FeasibilityEMERGENCT03766165

Microenterprise Intervention to Reduce Sexual Risk Behaviors in Young Adults

A study testing Intervention in people with Feasibility, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 24 yearsHealthy volunteers can take part
Conditions the study is for: Feasibility
What is being tested?: Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteUnited States
Study dates: 5 Dec 2018to 19 Aug 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 24 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

African American;
Aged 18-24;
Living in Baltimore City;
Having experienced one episode of homelessness in last 12 months;
Unemployed or employed fewer than 10 hours per week;
Not enrolled in school;
Owning a mobile phone with text messaging function;
Reporting at least one episode of unprotected/unsafe sex in prior 12 months

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205

Other trials in United States

About this study

Official title: The Engaging Microenterprise for Resource Generation and Health Empowerment (EMERGE) Project: Feasibility Trial of an Enhanced Microenterprise Intervention to Reduce Sexual Risk Behaviors in Young Adults

The study team will conduct a two-group study to examine the feasibility of implementing an enhanced microenterprise intervention to reduce sexual risk behaviors. The team will enroll approximately 40 young adults. Participants will be randomly assigned to one of two groups. The first group ("control") will receive text messages with information on job openings. The second group ("intervention") will receive text messages with information on job openings plus HIV prevention and business educational sessions, mentored apprenticeship, a start-up grant (provided in 6 payments), and HIV behavioral economics text messages.

Read the detailed description

The study team will conduct a two-group study to examine the feasibility of implementing an enhanced microenterprise intervention to reduce sexual risk behaviors. The team will enroll approximately 40 young adults, aged 18 to 24, who are African-American, homeless, out-of-school, unemployed or under-employed, report unprotected/unsafe sex, and have access to a cell phone. Participants will be randomly assigned to one of two groups. The first group ("control") will receive text messages with information on job openings. The second group ("intervention") will receive text messages with information on job openings plus HIV prevention and business educational sessions, mentored apprenticeship, a start-up grant (provided in 6 payments), and HIV behavioral economics text messages. Data will be collected for 26 weeks (week 1 to week 26). Participants will undergo a baseline in-person interview at the time of enrollment (week 1) and be randomized to a group after completing a 3-week run-in period (week 1 to week 3). Each group will receive the assigned activities for 20 weeks (week 4 to week 23). An endline in-person interview will be conducted in and around week 26, respectively. Participants will also complete a weekly text message survey from enrollment (week 1) to the end of the study (week 26). The study team will collect feasibility information pertaining to two primary outcomes: (i) the proportion of participants in both groups who have responded to 70% or more of the weekly text message surveys at week 26 and (ii) the proportion of participants in the intervention group who have completed 70% or more of intervention activities (i.e., text message receipt, session attendance, grant spending, and mentor contact) at week 23. As secondary outcomes, the study team will collect feasibility information about the proportion of all participants who receive one or more informational text messages each week, the proportion of all participants who respond to a text message survey each week, the proportion of intervention participants who attend an educational session each week, the proportion of intervention participants who receive one or more mentor contacts each week, and the proportion of intervention participants who spend one or more grant payments each week. The study team will also examine the completion and variation in behavioral outcomes pertaining to the proportion of participants in each group who report one or more unprotected/unsafe sex acts in the last week and last month, the proportion of participants in each group who report one or more safer sex acts in the last week and last month, the proportion of participants in each group who report one or more HIV prevention care-seeking or information-seeking acts in the last week and last month, and the proportion of participants in each group who report one or more paid hours of work in the last week and last month. The study is anticipated to start in December 2018.

Conditions: Feasibility
Being tested: Intervention, Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

InterventionBehavioural
Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.
ControlBehavioural
Participants will receive job announcements only.

