Pregnancy RelatedNCT03188237
AfyaJamii (Parenting Well): Evaluating the Feasibility of a Group Antenatal/Well-child Care Model in Pregnancy in Kenya
A study testing AfyaJamii in people with Pregnancy Related and Group, Peer, run by Moi University at 1 site in Kenya.
Trial summary
This proposal is a program evaluation of a group care delivery model designed for pregnant women that was implemented as a pilot project in Teso District, Kenya in 2012. Read more about this study
- Who is it for?
- Ages Up to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Group, Peer
- What is being tested?
- AfyaJamii
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteKenya
- Study dates
- Jan 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All facilities that participated in AfyaJamii
Who cannot join
- Any facility that did not offer AfyaJamii and was not been selected as a comparison facility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AfyaJamii (Parenting Well): Evaluating the Feasibility of a Group Antenatal and Well-child Care Model in Pregnancy in Kenya
This proposal is a program evaluation of a group care delivery model designed for pregnant women that was implemented as a pilot project in Teso District, Kenya in 2012.
Read the detailed description
The investigators will carry out a pre/post evaluation of this program comparing maternal and child health indicators collected at the facility and at 10 comparison facilities in the year prior to implementation (2012) and throughout the duration of the program (2013-2014). They will also analyze program attendance records, anonymous exit surveys, and training records.
- Conditions
- Pregnancy Related, Group, Peer
- Being tested
- AfyaJamii
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfyaJamiiBehavioural
AfyaJamii is a group antenatal and well-child care program developed in Kenya for use in Kenyan health centers
| Study group | Role | What they receive |
|---|---|---|
| AfyaJamii facility | Experimental | Facilities using AfyaJamii Receives: Behavioral: AfyaJamii |
| Referent facility | No intervention | Facilities using Focused Antenatal Care Individual Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facility 4 Antenatal Care (ANC) visits
Average monthly number 4 or more ANC facility visits
Measured: 18 months
Secondary outcomes (4)
Facility New Family Planning (FP)
Average monthly number new FP visits
Measured: 18 months
Facility Total FP
Average monthly number total FP visits
Measured: 18 months
Facility Delivery Rate
Average monthly number of Facility deliveries
Measured: 18 months
Facility Oral Polio Vaccine 0 (OPV0)
Average monthly number of OPV0 Immunization
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study startJan 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- AfyaJamii is a group care model in pregnancy facilitated by Government of Kenya (GOK) Community Health Volunteers (CHVs) and Ministry of Health (MOH) nurses. Pregnant women are assigned to specific care groups according to their Expected Date of Delivery (EDD) and meet 3 times antenatally and 4 times postnatally. These groups are meant to provide women with antenatal and postnatal care, peer support, and knowledge to improve their health outcomes and the health outcomes of their infants. This model of group prenatal and postnatal care is being evaluated as an alternative to the existing policy of focused antenatal care that individualizes care to a single woman at a time.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moi University
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada
- Responsible party
- Principal investigator, Astrid Christoffersen-Deb, Moi University
- Investigators
- Julia Songok, MBChB, Principal investigator, Moi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188237
- Sponsor's protocol ID
- UMoi2
- Status last verified
- Jun 2017
- First submitted
- 31 May 2017
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AfyaJamii (Parenting Well): Evaluating the Feasibility of a Group Antenatal and Well-child Care Model in Pregnancy in Kenya
- ClinicalTrials.gov ID
- NCT03188237
- Acronym / sponsor ID
- UMoi2
- Conditions
- Pregnancy Related, Group, Peer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Moi UniversityUniversity, hospital or other
- Collaborators
- Grand Challenges Canada
- Study start
- Jan 2012 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal is a program evaluation of a group care delivery model designed for pregnant women that was implemented as a pilot project in Teso District, Kenya in 2012.
Detailed description
The investigators will carry out a pre/post evaluation of this program comparing maternal and child health indicators collected at the facility and at 10 comparison facilities in the year prior to implementation (2012) and throughout the duration of the program (2013-2014). They will also analyze program attendance records, anonymous exit surveys, and training records.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- AfyaJamii is a group care model in pregnancy facilitated by Government of Kenya (GOK) Community Health Volunteers (CHVs) and Ministry of Health (MOH) nurses. Pregnant women are assigned to specific care groups according to their Expected Date of Delivery (EDD) and meet 3 times antenatally and 4 times postnatally. These groups are meant to provide women with antenatal and postnatal care, peer support, and knowledge to improve their health outcomes and the health outcomes of their infants. This model of group prenatal and postnatal care is being evaluated as an alternative to the existing policy of focused antenatal care that individualizes care to a single woman at a time.
| Arm | Type | Receives |
|---|---|---|
| AfyaJamii facility | Experimental | Behavioral: AfyaJamiiFacilities using AfyaJamii |
| Referent facility | No intervention | –Facilities using Focused Antenatal Care Individual Model |
Who may qualify
- Ages
- Up to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All facilities that participated in AfyaJamii
Key exclusion criteria (1 listed)
- Any facility that did not offer AfyaJamii and was not been selected as a comparison facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfyaJamiiAfyaJamii is a group antenatal and well-child care program developed in Kenya for use in Kenyan health centers | Behavioural | AfyaJamii facility |
Primary outcome
Facility 4 Antenatal Care (ANC) visits
Time frame: 18 months
Average monthly number 4 or more ANC facility visits
4 secondary outcomes
Facility New Family Planning (FP)
Time frame: 18 months
Facility Total FP
Time frame: 18 months
Facility Delivery Rate
Time frame: 18 months
Facility Oral Polio Vaccine 0 (OPV0)
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Songok, MBChB principal investigator
Moi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AfyaJamii in people with Pregnancy Related and Group, Peer, run by Moi University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facility 4 Antenatal Care (ANC) visits (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2017.