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 15-24 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.

Detailed Description

Not available

Study Timeline

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

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intention to receive the HIV vaccine following exposure to misinformation	4-8 weeks	The investigators we use a 7-point likert scale to measure HIV vaccine intentions, attitudes and beliefs

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes: Intention to receive the HIV vaccine 2-6 weeks following the exposure	3-6 months	Intention to receive the HIV vaccine 2-6 weeks following the exposure, believability and persuasiveness of misinformation, interest in sharing misinformation, and motivational threat associated with misinformation. This will be measured using various 7-point likert scales.
Subgroup analyses	3-6 months	The investigators will explore subgroup effects by relevant sociodemographic and behavioural factors including HIV risk, PrEP history, COVID-19 vaccine history, general vaccine. The investigators will estimate separate models interacting treatment arm with dichotomous subgroup effect modifiers of interest, all collected in the baseline survey, theses include: HIV risk score, history of PrEP use, COVID-19 vaccine history, general vaccine hesitancy, and HIV information avoidance. The coefficients of interest in these models will be on the interaction (treatment arm by subgroup) terms.

Trial Locations

Locations (1)

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