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| ID | Type | Description | Link |
|---|---|---|---|
| R21TW011361-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| Fogarty International Center of the National Institute of Health | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nthabi mHealth Application | Experimental | About 20 women from each of the ten district hospitals will be recruited. Each district hospital will have a separate administrative page on the Nthabi server where women will be enrolled with a unique username and password. Upon enrollment, the women will be asked to engage with Nthabi for two months to discuss the relevant content areas they are interested in learning more about. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mHealth Application | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
-None
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| Name | Affiliation | Role |
|---|---|---|
| Brian Jack, MD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lesotho Boston Health Alliance | Maseru | 105 | Lesotho |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39681895 | Derived | Nkabane-Nkholongo E, Mpata Mokgatle M, Bickmore T, Julce C, Thompson D, Jack BW. Change in sexual and reproductive health knowledge among young women using the conversational agent "Nthabi" in Lesotho: a clinical trial. BMC Glob Public Health. 2024 Sep 5;2(1):60. doi: 10.1186/s44263-024-00091-0. | |
| 38470460 | Derived | Nkabane-Nkholongo E, Mpata-Mokgatle M, Jack BW, Julce C, Bickmore T. Usability and Acceptability of a Conversational Agent Health Education App (Nthabi) for Young Women in Lesotho: Quantitative Study. JMIR Hum Factors. 2024 Mar 12;11:e52048. doi: 10.2196/52048. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nthabi mHealth Application | About 20 women from each of the ten district hospitals will be recruited. Each district hospital will have a separate administrative page on the Nthabi server where women will be enrolled with a unique username and password. Upon enrollment, the women will be asked to engage with Nthabi for two months to discuss the relevant content areas they are interested in learning more about. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nthabi mHealth Application | About 20 women from each of the ten district hospitals will be recruited. Each district hospital will have a separate administrative page on the Nthabi server where women will be enrolled with a unique username and password. Upon enrollment, the women will be asked to engage with Nthabi for two months to discuss the relevant content areas they are interested in learning more about. 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage change pre to post test | Baseline, 4 weeks |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nthabi mHealth Application | About 20 women from each of the ten district hospitals will be recruited. Each district hospital will have a separate administrative page on the Nthabi server where women will be enrolled with a unique username and password. Upon enrollment, the women will be asked to engage with Nthabi for two months to discuss the relevant content areas they are interested in learning more about. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Jack, MD | Boston University Chobanian & Avedisian School of Medicine, Family Medicine | 617-414-6207 | brian.jack@bmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2021 | Aug 20, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 3, 2021 | Aug 8, 2023 | ICF_001.pdf |
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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 38234736 | Derived | Nkabane-Nkholongo E, Mokgatle M, Bickmore T, Julce C, Thompson D, JAck B. Change in Sexual and Reproductive Health Knowledge among Young Women Using the Conversational Agent "Nthabi" in Lesotho: A Clinical Trial. Res Sq [Preprint]. 2023 Dec 28:rs.3.rs-3788533. doi: 10.21203/rs.3.rs-3788533/v1. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | Posted | Number | percentage strongly agree or agree | 4 weeks |
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| 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. | Posted | Number | percentage strongly agree or agree | 4 weeks |
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| 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. | Posted | Number | percentage strongly agree or agree | 4 weeks |
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| 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. | Posted | Number | percentage strongly agree or agree | 4 weeks |
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| 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. | Posted | Number | percentage strongly agree or agree | 4 weeks |
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| 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. | Posted | Number | percentage strongly agree or agree | 4 weeks |
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