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The provision of high-quality antenatal care (ANC) is important for preventing maternal and newborn mortality and morbidity, but only around half of pregnant women in Tanzania attended four or more ANC visits in 2019. Although there is emerging evidence on the benefit of community health worker (CHW) interventions on ANC uptake, few large-scale pragmatic trials have been conducted. This pragmatic cluster-randomized trial, implemented directly through the public sector health system, assessed the impact of an intervention that trained public sector CHWs to promote uptake of ANC. We randomized 60 administrative wards in Dar es Salaam to either a targeted CHW intervention or standard of care. The impact of the intervention was assessed using generalized estimating equations (GEE) with an independent working correlation matrix to account for clustering within wards. A total of 243,908 women were included in the analysis of our primary outcome of four or more ANC visits. The intervention significantly increased the likelihood of attending four or more ANC visits (RR 1.42; 95% CI: 1.05, 1.92), and had a modest beneficial effect on the total number of ANC visits (percent change: 7.7%; 95% CI: 0.2%, 15.5%). While slightly more women in the intervention arm attended ANC in their first trimester compared to the standard-of-care arm (19% vs 18.7%) the difference was not significant (RR:1.02; 95% CI: 0.84, 1.22). Our findings suggest that trained CHWs can increase attendance of ANC visits in Dar es Salaam and similar settings. However, additional interventions appear necessary to promote early initiation of ANC. This study demonstrates that routine health systems data can be leveraged for outcome assessment in trials and program evaluation, and that the results are likely superior, both in terms of bias and precision, to data that is collected specifically for science. [ABSTRACT FROM AUTHOR]

Background: Home delivery and late and infrequent attendance at antenatal care (ANC) are responsible for substantial avoidable maternal and pediatric morbidity and mortality in sub-Saharan Africa. This cluster-randomized trial aimed to determine the impact of a community health worker (CHW) intervention on the proportion of women who (i) visit ANC fewer than 4 times during their pregnancy and (ii) deliver at home.Methods and Findings: As part of a 2-by-2 factorial design, we conducted a cluster-randomized trial of a home-based CHW intervention in 2 of 3 districts of Dar es Salaam from 18 June 2012 to 15 January 2014. Thirty-six wards (geographical areas) in the 2 districts were randomized to the CHW intervention, and 24 wards to the standard of care. In the standard-of-care arm, CHWs visited women enrolled in prevention of mother-to-child HIV transmission (PMTCT) care and provided information and counseling. The intervention arm included additional CHW supervision and the following additional CHW tasks, which were targeted at all pregnant women regardless of HIV status: (i) conducting home visits to identify pregnant women and refer them to ANC, (ii) counseling pregnant women on maternal health, and (iii) providing home visits to women who missed an ANC or PMTCT appointment. The primary endpoints of this trial were the proportion of pregnant women (i) not making at least 4 ANC visits and (ii) delivering at home. The outcomes were assessed through a population-based household survey at the end of the trial period. We did not collect data on adverse events. A random sample of 2,329 pregnant women and new mothers living in the study area were interviewed during home visits. At the time of the survey, the mean age of participants was 27.3 years, and 34.5% (804/2,329) were pregnant. The proportion of women who reported having attended fewer than 4 ANC visits did not differ significantly between the intervention and standard-of-care arms (59.1% versus 60.7%, respectively; risk ratio [RR]: 0.97; 95% CI: 0.82-1.15; p = 0.754). Similarly, the proportion reporting that they had attended ANC in the first trimester did not differ significantly between study arms. However, women in intervention wards were significantly less likely to report having delivered at home (3.9% versus 7.3%; RR: 0.54; 95% CI: 0.30-0.95; p = 0.034). Mixed-methods analyses of additional data collected as part of this trial suggest that an important reason for the lack of effect on ANC outcomes was the perceived high economic burden and inconvenience of attending ANC. The main limitations of this trial were that (i) the outcomes were ascertained through self-report, (ii) the study was stopped 4 months early due to a change in the standard of care in the other trial that was part of the 2-by-2 factorial design, and (iii) the sample size of the household survey was not prespecified.Conclusions: A home-based CHW intervention in urban Tanzania significantly reduced the proportion of women who reported having delivered at home, in an area that already has very high uptake of facility-based delivery. The intervention did not affect self-reported ANC attendance. Policy makers should consider piloting, evaluating, and scaling interventions to lessen the economic burden and inconvenience of ANC.Trial Registration: ClinicalTrials.gov NCT01932138. [ABSTRACT FROM AUTHOR]

