Contributions to the literature
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This protocol demonstrates how to utilize implementation science methodologies to conduct a pragmatic trial in a low-income setting in order to improve service delivery and apply findings into practice.
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It provides a model for embedded implementation research in public sector service delivery to facilitate demand-driven research and adoption of scientific findings into policy implementation. Close collaboration and ownership amongst practitioners, policymakers, and researchers are crucial to address research questions for policy change of empirical value to local communities.
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This study will evaluate the effectiveness and implementation strategy of an integrated facility- and community-based initiative within a low-income health system and aims to provide generalizable evidence to policymakers that inform national community health strategy decisions.
Background
Context and Integrated Community-Based Health Systems Strengthening model
ICBHSS model component | Details | |
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1. | Community engagement meetings and feedback | - Pre-intervention consultation meetings with community leaders. - Community participation in CHW selection. - Biannual community review meetings with local leaders, community members, facility, and IH staff. - IH staff presentation of programmatic results and updates. - Community-provided feedback on ICBHSS implementation challenges, successes, and areas for improvement. |
2. | Removal of point-of-care costs in IH intervention public sector health facilities | - Pertains to all children under five, pregnant/post-partum women, women of reproductive age for family planning services, and people living with HIV infections who seek care at study sites. - Includes facility-based consultation fees, medications, supplies, and services provided at IH intervention sites and advanced care referrals at the district or regional hospital. - Selected fees and coverage population chosen in consultation with MoH and based on national and global guidelines. |
3. | Proactive community-based IMCI using trained, equipped, supervised, and salaried CHWs with additional services including linkage to family planning and counseling, HIV testing, and referrals | - Candidate selection from community by local leadership, health facility, and IH staff. - Preference for female residents who meet selection criteria (some literacy, pre-test/post-test results, demonstrated related competencies). - Pre-service 23-day training in IMCI, maternal health, and HIV counseling and testing led by MoH and IH staff. - In-service 5-day training in family planning and counseling led by MoH and IH staff. - All training materials developed in consultation with MoH and based on national/global guidelines and evidence-based materials from Association Togolaise pour le Bien-Être Familial, Better Birth Project, Last Mile Health, Muso, and Partners In Health. - Equipped with materials (training guides, backpacks, timers, thermometers, scales, MUACs, rapid tests, medical treatment for basic IMCI cases, notebooks, pens). - CWH consultations, referrals, medicines, and materials are provided free of charge. - Supportive supervision with coaching and mentoring by IH supervisor (nurse/medical assistant). - Regular observation of CHW service delivery through routine programmatic data and community feedback. - CHWs receive a regular equitable salary for full-time work through proactive case seeking and follow-up. |
4. | Clinical mentoring and enhanced supervision by a trained peer coach at public sector health facilities | - Onsite pre-service 4-day training in maternal, reproductive, neonatal, and child health and HIV led by IH clinical mentor (nurse/medical assistant) and medical director. - Training materials developed in collaboration with MoH and based on national/global guidelines and evidence-based materials from WHO, American Academy of Pediatrics, Ariadne Labs, Better Birth Project, Last Mile Health, Muso, and Partners In Health. - Weekly facility-based supportive supervision by IH clinical mentors (nurses, midwives, medical assistants) with prior experience in public sector health facilities. - Regular observation of facility staff service delivery through routine programmatic data and community feedback. |
5. | Basic infrastructure/equipment improvements and supply chain management training of pharmacy managers | - Formal infrastructure assessment and equipment needs with MoH using WHO’s SARA tool [41]. - Facilitate structural improvements to improve care delivery. - Equip facility with essential medicines and equipment identified by assessment and national health protocols. - Onsite training in supply-chain management practices, including proper storage of medicines, filling of stock cards, and orders based on average monthly input consumption. - Regular supervision and support by IH clinical mentor. |
Rationale for study design
Methods/design
Study aims
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Primary aim 1: effectiveness(1)Analyze longitudinal changes in maternal and child mortality and morbidity, quality of care parameters, and public sector facility readiness in catchment areas.
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Primary aim 2: implementation strategy(1)Identify barriers and facilitators contributing to access and quality of ICBHSS services;(2)Measure changes in coverage, health service utilization rates, and intervention adoption;(3)Determine ICBHSS implementation costs and return-on-investment estimates.
Design
Stepped-wedge cluster randomized control trial
Health facility assessments
Key informant interviews
Costing and return-on-investment assessment
Study setting
District | Study site | Catchment population* | Facility utilization rate** |
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Bassar | Bangéli | 16,169 | 42% |
Bassar | Kabou-Sara | 10,054 | 56% |
Bassar | Koundoum | 7,428 | 37% |
Bassar | Manga | 5,006 | 28% |
Bassar | Sanda-Afohou | 5,514 | 43% |
Binah | Asseré | 4,446 | 19% |
Binah | Boufalé | 4,212 | 48% |
Binah | Kouyorira | 4,364 | 26% |
Binah | N’Djei | 3,258 | 53% |
Binah | Pessaré | 8,002 | 26% |
Binah | Sirka | 5,980 | 51% |
Binah | Solla | 5,960 | 58% |
Dankpen | Koutière | 13,097 | 12% |
Dankpen | Kpétab | 8,208 | 22% |
Dankpen | Naware | 19,531 | 10% |
Dankpen | Solidarité | 8,157 | 24% |
Kéran | Kokou-Temberma | 8,722 | Unknown |
Kéran | Nadoba | 16,593 | Unknown |
Kéran | Natiponi | 7,636 | Unknown |
Kéran | Pangouda | 10,735 | Unknown |
Kéran | Warengo | 8,039 | Unknown |
Inclusion criteria
Community-based household surveys
Health facility surveys
Key informant interviews
Sample size determination
Randomization
Data collection and analysis
Study aim | RE-AIM framework domain | Outcome(s)/indicator(s) | Data source | Indicator definition/clarification |
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Study aim I: implementation strategy | Reach |
Health service coverage
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CHW home visits | Community-based household survey | Proportion of participants in the last year reporting a home visit by an IH CHW. | ||
CHW home treatment | Community-based household survey | Proportion of participants in the last year reporting treatment at home by an IH CHW | ||
Health facility treatment | Community-based household survey | Proportion of participants in the last year reporting care at a health facility. | ||
Early service access for child health
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Malaria coverage | Community-based household survey | Proportion of children under five reported febrile receiving guideline-based treatment within 24 h of symptom onset. | ||
Pneumonia coverage | Community-based household survey | Proportion of children under five with a cough and proportion of those receiving guideline-based treatment within 24 h of symptom onset. | ||
Gastrointestinal illness coverage | Community-based household survey | Proportion of children under five with diarrhea receiving guideline-based treatment within 24 h of symptom onset. | ||
Malnutrition coverage | Community-based household survey | Proportion of children under five with malnutrition receiving effective treatment. | ||
Coverage estimate of prenatal care | Community-based household survey | Proportion of pregnant women in the last two years who completed four ANC visits. | ||
Percentage of births at healthcare facility | Community-based household survey | Proportion of pregnant women in the last two years who delivered in a health facility | ||
Percentage of births at home |
Community-based household survey
| Proportion of pregnant women who delivered at home in last 2 years. | ||
Coverage estimate of post-natal care | Community-based household survey | Proportion of post-partum women who received post-natal care in last 2 years. | ||
Study aim 2: effectiveness | Effectiveness |
Primary outcome
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Children under five mortality rate | Community-based household survey | Using a standard birth/death history table, calculate under-five mortality rates, and compare risk of death before age five across surveys with the Cox proportional hazards regression using survey year as the explanatory variable. Children still alive and under age five at the time of survey will be right censored. | ||
Secondary outcomes
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Neonatal mortality rate | Community-based household survey | The neonatal mortality rates from all births reported by respondents in the 5 years prior to the survey using the same methods described for under-five mortality, adjusted for 28 days. | ||
Children under one mortality rate | Community-based household survey | The under-one mortality rates from all births reported by respondents in the 5 years prior to the survey using the same methods described for under-five, adjusted for 1 year. | ||
Children under two mortality rate | Community-based household survey | The under-two mortality rates from all births reported by respondents in the 5 years prior to the survey using the same methods described for under-five, adjusted for 2 years. | ||
Maternal mortality rate | Community-based household survey | |||
Quality of care parameters | ||||
Timeliness/promptitude of child care for malaria | Routine programmatic data | Proportion of children under five reported febrile and the proportion who received effective antimalarial treatment within 24 h of symptom onset. | ||
Timeliness/promptitude of child care for pneumonia | Routine programmatic data | Proportion of children under five reported with cough and the proportion of those children who received an effective pneumonia treatment within 24 h of symptom onset. | ||
Timeliness/promptitude of child care for diarrhea | Routine programmatic data | Proportion of children under five reported with diarrhea and the proportion of those children who received an effective treatment for diarrheal disease within 24 h of symptom onset. | ||
CHW technical competence | Routine programmatic data | Proportion of IH CHWs who adhere to evidence-based protocols for iCCM and maternal health. | ||
Facility clinical staff technical competence | Routine programmatic data | Proportion of facility clinical staff who adhere to evidence-based protocols for iCCM and maternal health. | ||
Equitable | Community-based household survey | Access differences in child mortality between maternal wealth quintiles, distance to facility, and education level. | ||
Healthcare readiness score | Health facility assessments | Examine facility changes in procurement, physical infrastructure, and management through annual readiness score [41]. | ||
Study aim I : implementation strategy | Adoption |
Community-level engagement
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Community engagement sessions | Routine programmatic data | Number of community forums and community members in attendance. | ||
Participant-level behavior change
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Child care cascades for fever, pneumonia, and diarrhea | Community-based household survey | Changes in childcare-seeking behavior over time for fever, pneumonia, and diarrhea in patients presenting to health clinic, CHW, or non-clinical site. Test if these proportions increased using the same approach to mixed-effects generalized linear models as described in the primary effectiveness outcome measure. | ||
Women of reproductive age cascade for antenatal care, facility-based delivery, and post-natal care | Community-based household survey | Changes in pregnant women care-seeking behavior over time, services delivered by IH CHWs, facility-based delivery, as well as antenatal care and post-natal care attendance. Test if these proportions increased using the same approach to mixed effects generalized linear models as described in the primary effectiveness outcome measure. | ||
Study aim I : implementation strategy | Implementation |
Qualitative interviews
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Fidelity | Key informant interviews | Degree that intervention(s) were implemented as planned in original protocol. | ||
Feasibility | Key informant interviews | Extent that an intervention can be carried out in a particular setting. | ||
Outer context [59] | Key informant interviews | Macro-level external factors including social, funding, and leadership. | ||
Inner context [59] | Key informant interviews | Micro-level internal factors including IH/MoH partnership, distinct issues about IH and MoH roles, feedback, facility, community, household, and individual level. | ||
Study aim I : implementation strategy | Maintenance |
Costing and return-on-investment assessment
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Annual price per capita | Costing surveys | Price per capita compared to current MoH funding using the Community Health Planning and Costing Tool [48] at the cluster level. | ||
Return on investment | Costing surveys |