NCT04354168

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
1.6 years until next milestone

Study Start

First participant enrolled

November 8, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 18, 2023

Completed
Last Updated

September 18, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

April 15, 2020

Results QC Date

August 23, 2023

Last Update Submit

August 23, 2023

Conditions

Preconception Care

Keywords

mHealthLesotho

Outcome Measures

Primary Outcomes (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.

    Baseline, 4 weeks

Secondary Outcomes (6)

  • Ease of Use of Nthabi App

    4 weeks

  • Nthabi App Health Education Content Organized and Timely

    4 weeks

  • Able to Complete Tasks Quickly Using Nthabi

    4 weeks

  • Enjoyed Using the Nthabi App

    4 weeks

  • Intend to Keep Using the Nthabi App

    4 weeks

  • +1 more secondary outcomes

Study Arms (1)

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.

Behavioral: mHealth Application

Interventions

mHealth ApplicationBEHAVIORAL

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.

Nthabi mHealth Application

Eligibility Criteria

Age18 Years - 28 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lesotho Boston Health Alliance

Maseru, 105, Lesotho

Location

Related Publications (3)

  • 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.

    PMID: 39681895DERIVED

  • 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.

    PMID: 38470460DERIVED

  • 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.

    PMID: 38234736DERIVED

Results Point of Contact

Title
Brian Jack, MD
Organization
Boston University Chobanian & Avedisian School of Medicine, Family Medicine
brian.jack@bmc.org
617-414-6207

Study Officials

  • Brian Jack, MD

    Boston University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 21, 2020

Study Start

November 8, 2021

Primary Completion

August 25, 2022

Study Completion

August 25, 2022

Last Updated

September 18, 2023

Results First Posted

September 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

LE(1)