NCT03157908

Brief Summary

Population mobility is frequent in South Africa and disrupts the continuity of HIV care. Postpartum, HIV-positive women are at elevated risk of dropping out of HIV care and are highly mobile. This pilot study aims to engage peripartum, HIV-positive women as potential users to evaluate a novel smartphone application to assist these women with linkage to new HIV facilities and prospectively describe the mobility of this population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 12, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2018

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

6 months

First QC Date

May 15, 2017

Last Update Submit

January 23, 2018

Conditions

HIV/AIDS

Keywords

South AfricaRetention in carePregnancyMobile health

Outcome Measures

Primary Outcomes (2)

  • Feasibility questionnaire

    Feasibility will be assessed via a face-to-face questionnaire to address the following questions: * What proportion of women eligible to participate chooses to participate in the study? * Are participants able to install the app on their phones? * How does real-world access to the internet affect the use of the app? * When is the optimal time for the participant to receive a notification? * How many notifications are sent? * What unexpected problems occurred? * What are the general usage patterns of the app?

    3 months

  • Acceptability questionnaire

    Acceptability will be assessed via a face-to-face questionnaire to address the following questions: * Do women find the app helpful? * How frequently do women engage with the app and under what circumstances? * Do women report that they think such an app should be offered to other pregnant women? What about to non-pregnant adults? * Are there other services that participants would like to see included on future version of the app? * Do women like the notifications?

    3 months

Secondary Outcomes (2)

  • Medical record review to assess potential efficacy

    3 months

  • Spatial analysis of GPS data

    3 months

Study Arms (1)

Smartphone app

EXPERIMENTAL

All participants in this pilot study will install the smartphone app for testing

Device: CareConekta

Interventions

CareConektaDEVICE

CareConekta is a smartphone app developed in parallel with a series of focus group discussions that uses global positioning system (GPS) data to identify the user's location to meet two primary functions: (1) to allow the participant to locate ART facilities in South Africa that are near her current location, and (2) to trace mobility prospectively.

Smartphone app

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing to enroll and provide written informed consent
  • ≥18 years old
  • HIV-positive
  • Pregnant (\>36 weeks gestation)
  • Able to read basic written English
  • Currently own a smartphone that meets the technical requirements
  • Willing to opt-in to installation of the app on her personal phone and to mobility tracking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gugulethu Community Health Centre

Cape Town, South Africa

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Kate Clouse, PhD, MPH

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

  • Tamsin K Phillips, MPH

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: Prospective cohort study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 17, 2017

Study Start

July 12, 2017

Primary Completion

January 18, 2018

Study Completion

January 18, 2018

Last Updated

January 25, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)