- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06013787
"Nuestras Historias": Evaluating the Impact of Community-Created Digital Stories on Pre- and Perinatal Health Motivation in the Peruvian Amazon
Study Overview
Status
Intervention / Treatment
Detailed Description
Background and Study Setting:
Parinari is a district in the Loreto region that has 30 communities with approximately 7264 people. The communities are very dispersed and only accessible by river. Inhabitants of this district do not have access to running water, electricity or sanitation and the majority live in poverty. Our study takes place in the 13 communities of Parinari where the Mama River project operated. Mama River selects community health workers (CHWs) who are able to use smartphones in these communities and trains them on the use of smartphones to collect information of new pregnancies, deliveries, alarms signs or deaths of pregnant women or newborns. CHWs then send this information via mobile phone to local health care providers. CHWs are also all trained in the delivery of verbal MCH educational messages to pregnant women, and perform home visits and group visits throughout pregnancies.
Methods:
Twelve communities (6 intervention, 6 control) were recruited and after a final evaluation we excluded two communities, as one had no pregnant women at time of study initiation. The remaining communities were divided into 5 pairs, where the two within the pair were similar in terms of overall population, distance from a health center, and number of pregnant women. One community in each pair was randomly assigned to the intervention group received the Mama River programming along with the digital story curriculum, and the other community to the control group, which received only the standard existing program with no digital stories.
The community agents in the five communities selected for the intervention received training on how to use and show the digital stories on solar-powered tablets.
During the recruitment phase, all pregnant women identified by Mama River were recruited into the trial, with an effort to also recruit their partners. All trial participants signed an informed consent prior to participating, and then completed the pre-intervention survey instrument that measured prenatal health knowledge, attitudes, and behavioral intentions for pregnancy and birth.
Then, in the intervention communities, the participants received home visits and attended group meetings with the community agent in which the digital story curriculum was shown and discussed. In the control communities, participants also received home visits and attended group meetings, but the community agents carried on their standard of practice without the digital stories.
One month after completing the pre-survey, participants completed a post-survey. Those in the intervention group had a slightly longer survey including a short quantitative questions regarding their reactions to the digital stories.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lima, Peru
- Universidad Peruana Cayetano Heredia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All female participants had to be confirmed pregnancies, living permanently within the selected communities of the Parinari District, and age 18 or older
- All male participants had to be partners of women who were confirmed to be pregnant, living permanently within the selected communities of the Parinari District, and age 18 or older
Exclusion Criteria:
- Participants were excluded if not pregnant, if not living in the correct communities or likely to travel away within the study time frame, or if did not consent to the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention Group
In the communities randomized into the intervention arm, the pregnant women who enrolled in the study received a month long prenatal health education intervention called "Nuestras Historias", a digital story curriculum.
This video-based curriculum was delivered by by community health workers during their normal home visits and group visits.
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"Nuestras Historias" is a digital story curriculum that is displayed on a small solar-powered tablet.
The curriculum is a collection of 7 digital stories used to discuss health issues during pregnancy that the community identified as important.
The digital stories are short videos that combine local photos and local voices sharing real-life narratives about experiences during pregnancy.
The videos were made in collaboration with community health workers and local mothers.
Other Names:
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No Intervention: Control Group
In the communities randomized to the control arm, the pregnant women who enrolled in study had normal visits and group visits with community health workers and received standard prenatal health education, but with no video intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prenatal Health Knowledge Change
Time Frame: Pre and post one month intervention
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Change in understanding of basic prenatal health information covered in curriculum, measured using our study's survey tool, which included knowledge questions from several validated studies and from the Peruvian government's manual for community health agents, total possible score of 45
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Pre and post one month intervention
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Prenatal Health Attitude Change
Time Frame: Pre and post one month intervention
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Change in attitudes towards local issues associated with pregnancy, measured via our study's survey tool with tailored questions to topics that are covered in the curriculum (adolescent pregnancy, domestic violence), and a previously validated measure on locus of control, total possible score of 8
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Pre and post one month intervention
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Change in Behavioral Intentions
Time Frame: Pre and post one month intervention
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Change in reported behavioral intentions for practices during pregnancy and at time of birth, measure via our study's survey tool, with a series of questions about the expected birth plan based on the Peruvian government's community agent guide and some video-specific questions, total possible score of 6
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Pre and post one month intervention
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Neha Limaye, MD, Fellow at UPCH and UW
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0000065203
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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