NCT06013787

Brief Summary

"Nuestras Historias" curriculum is a tablet-based digital story curriculum that was created through community-based participatory methods. It uses narrative videos to teach about local prenatal health issues in the Parinari District of Peru. This study aims to assess the impact of "Nuestras Historias" on pregnant women and their partners by measuring participants' changes in prenatal health knowledge, attitudes and behavioral intentions for pregnancy and birth after exposure to the curriculum. The study uses a cluster-randomized design, in which communities were match-paired and then randomized for pregnant women/partners to receive the "Nuestras Historias" curriculum vs. standard prenatal health teaching, delivered by local community health workers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2016

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2018

Completed
4.9 years until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2018

Enrollment Period

1 month

First QC Date

October 17, 2018

Last Update Submit

August 24, 2023

Conditions

Keywords

Community-based participatory researchDigital storytellingMaternal child healthCommunity health workersBehavior change communicationLow-resource settings

Outcome Measures

Primary Outcomes (3)

  • Prenatal Health Knowledge Change

    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

    Pre and post one month intervention

  • Prenatal Health Attitude Change

    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

    Pre and post one month intervention

  • Change in Behavioral Intentions

    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

    Pre and post one month intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: "Nuestras Historias"

Control Group

NO INTERVENTION

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.

Interventions

"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.

Also known as: A Digital Story Curriculum on Prenatal Health
Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Peruana Cayetano Heredia

Lima, Peru

Location

MeSH Terms

Conditions

Behavior

Study Officials

  • Neha Limaye, MD

    Fellow at UPCH and UW

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants were made aware through the informed consent that 1/2 of the communities would be receiving a video intervention. Care providers (community health workers who delivered the video intervention) were trained in it so were not blinded. Outcomes assessor was investigator
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster-matched randomized trial, by community, with 5 intervention communities and 5 control communities
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2018

First Posted

August 28, 2023

Study Start

April 10, 2016

Primary Completion

May 21, 2016

Study Completion

April 3, 2018

Last Updated

August 28, 2023

Record last verified: 2018-08

Locations