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Protecting Against HIV Vaccine Misinformation With Adolescent Girls and Young Women in South Africa

Protecting Against HIV Vaccine Misinformation With Adolescent Girls and Young Women in South Africa

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06700447
Acronym
PROTECT
Enrollment
2163
Registered
2024-11-22
Start date
2025-07-24
Completion date
2027-06-01
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Vaccine, Misinformation

Keywords

Prevention: Vaccines, Adolescent Girls and Young Women, South Africa, HIV

Brief summary

Adolescent girls and young women (AGYW) between the ages of 15-29 years continue to bear the brunt of Human Immunodeficiency Virus (HIV) infections in South Africa despite progress recorded in prevention and treatment programmes. The ongoing susceptibility of young women to HIV infection and the sub-optimal uptake of prevention options such as Pre-Exposure Prophylaxis (PrEP) that are highly effective creates a need for an HIV vaccine to benefit populations at substantial risk of HIV infection. However, lessons from previous vaccine studies and the recent COVID-19 vaccine have highlighted significant barriers to vaccine uptake, such as widespread misinformation and vaccine hesitancy. These challenges threaten the successful implementation of a future HIV vaccine. Building on these insights, this study will utilise psychological inoculation theory to develop and evaluate HIV vaccine messages among adolescent girls and young women. Primary objective: To compare changes in intentions to receive HIV vaccine following misinformation exposure in groups with and without psychological inoculation and behavioural economics boost. Secondary objectives: (1) To compare believability and persuasiveness of misinformation claims and motivational threat associated with misinformation in groups with and without psychological inoculation and behavioural economics boost. (2) To explore subgroup effects by relevant sociodemographic and behavioural factors including HIV risk, PrEP history, COVID-19 vaccine history, general vaccine hesitancy, and information avoidance. The investigators will conduct a two-arm randomized controlled trial of 2-3 inoculation messages that address emerging myths and misinformation about the HIV vaccine in South Africa. Participants will be randomly assigned to a control group or an intervention arm: enhanced inoculation message with insights from behavioural economics.

Interventions

Participants enrolled in the enhanced inoculation message arm will receive messages that warn them about impending HIV vaccine misinformation and explains why those claims are false or misleading, the messages will be enhanced with insights from behavioural economics see Appendix 5: "Inoculation message with a BE boost" for an example of the inoculation message. As part of the behavioural economics boost, participants may choose to receive a small token (e.g., sticker, badge, bracelet) with a message promoting vaccination as a consistency and commitment prime.

Participants enrolled in the control group will receive unrelated information on diabetes and nutrition topics of the same length as the inoculation messages. Please see Appendix 6 for an example of how this message will be structured. This will make the control group an attention control group and ensure that findings are not confounded by the intervention group spending more time and attentional resources on participation in the study.

Sponsors

University of Pennsylvania
Lead SponsorOTHER
University of Cape Town
CollaboratorOTHER
Boston University
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
Health Economics and Epidemiology Research Office, University of the Witwatersrand
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes

Inclusion criteria

* Female * Age 18-29 years * Self-reported history of sexual activity in the past 12 months * Self-reported HIV-negative status or unknown HIV status at enrolment * Willing and able to provide written informed consent * Able to read and understand English

Exclusion criteria

* Unwilling or unable to provide consent for study participation.

Design outcomes

Primary

MeasureTime frameDescription
HIV Vaccine Intention, at the End of the Baseline AssessmentAt the end of the baseline assessmentIntention 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.

