Study design
Connect was a cluster-randomized trial in geographic clusters covering 101 villages located in Rufiji, Kilombero and Ulanga Districts of Tanzania, where the Ifakara Health Institute operates a Health and Demographic Surveillance System (HDSS) that was adapted from core technology of the international agency known as the International Network of Field Sites with Continuous Demographic Evaluation of Populations and Their Health in Developing Countries (“INDEPTH Network”) [
23,
24]. In this approach, a census is taken at the onset of surveillance that defines population composition by age and familial relationships. Subsequent routine interviewer visits update database registers for deaths, births, migration in and out of households, changes in marital status, and establishment of new households [
25]. The HDSS has monitored population dynamics in parts of Kilombero and Ulanga Districts since 1996 (Ifakara HDSS) and in half of Rufiji District since 1998 (Rufiji HDSS). At the onset of Ifakara Health Institute HDSS operations, household interviews were conducted every 4 months. Since July 2013 however, household interviews to update database registers have been conducted every 6 months, in a new system that employed automated data editing and calculation of demographic rates.
Stratified randomization techniques were used to allocate 50 villages to the intervention group and 51 to the comparison group. The unit of experimental randomization was the village. In January 2010, a public drawing was organized to randomly assign villages (1:1) to intervention and comparison groups. Villages in the study area differ substantially by population size, location (rural or semi-urban), distance to the nearest health facility and health facility staffing. Stratification was segmented by four categories of village population size to ensure comparability between intervention and comparison areas. Each selected village received between one and four CHWs depending upon population size estimated in 2009. Because of the nature of services provided, it was impossible to mask the participants to their treatment status.
Objectives
The Connect Project aimed to test the child survival impact of the MMAM policy.
Its operational design aimed to be consistent with national health system structures and requirements, in order to facilitate national scale-up if results warranted such action. Candidate CHWs were required to have completed secondary school grade 10 in order to meet government employment requirements. The recruitment process was managed by Council Health Management Teams with support from the Council Education Officers to review and validate the certificates presented by candidates. Administration of the field operation was a program of the Ministry of Local Government. In this arrangement, the project awarded contracts to Council Health Management Teams, who committed resources to village governments. These local authorities were responsible for hiring, deploying, and compensating CHW. Village governments selected the candidates from a wide pool of potential CHWs who applied. The village assembly selected the finalists. They were required to be residents of the village where they would work. No salary guidelines existed for compensating CHW. However, to maintain equivalence with Government of Tanzania salary guidelines for entry level dispensary workers, all CHW were paid an annual salary in Tanzanian Shillings amounting to US$1348.21 [
26].
In compliance with government employment requirements, the duration of CHW training lasted 9 months with the goal of enabling CHW to provide the services that are summarized in Table
1. Training included orientation to human physiology, the treatment and prevention of common ailments, and community organization, as well as a supervised community-based practicum. CHWs were trained in the provision of the WHO recommended integrated management of childhood illness (IMCI) [
27,
28] Throughout the implementation period, CHWs provided family planning education, re-supply of oral contraceptives and condoms, sexually transmitted infections/HIV prevention education, safe motherhood and essential newborn care counseling, and provision of IMCI. The IMCI component involved following specific protocols to identify and treat sick children in the initial stages of uncomplicated malaria, pneumonia, or diarrhea. Treatment included antimalarial medicine (Artemether-Lumefantrine, ALu), antibiotics (Co-trimoxazole) and oral rehydration salts (ORS) with zinc sulphate, respectively [
29]. CHWs were trained to refer young infants (under 2 months) and children with severe diseases to health facilities [
30]. CHWs cooperated with Council Health Management Team planners and service providers in the coordination and household mobilization for under-5 health outreach services in communities, including those that focus on necessary immunizations, vitamin A supplementation and onchocersiasis prevention (Ivermectin). Each month, the CHWs developed a schedule of home visits and community mobilization in accordance with guidance from their supervisors. CHW training also developed core competencies in record keeping, community problem identification, planning, service implementation, monitoring and evaluation, and disease prevention outreach including water, sanitation and hygiene, nutrition, health education, and counseling [
19].
Table 1
Services provided by CHW for treatment community residents, by age category
Neonates | Essential newborn care: Immediate post partum home visits, Referral for sick children, |
Promotion of postnatal care |
Referral of low birth weight children & follow-up for “kangaroo mothercare.” |
Neonates and post-neonates | Immunization of newborns: Tetanus, DPT, BCG, |
Comprehensive expanded program on immunization |
Infancy and childhood | Community and doorstep provision of integrated management of childhood illness |
Promotion of safe water, sanitation, and hygiene |
Adolescence | Youth friendly reproductive health promotion, including HIV awareness and prevention. |
Adulthood | Treatment of common ailments: Malaria, respiratory infections, diarrheal diseases |
Family planning promotion and referral; family planning service provision for condoms and oral contraceptives. |
Health promotion: HIV and sexually transmitted diseases |
Pregnancy and intrapartum care: Pregnancy monitoring and doorstep promotion of antenatal care, skilled delivery, and birth spacing. Emergency referral for acute care needs. |
Promotion of health insurance enrollment, emergency care awareness, and service fee policies. |
After the training, CHWs were deployed to their villages as Council Authority employees, remunerated accordingly, and equipped with a mobile phone, bicycle, basic medical supplies and medicines, and service delivery registers. Each CHW was supervised by a Council Health Management Team consisting of a Connect field coordinator, village authorities, and health workers posted in a nearby health facility. Each Council Health Management Team received training in supportive supervision.
