Study Participant Information and Informed Consent
Study Title
Feasibility and Acceptability Study of a Comprehensive HIV Artificial Intelligence Toolkit
Introduction
You are invited to take part in a research study that involves using an Artificial Intelligence (AI) Companion on WhatsApp to guide you through various health-related topics, including HIV testing, sexual and reproductive health (SRH), and accessing care services. This study is focused on evaluating the experience and usability of this AI Companion among Adolescent Girls and Young Women (AGYW) integrated into an existing programme that offers these services in person - called Shout it Now.
What Is AI and the AI Companion?
AI is a smart system that can interact with you, much like a human would, providing useful health information and advice. In this study, you will use an AI Companion that offers guidance on a range of health topics, including sexual health, relationships, HIV prevention, and access to other health services.
The AI Companion is a private and friendly digital guide that works alongside Shout’s health services to help you take care of your health. Through WhatsApp, the AI Companion can chat with you about important topics like HIV prevention, sexual health, relationships, and HIV self-testing. It helps you get the right support, whether you want to do an HIV self-test at home or visit one of Shout’s mobile clinics to speak to a nurse. The AI Companion is here to make it easier, safer, and more comfortable for you to access the services you need.
Why Are We Doing This Study?
The aim of this study is to see how well the Self-Care from Anywhere model, which includes the AI Companion and Shout’s health services, helps AGYW like you access SRH, HIV prevention, and other care services. We are exploring whether this model can improve your access to health information and support, while offering non-judgemental, confidential guidance to help you make informed decisions about your health.
How does the Self-Care from Anywhere system use Artificial Intelligence (AI)?
The Self-Care from Anywhere system uses AI to make HIV care more private, convenient, and efficient. Here’s how it works:
AI Companion: The WhatsApp-based AI chat helps you understand your HIV risk, guides you through self-testing, and connects you to care or prevention services if needed.
Secure and Private: Your data is handled safely. Conversations do not include your phone number or any personal information unless you choose to share it. Data sent to AI services (like OpenAI or Anthropic) is not stored or used to improve those AI systems.
Accurate Testing Support: The AI uses computer vision (CV) to help interpret your HIV self-test result and ensure accuracy. Nurses review these results to provide follow-up care.
Locally Relevant and Fair: The AI has been developed with input from young women in South Africa and is monitored to provide accurate and culturally appropriate responses.
The system is designed to support you at every step, ensuring your health information remains confidential and your care needs are met efficiently.
What Will You Do in This Study?
This study allows you to interact with the AI Companion through WhatsApp to access health information and services at any time, but you will also be able to link to a human nurse via WhatsApp [if you choose to], or even access care and services at any of Shout’s mobile clinics. As part of the study, here’s what you’ll be able to do:
Chat with the AI Companion: Once you agree to the study’s Terms and Conditions (Ts&Cs) and provide your consent, you will interact with the AI Companion. It will answer questions about your health, relationships, and HIV prevention.
Health Guidance and Assessments: The AI Companion will provide personalised health assessments based on your responses and guide you through an HIV vulnerability assessment and other health services if needed.
HIV Self-Testing Support (Optional): If you qualify for HIV self-testing, the AI will guide you on how to perform a HIV self-test properly. After the test, you can upload a photo of the result for verification by the AI using computer vision technology to ensure accuracy. However, you will have the option of doing an HIV test with a Shout provider if you prefer.
Counselling and Support: The AI Companion will provide post-test counselling based on your test result. You will be offered HIV prevention options such as pre-exposure prophylaxis (PrEP) for negative results and support for accessing care if the result is positive. You will also have the option to connect with a Shout nurse for further guidance and services.
Follow-Up and Referral: After interacting with the AI, you will receive a unique referral number to help track your progress through health services. This number will be used for follow-up care, ensuring privacy without revealing your personal information. Furthermore, if you are an existing Shout client - you will be asked if Shout can link your patient file number to the study to ensure continuity of the care Shout has provided to you.
Surveys (Optional): You will have the option to complete a short survey to provide feedback on your experience with the AI Companion.
