Skydda mot felaktig information om hiv-vaccin med tonårsflickor och unga kvinnor i Sydafrika (PROTECT)
7 augusti 2026 uppdaterad av: University of Pennsylvania
Ungdomsflickor och unga kvinnor (AGYW) i åldrarna 15-24 år fortsätter att bära bördan av infektioner med humant immunbristvirus (HIV) i Sydafrika trots framsteg som noterats i förebyggande och behandlingsprogram.
Unga kvinnors pågående mottaglighet för HIV-infektion och det suboptimala utnyttjandet av förebyggande alternativ såsom Pre-Exposure Prophylaxis (PrEP) som är mycket effektiva skapar ett behov av ett HIV-vaccin för att gynna befolkningar med betydande risk för HIV-infektion.
Lärdomar från tidigare vaccinstudier och det senaste vaccinet mot covid-19 har dock visat på betydande hinder för vaccinupptagning, såsom utbredd desinformation och vaccinationstveksamhet.
Dessa utmaningar hotar den framgångsrika implementeringen av ett framtida HIV-vaccin.
Med utgångspunkt i dessa insikter kommer denna studie att använda psykologisk inokuleringsteori för att utveckla och utvärdera HIV-vaccinmeddelanden bland tonårsflickor och unga kvinnor.
Primärt mål: Att jämföra förändringar i avsikter att få HIV-vaccin efter exponering för desinformation i grupper med och utan psykologisk inokulering och beteendeekonomisk boost.
Sekundära mål: (1) Att jämföra trovärdigheten och övertalningsförmågan hos påståenden om desinformation och motiverande hot i samband med desinformation i grupper med och utan psykologisk inokulering och beteendeekonomisk boost.
(2) Att utforska undergruppseffekter av relevanta sociodemografiska och beteendemässiga faktorer, inklusive HIV-risk, PrEP-historia, COVID-19-vaccinhistoria, allmän vaccinationstveksamhet och undvikande av information.
Utredarna kommer att genomföra en trearmad randomiserad kontrollerad studie av 2-3 inokuleringsmeddelanden som tar upp nya myter och felaktig information om HIV-vaccinet i Sydafrika.
Deltagarna kommer att tilldelas slumpmässigt till en kontrollgrupp eller en av två interventionsarmar: (1) inokuleringsmeddelandearm, eller (2) förbättra inokuleringsmeddelandet med insikter från beteendeekonomi.
Studieöversikt
Status
Aktiv, inte rekryterande
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
2163
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Johannesburg, Sydafrika
- Health Economics and Epidemiology Research Office, University of the Witwatersrand
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
Inklusionskriterier:
- Kvinnlig
- Ålder 18-24 år
- Självrapporterad historia av sexuell aktivitet under de senaste 12 månaderna
- Självrapporterad HIV-negativ status eller okänd HIV-status vid inskrivningen
- Vill och kan ge skriftligt informerat samtycke
- Kunna läsa och förstå engelska
Uteslutningskriterier:
- Ovillig eller oförmögen att ge samtycke till studiedeltagande.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Kontrollera
Deltagare som är inskrivna i kontrollgruppen kommer att få oberoende information om diabetes och näringsämnen av samma längd som inokuleringsmeddelanden.
Se bilaga 6 för ett exempel på hur detta meddelande kommer att struktureras.
Detta kommer att göra kontrollgruppen till en uppmärksamhetskontrollgrupp och säkerställa att fynd inte förvirras av interventionsgruppen som spenderar mer tid och uppmärksamma resurser vid deltagande i studien.
|
Deltagare som är inskrivna i kontrollgruppen kommer att få oberoende information om diabetes och näringsämnen av samma längd som inokuleringsmeddelanden.
Se bilaga 6 för ett exempel på hur detta meddelande kommer att struktureras.
Detta kommer att göra kontrollgruppen till en uppmärksamhetskontrollgrupp och säkerställa att fynd inte förvirras av interventionsgruppen som spenderar mer tid och uppmärksamma resurser vid deltagande i studien.
|
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Övrig: Förbättrat inokuleringsmeddelande
Deltagare som är inskrivna i den förbättrade inokuleringsmeddelandearmen kommer att få meddelanden som varnar dem om förestående HIV -vaccin -felinformation och förklarar varför dessa påståenden är falska eller vilseledande, meddelandena kommer att förbättras med insikter från beteendeekonomi Se bilaga 5: "Inokuleringsmeddelande med ett boost" för ett exempel på inokuleringsmeddelandet.
Som en del av beteendekonomiförstärkningen kan deltagarna välja att få ett litet symbol (t.ex. klistermärke, märke, armband) med ett meddelande som främjar vaccination som en konsistens och engagemangspremi.
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Deltagare som är inskrivna i den förbättrade inokuleringsmeddelandearmen kommer att få meddelanden som varnar dem om förestående HIV -vaccin -felinformation och förklarar varför dessa påståenden är falska eller vilseledande, meddelandena kommer att förbättras med insikter från beteendeekonomi Se bilaga 5: "Inokuleringsmeddelande med ett boost" för ett exempel på inokuleringsmeddelandet.
Som en del av beteendekonomiförstärkningen kan deltagarna välja att få ett litet symbol (t.ex. klistermärke, märke, armband) med ett meddelande som främjar vaccination som en konsistens och engagemangspremi.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
HIV Vaccine Intention, at the End of the Baseline Assessment
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
HIV Vaccine Intention, Follow-up
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
24 juli 2025
Primärt slutförande (Faktisk)
16 oktober 2025
Avslutad studie (Beräknad)
1 juni 2027
Studieregistreringsdatum
Först inskickad
7 november 2024
Först inskickad som uppfyllde QC-kriterierna
18 november 2024
Första postat (Faktisk)
22 november 2024
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1R01MH132401 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
IPD-planbeskrivning
Utredarna bestämmer fortfarande datadelningsplanen och om vi kommer att dela IPD ännu
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .