Beskyttelse mod misinformation om hiv-vaccine med unge piger og unge kvinder i Sydafrika (PROTECT)
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Teniola Egbe, MPH, MBE
- Telefonnummer: 215-898-2939
- E-mail: tegbe@pennmedicine.upenn.edu
Undersøgelse Kontakt Backup
- Navn: Alison Buttenheim, PhD
- E-mail: abutt@nursing.upenn.edu
Studiesteder
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-
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Johannesburg, Sydafrika
- Health Economics and Epidemiology Research Office, University of the Witwatersrand
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Kvinde
- Alder 18-24 år
- Selvrapporteret historie om seksuel aktivitet inden for de seneste 12 måneder
- Selvrapporteret HIV-negativ status eller ukendt HIV-status ved indskrivning
- Villig og i stand til at give skriftligt informeret samtykke
- Kan læse og forstå engelsk
Ekskluderingskriterier:
- Uvillig eller ude af stand til at give samtykke til studiedeltagelse.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
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Aktiv komparator: Kontrollere
Deltagere, der er tilmeldt kontrolgruppen, vil modtage ikke -relaterede oplysninger om diabetes og ernæringsemner i samme længde som inokulationsmeddelelserne.
Se tillæg 6 for et eksempel på, hvordan denne meddelelse vil blive struktureret.
Dette vil gøre kontrolgruppen til en opmærksomhedskontrolgruppe og sikre, at fund ikke er forvirrede af interventionsgruppen, der bruger mere tid og opmærksomme ressourcer på deltagelse i undersøgelsen.
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Deltagere, der er tilmeldt kontrolgruppen, vil modtage ikke -relaterede oplysninger om diabetes og ernæringsemner i samme længde som inokulationsmeddelelserne.
Se tillæg 6 for et eksempel på, hvordan denne meddelelse vil blive struktureret.
Dette vil gøre kontrolgruppen til en opmærksomhedskontrolgruppe og sikre, at fund ikke er forvirrede af interventionsgruppen, der bruger mere tid og opmærksomme ressourcer på deltagelse i undersøgelsen.
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Andet: Forbedret inokuleringsmeddelelse
Deltagere, der er indskrevet i den forbedrede inokuleringsmeddelelsesarm, vil modtage beskeder, der advarer dem om forestående HIV -vaccine -fejlinformation og forklarer, hvorfor disse påstande er falske eller vildledende, vil meddelelserne blive forbedret med indsigt fra adfærdsøkonomi Se appendiks 5: "Inokuleringsmeddelelse med et være boost" for et eksempel på inokuleringsmeddelelsen.
Som en del af den adfærdsmæssige økonomi -boost kan deltagerne vælge at modtage et lille token (f.eks. Klistermærke, badge, armbånd) med en meddelelse, der fremmer vaccination som en konsistens og engagement prime.
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Deltagere, der er indskrevet i den forbedrede inokuleringsmeddelelsesarm, vil modtage beskeder, der advarer dem om forestående HIV -vaccine -fejlinformation og forklarer, hvorfor disse påstande er falske eller vildledende, vil meddelelserne blive forbedret med indsigt fra adfærdsøkonomi Se appendiks 5: "Inokuleringsmeddelelse med et være boost" for et eksempel på inokuleringsmeddelelsen.
Som en del af den adfærdsmæssige økonomi -boost kan deltagerne vælge at modtage et lille token (f.eks. Klistermærke, badge, armbånd) med en meddelelse, der fremmer vaccination som en konsistens og engagement prime.
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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HIV Vaccine Intention, at the End of the Baseline Assessment
Tidsramme: At the end of the baseline assessment
|
Intention to get the HIV vaccine, measured after inoculation intervention and misinformation exposure The intention to get the vaccine will be measured on a 0-10 scale.
Higher score means they are more likely to get the HIV vaccine.
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At the end of the baseline assessment
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
HIV Vaccine Intention, Follow-up
Tidsramme: 2-4 weeks
|
Intention to get the HIV vaccine, measured at follow-up survey following misinformation exposure and intervention.
Measured on a 0-10 scale.
Higher score means they are more likely to get the HIV vaccine.
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2-4 weeks
|
|
Recommend to Friends, at the End of the Baseline Assessment
Tidsramme: At the end of the baseline assessment
|
Intention to recommend the HIV vaccine to friends, measured at survey baseline following misinformation exposure and intervention.
Measured on a 0-10 scale.
Higher score means they are more likely to recommend the HIV vaccine to a friend.
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At the end of the baseline assessment
|
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Recommend to Friends, Follow-up
Tidsramme: 2-4 weeks
|
Intention to recommend the HIV vaccine to friends, measured at follow-up survey following misinformation exposure and intervention, controlling for baseline pre-intervention/exposure intention.
Measured on a 0-10 scale.
Higher score means they are more likely to recommend the HIV vaccine to a friend.