Your Rights, Right to Refuse or Withdraw
Your participation in this study is completely voluntary. You have the right to stop engaging with the AI Companion at any time without fear of prejudice. If you choose to stop interacting with the AI Companion, you can simply discontinue without needing to notify the study team. However, if you are identified as someone who may be at risk and have not engaged with the companion for an extended period, you may receive reminders or “nudges” encouraging you to reconnect and access further support if needed.
If you wish to formally withdraw from the study or have questions regarding your participation, you can contact us via email at sasha@auderenow.org. Additionally, the AI Companion offers an option in the chatbot menu to allow you to request the removal of your data or cease your involvement in the study. This ensures that you can manage your engagement in the study while maintaining control over your participation.
Confidentiality, Risks and Benefits
Confidentiality and Data Protection
If you choose not to provide your real name to the AI Companion, the data entered remains completely anonymous, minimizing the risk of disclosure. De-identified transcripts of your conversations with the AI companion will be shared with an external, independent panel of validation nurses. Your phone number will be stored and remain locked and only accessible to the nurse in the Clinical Portal, allowing the nurse to link you to any services you receive at Shout without needing to provide any other identifiable information. At the end of the study, a data scientist will match phone numbers collected during the study with those collected by Shout to link AI Companion users to the services they accessed (e.g., testing, prevention, or care) for analysis purposes only. Once matched, the data scientist will replace all phone numbers with unique identifiers, ensuring all analysis is conducted using de-identified data. Furthermore, all data used for reporting will be aggregated.
However, you do have the option to opt out of having your phone number accessible to both the nurse and the data scientist, in which case the unique referral number we provide will be another way to be able to anonymously link you to the Shout services you receive.
Data Protection
POPIA (POPI Act) stands for the Protection of Personal Information Act (2013). The act was introduced to promote the protection of personal information (e.g. race, gender, address, telephone number – to name a few) collected and processed by public and private bodies, amongst other reasons. The researcher/research institution is required to follow POPIA (POPI Act of 2013), for the processing of data collected for this research study.
Benefits
By participating, you will have access to private, confidential health information and guidance through the AI Companion. You will be able to learn more about your health, receive personalised advice, and be guided through HIV self-testing (if applicable). The AI Companion will also connect you to appropriate care and prevention services, ensuring you get the support you need. The study aims to improve the quality of health services for AGYW by exploring how AI can make health assessments more accessible, reduce stigma, and improve care engagement. The findings from this study will help refine AI health tools for future use.
Risks
There is a minimal risk that interacting with the AI Companion, especially during HIV testing, could cause anxiety. However, the AI will provide counselling and support to guide you through the process. The AI Companion and healthcare providers will not require you to share personal information, and your data will be confidential to protect your privacy. There is a slight chance of accidental disclosure, but all necessary measures, such as de-identification of your data and not asking for personal identifiers, are in place to safeguard your confidentiality.
Reimbursement
There is no compensation for your involvement in the study. However, if you wish to access in person services, testing [whether with a provider or to collect a self-testing kit], prevention or care - we will reimburse you for transport.
Ethics Approval
The Protocol of this study was submitted for approval to the South African Medical Association Research Ethics Committee (SAMAREC), a research ethics committee registered with the National Health Research Ethics Council. Written approval has been granted by SAMAREC for the conduct of the study. The study has been structured in accordance with the ‘Ethics in Health Research: Principles, Processes and Structures’ Guidelines, published by the Department of Health, as well as the Declaration of Helsinki (last updated October 2024), adopted by the World Medical Association (WMA), which deals with the recommendations for biomedical research involving human participants. Copies of these guidelines may be obtained from the researcher should you wish to review it.
Who to Contact
For questions or concerns about the study, you can contact:
Dr. Ntombifikile Mtshali (Shout)
Email: ntombifikile.mtshali@shoutitnow.org; Tel: +27 76 258 6316
Sasha Frade (Audere)
Email: sasha@auderenow.org; Tel: +27 82 350 5456