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

Not Applicable

Not yet recruiting

• Conditions: Misinformation; HIV Vaccine

• Registration Number: NCT06700447
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-07
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-22
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-11
• Primary Completion: 2026-12
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 4000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HIV vaccine intention, at the end of the baseline assessment	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 Outcome Measures

Name	Time	Method
HIV vaccine intention, follow-up	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.
Recommend to friends, at the end of the baseline assessment	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.
Recommend to friends, follow-up	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.
Credibility of inoculated exposure #1	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
Credibility of inoculated exposure #2	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
Credibility of inoculated exposure #3	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
Credibility of inoculated exposure #4	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
Anxiousness of inoculated exposure #1	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
Anxiousness of inoculated exposure #5	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
Anxiousness of inoculated exposure #6	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
Credibility of inoculated exposure #5	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
Anxiousness of inoculated exposure #3	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
Shareability of inoculated exposure #1	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
Shareability of inoculated exposure #2	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
Credibility of inoculated exposure #6	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
Anxiousness of inoculated exposure #4	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
Anxiousness of inoculated exposure #2	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
Shareability of inoculated exposure #3	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
Shareability of inoculated exposure #4	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
Shareability of inoculated exposure #5	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
Shareability of inoculated exposure #6	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
Credibility of inoculated exposure #1, follow-up	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
Credibility of inoculated exposure #2, follow-up	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
Shareability of inoculated exposure #1, follow-up	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
Shareability of inoculated exposure #2, follow-up	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
Anxiousness of inoculatedexposure #1, follow-up	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
Anxiousness of inoculated exposure #2, follow-up	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
Credibility of new claims, exposure #7, follow-up	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).
Credibility of new claims, exposure #8, follow-up	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).
Credibility of new claims, exposure #9, follow-up	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).
Credibility of new claims, exposure #10, follow-up	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).
Credibility of new claims, exposure #11, follow-up	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).
Anxiousness o of new claims, exposure #7, follow-up	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).
Anxiousness of new claims, claim #8, follow-up	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).
Anxiousness of new claims, exposure #9, follow-up	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).
Anxiousness of new claims, exposure #10, follow-up	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).
Anxiousness of new claims, exposure #11, follow-up	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).
Shareability of new claims, exposure #7, follow-up	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).
Shareability of new claims, exposure #8, follow-up	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).
Shareability of new claims, exposure #9, follow-up	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).
Shareability of new claims, exposure #10, follow-up	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).
Shareability of new claims, exposure #11, follow-up	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).

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States