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NCT Number: NCT06700447

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Misinformation Behavior Communication HIV Vaccine

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Economics and Epidemiology Research Office, University of the Witwatersrand

Johannesburg, South Africa

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enhanced inoculation message

Behavioral

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 information

Behavioral

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.

Primary outcomes

  1. 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 0-10 scale.

Secondary outcomes

  1. HIV vaccine intention, follow-up

    Time frame: 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.

  2. Recommend to friends, at the end of the baseline assessment

    Time frame: 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.

  3. Recommend to friends, follow-up

    Time frame: 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.

  4. Credibility of inoculated exposure #1

    Time frame: At the end of the baseline assessment

    Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about the HIV vaccine, likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against and four new claims. All measured on a 1-7 scale

  5. Credibility of inoculated exposure #2

    Time frame: At the end of the baseline assessment

    Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about the HIV vaccine, likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against and four new claims. All measured on a 1-7 scale

  6. Credibility of inoculated exposure #3

    Time frame: At the end of the baseline assessment

    Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about the HIV vaccine, likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against and four new claims. All measured on a 1-7 scale

  7. Credibility of inoculated exposure #4

    Time frame: At the end of the baseline assessment

    Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about the HIV vaccine, likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against and four new claims. All measured on a 1-7 scale

  8. Credibility of inoculated exposure #5

    Time frame: At the end of the baseline assessment

    Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about the HIV vaccine, likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against and four new claims. All measured on a 1-7 scale

  9. Credibility of inoculated exposure #6

    Time frame: At the end of the baseline assessment

    Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about the HIV vaccine, likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against and four new claims. All measured on a 1-7 scale

  10. Anxiousness of inoculated exposure #1

    Time frame: At the end of the baseline assessment

    Extent to which the claim makes you anxious or nervous about the HIV vaccine for both HIV vaccine claims specifically inoculated against and four new claims. All measured on a 1-7 scale

  11. Anxiousness of inoculated exposure #2

    Time frame: At the end of the baseline assessment

    Extent to which the claim makes you anxious or nervous about the HIV vaccine for both HIV vaccine claims specifically inoculated against and four new claims. All measured on a 1-7 scale

  12. Anxiousness of inoculated exposure #3

    Time frame: At the end of the baseline assessment

    Extent to which the claim makes you anxious or nervous about the HIV vaccine for both HIV vaccine claims specifically inoculated against and four new claims. All measured on a 1-7 scale

  13. Anxiousness of inoculated exposure #4

    Time frame: At the end of the baseline assessment

    Extent to which the claim makes you anxious or nervous about the HIV vaccine for both HIV vaccine claims specifically inoculated against and four new claims. All measured on a 1-7 scale

  14. Anxiousness of inoculated exposure #5

    Time frame: At the end of the baseline assessment

    Extent to which the claim makes you anxious or nervous about the HIV vaccine for both HIV vaccine claims specifically inoculated against and four new claims. All measured on a 1-7 scale

  15. Anxiousness of inoculated exposure #6

    Time frame: At the end of the baseline assessment

    Extent to which the claim makes you anxious or nervous about the HIV vaccine for both HIV vaccine claims specifically inoculated against and four new claims. All measured on a 1-7 scale

  16. Shareability of inoculated exposure #1

    Time frame: At the end of the baseline assessment

    Likelihood of your sharing the claim for both HIV vaccine claims specifically inoculated against and four new claims. All measured on a 1-7 scale

  17. Shareability of inoculated exposure #2

    Time frame: At the end of the baseline assessment

    Likelihood of your sharing the claim for both HIV vaccine claims specifically inoculated against and four new claims. All measured on a 1-7 scale

  18. Shareability of inoculated exposure #3

    Time frame: At the end of the baseline assessment

    Likelihood of your sharing the claim for both HIV vaccine claims specifically inoculated against and four new claims. All measured on a 1-7 scale

  19. Shareability of inoculated exposure #4

    Time frame: At the end of the baseline assessment

    Likelihood of your sharing the claim for both HIV vaccine claims specifically inoculated against and four new claims. All measured on a 1-7 scale

  20. Shareability of inoculated exposure #5

    Time frame: At the end of the baseline assessment

    Likelihood of your sharing the claim for both HIV vaccine claims specifically inoculated against and four new claims. All measured on a 1-7 scale

  21. Shareability of inoculated exposure #6

    Time frame: At the end of the baseline assessment

    Likelihood of your sharing the claim for both HIV vaccine claims specifically inoculated against and four new claims. All measured on a 1-7 scale

  22. Credibility of inoculated exposure #1, follow-up

    Time frame: 2-4 weeks

    Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about the HIV vaccine, likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against at baseline. Measured at follow-up on a 1-7 scale

  23. Credibility of inoculated exposure #2, follow-up

    Time frame: 2-4 weeks

    Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about the HIV vaccine, likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against at baseline. Measured at follow-up on a 1-7 scale

  24. Shareability of inoculated exposure #1, follow-up

    Time frame: 2-4 weeks

    Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about the HIV vaccine, likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against at baseline. Measured at follow-up on a 1-7 scale

