Clinical trial NCT06700447: Protecting Against HIV Vaccine Misinformation With Adolescent Girls and Young Women in South Africa
Official title: Protecting Against HIV Vaccine Misinformation With Adolescent Girls and Young Women in South Africa
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Misinformation
HIV Vaccine
Keywords: Prevention: Vaccines
Adolescent Girls and Young Women
South Africa
HIV
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: University of Cape Town
name: Boston University
name: National Institute of Mental Health (NIMH)
name: Health Economics and Epidemiology Research Office, University of the Witwatersrand
First posted: 2024-11-22
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Intention to receive the HIV vaccine following exposure to misinformation
timeFrame: 4-8 weeks
Secondary outcomes:
measure: Secondary outcomes: Intention to receive the HIV vaccine 2-6 weeks following the exposure
timeFrame: 3-6 months
measure: Subgroup analyses
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: