Availability of priority maternal and newborn health indicators: Cross-sectional analysis of pregnancy, childbirth and postnatal care registers from 21 countries.

Data from national health information systems are essential for routinely tracking progress, programmatic decision-making and to improve quality of services. Understanding the data elements captured in patient registers which are building blocks of national HMIS indicators, enables us to standardize data collection and measurement of key indicators for tracking progress towards achieving maternal and newborn health goals. This analysis was done through a review of antenatal care (ANC), childbirth and postnatal care (PNC) registers from 21 countries across five geographic regions. Between July and October 2020, country-based maternal and newborn experts, implementing agencies, program managers, and ministry of health personnel were asked to share the registers in use. Both paper-based and electronic registers were obtained. Twenty ANC registers, eighteen childbirth and thirteen PNC were available and analyzed. Both longitudinal and cross-sectional ANC and PNC registers were obtained, while the childbirth registers included in the analysis were all cross-sectional. Fifty-five percent (11/20) ANC registers and 54% (7/13) PNC registers were longitudinal. In four countries, the registers were electronic, while the rest were paper-based (17 countries). Sub-analysis of registers from four countries (Ghana, Kenya, Nigeria, and Zambia) where the 2017/2018 and 2019/2020 registers were available showed that the latest versions included 21/27 (78%) of data elements that are critical in the computation of key maternal and newborn care indicators. This analysis highlights some areas in where there are data gaps in data on pregnancy and childbirth. Program managers and health workers should use data gathered routinely to monitor the performance of their national health system and to guide the continuous improvement of health care services for women and newborns. The findings can help to inform the standardization of pregnancy and childbirth registers, and provide information for other countries seeking to introduce indicators in their health systems.

Impact of group antenatal care (G-ANC) versus individual antenatal care (ANC) on quality of care, ANC attendance and facility-based delivery: A pragmatic cluster-randomized controlled trial in Kenya and Nigeria.

BACKGROUND: Low quality and frequency of antenatal care (ANC) are associated with lower uptake of facility-based deliveries-a key intervention to reduce maternal and neonatal mortality. We implemented group ANC (G-ANC), an alternative service delivery model, in Kenya and Nigeria, to assess its impact on quality and attendance at ANC and uptake of facility-based delivery. METHODS: From October 2016‒January 2018, we conducted a facility-based, pragmatic, cluster-randomized controlled trial with 20 clusters per country. We recruited women <24 weeks gestation during their first ANC visit and enrolled women at intervention facilities who agreed to attend G-ANC in lieu of routine individual ANC. The G-ANC model consisted of five monthly 2-hour meetings with clinical assessments alongside structured gestationally specific group discussions and activities. Quality of care was defined as receipt of eight specific ANC interventions. Data were obtained through facility records and self-report during a home-based postpartum survey. Analysis was by intention to treat. FINDINGS: All women who completed follow up are included in the analysis (Nigeria: 1018/1075 enrolled women [94.7%], Kenya: 826/1013 [81.5%]). In Nigeria women in the intervention arm were more likely to have a facility-based delivery compared to those in the control arm (Nigeria: 76.7% [391/510] versus 54.1% [275/508]; aOR 2.30, CI 1.51-3.49). In both countries women in the intervention arm were more likely than those in the control arm to receive quality ANC (Nigeria: aOR 5.8, CI 1.98-17.21, p<0.001; Kenya: aOR 5.08, CI 2.31-11.16, p<0.001) and to attend at least four ANC visits (Nigeria: aOR 13.30, CI 7.69-22.99, p<0.001; Kenya: aOR 7.12, CI 3.91-12.97, p<0.001). CONCLUSIONS: G-ANC was associated with higher facility-based delivery rates in Nigeria, where those rates associated with individual ANC were low. In both Kenya and Nigeria it was associated with a higher proportion of women receiving quality ANC and higher frequency of ANC visits.

Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria.

Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration: Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017.

Mortality and clinical outcomes in HIV-infected children on antiretroviral therapy in Malawi, Lesotho, and Swaziland.

