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

University of Pennsylvania

Status: Begins enrollment in 5 months

Conditions: Misinformation; HIV Vaccine

Treatments: Behavioral: Standard inoculation message; Behavioral: Nutrition information; Behavioral: Enhanced inoculation message

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06700447

1R01MH132401 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Adolescent girls and young women (AGYW) between the ages of 15-24 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 behavioral 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 three-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 one of two intervention arms: (1) inoculation message arm, or (2) enhance inoculation message with insights from behavioural economics.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female
• Age 18-24 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,000 participants in 3 patient groups

Control

Active Comparator group

Description:

Participants enrolled in the control group will receive unrelated information on nutrition topics of the same length as the inoculation messages. 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.

Treatment:

Behavioral: Nutrition information

Enhanced inoculation message

Other group

Description:

Participants enrolled in the enhanced inoculation message arm will receive a similar inoculation message that is enhanced with insights from behavioural economics. 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. Following this message delivery, all participants will view/watch claims about the HIV vaccine some of which will be false or misleading. The vaccine misinformation claims will be presented using language (and in some cases, visual imagery) consistent with how misinformation exposure will occur in the information ecology (i.e., through social networks and in traditional and social media in real-world settings).

Treatment:

Behavioral: Enhanced inoculation message

Standard inoculation message

Other group

Description:

Participants enrolled in the standard inoculation message arm will receive a message that warns them about impending HIV vaccine misinformation and explains why that claim is false or misleading. Following this message delivery, all participants will view/watch claims about the HIV vaccine some of which will be false or misleading. The vaccine misinformation claims will be presented using language (and in some cases, visual imagery) consistent with how misinformation exposure will occur in the information ecology (i.e., through social networks and in traditional and social media in real-world settings).

Treatment:

Behavioral: Standard inoculation message