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| ID | Type | Description | Link |
|---|---|---|---|
| K01MH107310 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Survey and informational text messages | Experimental | Text-message survey and informational text messages |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text-message survey and informational text messages | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larissa Jennings, PhD MHS | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bloomberg School of Public Health | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32706656 | Derived | 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. |
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All de-identified IPD that underlie results in a publication will be shared.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Survey and Informational Text Messages | Text-message survey and informational text messages 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Number of participants enrolled in the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Survey and Informational Text Messages | Text-message survey and informational text messages 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number of participants enrolled in the study | Posted | Count of Participants | Participants | Week 1 |
|
5 weeks
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Survey and Informational Text Messages | Text-message survey and informational text messages 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Johns Hopkins Bloomberg School of Public Health | 410-955-3537 | ljennin6@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 28, 2019 | Feb 18, 2019 | Prot_SAP_000.pdf |
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|
| Participants |
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| Age, Continuous | Mean | Full Range | Age |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Recruited from community organization | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| 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. | Mean number of participants enrolled in the study who responded to the survey in week 1 | Posted | Mean | Standard Deviation | Mean number of responded questions | Week 1 |
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| 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. | Mean number of participants enrolled in the study who responded to the survey in week 1 | Posted | Mean | Standard Deviation | Mean number of hours | Week 1 |
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| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
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