Nthabi in Lesotho - Implementation

Preconception Care Clinical Trial

Official title:

Women's mHealth Program: Nthabi Application in Lesotho

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04354168
• Other study ID #: H-40268
• Secondary ID: R21TW011361-01
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Preconception Care

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