- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06700447
Beskyttelse mod misinformation om hiv-vaccine med unge piger og unge kvinder i Sydafrika (PROTECT)
7. august 2026 opdateret af: University of Pennsylvania
Unge piger og unge kvinder (AGYW) i alderen 15-24 år bærer fortsat hovedparten af infektioner med human immundefektvirus (HIV) i Sydafrika på trods af fremskridt i forebyggelses- og behandlingsprogrammer.
Unge kvinders vedvarende modtagelighed for HIV-infektion og den suboptimale optagelse af forebyggelsesmuligheder såsom Pre-Exposure Prophylaxis (PrEP), der er yderst effektive, skaber et behov for en HIV-vaccine til gavn for befolkninger med betydelig risiko for HIV-infektion.
Erfaringer fra tidligere vaccineundersøgelser og den nylige COVID-19-vaccine har imidlertid fremhævet betydelige barrierer for vaccineoptagelse, såsom udbredt misinformation og tøven med vacciner.
Disse udfordringer truer den vellykkede implementering af en fremtidig HIV-vaccine.
Med udgangspunkt i denne indsigt vil denne undersøgelse bruge psykologisk podningsteori til at udvikle og evaluere HIV-vaccinemeddelelser blandt unge piger og unge kvinder.
Primært mål: At sammenligne ændringer i intentioner om at modtage HIV-vaccine efter misinformationseksponering i grupper med og uden psykologisk inokulering og adfærdsøkonomisk boost.
Sekundære mål: (1) At sammenligne troværdigheden og overtalelsesevnen af misinformationspåstande og motiverende trussel forbundet med misinformation i grupper med og uden psykologisk inokulation og adfærdsøkonomisk boost.
(2) At udforske undergruppeeffekter af relevante sociodemografiske og adfærdsmæssige faktorer, herunder HIV-risiko, PrEP-historie, COVID-19-vaccinehistorie, generel vaccine-tøvenhed og undgåelse af information.
Efterforskerne vil gennemføre et tre-arms randomiseret kontrolleret forsøg med 2-3 inokulationsmeddelelser, der adresserer nye myter og misinformation om HIV-vaccinen i Sydafrika.
Deltagerne vil blive tilfældigt tildelt en kontrolgruppe eller en af to interventionsarme: (1) inokuleringsmeddelelsesarm eller (2) forbedre inokuleringsmeddelelsen med indsigt fra adfærdsøkonomi.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
2163
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Johannesburg, Sydafrika
- Health Economics and Epidemiology Research Office, University of the Witwatersrand
-
-
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
- Voksen
Tager imod sunde frivillige
Ja
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
|
At the end of the baseline assessment
|
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.
|
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.
|
At the end of the baseline assessment
|
|
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.
|
2-4 weeks
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Shareability of Inoculated Exposure #7
Tidsramme: 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
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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)
24. juli 2025
Primær færdiggørelse (Faktiske)
16. oktober 2025
Studieafslutning (Anslået)
1. juni 2027
Datoer for studieregistrering
Først indsendt
7. november 2024
Først indsendt, der opfyldte QC-kriterier
18. november 2024
Først opslået (Faktiske)
22. november 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1R01MH132401 (U.S. NIH-bevilling/kontrakt)
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