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Scaling bundled health services in rural Sierra Leone

Randomized controlled trial of bundled health services in rural Sierra Leone

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN61885353
Enrollment
90000
Registered
2024-11-16
Start date
2024-11-11
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of infectious diseases Infections and Infestations

Interventions

The Sierra Leone Ministry of Health will deploy Health Outreach Teams (HOT) for a door-to-door delivery of a bundle of child immunizations, HPV vaccination for teenage girls, and health products. HOTs

Sponsors

Wageningen University & Research
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: We primarily focus on households in rural communities that have either (i) at least one child under 5, and/or (ii) at least one girl aged 10-17. We will refer to these households as “project households” hereafter. A household is defined as a group of people who have usually slept in the same dwelling and taken their meals together for at least 9 of the 12 months preceding the interview (except for infants). If there is any ambiguity (e.g. children of the household head who have been studying another district in the last year), we consider the household members to be part of a single financial unit to determine whether they are part of the household. Inclusion criteria for health intervention activities (led by the MoH and CWW). Inclusion criteria are set by MoH: 1. All members of communities assigned to treatment conditions in our study are eligible to receive relevant information through participation in a sensitization/information campaign implemented at the community level 2. Project households: 2.1. Where children under 5 are eligible to receive Routine child immunization and deworming, Vitamin A, IPTi ORS/Zinc: 2.2. Girls age 10 – 17 are eligible for the HPV vaccine 3. Both types of households are eligible to receive Chlorine tablets. Inclusion criteria for research activities (led by the research team): 1. All individuals aged 18 or older residing in study communities are eligible to be interviewed in the census. Respondents must consent to the survey. 2. All individuals aged 18 or above from project households are eligible to be interviewed for subsequent surveys. In addition, we include a sample of up to 20 non-project households. Information pertaining to the vaccination status of teens and children and/or the use of health products (ORS/Zinc, IPTi, Vitamin A supplementation, chlorine and deworming) will be collected from the caregivers. Respondents must consent to the survey.

Exclusion criteria

Exclusion criteria: Exclusion criteria for health intervention activities (led by the MoH and CWW). Exclusion criteria are set by MoH. For health products: Project households where caregivers do not consent to receive health products. For Vaccines 1. Children in the eligible age range whose caregivers do not consent. 2. Children outside the age range. 3. Children under 5 are not eligible to receive vaccines 4. Girls aged 10-17 are not eligible to receive the HPV vaccine. 5. Children in the eligible age range who may experience severe adverse effects from the vaccination due to co-morbidities or other exclusion criteria set by MoH. Exclusion criteria for research activities (led by the research team): Non-consenting survey respondents.

Design outcomes

Primary

MeasureTime frame
1. For H1: Verified vaccination status for routine childhood immunization, HPV and health products or young children (Vit A, Deworming, IPTi) amongst the eligible population, measured using vaccine cards, at baseline, 3- and 6-month follow-up 2. For H2: The availability or verified use of chlorine amongst the project households, measured using household surveys and chlorine strips at baseline, 3- and 6-month follow-up

Secondary

MeasureTime frame
The following secondary outcome measures will be assessed at baseline, and the 3- and 6-month follow-up: 1. For SH1: Reported use of ORS/Zinc to treat diarrhea amongst children 0 to 5 years in project households, measured using survey question (yes/no) 2. For SH2: Knowledge of vaccines and health products score amongst adult caregivers in project households, measured using a survey based knowledge index 3. For SH3: Attitudes toward vaccines and health products score amongst adult caregivers in project households, measured using survey based attitude index 4. For SH4: Reported incidence of malaria amongst children 0 to 5 years in eligible population, measured using survey question (yes/no) 5. For SH5: Reported incidence of diarrhea amongst children 0 to 5 years in project households, measured using survey question (yes/no) 6. For SH6: Reported incidence of diarrhea amongst children above 5 and adults in project households, measured using survey question (yes/no) 7. For SH7: Reported use of ORS/Zinc to treat diarrhea amongst children above 5 and adults in project households, measured using survey question (yes/no) 8. For SH8: Reported incidence of malaria amongst children above 5 and adults in project households, measured using survey question (yes/no) 9. For SH9: Reported incidence of diarrhea in non-project households, measured using survey question (yes/no) 10. For SH10: Reported household expenditures on curative health expenditures in project households, measured using survey question (yes/no) Outcomes for longer run analysis will be specified as part of a separate registration at a later stage.

Countries

Sierra Leone

Contacts

Public ContactMaarten Voors
maarten.voors@wur.nl+31 317 484879

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026