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Trial registered on ANZCTR


Registration number
ACTRN12618000609257
Ethics application status
Approved
Date submitted
1/04/2018
Date registered
19/04/2018
Date last updated
19/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can community health worker home visiting improve care seeking and health service use in fragile states such as Afghanistan? A population based intervention study
Scientific title
Can community health worker home visiting improve care seeking and health service use in fragile states such as Afghanistan? A population based intervention study
Secondary ID [1] 294480 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Newborn mortality 307243 0
Condition category
Condition code
Public Health 306361 306361 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention was a standardised training and supportive supervision package aimed at improving CHW capacity to provide maternal and neonatal home visits and behaviour change communication (BCC) messages from as early as possible in the antenatal period to 28 days postpartum. It was specifically targeted to female CHWs in the study area. All (100%) 289 female CHWs in the study area received the training package.
The intervention had five components. (i) Structured home visiting schedule. Each CHW was trained to provide eight home visits (four during the antenatal period and four in the postnatal period (day 1, day 3, day 7, day 28) and to provide health promotion and BCC messages at each visit. (ii) Structured and simplified MCH BCC training ‘curriculum’. This was based on the standardised World Health Organization (WHO) UNICEF CHW training package. It included topics that the CHW should provide to mothers at the home visits about: birth preparedness, care seeking for ANC, delivery care, and newborn care (including hygiene, nutrition, thermal care, danger signs for illness). As most of the CHWs in Afghanistan cannot read or write, locally appropriate tools were developed and pretested including pictorial counselling flip cards for birth preparedness, antenatal care, facility delivery, newborn greetings, postnatal care of mother and newborn, and maternal and newborn danger signs. Each training session lasted for five days and was followed by three 4-hour ‘on the job’ refresher sessions over a twelve month intervention period. (iii) Structured ‘Training of Trainers’ (ToT) program. Two female government supervisors, one per district, were trained over a five day period using the locally developed tools and training curriculum. The supervisors then provided training to the female CHWs as described above. (iv) Supportive supervision program. The female CHWs were visited once per month by the supervisors over a period of 12 months to provide advice and monitoring. These visits included both scheduled and random unscheduled visits. (v) Performance based incentive program. CHWs were provided with a family kit (consisting of cooking and eating utensils including pots, plates, spoons, towels and soap) for their own use at the beginning of the project if they mapped and registered pregnant women in their catchment areas. They were provided with an additional kit if the woman delivered at a health facility
Intervention code [1] 300776 0
Prevention
Comparator / control treatment
The control districts received standard care by CHWs who did not receive specific training in MCH and BCC. All health facilities in the intervention and control areas received a health system strengthening (HSS) package over the 12 months prior to the intervention delivery and throughout the intervention period. This included: (i) the standard WHO/UNICEF training package to midwives and neonatal nurses in essential newborn care (ENC) and Emergency Obstetric and Newborn Care (EmONC) and (ii) training to local community health action groups (CHAGs) in essential antenatal and newborn care.
Control group
Active

Outcomes
Primary outcome [1] 305374 0
The primary outcome measure was the proportion of women who reported delivering in a health facility in the study area (patient reported).
Timepoint [1] 305374 0
Measured at endline ie 12 months after the intervention commenced ( and 28 days postnatal).
Secondary outcome [1] 344983 0
Proportion of women who received at least one ANC visit (self reported)
Timepoint [1] 344983 0
Measured at endline ie 12 months after the intervention commenced (28 days postnatal).
Secondary outcome [2] 345220 0
Proportion of women who received at least one PNC visit (self reported)
Timepoint [2] 345220 0
Measured at endline ie 12 months after the intervention commenced (28 days post natal)
Secondary outcome [3] 345221 0
Proportion of women who initiated breastfeeding within 1 hour postnatal (self reported)
Timepoint [3] 345221 0
Measured at endline ie 12 months after the intervention commenced (28 days postnatal)

Eligibility
Key inclusion criteria
All pregnant women regardless of gestation who live in the study area (ie the whole geographic area of Arghandab, Dand, Bamyan, Yakawalang intervention districts and the whole geographic area of Speenboldak, Daman, Panjab and Waras control districts.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusions

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nil
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We used a multivariable ‘’difference-in-differences’’ approach to estimate the mean effect of the intervention on each outcome. The ‘’difference-in-differences’’ approach is based on comparing mean differences in the intervention group (before and after the intervention) to mean differences in the control group and assumes that trends in both groups are the same in the absence of the intervention. Multivariable linear regression models were constructed to adjust for clustering by district and potential confounders decided a priori and to calculate adjusted mean differences (AMD), 95% confidence intervals (95% CI) and corresponding p values. SAS version 9.4 was used for all analyses.
In the endline sample we also assessed whether attending ANC, knowledge about birth preparedness, or socio demographic factors were associated with facility or SBA-attended birth. Log Binomial and Poisson models with robust variances were used to estimate adjusted relative risks, 95% CIs, and corresponding p values.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2016
Date of last participant enrolment
Anticipated
Actual
31/03/2017
Date of last data collection
Anticipated
Actual
30/04/2017
Sample size
Target
2780
Accrual to date
Final
2780
Recruitment outside Australia
Country [1] 10248 0
Afghanistan
State/province [1] 10248 0
Multiple

Funding & Sponsors
Funding source category [1] 299106 0
Charities/Societies/Foundations
Name [1] 299106 0
Unicef
Country [1] 299106 0
Afghanistan
Primary sponsor type
Charities/Societies/Foundations
Name
UNICEF
Address
UNICEF Afghanistan, UNOCA compound, Jalalabad Road, Kabul, Afghanistan
Country
Afghanistan
Secondary sponsor category [1] 298361 0
None
Name [1] 298361 0
Address [1] 298361 0
Country [1] 298361 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300038 0
Afghanistan Ministry of Public Health IRB
Ethics committee address [1] 300038 0
Ethics committee country [1] 300038 0
Afghanistan
Date submitted for ethics approval [1] 300038 0
01/10/2015
Approval date [1] 300038 0
02/12/2015
Ethics approval number [1] 300038 0
361521

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82350 0
Dr Karen Edmond
Address 82350 0
Unicef Afghanistan, UNOCA Compound, Jalalabad Road, Kabul, Afghanistan
Country 82350 0
Afghanistan
Phone 82350 0
+93 730717600
Fax 82350 0
Email 82350 0
kedmond@unicef.org
Contact person for public queries
Name 82351 0
Karen Edmond
Address 82351 0
Unicef Afghanistan, UNOCA Compound, Jalalabad Road, Kabul, Afghanistan
Country 82351 0
Afghanistan
Phone 82351 0
+93 730717600
Fax 82351 0
Email 82351 0
kedmond@unicef.org
Contact person for scientific queries
Name 82352 0
Karen Edmond
Address 82352 0
Unicef Afghanistan, UNOCA Compound, Jalalabad Road, Kabul, Afghanistan
Country 82352 0
Afghanistan
Phone 82352 0
+93 730717600
Fax 82352 0
Email 82352 0
kedmond@unicef.org

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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