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The EMERGE Project: Feasibility of Assessing Economic and Sexual Risk Behaviors Using Text Messages in Young Adults

10. april 2019 opdateret af: Johns Hopkins Bloomberg School of Public Health

The Engaging Microenterprise for Resource Generation and Health Empowerment (EMERGE) Project: Feasibility of Assessing Economic and Sexual Risk Behaviors Using Text Messages in Homeless Young Adults

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

17

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21205
        • Johns Hopkins Bloomberg School of Public Health

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 24 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Survey and informational text messages
Text-message survey and informational text messages
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Who Respond to the Survey in Week 1
Tidsramme: 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
Tidsramme: 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
Tidsramme: Week 1
Mean number of hours from sending a survey to enrolled participants to receiving their response in Week 1.
Week 1

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Samarbejdspartnere

National Institute of Mental Health (NIMH)

Efterforskere

  • Ledende efterforsker: Larissa Jennings, PhD MHS, Johns Hopkins Bloomberg School of Public Health

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. juli 2017

Primær færdiggørelse (Faktiske)

19. september 2017

Studieafslutning (Faktiske)

19. september 2017

Datoer for studieregistrering

Først indsendt

25. juli 2017

Først indsendt, der opfyldte QC-kriterier

31. juli 2017

Først opslået (Faktiske)

3. august 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. april 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. april 2019

Sidst verificeret

1. april 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • IRB0007563
  • K01MH107310 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

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

IPD-delingstidsramme

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.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • Studieprotokol

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Gennemførlighed

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner