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Beskyttelse mot feilinformasjon om hivvaksine med ungdomsjenter og unge kvinner i Sør-Afrika (PROTECT)

7. august 2026 oppdatert av: University of Pennsylvania
Ungdomsjenter og unge kvinner (AGYW) i alderen 15-24 år fortsetter å bære hovedtyngden av infeksjoner med humant immunsviktvirus (HIV) i Sør-Afrika til tross for fremgang registrert i forebyggings- og behandlingsprogrammer. Unge kvinners pågående mottakelighet for HIV-infeksjon og det suboptimale opptaket av forebyggingsalternativer som Pre-Exposure Prophylaxis (PrEP) som er svært effektive, skaper et behov for en HIV-vaksine for å være til fordel for populasjoner med betydelig risiko for HIV-infeksjon. Imidlertid har lærdommer fra tidligere vaksinestudier og den nylige COVID-19-vaksinen fremhevet betydelige barrierer for vaksineopptak, som utbredt feilinformasjon og vaksinenøling. Disse utfordringene truer en vellykket implementering av en fremtidig HIV-vaksine. Ved å bygge på denne innsikten vil denne studien bruke psykologisk inokulasjonsteori for å utvikle og evaluere meldinger om hiv-vaksine blant unge jenter og unge kvinner. Primært mål: Å sammenligne endringer i intensjoner om å motta HIV-vaksine etter eksponering for feilinformasjon i grupper med og uten psykologisk inokulering og adferdsøkonomisk boost. Sekundære mål: (1) Å sammenligne troverdigheten og overtalelsesevnen til påstander om feilinformasjon og motiverende trussel forbundet med feilinformasjon i grupper med og uten psykologisk inokulering og atferdsøkonomisk boost. (2) For å utforske undergruppeeffekter etter relevante sosiodemografiske og atferdsmessige faktorer, inkludert HIV-risiko, PrEP-historie, COVID-19-vaksinehistorie, generell vaksinenøling og informasjonsunngåelse. Etterforskerne vil gjennomføre en tre-arms randomisert kontrollert studie av 2-3 inokulasjonsmeldinger som tar for seg nye myter og feilinformasjon om HIV-vaksinen i Sør-Afrika. Deltakerne vil bli tilfeldig tildelt en kontrollgruppe eller en av to intervensjonsarmer: (1) inokulasjonsmeldingsarm, eller (2) forbedre inokulasjonsmeldingen med innsikt fra atferdsøkonomi.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

2163

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inkluderingskriterier:

  • Hunn
  • Alder 18-24 år
  • Selvrapportert historie med seksuell aktivitet de siste 12 månedene
  • Selvrapportert HIV-negativ status eller ukjent HIV-status ved innmelding
  • Villig og i stand til å gi skriftlig informert samtykke
  • Kunne lese og forstå engelsk

Ekskluderingskriterier:

  • Uvillig eller ute av stand til å gi samtykke til studiedeltakelse.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Kontroll
Deltakerne som er påmeldt i kontrollgruppen, vil motta ikke -relatert informasjon om diabetes og ernæringstemaer med samme lengde som inokulasjonsmeldingene. Se vedlegg 6 for et eksempel på hvordan denne meldingen vil være strukturert. Dette vil gjøre kontrollgruppen til en oppmerksomhetskontrollgruppe og sikre at funnene ikke blir forvirret av intervensjonsgruppen som bruker mer tid og oppmerksomhetsressurser på deltakelse i studien.
Deltakerne som er påmeldt i kontrollgruppen, vil motta ikke -relatert informasjon om diabetes og ernæringstemaer med samme lengde som inokulasjonsmeldingene. Se vedlegg 6 for et eksempel på hvordan denne meldingen vil være strukturert. Dette vil gjøre kontrollgruppen til en oppmerksomhetskontrollgruppe og sikre at funnene ikke blir forvirret av intervensjonsgruppen som bruker mer tid og oppmerksomhetsressurser på deltakelse i studien.
Annen: Forbedret inokulasjonsmelding
Deltakerne som er registrert i den forbedrede inokulasjonsmeldingsarmen, vil motta meldinger som advarer dem om forestående HIV -vaksine feilinformasjon og forklarer hvorfor disse påstandene er falske eller misvisende, meldingene vil bli forbedret med innsikt fra atferdsøkonomi se vedlegg 5: "Inokulasjonsmelding med en være boost" for et eksempel på inokulasjonsmeldingen. Som en del av atferdsøkonomisk boost, kan deltakerne velge å motta et lite symbol (f.eks. Klistremerke, merke, armbånd) med en melding som fremmer vaksinasjon som en konsistens og engasjement prime.
Deltakerne som er registrert i den forbedrede inokulasjonsmeldingsarmen, vil motta meldinger som advarer dem om forestående HIV -vaksine feilinformasjon og forklarer hvorfor disse påstandene er falske eller misvisende, meldingene vil bli forbedret med innsikt fra atferdsøkonomi se vedlegg 5: "Inokulasjonsmelding med en være boost" for et eksempel på inokulasjonsmeldingen. Som en del av atferdsøkonomisk boost, kan deltakerne velge å motta et lite symbol (f.eks. Klistremerke, merke, armbånd) med en melding som fremmer vaksinasjon som en konsistens og engasjement prime.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

24. juli 2025

Primær fullføring (Faktiske)

16. oktober 2025

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

7. november 2024

Først innsendt som oppfylte QC-kriteriene

18. november 2024

Først lagt ut (Faktiske)

22. november 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1R01MH132401 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

Etterforskerne bestemmer fortsatt datadelingsplanen og om vi skal dele IPD ennå

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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