  25. Shareability of inoculated exposure #2, follow-up

    Time frame: 2-4 weeks

    Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about the HIV vaccine, likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against at baseline. Measured at follow-up on a 1-7 scale

  26. Anxiousness of inoculatedexposure #1, follow-up

    Time frame: 2-4 weeks

    Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about the HIV vaccine, likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against at baseline. Measured at follow-up on a 1-7 scale

  27. Anxiousness of inoculated exposure #2, follow-up

    Time frame: 2-4 weeks

    Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about the HIV vaccine, likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against at baseline. Measured at follow-up on a 1-7 scale

  28. Credibility of new claims, exposure #7, follow-up

    Time frame: 2-4 weeks

    Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about the HIV vaccine, likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against at baseline. Each measured at follow-up on a 1-7 scale for each of 5 claims, and then summed for a global index (range: 5-35).

  29. Credibility of new claims, exposure #8, follow-up

    Time frame: 2-4 weeks

    Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about the HIV vaccine, likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against at baseline. Each measured at follow-up on a 1-7 scale for each of 5 claims, and then summed for a global index (range: 5-35).

  30. Credibility of new claims, exposure #9, follow-up

    Time frame: 2-4 weeks

    Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about the HIV vaccine, likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against at baseline. Each measured at follow-up on a 1-7 scale for each of 5 claims, and then summed for a global index (range: 5-35).

  31. Credibility of new claims, exposure #10, follow-up

    Time frame: 2-4 weeks

    Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about the HIV vaccine, likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against at baseline. Each measured at follow-up on a 1-7 scale for each of 5 claims, and then summed for a global index (range: 5-35).

  32. Credibility of new claims, exposure #11, follow-up

    Time frame: 2-4 weeks

    Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about the HIV vaccine, likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against at baseline. Each measured at follow-up on a 1-7 scale for each of 5 claims, and then summed for a global index (range: 5-35).

  33. Anxiousness o of new claims, exposure #7, follow-up

    Time frame: 2-4 weeks

    Extent to which the claim makes you anxious or nervous about the HIV vaccine for both HIV vaccine claims specifically inoculated against at baseline. Each measured at follow-up on a 1-7 scale for each of 5 claims, and then summed for a global index (range: 5-35).

  34. Anxiousness of new claims, claim #8, follow-up

    Time frame: 2-4 weeks

    Extent to which the claim makes you anxious or nervous about the HIV vaccine for both HIV vaccine claims specifically inoculated against at baseline. Each measured at follow-up on a 1-7 scale for each of 5 claims, and then summed for a global index (range: 5-35).

  35. Anxiousness of new claims, exposure #9, follow-up

    Time frame: 2-4 weeks

    Extent to which the claim makes you anxious or nervous about the HIV vaccine for both HIV vaccine claims specifically inoculated against at baseline. Each measured at follow-up on a 1-7 scale for each of 5 claims, and then summed for a global index (range: 5-35).

  36. Anxiousness of new claims, exposure #10, follow-up

    Time frame: 2-4 weeks

    Extent to which the claim makes you anxious or nervous about the HIV vaccine for both HIV vaccine claims specifically inoculated against at baseline. Each measured at follow-up on a 1-7 scale for each of 5 claims, and then summed for a global index (range: 5-35).

  37. Anxiousness of new claims, exposure #11, follow-up

    Time frame: 2-4 weeks

    Extent to which the claim makes you anxious or nervous about the HIV vaccine for both HIV vaccine claims specifically inoculated against at baseline. Each measured at follow-up on a 1-7 scale for each of 5 claims, and then summed for a global index (range: 5-35).

  38. Shareability of new claims, exposure #7, follow-up

    Time frame: 2-4 weeks

    Likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against at baseline. Each measured at follow-up on a 1-7 scale for each of 5 claims, and then summed for a global index (range: 5-35).

  39. Shareability of new claims, exposure #8, follow-up

    Time frame: 2-4 weeks

    Likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against at baseline. Each measured at follow-up on a 1-7 scale for each of 5 claims, and then summed for a global index (range: 5-35).

  40. Shareability of new claims, exposure #9, follow-up

    Time frame: 2-4 weeks

    Likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against at baseline. Each measured at follow-up on a 1-7 scale for each of 5 claims, and then summed for a global index (range: 5-35).

  41. Shareability of new claims, exposure #10, follow-up

    Time frame: 2-4 weeks

    Likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against at baseline. Each measured at follow-up on a 1-7 scale for each of 5 claims, and then summed for a global index (range: 5-35).

  42. Shareability of new claims, exposure #11, follow-up

    Time frame: 2-4 weeks

    Likelihood of your sharing the claim, for both HIV vaccine claims specifically inoculated against at baseline. Each measured at follow-up on a 1-7 scale for each of 5 claims, and then summed for a global index (range: 5-35).

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Boston University
  • Health Economics and Epidemiology Research Office, University of the Witwatersrand
  • National Institute of Mental Health (NIMH)
  • University of Cape Town

Registry information

Acronym: PROTECT

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 22, 2024
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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