Background: Mother-to-child transmission of HIV remains an important public health problem in sub-Saharan Africa. As HIV testing and linkage to PMTCT occurs in antenatal care (ANC), major challenges for any PMTCT option in developing countries, including Tanzania, are delays in the first ANC visit and a low overall number of visits. Community health workers (CHWs) have been effective in various settings in increasing the uptake of clinical services and improving treatment retention and adherence. At the beginning of this trial in January 2013, the World Health Organization recommended either of two medication regimens, Option A or B, for prevention of mother-to-child transmission of HIV (PMTCT). It is still largely unclear which option is more effective when implemented in a public healthcare system. This study aims to determine the effectiveness, cost-effectiveness, acceptability, and feasibility of: (1) a community health worker (CWH) intervention and (2) PMTCT Option B in improving ANC and PMTCT outcomes. Methods/Design: This study is a cluster-randomized controlled health systems implementation trial with a two-by-two factorial design. All 60 administrative wards in the Kinondoni and Ilala districts in Dar es Salaam were first randomly allocated to either receiving the CHW intervention or not, and then to receiving either Option B or A. Under the standard of care, facility-based health workers follow up on patients who have missed scheduled appointments for PMTCT, first through a telephone call and then with a home visit. In the wards receiving the CHW intervention, the CHWs: (1) identify pregnant women through home visits and refer them to antenatal care; (2) provide education to pregnant women on antenatal care, PMTCT, birth, and postnatal care; (3) routinely follow up on all pregnant women to ascertain whether they have attended ANC; and (4) follow up on women who have missed ANC or PMTCT appointments. [ABSTRACT FROM AUTHOR]

Background: There is a dearth of evidence on the causal effects of different care delivery approaches on health system satisfaction. A better understanding of public satisfaction with the health system is particularly important within the context of task shifting to community health workers (CHWs). This paper determines the effects of a CHW program focused on maternal health services on public satisfaction with the health system among women who are pregnant or have recently delivered.Methods: From January 2013 to April 2014, we carried out a cluster-randomized controlled health system implementation trial of a CHW program. Sixty wards in Dar es Salaam, Tanzania, were randomly allocated to either a maternal health CHW program (36 wards) or the standard of care (24 wards). From May to August 2014, we interviewed a random sample of women who were either currently pregnant or had recently delivered a child. We used five-level Likert scales to assess women's satisfaction with the CHW program and with the public-sector health system in Dar es Salaam.Results: In total, 2329 women participated in the survey (response rate 90.2%). Households in intervention areas were 2.3 times as likely as households in control areas to have ever received a CHW visit (95% CI 1.8, 3.0). The intervention led to a 16-percentage-point increase in women reporting they were satisfied or very satisfied with the CHW program (95% CI 3, 30) and a 15-percentage-point increase in satisfaction with the public-sector health system (95% CI 3, 27).Conclusions: A CHW program for maternal and child health in Tanzania achieved better public satisfaction than the standard CHW program. Policy-makers and implementers who are involved in designing and organizing CHW programs should consider the potential positive impact of the program on public satisfaction.Trial Registration: ClinicalTrials.gov, EJF22802. [ABSTRACT FROM AUTHOR]

Background: Mother-to-child transmission of HIV remains an important public health problem in sub-Saharan Africa. As HIV testing and linkage to PMTCT occurs in antenatal care (ANC), major challenges for any PMTCT option in developing countries, including Tanzania, are delays in the first ANC visit and a low overall number of visits. Community health workers (CHWs) have been effective in various settings in increasing the uptake of clinical services and improving treatment retention and adherence. At the beginning of this trial in January 2013, the World Health Organization recommended either of two medication regimens, Option A or B, for prevention of mother-to-child transmission of HIV (PMTCT). It is still largely unclear which option is more effective when implemented in a public healthcare system. This study aims to determine the effectiveness, cost-effectiveness, acceptability, and feasibility of: (1) a community health worker (CWH) intervention and (2) PMTCT Option B in improving ANC and PMTCT outcomes.Methods/design: This study is a cluster-randomized controlled health systems implementation trial with a two-by-two factorial design. All 60 administrative wards in the Kinondoni and Ilala districts in Dar es Salaam were first randomly allocated to either receiving the CHW intervention or not, and then to receiving either Option B or A. Under the standard of care, facility-based health workers follow up on patients who have missed scheduled appointments for PMTCT, first through a telephone call and then with a home visit. In the wards receiving the CHW intervention, the CHWs: (1) identify pregnant women through home visits and refer them to antenatal care; (2) provide education to pregnant women on antenatal care, PMTCT, birth, and postnatal care; (3) routinely follow up on all pregnant women to ascertain whether they have attended ANC; and (4) follow up on women who have missed ANC or PMTCT appointments.Trial Registration: ClinicalTrials.gov: EJF22802. Registration date: 14 May 2013. [ABSTRACT FROM AUTHOR]