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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03237871
Other study ID # IRB0007563
Secondary ID K01MH107310
Status Completed
Phase N/A
First received
Last updated
Start date July 7, 2017
Est. completion date September 19, 2017

Study information

Verified date April 2019
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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 study 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. The single-group study is anticipated to start in August 2017.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date September 19, 2017
Est. primary completion date September 19, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility Inclusion Criteria:

- 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).

Exclusion Criteria:

- Aged 17 or younger.

- Older than 24 years

- Unwilling to provide consent for study participation

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Text-message survey and informational text messages
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.

Locations

Country Name City State
United States Johns Hopkins Bloomberg School of Public Health Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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