NCT03237871

Brief Summary

As part of the development of the Engaging Microenterprise for Resource Generation and Health Empowerment (EMERGE) Project, the study team will conduct a single-group study to examine the feasibility of assessing economic and sexual risk behaviors using text messages. The team will enroll approximately 20 young adults, aged 18 to 24, who are African-American, homeless, out-of-school, and un/under-employed. Participants will complete a text-messaged survey each week for 5 weeks. The study team will collect information about the number of participants who respond to the weekly survey, the number of questions to which they respond in each survey, and the number of hours from sending a survey to participants to receiving their response. As an exploratory aim, participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment. The study team will obtain qualitative feedback from participants regarding text messages they most and least liked. The survey is not designed to evaluate the effectiveness of the text message intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 12, 2019

Completed
Last Updated

April 12, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

July 25, 2017

Results QC Date

January 28, 2019

Last Update Submit

April 10, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Number of Participants Who Respond to the Survey in Week 1

    Number of enrolled participants who respond to the survey in Week 1. Measure type 'number' was used for small sample size and as described in the original registration protocol.

    Week 1

  • Mean Number of Questions to Which Participant Respond in Each Survey in Week 1

    Mean number of questions to which enrolled participant respond in each survey in Week 1.

    Week 1

  • Mean Number of Hours From Sending a Survey to Participants to Receiving Their Response in Week 1

    Mean number of hours from sending a survey to enrolled participants to receiving their response in Week 1.

    Week 1

Study Arms (1)

Survey and informational text messages

EXPERIMENTAL

Text-message survey and informational text messages

Behavioral: Text-message survey and informational text messages

Interventions

Participants will complete a text-messaged survey each week for 5 weeks assessing economic and sexual risk behaviors. Participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment.

Survey and informational text messages

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals will be included in the study if, at the time of enrollment, they are:
  • African American
  • Aged 18-24
  • Living in Baltimore City
  • Experiencing homelessness in the past 12 months
  • Employed fewer than 10 hours per week
  • Not enrolled in school
  • Ownership of a mobile phone with text-messaging capacity
  • Reporting at least one episode of unprotected sex in prior 6 months or one other personal or sexual partner HIV risk factor within prior 6 months (STI diagnosis, sex while high or drunk, sex exchange, illicit drug use, alcohol dependence).

You may not qualify if:

  • Aged 17 or younger.
  • Older than 24 years
  • Unwilling to provide consent for study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

  • Jennings Mayo-Wilson L, Glass NE, Labrique A, Davoust M, Ssewamala FM, Linnemayr S, Johnson MW. Feasibility of Assessing Economic and Sexual Risk Behaviors Using Text Message Surveys in African-American Young Adults Experiencing Homelessness and Unemployment: Single-Group Study. JMIR Form Res. 2020 Jul 17;4(7):e14833. doi: 10.2196/14833.

Results Point of Contact

Title
Principal Investigator
Organization
Johns Hopkins Bloomberg School of Public Health

Study Officials

  • Larissa Jennings, PhD MHS

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

July 25, 2017

First Posted

August 3, 2017

Study Start

July 7, 2017

Primary Completion

September 19, 2017

Study Completion

September 19, 2017

Last Updated

April 12, 2019

Results First Posted

April 12, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

All de-identified IPD that underlie results in a publication will be shared.

Shared Documents
STUDY PROTOCOL
Time Frame
De-identified individual patient data (IPD) that under results in a publication will become available 12 months after publication and will be available for 24 months.
Access Criteria
Sponsor approval for data sharing will be sought. Only bona fide research groups are eligible to access data as evidenced via curriculum vitae (CV) and the involvement of a qualified statistician or qualitative research scientist. Data access requests should be made via email application to the principal investigator detailing the specific requirements and the proposed research and publication plan. Data access requests will be reviewed against specific criteria by the data custodians. Decisions about requests will be made promptly and no more than 3 months after receipt of request.

Locations