Feasibility
Conditions
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.
Detailed 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.
Interventions
BEHAVIORALText-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.
Sponsors
National Institute of Mental Health (NIMH)
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Respond to the Survey in Week 1 | 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. |
| Mean Number of Questions to Which Participant Respond in Each Survey in Week 1 | Week 1 | Mean number of questions to which enrolled participant respond in each survey in Week 1. |
| Mean Number of Hours From Sending a Survey to Participants to Receiving Their Response in Week 1 | Week 1 | Mean number of hours from sending a survey to enrolled participants to receiving their response in Week 1. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Survey and Informational Text Messages |
|---|---|
| Age, Categorical <=18 years | 3 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 21.2 Age |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Recruited from community organization | 17 Participants |
| Region of Enrollment United States | 17 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
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.
Time frame: Week 1
Population: Mean number of participants enrolled in the study who responded to the survey in week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Survey and Informational Text Messages | Mean Number of Hours From Sending a Survey to Participants to Receiving Their Response in Week 1 | 1.7 Mean number of hours | Standard Deviation 2.2 |
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.
Time frame: Week 1
Population: Mean number of participants enrolled in the study who responded to the survey in week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Survey and Informational Text Messages | Mean Number of Questions to Which Participant Respond in Each Survey in Week 1 | 10.1 Mean number of responded questions | Standard Deviation 5.2 |
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.
Time frame: Week 1
Population: Number of participants enrolled in the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Survey and Informational Text Messages | Number of Participants Who Respond to the Survey in Week 1 | 7 Participants |