Health Knowledge, Attitudes, PracticeNCT06013787
"Nuestras Historias": Evaluating the Impact of Community-Created Digital Stories on Pre- and Perinatal Health Motivation in the Peruvian Amazon
A study testing "Nuestras Historias" in people with Health Knowledge, Attitudes, Practice and Maternal Behavior, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitudes, Practice, Maternal Behavior
- What is being tested?
- "Nuestras Historias"
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePeru
- Study dates
- 10 Apr 2016to 3 Apr 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
"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.
Read the 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.
- Being tested
- "Nuestras Historias"
- Keywords
- Community-based participatory research, Digital storytelling, Maternal child health, Community health workers, Behavior change communication, Low-resource settings
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Nuestras Historias"Behavioural
Also called A Digital Story Curriculum on Prenatal Health
"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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Pre and post one month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start10 Apr 2016
- Primary completion21 May 2016
- Study completion3 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Knowledge, Attitudes, PracticeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-matched randomized trial, by community, with 5 intervention communities and 5 control communities
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Sponsor
- Investigators
- Neha Limaye, MD, Principal investigator, Fellow at UPCH and UW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013787
- Sponsor's protocol ID
- 0000065203
- Status last verified
- Aug 2018
- First submitted
- 17 Oct 2018
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At present, all data is securely stored. If study is published, de-identified data will be made available via a secure sharing method.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Nuestras Historias": Evaluating the Impact of Community-Created Digital Stories on Pre- and Perinatal Health Motivation in the Peruvian Amazon
- ClinicalTrials.gov ID
- NCT06013787
- Acronym / sponsor ID
- 0000065203
- Keywords
- Community-based participatory research, Digital storytelling, Maternal child health, Community health workers, Behavior change communication, Low-resource settings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- 10 Apr 2016 (actual)
- Primary completion
- 21 May 2016 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 28 Aug 2023 (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.
"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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-matched randomized trial, by community, with 5 intervention communities and 5 control communities
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: "Nuestras Historias"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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| "Nuestras Historias"Also: A Digital Story Curriculum on Prenatal Health"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. | Behavioural | Intervention Group |
Primary outcome
Prenatal Health Knowledge Change
Time frame: Pre and post one month intervention
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
Prenatal Health Attitude Change
Time frame: Pre and post one month intervention
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
Change in Behavioral Intentions
Time frame: Pre and post one month intervention
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
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 28 Aug 2023.
- Individual participant dataSharing planned: Undecided. At present, all data is securely stored. If study is published, de-identified data will be made available via a secure sharing method.
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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.
Neha Limaye, MD principal investigator
Fellow at UPCH and UW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Nuestras Historias" in people with Health Knowledge, Attitudes, Practice and Maternal Behavior, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
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 2 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 28 Aug 2023. 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 Peru. 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?
Prenatal Health Knowledge Change (time frame: Pre and post one month intervention). The study lists 3 primary outcomes in all. 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 28 Aug 2023.