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Bescherming tegen desinformatie over HIV-vaccins bij adolescente meisjes en jonge vrouwen in Zuid-Afrika (PROTECT)

7 augustus 2026 bijgewerkt door: University of Pennsylvania
Adolescente meisjes en jonge vrouwen (AGYW) in de leeftijd van 15 tot 24 jaar blijven het zwaarst getroffen door infecties met het Humaan Immunodeficiëntie Virus (HIV) in Zuid-Afrika, ondanks de geboekte vooruitgang in preventie- en behandelingsprogramma's. De voortdurende gevoeligheid van jonge vrouwen voor HIV-infectie en de suboptimale toepassing van preventieopties zoals Pre-Exposure Profylaxe (PrEP) die zeer effectief zijn, creëren een behoefte aan een HIV-vaccin ten behoeve van bevolkingsgroepen met een aanzienlijk risico op HIV-infectie. De lessen uit eerdere vaccinstudies en het recente COVID-19-vaccin hebben echter aanzienlijke barrières voor de opname van vaccins aan het licht gebracht, zoals wijdverbreide verkeerde informatie en aarzeling over vaccins. Deze uitdagingen vormen een bedreiging voor de succesvolle implementatie van een toekomstig HIV-vaccin. Voortbouwend op deze inzichten zal deze studie de psychologische inentingstheorie gebruiken om HIV-vaccinboodschappen onder adolescente meisjes en jonge vrouwen te ontwikkelen en te evalueren. Primaire doelstelling: Het vergelijken van veranderingen in de intenties om een ​​HIV-vaccin te krijgen na blootstelling aan desinformatie in groepen met en zonder psychologische inenting en een impuls voor de gedragseconomie. Secundaire doelstellingen: (1) Het vergelijken van de geloofwaardigheid en overtuigingskracht van beweringen over desinformatie en de motiverende dreiging die gepaard gaat met desinformatie in groepen met en zonder psychologische inenting en een boost voor gedragseconomie. (2) Het onderzoeken van subgroepeffecten op basis van relevante sociaal-demografische en gedragsfactoren, waaronder het HIV-risico, PrEP-geschiedenis, COVID-19-vaccinatiegeschiedenis, algemene aarzeling over vaccins en het vermijden van informatie. De onderzoekers zullen een driearmige, gerandomiseerde, gecontroleerde studie uitvoeren met 2-3 inentingsboodschappen die opkomende mythen en verkeerde informatie over het HIV-vaccin in Zuid-Afrika aanpakken. Deelnemers worden willekeurig toegewezen aan een controlegroep of aan een van de twee interventiearmen: (1) de inentingsboodschapsarm, of (2) het versterken van de inentingsboodschap met inzichten uit de gedragseconomie.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Werkelijk)

2163

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Johannesburg, Zuid-Afrika
        • Health Economics and Epidemiology Research Office, University of the Witwatersrand

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusiecriteria:

  • Vrouwelijk
  • Leeftijd 18-24 jaar
  • Zelfgerapporteerde geschiedenis van seksuele activiteit in de afgelopen 12 maanden
  • Zelfgerapporteerde HIV-negatieve status of onbekende HIV-status bij inschrijving
  • Bereid en in staat om schriftelijke geïnformeerde toestemming te geven
  • Engels kunnen lezen en begrijpen

Uitsluitingscriteria:

  • Niet bereid of niet in staat om toestemming te geven voor deelname aan het onderzoek.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Controle
Deelnemers die zijn ingeschreven in de controlegroep ontvangen niet -gerelateerde informatie over diabetes en voedingsonderwerpen van dezelfde lengte als de inoculatieberichten. Zie Bijlage 6 voor een voorbeeld van hoe dit bericht wordt gestructureerd. Dit maakt de controlegroep tot een aandachtscontrolegroep en zorgt ervoor dat de bevindingen niet worden verward door de interventiegroep die meer tijd en aandachtsbronnen besteedt aan deelname aan het onderzoek.
Deelnemers die zijn ingeschreven in de controlegroep ontvangen niet -gerelateerde informatie over diabetes en voedingsonderwerpen van dezelfde lengte als de inoculatieberichten. Zie Bijlage 6 voor een voorbeeld van hoe dit bericht wordt gestructureerd. Dit maakt de controlegroep tot een aandachtscontrolegroep en zorgt ervoor dat de bevindingen niet worden verward door de interventiegroep die meer tijd en aandachtsbronnen besteedt aan deelname aan het onderzoek.
Ander: Verbeterde inoculatieboodschap
Deelnemers die zijn ingeschreven in de verbeterde inoculatiebericht ARM ontvangen berichten die hen waarschuwen voor dreigende verkeerde informatie over HIV -vaccin en legt uit waarom die claims vals of misleidend zijn, de berichten zullen worden verbeterd met inzichten uit gedragseconomie Zie Bijlage 5: "Inoculatieboodschap met een Boost" voor een voorbeeld van het inoculatieboodschap. Als onderdeel van de boost van de gedragseconomie kunnen deelnemers ervoor kiezen om een klein token te ontvangen (bijv. Sticker, badge, armband) met een bericht dat vaccinatie bevordert als een consistentie en commitment prime.
Deelnemers die zijn ingeschreven in de verbeterde inoculatiebericht ARM ontvangen berichten die hen waarschuwen voor dreigende verkeerde informatie over HIV -vaccin en legt uit waarom die claims vals of misleidend zijn, de berichten zullen worden verbeterd met inzichten uit gedragseconomie Zie Bijlage 5: "Inoculatieboodschap met een Boost" voor een voorbeeld van het inoculatieboodschap. Als onderdeel van de boost van de gedragseconomie kunnen deelnemers ervoor kiezen om een klein token te ontvangen (bijv. Sticker, badge, armband) met een bericht dat vaccinatie bevordert als een consistentie en commitment prime.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
HIV Vaccine Intention, at the End of the Baseline Assessment
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
HIV Vaccine Intention, Follow-up
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

24 juli 2025

Primaire voltooiing (Werkelijk)

16 oktober 2025

Studie voltooiing (Geschat)

1 juni 2027

Studieregistratiedata

Eerst ingediend

7 november 2024

Eerst ingediend dat voldeed aan de QC-criteria

18 november 2024

Eerst geplaatst (Werkelijk)

22 november 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

7 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 1R01MH132401 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

De onderzoekers zijn nog bezig met het bepalen van het plan voor het delen van gegevens en of we IPD al gaan delen

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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