergency obstetric/neonatal care in communities with high maternal and perinatal mortality.
Study Design
In 2009, prior to intervention, we surveyed 136 hospitals and 228 clinics in 7 sites in Africa, Asia, and Latin America regarding staffing, availability of equipment/ medications, and procedures including cesarean section.
Results
The coverage of physicians and nurses/midwives was poor in Africa and Latin America. In Africa, only 20% of hospitals had full-time physicians. Only 70% of hospitals in Africa and Asia had performed cesarean sections in the last 6 months. Oxygen was unavailable in 40% of African hospitals and 17% of Asian hospitals. Blood was unavailable in 80% of African and Asian hospitals.
Conclusions
Assuming that adequate facility services are necessary to improve pregnancy outcomes, it is not surprising that maternal and perinatal mortality rates in the areas surveyed are high. The data presented emphasize that to reduce mortality in these areas, resources that result in improved staffing and sufficient equipment, supplies, and medication, along with training, are required.
doi:10.1055/s-0032-1333409
PMCID: PMC3664648  PMID: 23329566
emergency obstetric and neonatal care; developing countries; perinatal mortality
18.  Unintended Pregnancy among HIV Positive Couples Receiving Integrated HIV Counseling, Testing, and Family Planning Services in Zambia 
PLoS ONE  2013;8(9):e75353.
Objective
We describe rates of unintended pregnancy among HIV positive couples in Lusaka, Zambia. We also identify factors associated with unintended pregnancy among oral contraceptive pill (OCP) using couples in this cohort.
Design
Data were analyzed from couples randomized in a factorial design to two family planning intervention videos.
Methods
Rates of unintended pregnancy were stratified by contraceptive method used at time of pregnancy. Predictors of time to unintended pregnancy among OCP users were determined via multivariate Cox modeling.
Results
The highest rates of unintended pregnancy were observed among couples requesting condoms only (26.4/100CY) or OCPs (20.7/100CY); these rates were not significantly different. OCP users accounted for 37% of the couple-years (CY) observed and 87% of unintended pregnancies. Rates of unintended pregnancy for injectable (0.7/100CY) and intrauterine device (1.6/100CY) users were significantly lower relative to condom only users. No pregnancies occurred among contraceptive implant users or after tubal ligation. Factors associated (p<0.05) with time to unintended pregnancy among OCP users in multivariate analysis included the man wanting more children, the woman being HIV negative versus having stage IV HIV disease, and the woman reporting: younger age, no previous OCP use, missed OCPs, or sex without a condom.
Conclusions
Long-acting reversible contraceptive methods were effective in the context of integrated couples HIV prevention and contraceptive services. Injectable methods were also effective in this context. Given the high user failure rate of OCPs, family planning efforts should promote longer-acting methods among OCP users wishing to avoid pregnancy. Where other methods are not available or acceptable, OCP adherence counseling is needed, especially among younger and new OCP users.
Trial registration
ClinicalTrials.gov NCT00067522
doi:10.1371/journal.pone.0075353
PMCID: PMC3787093  PMID: 24098692
19.  The Maternal and Newborn Health Registry Study of the Global Network for Women’s and Children’s Health Research 
Objective
To implement a vital statistics registry system to register pregnant women and document birth outcomes in the Global Network for Women’s and Children’s Health Research sites in Asia, Africa, and Latin America.
Methods
The Global Network sites began a prospective population-based pregnancy registry to identify all pregnant women and record pregnancy outcomes up to 42 days post-delivery in more than 100 defined low-resource geographic areas (clusters). Pregnant women were registered during pregnancy, with 42-day maternal and neonatal follow-up recorded—including care received during the pregnancy and postpartum periods. Recorded outcomes included stillbirth, neonatal mortality, and maternal mortality rates.
Results
In 2010, 72 848 pregnant women were enrolled and 6-week follow-up was obtained for 97.8%. Across sites, 40.7%, 24.8%, and 34.5% of births occurred in a hospital, health center, and home setting, respectively. The mean neonatal mortality rate was 23 per 1000 live births, ranging from 8.2 to 48.5 per 1000 live births. The mean stillbirth rate ranged from 13.7 to 54.4 per 1000 births.
Conclusion
The registry is an ongoing study to assess the impact of interventions and trends regarding pregnancy outcomes and measures of care to inform public health.
doi:10.1016/j.ijgo.2012.04.022
PMCID: PMC3417109  PMID: 22738806
Maternal mortality; Neonatal mortality; Perinatal mortality; Pregnancy; Registry; Stillbirth
20.  Fertility goal-based counseling increases contraceptive implant and IUD use in HIV discordant couples in Rwanda and Zambia 
Contraception  2012;88(1):74-82.
Background
HIV discordant heterosexual couples are faced with the dual challenge of preventing sexual HIV transmission and unplanned pregnancies with the attendant risk of perinatal HIV transmission. Our aim was to examine uptake of two long-acting reversible contraceptive (LARC) methods – intrauterine devices (IUDs) and hormonal implants – among HIV discordant couples in Rwanda and Zambia.
Study Design
Women were interviewed alone or with their partner during routine cohort study follow-up visits to ascertain fertility goals; those not pregnant, not infertile, not already using LARC, and wishing to limit or delay fertility for ≥3 years were counseled on LARC methods and offered an IUD and implant on-site.
Results
Among 409 fertile Rwandan women interviewed (126 alone, 283 with partners), 365 (89%) were counseled about LARC methods and 130 (36%) adopted a method (100 implant, 30 IUD). Of 787 fertile Zambian women interviewed (457 alone, 330 with partners), 528 (67%) received LARC counseling, of whom 177 (34%) adopted a method (139 implant, 38 IUD). In both countries, a woman’s younger age was predictive of LARC uptake. LARC users reported fewer episodes of unprotected sex than couples using only condoms.
Conclusions
Integrated fertility-goal based family planning counseling and access to LARC methods with reinforcement of dual-method use prompted uptake of IUDs and implants and reduced unprotected sex among HIV-discordant couples in two African capital cities.
doi:10.1016/j.contraception.2012.10.004
PMCID: PMC3625675  PMID: 23153896
contraception; family planning; HIV; intrauterine devices; implant
21.  Neurodevelopmental Outcomes in Infants Requiring Resuscitation in Developing Countries 
The Journal of Pediatrics  2011;160(5):781-785.e1.
Objective
To determine whether resuscitation of infants who failed to develop effective breathing at birth increases survivors with neurodevelopmental impairment.
Study design
Infants unresponsive to stimulation who received bag and mask ventilation at birth in a resuscitation trial and infants who did not require any resuscitation were randomized to early neurodevelopmental intervention or control. Infants were evaluated by trained neurodevelopmental evaluators masked to both their resuscitation history and intervention group. The 12-month neurodevelopmental outcome data for both resuscitated and non-resuscitated infants randomized to the control groups are reported.
Results
The study provided no evidence of a difference between the resuscitated (N = 86) and the non-resuscitated infants (N = 115) in the percentage of infants at 12 months with a mental developmental index < 85 on the Bayley Scales of Infant Development-II (primary outcome) (18% versus 12%; p = 0.22) and in other neurodevelopmental outcomes.
Conclusions
The overwhelming majority of infants who received resuscitation with bag and mask ventilation at birth have 12-month neurodevelopmental outcomes in the normal range. Longer follow-up is needed because of increased risk for neurodevelopmental impairments.
doi:10.1016/j.jpeds.2011.10.007
PMCID: PMC3309169  PMID: 22099522
Resuscitation; intellectual disability; low and middle income countries; neonatal mortality; infant mortality; developmental outcome
22.  Prevalence of seroconversion symptoms and relationship to set point viral load: Findings from a subtype C epidemic, 1995–2009 
AIDS (London, England)  2012;26(2):175-184.
Objective
To describe symptoms, physical exam findings, and set point viral load associated with acute HIV seroconversion in a heterosexual cohort of discordant couples in Zambia.
Design
We followed HIV serodiscordant couples in Lusaka, Zambia from 1995–2009 with HIV testing of negative partners and symptom inventories 3-monthly, and physical examinations annually.
Methods
We compared prevalence of self-reported or treated symptoms (malaria syndrome, chronic diarrhea, asthenia, night sweats, and oral candidiasis) and annual physical exam [PE] findings (unilateral or bilateral neck, axillary, or inguinal adenopathy; and dermatosis) in seroconverting versus HIV-negative or HIV-positive intervals, controlling for repeated observations, age, and sex. A composite score comprised of significant symptoms and PE findings predictive of seroconversion versus HIV-negative intervals was constructed. We modeled the relationship between number of symptoms and PE findings at seroconversion and log set-point viral load [VL] using linear regression.
Results
2,388 HIV-negative partners were followed for a median of 18 months; 429 seroconversions occurred. Neither symptoms nor PE findings were reported for most seroconverters. Seroconversion was significantly associated with malaria syndrome among non-diarrheic patients (adjusted odds ratio [aOR]=4.0) night sweats (aOR=1.4), and bilateral axillary (aOR = 1.6), inguinal (aOR=2.2), and neck (aOR=2.2) adenopathy relative to HIV-negative intervals. Median number of symptoms was positively associated with set-point VL (p<0.001).
Conclusions
Though most acute and early infections were asymptomatic, malaria syndrome was more common and more severe during seroconversion compared with HIV-negative and HIV-positive intervals. When present, symptoms and physical exam findings were non-specific and associated with higher set point viremia.
doi:10.1097/QAD.0b013e32834ed8c8
PMCID: PMC3589587  PMID: 22089380
HIV; seroconversion syndrome; set point HIV viral load
23.  Newborn Care Training and Perinatal Mortality in Communities in Developing Countries 
The New England journal of medicine  2010;362(7):614-623.