Study groups in NCT03766165
Study group	Role	What they receive
Intervention	Experimental	Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant. Receives: Behavioral: Intervention
Control	Other	Job announcements only Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Participants in Both Groups Who Have Responded to 70% or More of the Weekly Text Message Surveys
Proportion of participants in both groups who have responded to 70% or more of the weekly text message surveys (description)
Measured: Measured at week 26
Proportion of Intervention Participants Who Have Completed 70% or More of Intervention Activities (i.e., Text Message Receipt, Session Attendance, Grant Spending, and Mentor Contact)
Proportion of intervention participants who have completed 70% or more of intervention activities (i.e., text message receipt, session attendance, grant spending, and mentor contact) (description)
Measured: Measured at week 23

Secondary outcomes (13)

Proportion of All Participants Who Receive One or More Informational Text Messages
Proportion of all participants who receive one or more informational text messages (description)
Measured: Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23
Proportion of All Participants Who Respond to the Text Message Survey
Proportion of all participants who respond to the text message survey (description)
Measured: Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Proportion of Intervention Participants Who Attend an Educational Session
Proportion of intervention participants who attend an educational session (description)
Measured: Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Proportion of intervention participants who receive one or more mentor contacts (description)
Measured: Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23
Proportion of Intervention Participants Who Spend One or More Grant Payments
Proportion of intervention participants who spend one or more grant payments (description)
Measured: Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23
Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Week
Proportion of participants in each group who report one or more unprotected sex acts in last week (description)
Measured: Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Month
Proportion of participants in each group who report one or more unprotected sex acts in last month (description)
Measured: Measured at week 1 and 26
Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Week
Proportion of participants in each group who report one or more safer sex acts in last week (description)
Measured: Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Month
Proportion of participants in each group who report one or more safer sex acts in last month (description)
Measured: Measured at week 1 and 26
Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Week
Proportion of participants in each group who report one or more HIV preventive care-seeking or information-seeking acts in last week (description)
Measured: Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Month
Proportion of participants in each group who report one or more HIV preventive care-seeking or information-seeking acts in last month (description)
Measured: Measured at week 1 and 26
Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Week
Proportion of participants in each group who report one or more paid hours of work in the last week (description)
Measured: Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Month
Proportion of participants in each group who report one or more paid hours of work in the last month (description)
Measured: Measured weekly at week 1 and 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Dec 201819 Aug 2019

First posted6 Dec 2018
Study start5 Dec 2018
Primary completion19 Aug 2019
Study completion19 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for FeasibilityStudies of the same condition, open and under way.
More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03766165
Sponsor's protocol ID: IRB00008833
Other IDs: K01MH107310
Acronym: EMERGE
Status last verified: Sep 2020
First submitted: 4 Dec 2018
Last updated: 22 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual patient data (IPD) will be shared.

Publications

Jennings Mayo-Wilson L, Coleman J, Timbo F, Latkin C, Torres Brown ER, Butler AI, Conserve DF, Glass NE. Acceptability of a feasibility randomized clinical trial of a microenterprise intervention to reduce sexual risk behaviors and increase employment and HIV preventive practices (EMERGE) in young adults: a mixed methods assessment. BMC Public Health. 2020 Dec 2;20(1):1846. doi: 10.1186/s12889-020-09904-x.
PubMed 33267860
Jennings Mayo-Wilson L, Coleman J, Timbo F, Ssewamala FM, Linnemayr S, Yi GT, Kang BA, Johnson MW, Yenokyan G, Dodge B, Glass NE. Microenterprise Intervention to Reduce Sexual Risk Behaviors and Increase Employment and HIV Preventive Practices Among Economically-Vulnerable African-American Young Adults (EMERGE): A Feasibility Randomized Clinical Trial. AIDS Behav. 2020 Dec;24(12):3545-3561. doi: 10.1007/s10461-020-02931-0.
PubMed 32494942
Mayo-Wilson LJ, Glass NE, Ssewamala FM, Linnemayr S, Coleman J, Timbo F, Johnson MW, Davoust M, Labrique A, Yenokyan G, Dodge B, Latkin C. Microenterprise intervention to reduce sexual risk behaviors and increase employment and HIV preventive practices in economically-vulnerable African-American young adults (EMERGE): protocol for a feasibility randomized clinical trial. Trials. 2019 Jul 17;20(1):439. doi: 10.1186/s13063-019-3529-7.
PubMed 31315685

