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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04354168
Other study ID # H-40268
Secondary ID R21TW011361-01
Status Completed
Phase N/A
First received
Last updated
Start date November 8, 2021
Est. completion date August 25, 2022

Study information

Verified date August 2023
Source Boston University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project will determine how well the mobile health (mHealth) Nthabi application is introduced and used at district hospitals in Lesotho. This will help with measuring the effectiveness of an evidence-based mHealth application in a low-income country. Three factors will be studied when assessing the mHealth application's overall impact: 1) end-user content knowledge 2) pre and post stage of change and 3) system usage. This data will be collected by the mHealth application. End-users will use the mHealth application over a period of two months. Results will be shared with the clinical, health services research, information technology, and policy communities.


Description:

Lesotho has second-highest HIV and fifth-highest tuberculosis prevalence rates worldwide, and a maternal mortality rate (1024/100,000) that is among the highest in Africa. As there are only 6.2 nurses and 0.5 physicians per 10,000 people, both about one-third of the African average, there is an enormous need for eHealth systems to assist the clinical care system. Preconception care is an effort to focus on engaging young women in their health before they become pregnant since many women enter pregnancy at risk for poor outcomes because of preexisting medical conditions or not following evidence-based preventive action. In 2013, the WHO prioritized research that focuses on developing, delivering, and scaling preconception women's health interventions in low and middle-income countries to optimize health and birth outcomes. The WHO emphasized implementation research as the key step in helping to maximize the coverage and uptake of preconception care to enhance the long-term health outcomes for women and their children. The existing "Gabby" system is a patient-facing, user-friendly, evidence-based, scalable, culturally adaptive, health communication system designed to improve women's health. The investigator's team has developed and tested several Embodied Conversational Agents (ECAs), which are virtual characters designed using expertise from health communication, psychotherapy, social psychology, sociolinguistics, linguistics, and communication theory. For this project, the investigators will first adapt the existing "Gabby" system to a culturally appropriate mHealth application, called "Nthabi", and second, study the impact of the Nthabi application into district hospitals in Lesotho in partnership with the Lesotho Boston Health Alliance (LeBoHA) using the existing educational infrastructure. The research team will assess the effectiveness of Nthabi based on the periodic stage of change assessments over the two-month implementation, end-user content knowledge, and system usage.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date August 25, 2022
Est. primary completion date August 25, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 28 Years
Eligibility Inclusion Criteria: - Female Resident of Lesotho - English Speaking - Have access to an Android smartphone - Not currently pregnant at time of enrollment Exclusion Criteria: -None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
mHealth Application
Nthabi mHealth Application delivers educational content and recommendations to minimize or eliminate health risks. The content is delivered via the Nthabi application downloaded on an Android phone smartphone. End-users can select from a list of topics relevant to the Lesotho population to engage with the conversational agent, Nthabi, and discuss conditions such as tuberculosis, HIV testing, healthy diet, and family planning.

Locations

Country Name City State
Lesotho Lesotho Boston Health Alliance Maseru

Sponsors (2)

Lead Sponsor Collaborator
Boston University Fogarty International Center of the National Institute of Health

Country where clinical trial is conducted

Lesotho, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Preconception Health Knowledge Change in preconception health knowledge will be assessed by a change in the percentage correct scores between the Pre and Post tests which were developed by the investigator. Higher positive change scores suggest more knowledge about preconception health. Baseline, 4 weeks
Secondary Ease of Use of Nthabi App This outcome was assessed by responses to a specific question in an investigator developed survey containing 22 questions eliciting responses on a 4-point Likert scale (strongly agree, agree, disagree, and strongly disagree). The higher the percentage of strongly agree or agree responses the more favorable the results. 4 weeks
Secondary Nthabi App Health Education Content Organized and Timely This outcome was assessed by responses to a specific question in an investigator developed survey containing 22 questions eliciting responses on a 4-point Likert scale (strongly agree, agree, disagree, and strongly disagree). The higher the percentage of strongly agree or agree responses the more favorable the results. 4 weeks
Secondary Able to Complete Tasks Quickly Using Nthabi This outcome was assessed by responses to a specific question in an investigator developed survey containing 22 questions eliciting responses on a 4-point Likert scale (strongly agree, agree, disagree, and strongly disagree). The higher the percentage of strongly agree or agree responses the more favorable the results. 4 weeks
Secondary Enjoyed Using the Nthabi App This outcome was assessed by responses to a specific question in an investigator developed survey containing 22 questions eliciting responses on a 4-point Likert scale (strongly agree, agree, disagree, and strongly disagree). The higher the percentage of strongly agree or agree responses the more favorable the results. 4 weeks
Secondary Intend to Keep Using the Nthabi App This outcome was assessed by responses to a specific question in an investigator developed survey containing 22 questions eliciting responses on a 4-point Likert scale (strongly agree, agree, disagree, and strongly disagree). The higher the percentage of strongly agree or agree responses the more favorable the results. 4 weeks
Secondary The Nthabi App Was Culturally Appropriate This outcome was assessed by responses to a specific question in an investigator developed survey containing 22 questions eliciting responses on a 4-point Likert scale (strongly agree, agree, disagree, and strongly disagree). The higher the percentage of strongly agree or agree responses the more favorable the results. 4 weeks
See also
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