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2-4 weeks
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Credibility of Inoculated Exposure #1
Tidsramme: At the end of the baseline assessment
|
Extent to which claim #1 made the participants believe the credibility of the information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
At the end of the baseline assessment
|
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Credibility of Inoculated Exposure #2
Tidsramme: At the end of the baseline assessment
|
Extent to which claim #2 made the participants believe the credibility of the information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
At the end of the baseline assessment
|
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Credibility of Inoculated Exposure #3
Tidsramme: At the end of the baseline assessment
|
Extent to which claim #3 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
At the end of the baseline assessment
|
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Credibility of Inoculated Exposure #4
Tidsramme: At the end of the baseline assessment
|
Extent to which claim #4 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
At the end of the baseline assessment
|
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Credibility of Inoculated Exposure #5
Tidsramme: At the end of the baseline assessment
|
Extent to which claim #5 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
At the end of the baseline assessment
|
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Credibility of Inoculated Exposure #6
Tidsramme: At the end of the baseline assessment
|
Extent to which claim #6 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
At the end of the baseline assessment
|
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Anxiousness of Inoculated Exposure #1
Tidsramme: At the end of the baseline assessment
|
Extent to which claim #1 made the participants anxious or nervous about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
At the end of the baseline assessment
|
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Anxiousness of Inoculated Exposure #2
Tidsramme: At the end of the baseline assessment
|
Extent to which claim #2 made the participants anxious or nervous about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
At the end of the baseline assessment
|
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Anxiousness of Inoculated Exposure #3
Tidsramme: At the end of the baseline assessment
|
Extent to which claim #3 made the participants anxious or nervous about the HIV vaccine.
TThey were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
At the end of the baseline assessment
|
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Anxiousness of Inoculated Exposure #4
Tidsramme: At the end of the baseline assessment
|
Extent to which claim #4 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
At the end of the baseline assessment
|
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Anxiousness of Inoculated Exposure #5
Tidsramme: At the end of the baseline assessment
|
Extent to which claim #5 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
At the end of the baseline assessment
|
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Anxiousness of Inoculated Exposure #6
Tidsramme: At the end of the baseline assessment
|
Extent to which claim #6 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
At the end of the baseline assessment
|
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Shareability of Inoculated Exposure #1
Tidsramme: At the end of the baseline assessment
|
Extent to which claim #1 made the participants more likely to share information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
At the end of the baseline assessment
|
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Shareability of Inoculated Exposure #7
Tidsramme: At the end of the baseline assessment
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Extent to which claim #7 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
At the end of the baseline assessment
|
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Shareability of Inoculated Exposure #3
Tidsramme: At the end of the baseline assessment
|
Extent to which claim #3 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
At the end of the baseline assessment
|
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Shareability of Inoculated Exposure #4
Tidsramme: At the end of the baseline assessment
|
Extent to which claim #4 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
At the end of the baseline assessment
|
|
Shareability of Inoculated Exposure #5
Tidsramme: At the end of the baseline assessment
|
Extent to which claim #5 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
At the end of the baseline assessment
|
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Shareability of Inoculated Exposure #6
Tidsramme: At the end of the baseline assessment
|
Extent to which claim #6 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
At the end of the baseline assessment
|
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Credibility of Inoculated Exposure #1, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #1 made the participants believe the credibility of the information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
2-4 weeks
|
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Credibility of Inoculated Exposure #2, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #2 made the participants believe the credibility of the information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
2-4 weeks
|
|
Shareability of Inoculated Exposure #1, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #1 made the participants more likely to share information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
2-4 weeks
|
|
Shareability of Inoculated Exposure #2, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #2 made the participants more likely to share information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
2-4 weeks
|
|
Anxiousness of Inoculated Exposure #1, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #1 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
2-4 weeks
|
|
Anxiousness of Inoculated Exposure #2, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #2 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
2-4 weeks
|
|
Credibility of New Claims, Exposure #12, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #12 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
2-4 weeks
|
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Credibility of New Claims, Exposure #8, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #8 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
2-4 weeks
|
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Credibility of New Claims, Exposure #9, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #9 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
2-4 weeks
|
|
Credibility of New Claims, Exposure #10, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #10 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
2-4 weeks
|
|
Credibility of New Claims, Exposure #11, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #11 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
2-4 weeks
|
|
Anxiousness o of New Claims, Exposure #12, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #12 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
2-4 weeks
|
|
Anxiousness of New Claims, Claim #8, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #8 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
2-4 weeks
|
|
Anxiousness of New Claims, Exposure #9, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #9 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
2-4 weeks
|
|
Anxiousness of New Claims, Exposure #10, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #10 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
2-4 weeks
|
|
Anxiousness of New Claims, Exposure #11, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #11 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
2-4 weeks
|
|
Shareability of New Claims, Exposure #12, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #12 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
2-4 weeks
|
|
Shareability of New Claims, Exposure #8, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #8 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
2-4 weeks
|
|
Shareability of New Claims, Exposure #9, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #9 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
2-4 weeks
|
|
Shareability of New Claims, Exposure #10, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #10 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
2-4 weeks
|
|
Shareability of New Claims, Exposure #11, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #11 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
2-4 weeks
|
|
Credibility of Inoculated Exposure #7
Tidsramme: At the end of the baseline assessment
|
Extent to which claim #7 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
At the end of the baseline assessment
|
|
Anxiousness of Inoculated Exposure #7
Tidsramme: At the end of the baseline assessment
|
Extent to which claim #7 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
At the end of the baseline assessment
|
|
Shareability of Inoculated Exposure #2
Tidsramme: At the end of the baseline assessment
|
Extent to which claim #2 made the participants more likely to share information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
At the end of the baseline assessment
|
|
Credibility of New Claims, Exposure #13, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #13 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
2-4 weeks
|
|
Anxiousness of New Claims, Exposure #13, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #13 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
2-4 weeks
|
|
Shareability of New Claims, Exposure #13, Follow-up
Tidsramme: 2-4 weeks
|
Extent to which claim #13 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
2-4 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 1R01MH132401 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .