Protezione dalla disinformazione sui vaccini contro l’HIV nei confronti delle ragazze adolescenti e delle giovani donne in Sud Africa (PROTECT)
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Teniola Egbe, MPH, MBE
- Numero di telefono: 215-898-2939
- Email: tegbe@pennmedicine.upenn.edu
Backup dei contatti dello studio
- Nome: Alison Buttenheim, PhD
- Email: abutt@nursing.upenn.edu
Luoghi di studio
-
-
-
Johannesburg, Sud Africa
- Health Economics and Epidemiology Research Office, University of the Witwatersrand
-
-
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
Criteri di inclusione:
- Femmina
- Età 18-24 anni
- Storia auto-riferita di attività sessuale negli ultimi 12 mesi
- Stato HIV negativo autodichiarato o stato HIV sconosciuto al momento dell'arruolamento
- Disposto e in grado di fornire il consenso informato scritto
- In grado di leggere e comprendere l'inglese
Criteri di esclusione:
- Non disposti o incapaci di fornire il consenso per la partecipazione allo studio.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Comparatore attivo: Controllare
I partecipanti iscritti al gruppo di controllo riceveranno informazioni non correlate sul diabete e argomenti nutrizionali della stessa lunghezza dei messaggi di inoculazione.
Si prega di consultare l'Appendice 6 per un esempio di come sarà strutturato questo messaggio.
Ciò renderà il gruppo di controllo un gruppo di controllo dell'attenzione e assicurerà che i risultati non siano confusi dal gruppo di intervento che spendono più tempo e risorse di attenzione sulla partecipazione allo studio.
|
I partecipanti iscritti al gruppo di controllo riceveranno informazioni non correlate sul diabete e argomenti nutrizionali della stessa lunghezza dei messaggi di inoculazione.
Si prega di consultare l'Appendice 6 per un esempio di come sarà strutturato questo messaggio.
Ciò renderà il gruppo di controllo un gruppo di controllo dell'attenzione e assicurerà che i risultati non siano confusi dal gruppo di intervento che spendono più tempo e risorse di attenzione sulla partecipazione allo studio.
|
|
Altro: Messaggio di inoculazione migliorato
I partecipanti iscritti al braccio del messaggio di inoculazione potenziato riceveranno messaggi che li avverteranno sull'imminente disinformazione del vaccino contro l'HIV e spiega perché tali affermazioni sono false o fuorvianti, i messaggi saranno migliorati con approfondimenti dell'economia comportamentale Vedi Appendice 5: "Messaggio di inoculazione con una spinta" per un esempio di messaggio di inoculazione.
Come parte della spinta economica comportamentale, i partecipanti possono scegliere di ricevere un piccolo token (ad es. Adesivo, badge, braccialetto) con un messaggio che promuove la vaccinazione come coerenza e impegno.
|
I partecipanti iscritti al braccio del messaggio di inoculazione potenziato riceveranno messaggi che li avverteranno sull'imminente disinformazione del vaccino contro l'HIV e spiega perché tali affermazioni sono false o fuorvianti, i messaggi saranno migliorati con approfondimenti dell'economia comportamentale Vedi Appendice 5: "Messaggio di inoculazione con una spinta" per un esempio di messaggio di inoculazione.
Come parte della spinta economica comportamentale, i partecipanti possono scegliere di ricevere un piccolo token (ad es. Adesivo, badge, braccialetto) con un messaggio che promuove la vaccinazione come coerenza e impegno.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
HIV Vaccine Intention, at the End of the Baseline Assessment
Lasso di tempo: 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
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
HIV Vaccine Intention, Follow-up
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 1R01MH132401 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .