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Preconception CareNCT04354168

Nthabi in Lesotho - Implementation

A study testing mHealth Application in people with Preconception Care, run by Boston University at 1 site in Lesotho.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 28 years, women onlyHealthy volunteers can take part
Conditions the study is for
Preconception Care
What is being tested?
mHealth Application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteLesotho
Study dates
8 Nov 2021to 25 Aug 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 28 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • -None

Trial locations and contacts

1 site in 1 country.

Lesotho1 site

  • Lesotho Boston Health Alliance

    Maseru, 105

Other trials in Lesotho

About this study

Official title: Women's mHealth Program: Nthabi Application in Lesotho

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.

Read the 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.

Being tested
mHealth Application
Keywords
mHealth, Lesotho

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mHealth ApplicationBehavioural

    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.

Study groups in NCT04354168
Study groupRoleWhat they receive
Nthabi mHealth ApplicationExperimentalAbout 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.
Receives: Behavioral: mHealth Application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 4 weeks

Secondary outcomes (6)

  1. 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.

    Measured: 4 weeks

  2. 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.

    Measured: 4 weeks

  3. 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.

    Measured: 4 weeks

  4. 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.

    Measured: 4 weeks

  5. 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.

    Measured: 4 weeks

  6. 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.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2020
  2. Study start8 Nov 2021
  3. Primary completion25 Aug 2022
  4. Study completion25 Aug 2022

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04354168
Sponsor's protocol ID
H-40268
Other IDs
R21TW011361-01
Status last verified
Aug 2023
First submitted
15 Apr 2020
Last updated
18 Sep 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39681895

  • 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.

    PubMed 38470460

  • 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.

    PubMed 38234736

Questions about this trial

What is this clinical trial studying?

A study testing mHealth Application in people with Preconception Care, run by Boston University at 1 site in Lesotho.

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 4 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 18 Sep 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 Lesotho. 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?

Yes. Results are posted in the registry (first posted 18 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Preconception Health Knowledge (time frame: Baseline, 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04354168, which also lists 3 linked publications.

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 18 Sep 2023.

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