Background
Ninety-eight percent of the 3.7 million neonatal deaths and 3.3 million stillbirths per year occur in developing countries, and evaluation of community-based interventions is needed.
Methods
Using a train-the-trainer model, local instructors trained birth attendants from rural communities in six countries (Argentina, Democratic Republic of Congo, Guatemala, India, Pakistan, and Zambia) in the World Health Organization Essential Newborn Care course (routine neonatal care, resuscitation, thermoregulation, breastfeeding, kangaroo care, care of the small baby, and common illnesses), and in a modified version of the American Academy of Pediatrics Neonatal Resuscitation Program (in depth basic resuscitation), except in Argentina.
The Essential Newborn Care intervention was assessed with a before and after design (N=57, 643). The Neonatal Resuscitation Program intervention was assessed as a cluster randomized controlled trial (N=62,366). The primary outcome was 7-day neonatal mortality.
Results
The 7-day follow-up rate was 99.2%. Following Essential Newborn Care training, there was no significant reduction from baseline in all-cause 7-day neonatal (RR 0.99; CI 0.81, 1.22) or perinatal mortality; there was a significant reduction in the stillbirth rate (RR 0.69; CI 0.54, 0.88; p<0.01). Seven-day neonatal mortality, stillbirth, and perinatal mortality were not reduced in clusters randomized to Neonatal Resuscitation Program training as compared with control clusters.
Conclusions
Seven-day neonatal mortality did not decrease following the introduction of Essential Newborn Care training of community-based birth attendants, although the rate of stillbirths was reduced following this intervention. Subsequent training in the Neonatal Resuscitation Program did not significantly reduce the mortality rates. (clinicaltrials.gov number, NCT00136708).
doi:10.1056/NEJMsa0806033
PMCID: PMC3565382  PMID: 20164485
neonatal mortality; perinatal mortality; developing countries; health systems; effectiveness
24.  Local Residents Trained As ‘Influence Agents’ Most Effective In Persuading African Couples On HIV Counseling and Testing 
Health affairs (Project Hope)  2011;30(8):1488-1497.
Couples in sub-Saharan Africa are the largest group in the world at risk for HIV infection. Couples counseling and testing programs have been shown to reduce HIV transmission, but such programs remain rare in Africa. Before couples counseling and testing can become the norm, it is essential to increase demand for the services. We evaluated the effectiveness of several promotional strategies during a two -year program in Kitwe and Ndola, Zambia. The program attracted more than 7,600 couples through the use of radio broadcasts, billboards, and other strategies. The most effective recruiting technique was the use of local residents trained as “influence agents” to reach out to friends, neighbors, and others in their sphere of influence. Of the estimated 2.5 million new cases of HIV in adults and children in 2009, more than two-thirds occurred in sub-Saharan Africa.1 In Zambia, the prevalence of HIV among adults in urban and rural areas is estimated at 19 and 10 percent, respectively.2 Most HIV transmission in sub-Saharan Africa is heterosexual and occurs between cohabiting partners with discordant HIV test results3–5—that is, only one partner is HIV-positive. Thus, most new cases of HIV occur when someone infects his or her heterosexual partner. Sub-Saharan African couples with discordant HIV test results are the world’s largest risk group for HIV.6 Approximately 20 percent of Zambian couples have discordant HIV results, a rate consistent with estimates from Uganda, Rwanda, Tanzania, and Kenya.7–14
doi:10.1377/hlthaff.2009.0994
PMCID: PMC3503238  PMID: 21821565
25.  The cost of implementing a nationwide program to decrease the epilepsy treatment gap in a high gap country 
Neurology International  2012;4(3):e14.
Healthcare systems in many low income countries have evolved to provide services for acute, infections and are poorly structured for the provision of chronic, non-communicable diseases which are increasingly common. Epilepsy is a common chronic neurologic condition and antiepileptic drugs are affordable, but the epilepsy treatment gap remains >90% in most African countries. The World Health Organization has recently released evidence-based guidelines for epilepsy care provision at the primary care level. Based upon these guidelines, we estimated all direct costs associated with epilepsy care provision as well as the cost of healthcare worker training and social marketing. We developed a model for epilepsy care delivery primarily by primary healthcare workers. We then used a variety of sources to develop cost estimates for the actual implementation and maintenance of this program being as comprehensive as possible to include all costs incurred within the health sector. Key sensitivity analyses were completed to better understand how changes in costs for individual aspects of care impact the overall cost of care delivery. Even after including the costs of healthcare worker retraining, social marketing and capital expenditures, epilepsy care can be provided at less than $25.00 per person with epilepsy per year. This is substantially less than for drugs alone for other common chronic conditions. Implementation of epilepsy care guidelines for patients receiving care at the primary care level is a cost effective approach to decreasing the epilepsy treatment gap in high gap, low income countries.
doi:10.4081/ni.2012.e14
PMCID: PMC3555216  PMID: 23355927
epilepsy; treatment gap; cost; Africa.

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