Clinical trial NCT04354168: Nthabi in Lesotho - Implementation
Official title: Women's mHealth Program: Nthabi Application in Lesotho
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preconception Care
Keywords: mHealth
Lesotho
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2020-04-21
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Female Resident of Lesotho
* English Speaking
* Have access to an Android smartphone
* Not currently pregnant at time of enrollment

Exclusion Criteria:

-None

Primary outcomes:
measure: Change in Preconception Health Knowledge
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Ease of Use of Nthabi App
timeFrame: 4 weeks
measure: Nthabi App Health Education Content Organized and Timely
timeFrame: 4 weeks
measure: Able to Complete Tasks Quickly Using Nthabi
timeFrame: 4 weeks
measure: Enjoyed Using the Nthabi App
timeFrame: 4 weeks
measure: Intend to Keep Using the Nthabi App
timeFrame: 4 weeks
measure: The Nthabi App Was Culturally Appropriate
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Maseru
country: Lesotho
facility: Lesotho Boston Health Alliance
Study officials:
affiliation: Boston University
name: Brian Jack, MD
role: PRINCIPAL_INVESTIGATOR
References: