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Schutz vor Fehlinformationen über HIV-Impfstoffe bei heranwachsenden Mädchen und jungen Frauen in Südafrika (PROTECT)

7. August 2026 aktualisiert von: University of Pennsylvania
Heranwachsende Mädchen und junge Frauen (AGYW) im Alter zwischen 15 und 24 Jahren tragen in Südafrika weiterhin die Hauptlast der Infektionen mit dem Humanen Immundefizienzvirus (HIV), obwohl bei den Präventions- und Behandlungsprogrammen Fortschritte zu verzeichnen sind. Die anhaltende Anfälligkeit junger Frauen für eine HIV-Infektion und die nicht optimale Nutzung hochwirksamer Präventionsoptionen wie der Präexpositionsprophylaxe (PrEP) machen einen HIV-Impfstoff erforderlich, der Bevölkerungsgruppen mit einem erheblichen Risiko einer HIV-Infektion zugute kommt. Die Lehren aus früheren Impfstoffstudien und dem jüngsten COVID-19-Impfstoff haben jedoch erhebliche Hindernisse für die Einführung von Impfstoffen aufgezeigt, wie etwa weit verbreitete Fehlinformationen und Impfzögerlichkeit. Diese Herausforderungen gefährden die erfolgreiche Umsetzung eines zukünftigen HIV-Impfstoffs. Aufbauend auf diesen Erkenntnissen wird diese Studie die psychologische Impftheorie nutzen, um HIV-Impfbotschaften bei heranwachsenden Mädchen und jungen Frauen zu entwickeln und zu bewerten. Hauptziel: Vergleich der Veränderungen in der Absicht, eine HIV-Impfung zu erhalten, nachdem Fehlinformationen in Gruppen mit und ohne psychologische Impfung und verhaltensökonomischer Verstärkung aufgetreten sind. Sekundäre Ziele: (1) Vergleich der Glaubwürdigkeit und Überzeugungskraft von Fehlinformationsbehauptungen und der mit Fehlinformationen verbundenen Motivationsbedrohung in Gruppen mit und ohne psychologische Impfung und verhaltensökonomischem Boost. (2) Untersuchung von Untergruppeneffekten anhand relevanter soziodemografischer und Verhaltensfaktoren, einschließlich HIV-Risiko, PrEP-Anamnese, COVID-19-Impfanamnese, allgemeiner Impfskepsis und Informationsvermeidung. Die Forscher werden eine dreiarmige, randomisierte, kontrollierte Studie mit 2-3 Impfmeldungen durchführen, die sich mit aufkommenden Mythen und Fehlinformationen über den HIV-Impfstoff in Südafrika befassen. Die Teilnehmer werden nach dem Zufallsprinzip einer Kontrollgruppe oder einem von zwei Interventionsarmen zugeordnet: (1) Impfnachrichtenarm oder (2) Impfbotschaft mit Erkenntnissen aus der Verhaltensökonomie erweitern.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

2163

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

      • Johannesburg, Südafrika
        • Health Economics and Epidemiology Research Office, University of the Witwatersrand

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

Einschlusskriterien:

  • Weiblich
  • Alter 18-24 Jahre
  • Selbstberichtete Vorgeschichte sexueller Aktivitäten in den letzten 12 Monaten
  • Selbstberichteter HIV-negativer Status oder unbekannter HIV-Status bei der Einschreibung
  • Bereit und in der Lage, eine schriftliche Einverständniserklärung abzugeben
  • Kann Englisch lesen und verstehen

Ausschlusskriterien:

  • Nicht bereit oder nicht in der Lage, der Studienteilnahme zuzustimmen.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Kontrolle
Die Teilnehmer, die in die Kontrollgruppe eingeschrieben sind, erhalten nicht verwandte Informationen zu Diabetes und Ernährungsthemen derselben Länge wie die Inokulationsnachrichten. In Anhang 6 finden Sie ein Beispiel dafür, wie diese Nachricht strukturiert wird. Dadurch wird die Kontrollgruppe zu einer Aufmerksamkeitskontrollgruppe und stellt sicher, dass die Ergebnisse durch die Interventionsgruppe, die mehr Zeit und Aufmerksamkeitsressourcen für die Teilnahme an der Studie verbringen, nicht verwechselt werden.
Die Teilnehmer, die in die Kontrollgruppe eingeschrieben sind, erhalten nicht verwandte Informationen zu Diabetes und Ernährungsthemen derselben Länge wie die Inokulationsnachrichten. In Anhang 6 finden Sie ein Beispiel dafür, wie diese Nachricht strukturiert wird. Dadurch wird die Kontrollgruppe zu einer Aufmerksamkeitskontrollgruppe und stellt sicher, dass die Ergebnisse durch die Interventionsgruppe, die mehr Zeit und Aufmerksamkeitsressourcen für die Teilnahme an der Studie verbringen, nicht verwechselt werden.
Sonstiges: Verbesserte Inokulationsnachricht
Die Teilnehmer, die in den ARM der erweiterten Inokulationsmeldung eingeschrieben sind, erhalten Nachrichten, die sie vor der bevorstehenden Fehlinformation des HIV -Impfstoffs warnen und erklärt, warum diese Behauptungen falsch oder irreführend sind. Im Rahmen des Verhaltensökonomie -Schubs können die Teilnehmer ein kleines Token (z. B. Aufkleber, Abzeichen, Armband) mit einer Nachricht erhalten, die die Impfung als Konsequenz- und Verpflichtungspunkt fördert.
Die Teilnehmer, die in den ARM der erweiterten Inokulationsmeldung eingeschrieben sind, erhalten Nachrichten, die sie vor der bevorstehenden Fehlinformation des HIV -Impfstoffs warnen und erklärt, warum diese Behauptungen falsch oder irreführend sind. Im Rahmen des Verhaltensökonomie -Schubs können die Teilnehmer ein kleines Token (z. B. Aufkleber, Abzeichen, Armband) mit einer Nachricht erhalten, die die Impfung als Konsequenz- und Verpflichtungspunkt fördert.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
HIV Vaccine Intention, at the End of the Baseline Assessment
Zeitfenster: 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.
At the end of the baseline assessment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
HIV Vaccine Intention, Follow-up
Zeitfenster: 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.
2-4 weeks
Recommend to Friends, at the End of the Baseline Assessment
Zeitfenster: 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.
At the end of the baseline assessment
Recommend to Friends, Follow-up
Zeitfenster: 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.
2-4 weeks
Credibility of Inoculated Exposure #1
Zeitfenster: 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
Credibility of Inoculated Exposure #2
Zeitfenster: 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
Credibility of Inoculated Exposure #3
Zeitfenster: 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
Credibility of Inoculated Exposure #4
Zeitfenster: 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
Credibility of Inoculated Exposure #5
Zeitfenster: 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
Credibility of Inoculated Exposure #6
Zeitfenster: 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
Anxiousness of Inoculated Exposure #1
Zeitfenster: 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
Anxiousness of Inoculated Exposure #2
Zeitfenster: 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
Anxiousness of Inoculated Exposure #3
Zeitfenster: 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
Anxiousness of Inoculated Exposure #4
Zeitfenster: 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
Anxiousness of Inoculated Exposure #5
Zeitfenster: 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
Anxiousness of Inoculated Exposure #6
Zeitfenster: 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
Shareability of Inoculated Exposure #1
Zeitfenster: 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
Shareability of Inoculated Exposure #7
Zeitfenster: At the end of the baseline assessment
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
Shareability of Inoculated Exposure #3
Zeitfenster: 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
Shareability of Inoculated Exposure #4
Zeitfenster: 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
Zeitfenster: 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
Shareability of Inoculated Exposure #6
Zeitfenster: 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
Credibility of Inoculated Exposure #1, Follow-up
Zeitfenster: 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
Credibility of Inoculated Exposure #2, Follow-up
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Credibility of New Claims, Exposure #8, Follow-up
Zeitfenster: 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
Credibility of New Claims, Exposure #9, Follow-up
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Mitarbeiter

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

24. Juli 2025

Primärer Abschluss (Tatsächlich)

16. Oktober 2025

Studienabschluss (Geschätzt)

1. Juni 2027

Studienanmeldedaten

Zuerst eingereicht

7. November 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. November 2024

Zuerst gepostet (Tatsächlich)

22. November 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 1R01MH132401 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Beschreibung des IPD-Plans

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Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .