Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202311613424063 Date of Approval: 21/11/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Protecting against HIV vaccine misinformation in South Africa
Official scientific title Protecting against HIV vaccine misinformation in South Africa
Brief summary describing the background and objectives of the trial Background: A safe, effective, affordable and acceptable vaccine against HIV has been an epidemic-ending goal for decades, and recent years have seen substantial progress in developing promising candidate vaccines. For groups such as adolescent girls and young women (AGYW) in sub-Saharan Africa, access and uptake of vaccines will be essential for reducing the exceptionally high HIV incidence observed in recent years. This is particularly true in South Africa, which has both the world’s largest HIV epidemic and several active HIV vaccine trial programs. While an effective HIV vaccine has the potential to substantially reduce HIV incidence in South Africa, realising this potential will require widespread vaccine uptake. However, the lived experiences of both the HIV epidemic and the ongoing COVID-19 pandemic have laid the groundwork for an infodemic of HIV vaccine misinformation. Likely attributes of the HIV vaccine (e.g., only partial protection against HIV), low trust in governmental and medical research institutions, and poor understanding of how vaccines work will leave the same populations that will benefit most from a vaccine also highly vulnerable to misinformation. Objectives: To rate HIV vaccine misinformation and related claims based on the level of concern among women in South Africa. Approach: This will be an exploratory study to identify the most concerning claims about the HIV vaccine. We will identify the most common HIV misinformation claims through various sources including grey and scientific literature, social media, mainstream media, and consultation with experts in the HIV vaccine field. The claims identified through these sources will be presented to participants in an online survey to rate them based on vaccine concerns that may result in reduced intentions to take an HIV vaccine when it becomes available.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 16/10/2023
Actual trial start date 31/12/2025
Anticipated date of last follow up 30/06/2025
Actual Last follow-up date 31/12/2025
Anticipated target sample size (number of participants) 133
Actual target sample size (number of participants) 133
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
666 2023 University of Cape Town
854420 University of Pennsylvania
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Women 18 to 29 years Participants will be shown a randomly selected subset of 9 claims about the HIV vaccine from the full set of claims and asked to select the 3 claims that they find most concerning. From the remaining list of 6 claims, participants will then select the 3 claims that they find least concerning. The process will be repeated once more, drawing the second set of 9 messages from the remaining pool of claims not shown in the first round (i.e, selection without replacement); individuals will again select the 3 messages they found most concerning and then choose the 3 that they found least concerning from the remaining 6. Data will be collected over a 3 months period for this specific study. This study will build upon a contextual inquiry that aims to identify HIV misinformation claims relevant to the South African context. The claims will be sourced through grey and scientific literature, social media and mainstream media, and consultation with experts in the field of HIV vaccines. We will conduct an online survey with study participants to identify the misinformation claims that participants find most concerning. Participants will be shown a randomly selected subset of 9 claims about the HIV vaccine from the full set of claims and asked to select the 3 claims that they find most concerning. From the remaining list of 6 claims, participants will then select the 3 claims that they find least concerning. The process will be repeated once more, drawing the second set of 9 messages from the remaining pool of claims not shown in the first round (i.e, selection without replacement); individuals will again select the 3 messages they found most concerning and then choose the 3 that they found least concerning from the remaining 6. Upon completion of the study, participants will view a “debrief” message that emphasises the fact that the information about the HIV vaccine that they viewed was incorrect or misleading. A simple statement appropriate for a wide range of reading levels will be offered that summarises the current state of knowledge and evidence about the HIV vaccine. 133
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Female Age 18-29 years Living in South Africa Able to read and understand English Unwilling or unable to provide consent for study participation Adult: 19 Year-44 Year 18 Year(s) 29 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 07/09/2023 University of the Witwatersrand HREC Medical
Ethics Committee Address
Street address City Postal code Country
31 Princess of Wales Terrace, Parktown Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be participants’ rating of their level of concern about misinformation claims. monthly
Secondary Outcome Identification of concerning misinformation claims. 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Participant will be recruited from online platforms which may include but not limited to Prolific Academic or MoyaApp Research Pane or Choma These are online platforms and no street address can be provided Participants will be recruited from South Africa but no specific city can be provided N/A South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Pennsylvania University of Pennsylvania, Philadephia Philadelphia 19104 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Pennsylvania Philadelphia, PA Philadelphia 19104 United States of America University
COLLABORATORS
Name Street address City Postal code Country
University of Pennsylvania 3451 Walnut Street Philadelphia PA 19104 United States of America
University of Cape Town Woolsack Drive, Rondebosch Cape Town 7701 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alison Buttenheim abutt@nursing.upenn.edu +12152848413 423 Guardian Drive, Blockley Hall, University of Pennsylvania
City Postal code Country Position/Affiliation
Philadelphia 19104 United States of America Associate Professor
Role Name Email Phone Street address
Scientific Enquiries Brendan Maughan Brown brendan.maughanbrown@gmail.com +27721456155 Level 3, School of Economics Building Middle Campus University of Cape Town
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Chief Research Officer
Role Name Email Phone Street address
Public Enquiries Candice Chetty Makkan cchetty@heroza.org +27832892181 Sunnyside Office Park, Building C, First Floor, 32 Princess of Wales Terrace, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Senior Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes This study ensures all parties adhere to the Protection of Private Information Act (POPIA). The study databases resulting from data collection will not contain identifying information and will be organised by assigned unique identifiers. All database files will also be password-protected, and only study staff will have access to the files. The study team based in South Africa and those outside of South Africa will be given access to the de-identified data through a Secure File Transfer Protocol (SFTP) link. All data will be managed by HE2RO’s data management system. Participants complete the study survey on Qualtrics, which is an online database. There will be no paper based records. All data will be captured and stored electronically on Qualtrics which holds high data security features necessary for academic research. The electronic study records will be kept for six years after study completion before destroying them. Informed Consent Form,Study Protocol 12 months De-identified data will be used for study reporting
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information