MisinformationPROTECTNCT06700447
Protecting Against HIV Vaccine Misinformation With Adolescent Girls and Young Women in South Africa
A study testing Enhanced inoculation message and Nutrition information in people with Misinformation and HIV Vaccine, run by University of Pennsylvania at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Misinformation, HIV Vaccine
- What is being tested?
- Enhanced inoculation message and Nutrition information
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,163 participants
- Where
- 1 siteSouth Africa
- Study dates
- 24 Jul 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Unwilling or unable to provide consent for study participation.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Health Economics and Epidemiology Research Office, University of the Witwatersrand
Johannesburg
About this study
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.
- Conditions
- Misinformation, HIV Vaccine
- Being tested
- Enhanced inoculation message, Nutrition information
- Keywords
- Prevention: Vaccines, Adolescent Girls and Young Women, South Africa, HIV
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced inoculation messageBehavioural
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.
Nutrition informationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 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. Receives: Behavioral: Nutrition information |
| Enhanced inoculation message | Other | 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. Receives: Behavioral: Enhanced inoculation message |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Vaccine Intention, 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 1-10 scale. Higher score means they are more likely to get the HIV vaccine.
Measured: At the end of the baseline assessment
Secondary outcomes (48)
HIV Vaccine Intention, Follow-up
Intention to get the HIV vaccine, measured at follow-up survey following misinformation exposure and intervention. Measured on a 1-10 scale. Higher score means they are more likely to get the HIV vaccine.
Measured: 2-4 weeks
Recommend to Friends, 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 1-10 scale. Higher score means they are more likely to recommend the HIV vaccine to a friend.
Measured: At the end of the baseline assessment
Recommend to Friends, Follow-up
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 1-10 scale. Higher score means they are more likely to recommend the HIV vaccine to a friend.
Measured: 2-4 weeks
Credibility of Inoculated Exposure #1
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.
Measured: At the end of the baseline assessment
Credibility of Inoculated Exposure #2
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.
Measured: At the end of the baseline assessment
Credibility of Inoculated Exposure #3
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.
Measured: At the end of the baseline assessment
Credibility of Inoculated Exposure #4
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.
Measured: At the end of the baseline assessment
Credibility of Inoculated Exposure #5
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.
Measured: At the end of the baseline assessment
Credibility of Inoculated Exposure #6
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.
Measured: At the end of the baseline assessment
Anxiousness of Inoculated Exposure #1
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.
Measured: At the end of the baseline assessment
Anxiousness of Inoculated Exposure #2
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.
Measured: At the end of the baseline assessment
Anxiousness of Inoculated Exposure #3
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.
Measured: At the end of the baseline assessment
Anxiousness of Inoculated Exposure #4
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.
Measured: At the end of the baseline assessment
Anxiousness of Inoculated Exposure #5
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.
Measured: At the end of the baseline assessment
Anxiousness of Inoculated Exposure #6
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.
Measured: At the end of the baseline assessment
Shareability of Inoculated Exposure #1
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.
Measured: At the end of the baseline assessment
Shareability of Inoculated Exposure #7
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.
Measured: At the end of the baseline assessment
Shareability of Inoculated Exposure #3
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.
Measured: At the end of the baseline assessment
Shareability of Inoculated Exposure #4
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.
Measured: At the end of the baseline assessment
Shareability of Inoculated Exposure #5
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.
Measured: At the end of the baseline assessment
Shareability of Inoculated Exposure #6
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.
Measured: At the end of the baseline assessment
Credibility of Inoculated Exposure #1, Follow-up
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.
Measured: 2-4 weeks
Credibility of Inoculated Exposure #2, Follow-up
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.
Measured: 2-4 weeks
Shareability of Inoculated Exposure #1, Follow-up
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.
Measured: 2-4 weeks
Shareability of Inoculated Exposure #2, Follow-up
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.
Measured: 2-4 weeks
Anxiousness of Inoculated Exposure #1, Follow-up
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.
Measured: 2-4 weeks
Anxiousness of Inoculated Exposure #2, Follow-up
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.
Measured: 2-4 weeks
Credibility of New Claims, Exposure #12, Follow-up
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.
Measured: 2-4 weeks
Credibility of New Claims, Exposure #8, Follow-up
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.
Measured: 2-4 weeks
Credibility of New Claims, Exposure #9, Follow-up
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.
Measured: 2-4 weeks
Credibility of New Claims, Exposure #10, Follow-up
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.
Measured: 2-4 weeks
Credibility of New Claims, Exposure #11, Follow-up
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.
Measured: 2-4 weeks
Anxiousness o of New Claims, Exposure #12, Follow-up
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.
Measured: 2-4 weeks
Anxiousness of New Claims, Claim #8, Follow-up
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.
Measured: 2-4 weeks
Anxiousness of New Claims, Exposure #9, Follow-up
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.
Measured: 2-4 weeks
Anxiousness of New Claims, Exposure #10, Follow-up
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.
Measured: 2-4 weeks
Anxiousness of New Claims, Exposure #11, Follow-up
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.
Measured: 2-4 weeks
Shareability of New Claims, Exposure #12, Follow-up
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.
Measured: 2-4 weeks
Shareability of New Claims, Exposure #8, Follow-up
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.
Measured: 2-4 weeks
Shareability of New Claims, Exposure #9, Follow-up
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.
Measured: 2-4 weeks
Shareability of New Claims, Exposure #10, Follow-up
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.
Measured: 2-4 weeks
Shareability of New Claims, Exposure #11, Follow-up
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.
Measured: 2-4 weeks
Credibility of Inoculated Exposure #7
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.
Measured: At the end of the baseline assessment
Anxiousness of Inoculated Exposure #7
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.
Measured: At the end of the baseline assessment
Shareability of Inoculated Exposure #2
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.
Measured: At the end of the baseline assessment
Credibility of New Claims, Exposure #13, Follow-up
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.
Measured: 2-4 weeks
Anxiousness of New Claims, Exposure #13, Follow-up
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.
Measured: 2-4 weeks
Shareability of New Claims, Exposure #13, Follow-up
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.
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start24 Jul 2025
- Primary completion16 Oct 2025
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MisinformationStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town, Boston University, National Institute of Mental Health (NIMH), Health Economics and Epidemiology Research Office, University of the Witwatersrand
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700447
- Sponsor's protocol ID
- 1R01MH132401
- Other IDs
- 1R01MH132401
- Acronym
- PROTECT
- Status last verified
- Aug 2026
- First submitted
- 7 Nov 2024
- Last updated
- 24 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators are still determining the data sharing plan and if we will be sharing IPD yet
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protecting Against HIV Vaccine Misinformation With Adolescent Girls and Young Women in South Africa
- ClinicalTrials.gov ID
- NCT06700447
- Acronym / sponsor ID
- PROTECT / 1R01MH132401
- Conditions
- Misinformation, HIV Vaccine
- Keywords
- Prevention: Vaccines, Adolescent Girls and Young Women, South Africa, HIV
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,163 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of Cape Town, Boston University, National Institute of Mental Health (NIMH), Health Economics and Epidemiology Research Office, University of the Witwatersrand
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Posted 28 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Nutrition informationParticipants 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. |
| Enhanced inoculation message | Other | Behavioral: Enhanced inoculation messageParticipants 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. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Unwilling or unable to provide consent for study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced inoculation messageParticipants 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. | Behavioural | Enhanced inoculation message |
| Nutrition informationParticipants 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. | Behavioural | Control |
Primary outcome
HIV Vaccine Intention, at the End of the Baseline Assessment
Time frame: 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 1-10 scale. Higher score means they are more likely to get the HIV vaccine.
48 secondary outcomes
HIV Vaccine Intention, Follow-up
Time frame: 2-4 weeks
Recommend to Friends, at the End of the Baseline Assessment
Time frame: At the end of the baseline assessment
Recommend to Friends, Follow-up
Time frame: 2-4 weeks
Credibility of Inoculated Exposure #1
Time frame: At the end of the baseline assessment
Credibility of Inoculated Exposure #2
Time frame: At the end of the baseline assessment
Credibility of Inoculated Exposure #3
Time frame: At the end of the baseline assessment
Credibility of Inoculated Exposure #4
Time frame: At the end of the baseline assessment
Credibility of Inoculated Exposure #5
Time frame: At the end of the baseline assessment
Credibility of Inoculated Exposure #6
Time frame: At the end of the baseline assessment
Anxiousness of Inoculated Exposure #1
Time frame: At the end of the baseline assessment
Anxiousness of Inoculated Exposure #2
Time frame: At the end of the baseline assessment
Anxiousness of Inoculated Exposure #3
Time frame: At the end of the baseline assessment
Anxiousness of Inoculated Exposure #4
Time frame: At the end of the baseline assessment
Anxiousness of Inoculated Exposure #5
Time frame: At the end of the baseline assessment
Anxiousness of Inoculated Exposure #6
Time frame: At the end of the baseline assessment
Shareability of Inoculated Exposure #1
Time frame: At the end of the baseline assessment
Shareability of Inoculated Exposure #7
Time frame: At the end of the baseline assessment
Shareability of Inoculated Exposure #3
Time frame: At the end of the baseline assessment
Shareability of Inoculated Exposure #4
Time frame: At the end of the baseline assessment
Shareability of Inoculated Exposure #5
Time frame: At the end of the baseline assessment
Shareability of Inoculated Exposure #6
Time frame: At the end of the baseline assessment
Credibility of Inoculated Exposure #1, Follow-up
Time frame: 2-4 weeks
Credibility of Inoculated Exposure #2, Follow-up
Time frame: 2-4 weeks
Shareability of Inoculated Exposure #1, Follow-up
Time frame: 2-4 weeks
Shareability of Inoculated Exposure #2, Follow-up
Time frame: 2-4 weeks
Anxiousness of Inoculated Exposure #1, Follow-up
Time frame: 2-4 weeks
Anxiousness of Inoculated Exposure #2, Follow-up
Time frame: 2-4 weeks
Credibility of New Claims, Exposure #12, Follow-up
Time frame: 2-4 weeks
Credibility of New Claims, Exposure #8, Follow-up
Time frame: 2-4 weeks
Credibility of New Claims, Exposure #9, Follow-up
Time frame: 2-4 weeks
Credibility of New Claims, Exposure #10, Follow-up
Time frame: 2-4 weeks
Credibility of New Claims, Exposure #11, Follow-up
Time frame: 2-4 weeks
Anxiousness o of New Claims, Exposure #12, Follow-up
Time frame: 2-4 weeks
Anxiousness of New Claims, Claim #8, Follow-up
Time frame: 2-4 weeks
Anxiousness of New Claims, Exposure #9, Follow-up
Time frame: 2-4 weeks
Anxiousness of New Claims, Exposure #10, Follow-up
Time frame: 2-4 weeks
Anxiousness of New Claims, Exposure #11, Follow-up
Time frame: 2-4 weeks
Shareability of New Claims, Exposure #12, Follow-up
Time frame: 2-4 weeks
Shareability of New Claims, Exposure #8, Follow-up
Time frame: 2-4 weeks
Shareability of New Claims, Exposure #9, Follow-up
Time frame: 2-4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. The investigators are still determining the data sharing plan and if we will be sharing IPD yet
Related trials for Misinformation
Not yet recruiting
Development and Evaluation of a Digital Educational Intervention to Improve Vaccine Confidence and Communication Among Registered Nurses: Protocol for a Randomized Controlled Trial (VaxNurse-RCT).
Vaccine Hesitancy, Vaccine Acceptance
Recruiting
Protecting Against Lenacapavir Misinformation With Young Women in Gauteng, South Africa ( PROTECT-L)
Misinformation, Lenacapavir
Recruiting
Building Cognitive Resilience to Vaccine Misinformation Using AI in Europe
Healthy
Not yet recruiting
Social Media Withdrawal in Pregnancy: Effects on Maternal Mental Health and Misinformation
Pregnancy
Not yet recruiting
Cognitive and Emotional Inoculation Against Nutrition-Related Misinformation in Young Adults
Health Misinformation, Misinformation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced inoculation message and Nutrition information in people with Misinformation and HIV Vaccine, run by University of Pennsylvania at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Vaccine Intention, at the End of the Baseline Assessment (time frame: At the end of the baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.