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

NCT06700447 | Active Not Recruiting DMC

• 1 other identifier: 1R01MH132401
• Study Type: interventional
• Target: 2,163
• Locations: 1 country
• Sites: 1

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.

Conditions

Misinformation; HIV Vaccine

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 0-10 scale.

  At the end of the baseline assessment

Secondary Outcomes (42)

• HIV vaccine intention, follow-up

  2-4 weeks

• Recommend to friends, at the end of the baseline assessment

  At the end of the baseline assessment

• Recommend to friends, follow-up

  2-4 weeks

• Credibility of inoculated exposure #1

  At the end of the baseline assessment

• Credibility of inoculated exposure #2

  At the end of the baseline assessment

Study Arms (2)

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.

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.

Behavioral: Enhanced inoculation message

Interventions

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.

Enhanced inoculation message

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.

Control

Eligibility Criteria

• Age: 18 Years - 29 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Unwilling or unable to provide consent for study participation.

Sponsors & Collaborators

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

Study Sites (1)

Health Economics and Epidemiology Research Office, University of the Witwatersrand

Johannesburg, South Africa

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 22, 2024
• Study Start: July 24, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-04

Locations

ZA (1)