Title: Prevention Accelerator for Communities on the Edge of Sex Work (PACE): Pilot Study of a Comprehensive HIV Care and Prevention AI Toolkit among women on the edge of sex work
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 piloting this AI Companion among women on the edge of sex work integrated into an existing programme that offers these services in person - called CeSSHAR.
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 CeSSHAR’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 CeSSHAR’s clinics to access services 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 PACE model, which includes the AI Companion and CeSSHAR’s health services, helps women at the edge of sex work like 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 PACE system use Artificial Intelligence (AI)?
The PACE 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 CeSSHAR’s 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 CeSSHAR 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 for negative results and support for accessing care if the result is positive. You will also have the option to connect with a CeSSHAR 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 CeSSHAR client - you will be asked if CeSSHAR can link your patient file number to the study to ensure continuity of the care CeSSHAR 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.
Participation in this study is voluntary. If you decide not to participate in this study, your decision will not affect your future relations with CeSHHAR, its personnel, and associated clinics and the MOHCC and NAC. If you decide to participate, you are free to withdraw your consent and to discontinue participation at any time without penalty. Please contact Dr Sungai Chabata 077 357 7686 if you wish to withdraw from this study.
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 CeSSHAR without needing to provide any other identifiable information. Every month, a data scientist will match phone numbers collected during the study with those collected by CeSSHAR 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 CeSSHAR services you receive.
Data Protection - This study is subject to the Data Protection Act [Chapter 11:12] of 2021, which governs the lawful collection, use, and safeguarding of personal information in Zimbabwe. The Act was enacted to promote the protection of personal data (such as your name, gender, race, address, and contact details) that may be collected and processed by both public and private entities.
In accordance with this law, the researcher and affiliated research institution are obligated to process any personal information you provide for this study in a lawful, fair, and secure manner. Your information will be used only for the purposes of this research and will be stored and shared in compliance with applicable data protection requirements.
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 women at the edge of sex work 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.
In the unlikely event that you are harmed because of being in this study, you will be given immediate necessary attention to address your harm. You will not be giving up any of your legal rights by agreeing to this.
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
This pilot study is embedded within ongoing programmatic work conducted by CeSHHAR Zimbabwe and forms part of the PACE program. As such, it does not require separate ethical review by the Medical Research Council of Zimbabwe (MRCZ) or the London School of Hygiene and Tropical Medicine (LSHTM), as the broader initiative has already received ethical approval under the main PACE protocol (MRCZ/A/3290). The study will be conducted in accordance with the ethical principles outlined in the Declaration of Helsinki (last revised October 2024), and applicable international guidelines for ethical conduct in public health evaluations. Copies of these guidelines are available from the research team upon request.
Who to Contact
If you ever have any questions about this study, or in the event of injury, contact: Prof. Frances Cowan at 0772 257 949 or Dr Sungai Chabata 077 357 7686 at 10, Coronation Avenue, Greendale, Harare, or the study nurses at the clinic.