Secondary

MeasureTime frameDescription
Recommend to Friends, at the End of the Baseline AssessmentAt the end of the baseline assessmentIntention 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.
Recommend to Friends, Follow-up2-4 weeksIntention 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.
Credibility of Inoculated Exposure #1At the end of the baseline assessmentExtent 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.
Credibility of Inoculated Exposure #2At the end of the baseline assessmentExtent 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.
Credibility of Inoculated Exposure #3At the end of the baseline assessmentExtent 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.
Credibility of Inoculated Exposure #4At the end of the baseline assessmentExtent 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.
Credibility of Inoculated Exposure #5At the end of the baseline assessmentExtent 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.
Credibility of Inoculated Exposure #6At the end of the baseline assessmentExtent 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.
Anxiousness of Inoculated Exposure #1At the end of the baseline assessmentExtent 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.
Anxiousness of Inoculated Exposure #2At the end of the baseline assessmentExtent 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.
Anxiousness of Inoculated Exposure #3At the end of the baseline assessmentExtent 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.
Anxiousness of Inoculated Exposure #4At the end of the baseline assessmentExtent 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.
Anxiousness of Inoculated Exposure #5At the end of the baseline assessmentExtent 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.
Anxiousness of Inoculated Exposure #6At the end of the baseline assessmentExtent 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.
Shareability of Inoculated Exposure #1At the end of the baseline assessmentExtent 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.
Shareability of Inoculated Exposure #7At the end of the baseline assessmentExtent 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.
Shareability of Inoculated Exposure #3At the end of the baseline assessmentExtent 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.
Shareability of Inoculated Exposure #4At the end of the baseline assessmentExtent 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.
Shareability of Inoculated Exposure #5At the end of the baseline assessmentExtent 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.
Shareability of Inoculated Exposure #6At the end of the baseline assessmentExtent 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.
Credibility of Inoculated Exposure #1, Follow-up2-4 weeksExtent 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.
Credibility of Inoculated Exposure #2, Follow-up2-4 weeksExtent 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.
Shareability of Inoculated Exposure #1, Follow-up2-4 weeksExtent 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.
Shareability of Inoculated Exposure #2, Follow-up2-4 weeksExtent 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.
Anxiousness of Inoculated Exposure #1, Follow-up2-4 weeksExtent 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.
Anxiousness of Inoculated Exposure #2, Follow-up2-4 weeksExtent 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.
Credibility of New Claims, Exposure #12, Follow-up2-4 weeksExtent 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.
Credibility of New Claims, Exposure #8, Follow-up2-4 weeksExtent 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.
Credibility of New Claims, Exposure #9, Follow-up2-4 weeksExtent 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.
Credibility of New Claims, Exposure #10, Follow-up2-4 weeksExtent 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.
Credibility of New Claims, Exposure #11, Follow-up2-4 weeksExtent 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.
Anxiousness o of New Claims, Exposure #12, Follow-up2-4 weeksExtent 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.
Anxiousness of New Claims, Claim #8, Follow-up2-4 weeksExtent 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.
Anxiousness of New Claims, Exposure #9, Follow-up2-4 weeksExtent 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.
Anxiousness of New Claims, Exposure #10, Follow-up2-4 weeksExtent 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.
Anxiousness of New Claims, Exposure #11, Follow-up2-4 weeksExtent 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.
Shareability of New Claims, Exposure #12, Follow-up2-4 weeksExtent 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.
Shareability of New Claims, Exposure #8, Follow-up2-4 weeksExtent 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.
Shareability of New Claims, Exposure #9, Follow-up2-4 weeksExtent 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.
Shareability of New Claims, Exposure #10, Follow-up2-4 weeksExtent 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.
Shareability of New Claims, Exposure #11, Follow-up2-4 weeksExtent 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.
HIV Vaccine Intention, Follow-up2-4 weeksIntention 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.
Anxiousness of Inoculated Exposure #7At the end of the baseline assessmentExtent 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.
Shareability of Inoculated Exposure #2At the end of the baseline assessmentExtent 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.
Credibility of New Claims, Exposure #13, Follow-up2-4 weeksExtent 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.
Anxiousness of New Claims, Exposure #13, Follow-up2-4 weeksExtent 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.
Shareability of New Claims, Exposure #13, Follow-up2-4 weeksExtent 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.
Credibility of Inoculated Exposure #7At the end of the baseline assessmentExtent 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.

Countries

South Africa

Baseline characteristics

Characteristic
Age, Continuous25.1 years
STANDARD_DEVIATION 2.6
Race/Ethnicity, Customized
Race
African/Black
997 Participants
Race/Ethnicity, Customized
Race
Coloured/Mixed
103 Participants
Race/Ethnicity, Customized
Race
Indian
6 Participants
Race/Ethnicity, Customized
Race
Other
3 Participants
Race/Ethnicity, Customized
Race
White
26 Participants
Region of Enrollment
South Africa
1083 Participants
Sex: Female, Male
Female
1083 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026