Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06013787 |
Other study ID # |
0000065203 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 10, 2016 |
Est. completion date |
April 3, 2018 |
Study information
Verified date |
August 2018 |
Source |
Universidad Peruana Cayetano Heredia |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.