OBJECTIVE: To determine mortality and immune status improvement in HIV-infected pediatric patients on antiretroviral treatment (ART) in Malawi, Lesotho, and Swaziland. METHODS: We conducted a retrospective cohort study of patients aged <12 years at ART initiation at 3 sites in sub-Saharan Africa between 2004 and 2009. Twelve-month and overall mortality were estimated, and factors associated with mortality and immune status improvement were evaluated. RESULTS: Included in the study were 2306 patients with an average follow-up time on ART of 2.3 years (interquartile range 1.5-3.1 years). One hundred four patients (4.5%) died, 9.0% were lost to follow-up, and 1.3% discontinued ART. Of the 104 deaths, 77.9% occurred in the first year of treatment with a 12-month mortality rate of 3.5%. The overall mortality rate was 2.25 deaths/100 person-years (95% confidence interval [CI] 1.84-2.71). Increased 12-month mortality was associated with younger age; <6 months (hazard ratio [HR] = 8.11, CI 4.51-14.58), 6 to <12 months (HR = 3.43, CI 1.96-6.02), and 12 to <36 months (HR = 1.92, CI 1.16-3.19), and World Health Organization stage IV (HR = 4.35, CI 2.19-8.67). Immune status improvement at 12 months was less likely in patients with advanced disease and age <12 months. CONCLUSIONS: Despite challenges associated with pediatric ART in developing countries, low mortality and good treatment outcomes can be achieved. However, outcomes are worse in younger patients and those with advanced disease at the time of ART initiation, highlighting the importance of early diagnosis and treatment.

Inadequate coordination of maternal and infant HIV services detrimentally affects early infant diagnosis outcomes in Lilongwe, Malawi.

OBJECTIVE: To assess the continuity of care and outcome of pediatric HIV prevention, testing, and treatment services, focusing on early infant diagnosis with DNA polymerase chain reaction (PCR). DESIGN: A retrospective observational cohort. METHODS: Maternal HIV antibody, infant HIV DNA PCR test results, and outcome data from HIV-infected infants from the prevention of mother-to-child transmission, early infant diagnosis, and pediatric HIV treatment programs operating in Lilongwe, Malawi, between 2004 and 2008 were collected, merged, and analyzed. RESULTS: Of the 14,669 pregnant women who tested HIV antibody positive, 7875 infants (53.7%) received HIV DNA PCR testing. One thousand eighty-four infants (13.8%) were HIV infected. Three hundred twenty (29.5%) children enrolled into pediatric HIV care, with 202 (63.1%) at the Baylor Center of Excellence. Among these, antiretroviral therapy was initiated on 110 infants (54.5%) whose median age was 9.1 months (interquartile range, 5.4-13.8) and a median of 2.5 months (interquartile range, 1.4-5.2) after HIV clinic registration. Sixty-nine HIV-infected infants (34.2%) died or were lost by December 2008. Initiation of antiretroviral therapy increased the likelihood of survival 7-fold (odds ratio, 7.1; 95% confidence interval, 3.68 to 13.70). CONCLUSIONS: Separate programs for maternal and infant HIV prevention and care services demonstrated high attrition rates of HIV-exposed and HIV-infected infants, elevated levels of mother-to-child transmission, late infant diagnosis, delayed pediatric antiretroviral therapy initiation, and high HIV-infected infant mortality. Antiretroviral therapy increased HIV-infected infant survival, emphasizing the urgent need for improved service coordination and strategies that increase access to infant HIV diagnosis, improve patient retention, and reduce antiretroviral therapy initiation delays.

Discontinuation of standard first-line antiretroviral therapy in a cohort of 1434 Malawian children.

The standard first-line antiretroviral (ART) regimen in Malawi for both adults and children is a fixed-dose combination tablet containing stavudine (d4T), lamivudine (3TC) and nevirapine (NVP). This regimen has been shown to yield satisfactory virologic and immunologic outcomes in children. Published studies have described insights into discontinuation of first-line regimen and toxicities of ART in adults, but similar studies in paediatric populations are lacking. A retrospective cohort study was undertaken to assess reasons for discontinuation of the standard first-line ART regimen (d4T/3TC/NVP) in a paediatric population. In total, 1434 patients met eligibility criteria and were included. The cohort had mean and median age at ART initiation of 4.7 years and 2.9 years, respectively (range: 0.1 months-18.7 years). The gender distribution was 47% female and 53% male. Median follow-up time on ART was 1.8 years (range: 2 weeks-3.9 years). A majority (96.2%) of patients were on the standard first-line ART regimen, while 3.8% (54) were on a different regimen. Twenty-eight patients (2.0%) were on an alternative first-line regimen due to toxicities, 22 patients (1.5%) were on a second-line regimen due to ART failure, and four patients (0.3%) were on a non-standard regimen for other clinical reasons. Of the 28 patients who experienced toxicities requiring ART regimen change, 60.7% (17) were caused by NVP, 39.3% (11) by d4T, and none by 3TC. The median time from first-line ART initiation to alternative first-line ART was two months (range: 10 days-28.1 months); 60.7% of patients on alternative first-line ART were male. Average time on ART until switch to second-line ART regimen was 16.3 months (SD: 9.3 months). The probability of failure after one year on first-line regimen was 1.6% (95% CI: 0.9-2.6). There was no compelling evidence in this cohort, representing approximately 10% of all children on ART in Malawi, to support changing the standard paediatric first-line regimen based on early toxicities or failure. However, experience from the national adult cohort, longer term follow up of the paediatric cohort in this study, emerging data on resistance after single-dose NVP containing mother to child transmission antiretroviral prophylaxis, and new 2009 World Health Organization ART recommendations may influence national policy change to a different first-line regimen.

Task shifting routine inpatient pediatric HIV testing improves program outcomes in urban Malawi: a retrospective observational study.

BACKGROUND: This study evaluated two models of routine HIV testing of hospitalized children in a high HIV-prevalence resource-constrained African setting. Both models incorporated "task shifting," or the allocation of tasks to the least-costly, capable health worker. METHODS AND FINDINGS: Two models were piloted for three months each within the pediatric department of a referral hospital in Lilongwe, Malawi between January 1 and June 30, 2008. Model 1 utilized lay counselors for HIV testing instead of nurses and clinicians. Model 2 further shifted program flow and advocacy responsibilities from counselors to volunteer parents of HIV-infected children, called "patient escorts." A retrospective review of data from 6318 hospitalized children offered HIV testing between January-December 2008 was conducted. The pilot quarters of Model 1 and Model 2 were compared, with Model 2 selected to continue after the pilot period. There was a 2-fold increase in patients offered HIV testing with Model 2 compared with Model 1 (43.1% vs 19.9%, p<0.001). Furthermore, patients in Model 2 were younger (17.3 vs 26.7 months, p<0.001) and tested sooner after admission (1.77 vs 2.44 days, p<0.001). There were no differences in test acceptance or enrollment rates into HIV care, and the program trends continued 6 months after the pilot period. Overall, 10244 HIV antibody tests (4779 maternal; 5465 child) and 453 DNA-PCR tests were completed, with 97.8% accepting testing. 19.6% of all mothers (n = 1112) and 8.5% of all children (n = 525) were HIV-infected. Furthermore, 6.5% of children were HIV-exposed (n = 405). Cumulatively, 72.9% (n = 678) of eligible children were evaluated in the hospital by a HIV-trained clinician, and 68.3% (n = 387) successfully enrolled into outpatient HIV care. CONCLUSIONS/SIGNIFICANCE: The strategy presented here, task shifting from lay counselors alone to lay counselors and patient escorts, greatly improved program outcomes while only marginally increasing operational costs. The wider implementation of this strategy could accelerate pediatric HIV care access in high-prevalence settings.

Growth in HIV-infected children receiving antiretroviral therapy at a pediatric infectious diseases clinic in Uganda.

Antiretroviral therapy (ART) improves growth and survival of HIV-infected individuals. We designed a retrospective cohort study to assess clinical factors associated with growth in HIV-infected children on ART in Uganda between July 2003 and March 2006. Height and weight measurements taken pre- and post-ART initiation for at least 6 months were age- and gender-standardized to CDC 2000 reference. We analyzed medical records of 749 children receiving ART. Descriptive and logistic regression analyses were conducted to identify covariates associated with risk of either stunting or being underweight. Longitudinal regression analysis with a mixed model using autoregressive covariance structure was used to compare change in height and weight before and after initiation of ART. The mean age of the study population at first visit was 7.5 years. Mean height-for-age, weight-for-age, and weight-for-height percentiles at first visit were 8.6, 7.7, and 7.9, respectively. At last visit mean height-for-age, weight-for-age, and weight-for-height percentiles were 8.6, 13.3, and 13.8, respectively. Baseline weight-for-age z score of 1 or more was protective against stunting (odds ratio [OR] 0.25, confidence interval [CI] 0.18-0.35) while baseline height-for-age z score of 1 or more was protective against becoming underweight (OR 0.75, CI 0.63-0.88). Children in World Health Organization (WHO) stages II, III, and IV at baseline were 1.5 times more likely to become underweight (OR 1.51, CI 1.07-2.14). Initiation of ART resulted in improvement in mean standardized weight-for-age z score and weight-for-age percentiles (p < 0.001). Weight-for-age percentile and z score improved significantly after initiation of ART. This pediatric population gained weight more rapidly than height after initiation of ART.