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Engaging Microenterprise for Resource Generation and Health Empowerment (EMERGE) Project: Feasibility Trial of an Enhanced Microenterprise Intervention to Reduce Sexual Risk Behaviors in Young Adults
ClinicalTrials.gov ID: NCT03766165
Acronym / sponsor ID: EMERGE / IRB00008833
Conditions: Feasibility
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 5 Dec 2018 (actual)
Primary completion: 19 Aug 2019 (actual)
Study completion: 19 Aug 2019 (actual)
First posted: 6 Dec 2018 (actual)
Results: Posted 22 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study team will conduct a two-group study to examine the feasibility of implementing an enhanced microenterprise intervention to reduce sexual risk behaviors. The team will enroll approximately 40 young adults. Participants will be randomly assigned to one of two groups. The first group ("control") will receive text messages with information on job openings. The second group ("intervention") will receive text messages with information on job openings plus HIV prevention and business educational sessions, mentored apprenticeship, a start-up grant (provided in 6 payments), and HIV behavioral economics text messages.

Detailed description

The study team will conduct a two-group study to examine the feasibility of implementing an enhanced microenterprise intervention to reduce sexual risk behaviors. The team will enroll approximately 40 young adults, aged 18 to 24, who are African-American, homeless, out-of-school, unemployed or under-employed, report unprotected/unsafe sex, and have access to a cell phone. Participants will be randomly assigned to one of two groups. The first group ("control") will receive text messages with information on job openings. The second group ("intervention") will receive text messages with information on job openings plus HIV prevention and business educational sessions, mentored apprenticeship, a start-up grant (provided in 6 payments), and HIV behavioral economics text messages. Data will be collected for 26 weeks (week 1 to week 26). Participants will undergo a baseline in-person interview at the time of enrollment (week 1) and be randomized to a group after completing a 3-week run-in period (week 1 to week 3). Each group will receive the assigned activities for 20 weeks (week 4 to week 23). An endline in-person interview will be conducted in and around week 26, respectively. Participants will also complete a weekly text message survey from enrollment (week 1) to the end of the study (week 26). The study team will collect feasibility information pertaining to two primary outcomes: (i) the proportion of participants in both groups who have responded to 70% or more of the weekly text message surveys at week 26 and (ii) the proportion of participants in the intervention group who have completed 70% or more of intervention activities (i.e., text message receipt, session attendance, grant spending, and mentor contact) at week 23. As secondary outcomes, the study team will collect feasibility information about the proportion of all participants who receive one or more informational text messages each week, the proportion of all participants who respond to a text message survey each week, the proportion of intervention participants who attend an educational session each week, the proportion of intervention participants who receive one or more mentor contacts each week, and the proportion of intervention participants who spend one or more grant payments each week. The study team will also examine the completion and variation in behavioral outcomes pertaining to the proportion of participants in each group who report one or more unprotected/unsafe sex acts in the last week and last month, the proportion of participants in each group who report one or more safer sex acts in the last week and last month, the proportion of participants in each group who report one or more HIV prevention care-seeking or information-seeking acts in the last week and last month, and the proportion of participants in each group who report one or more paid hours of work in the last week and last month. The study is anticipated to start in December 2018.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Behavioral: InterventionJob announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.
Control	Other	Behavioral: ControlJob announcements only

Who may qualify

Ages: 18 to 24 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

African American;
Aged 18-24;
Living in Baltimore City;
Having experienced one episode of homelessness in last 12 months;
Unemployed or employed fewer than 10 hours per week;

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
InterventionParticipants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.	Behavioural	Intervention
ControlParticipants will receive job announcements only.	Behavioural	Control