Because of training facility availability constraints, CHWs were trained in two batches and deployed in 25 villages in Ifakara and Rufiji HDSS areas in August of 2011 and in 25 remaining villages in August of 2012. Therefore, the start dates of exposure to the program varied by cluster. All clusters that received CHW in 2012 were treated as comparison villages for the period from August 2011 through July 2012. A total of 142 paid CHWs were deployed in the 50 intervention villages. Connect was implemented from August of 2011 through June of 2013 by a project team of the Ifakara Health Institute During this period, CHW services were comprised of household visits and their mobilization of men’s and women’s groups for discussion of specific health topics, with logistics support for essential drugs provided by staff of the Ifakara Health Institute. In 2013, the governing steering committee of the project integrated all logistics support for the project CHW operations into routine mechanisms of the Ministry of Health and Social Welfare. Although this action did not change the experimental design, the operational changes imposed were tantamount to transitioning the project from a randomized cluster trial to an embedded research design [
31].
Donor support fully financed project implementation for the first 2 years. During this initial phase, Connect functioned as a primary research trial of the efficacy of CHW deployment. Starting in year 3 of the intervention (July 2013), the implementation of health system support functions, including supervision, logistics, and pharmaceutical supply, was managed by the local government authorities, with technical assistance and financial support for all intervention components, except CHW salaries which were vested in administrative mechanisms of district authorities.
This approach to project management in years 3 and 4 of the project, shifted the trial from an assessment of CHW efficacy to an assessment of the overall system of community-based care effectiveness, in the manner of assuming that the general administration of the scheme was a component of the trial. This effectiveness assessment phase, termed “embedded science,” was intended to maximize integration of project activities into public sector management mechanisms that would ultimately assume responsibility for the large scale utilization of results [
31,
32]. Connect staff continuously monitored implementation through field visits and communication and coordination with the Council Health Management Teams responsible for sustaining the flow of resources to communities, and local government officials responsible supervising each CHW.
To ensure health service quality, a dual supervisory system was specified whereby dispensary paramedics maintained oversight of service operations. Local Ministry of Health and Social Welfare dispensary staff also managed the distribution of medicines, supplies and salaries, and continuously recorded implementation problems such as stock-outs of essential medicines and supplies and periods during which salaries were not paid. Meticulous record keeping throughout implementation identifies for each village the months in which the program was or was not implemented according to plan, permitted the imposition of time conditional parameters for the degree of implementation in the statistical analysis of impact.
No paid CHW intervention was planned for the comparison villages. In some comparison villages, there were volunteer CHW and traditional birth attendants who had previously been trained and deployed many years before the trial. Although they did not receive any support from the project during the trial, they may have benefitted from annual vaccination campaigns and may have engaged in some community-based health promotion services. To assess contamination bias, we analyzed the services delivered at the facility level in comparison villages and survey responses. The intervention did not improve the quality and content of care at standard health facilities, as these services were shared by people in both intervention and comparison villages. Health facilities in the study areas were mainly dispensaries with two or three staff members, a consultation room and a basic delivery room. Only one regional hospital was available within the study area in Kilombero. Kilombero also had three health centers and Ulanga had one health center. Rufiji had one private hospital and two health centers. No evidence of contamination bias emerged from analysis of data collected in 2011 and 2013.
Secondary objectives
Although several measures of morbidity, mortality, health seeking behavior, health service utilization, and program implementation were assessed as specified outcomes, this paper assesses the primary outcome that the Connect CHW program was designed to evaluate: Whether or not the CHW program reduced the under-5 mortality rate, under 5 mortality rate (5q0), defined as the probability of dying between birth and age-5. Testing the effect of Connect on the neonatal mortality rate and the infant mortality rate (1q0) are also evaluated.
Data used to derive primary and secondary measures were obtained longitudinally through analysis of HDSS data. Other coverage and maternal and child behavioral outcomes were measured continuously using the HDSS and augmented with additional data from household surveys at baseline and endline. This monitoring included the assessment of a range of health outcomes which are not presented in this paper, including the maternal mortality ratio and adult mortality rates, childhood morbidity, cause of death distribution for children under-five, life years gained, coverage of health services (e.g., rates of antenatal care, skilled attendance at birth, facility delivery, post-natal care, immunization, treatment with oral rehydration solution (ORS), antimalarial medicines, and antibiotics and contraceptive prevalence) the total fertility rate, parental health seeking behaviors during child illness, and other parental health behaviors such as prevalence of immediate and exclusive breastfeeding.