Primary outcome

Proportion of Participants in Both Groups Who Have Responded to 70% or More of the Weekly Text Message Surveys
Time frame: Measured at week 26
Proportion of participants in both groups who have responded to 70% or more of the weekly text message surveys (description)
Proportion of Intervention Participants Who Have Completed 70% or More of Intervention Activities (i.e., Text Message Receipt, Session Attendance, Grant Spending, and Mentor Contact)
Time frame: Measured at week 23
Proportion of intervention participants who have completed 70% or more of intervention activities (i.e., text message receipt, session attendance, grant spending, and mentor contact) (description)

13 secondary outcomes

Proportion of All Participants Who Receive One or More Informational Text Messages
Time frame: Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23
Proportion of All Participants Who Respond to the Text Message Survey
Time frame: Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Proportion of Intervention Participants Who Attend an Educational Session
Time frame: Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Time frame: Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23
Proportion of Intervention Participants Who Spend One or More Grant Payments
Time frame: Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23
Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Week
Time frame: Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Month
Time frame: Measured at week 1 and 26
Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Week
Time frame: Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Month
Time frame: Measured at week 1 and 26
Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Week
Time frame: Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Month
Time frame: Measured at week 1 and 26
Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Week
Time frame: Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Month
Time frame: Measured weekly at week 1 and 26

Results and safety

Results posted to the registry on 22 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	19	19
Control	19	19

Primary outcome: Proportion of Participants in Both Groups Who Have Responded to 70% or More of the Weekly Text Message Surveys

Time frame: Measured at week 26. Count of participants. Unit: Participants

Measure	Intervention n = 19	Control n = 19
Value	5	9

Population analysed: Participants in both groups

Primary outcome: Proportion of Intervention Participants Who Have Completed 70% or More of Intervention Activities (i.e., Text Message Receipt, Session Attendance, Grant Spending, and Mentor Contact)

Time frame: Measured at week 23. Count of participants. Unit: Participants

Measure	Intervention n = 19
Value	11

Population analysed: Intervention participants

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: 20 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 19 (0%)	0 of 19 (0%)	0 of 19
Control	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Limitations and caveats (from the sponsor): All measures were self-reported and may be subject to reporting biases.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33267860Jennings Mayo-Wilson L, Coleman J, Timbo F, Latkin C, Torres Brown ER, Butler AI, Conserve DF, Glass NE. Acceptability of a feasibility randomized clinical trial of a microenterprise intervention to reduce sexual risk behaviors and increase employment and HIV preventive practices (EMERGE) in young adults: a mixed methods assessment. BMC Public Health. 2020 Dec 2;20(1):1846. doi: 10.1186/s12889-020-09904-x.
Derived from this study: PubMed 32494942Jennings Mayo-Wilson L, Coleman J, Timbo F, Ssewamala FM, Linnemayr S, Yi GT, Kang BA, Johnson MW, Yenokyan G, Dodge B, Glass NE. Microenterprise Intervention to Reduce Sexual Risk Behaviors and Increase Employment and HIV Preventive Practices Among Economically-Vulnerable African-American Young Adults (EMERGE): A Feasibility Randomized Clinical Trial. AIDS Behav. 2020 Dec;24(12):3545-3561. doi: 10.1007/s10461-020-02931-0.
Derived from this study: PubMed 31315685Mayo-Wilson LJ, Glass NE, Ssewamala FM, Linnemayr S, Coleman J, Timbo F, Johnson MW, Davoust M, Labrique A, Yenokyan G, Dodge B, Latkin C. Microenterprise intervention to reduce sexual risk behaviors and increase employment and HIV preventive practices in economically-vulnerable African-American young adults (EMERGE): protocol for a feasibility randomized clinical trial. Trials. 2019 Jul 17;20(1):439. doi: 10.1186/s13063-019-3529-7.
Individual participant dataSharing planned: Yes. De-identified individual patient data (IPD) will be shared.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Larissa Jennings Mayo-Wilson, PhD MHS principal investigator

Johns Hopkins Bloomberg School of Public Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Feasibility, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants in Both Groups Who Have Responded to 70% or More of the Weekly Text Message Surveys (time frame: Measured at week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03766165, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.