Chatbot for HIV Prevention

Not yet recruiting at 3 trial locations

Overseen By Zhao Ni

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Antiretrovirals

Disqualifiers: Non-resident US South, others

Compensation: Varies

Number of Visits: 30

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a chatbot designed to increase awareness and use of PrEP, a medication that helps prevent HIV. It focuses on Black men who have sex with men in the Southern U.S., aiming to support safer sexual practices. The study compares those using the chatbot with a control group to evaluate its effectiveness. Eligible participants must be HIV-negative Black men, over 18, with internet access, who haven't been on HIV treatment and have had condomless sex with another man in the last six months. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance HIV prevention strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have received antiretroviral therapy (ART) treatment.

What prior data suggests that this chatbot is safe for promoting PrEP awareness?

Research has shown that using chatbots to help prevent HIV is safe. One study found these chatbots practical and well-received for encouraging HIV testing and the use of PrEP, a medicine that helps prevent HIV. Chatbots offer anonymous and ongoing support, allowing people to learn about HIV prevention without any known risks. Although chatbots continue to improve, no safety issues have been reported in their use for this purpose. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using chatbots for PrEP awareness because they offer a unique way to engage people in HIV prevention. Unlike traditional methods like in-person counseling or pamphlets, chatbots can provide personalized information and support 24/7 through digital platforms. This accessibility and adaptability make them a potentially powerful tool for reaching wider audiences, particularly tech-savvy individuals or those who prefer private, digital interactions. By enhancing awareness and understanding of PrEP through interactive conversations, chatbots could significantly improve HIV prevention efforts.

What evidence suggests that this chatbot is effective for promoting PrEP awareness among Black men who have sex with men?

Research has shown that chatbots can effectively provide accurate information about preventing HIV. In this trial, participants in the intervention group will interact with a chatbot designed to increase PrEP awareness. Studies have found that AI chatbots give clear and unbiased advice on HIV topics. One study highlighted their potential to increase the use of PrEP, a medication that helps prevent HIV, by sharing important health information. Chatbots have been evaluated for their ability to customize responses for each user, making the information more relevant and engaging. Overall, while chatbots seem promising in raising awareness about PrEP, more work is needed to address any ethical and practical concerns. ^{1 2 6 7 8}

Who Is on the Research Team?

Zhao Ni

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for cisgender Black men who have sex with men (MSM), are at least 18 years old, speak English, and have had condomless sex in the past 6 months. They must be HIV negative or untested and have Internet access.

Inclusion Criteria

Speaking English

Having Internet access

HIV negative or untested

Exclusion Criteria

Having lived in the US South less than 3 months

I have been treated with antiretroviral therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage with a chatbot intervention to promote PrEP awareness and uptake

12 weeks

Baseline, 30 days, 60 days, and 90 days assessments

Follow-up

Participants are monitored for changes in PrEP awareness and uptake, usability, and other secondary outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Chatbot for PrEP Awareness

Trial Overview

The study is testing a chatbot designed to increase awareness and use of PrEP (a medication to prevent HIV) among Black MSM in the Southern US compared to general educational messages about PrEP.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 1 Intervention

Group II: Control group Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Published Research Related to This Trial

The mSMART mobile health intervention showed high feasibility and acceptability among 15 Black men who have sex with men (MSM) already prescribed PrEP, with an impressive 82% daily usage rate and positive feedback on user-friendliness.

Participants demonstrated improved PrEP adherence, as indicated by biomarker scores, suggesting that gamified interventions like mSMART could effectively enhance medication adherence and reduce barriers to taking PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Efficacy of a Gamified Mobile Health Contingency Management Intervention for PrEP Adherence Among Black MSM. Mitchell, JT., Burns, CM., Atkinson, B., et al.[2023]

Nearly half of the participants (47%) who started pre-exposure prophylaxis (PrEP) for HIV prevention discontinued its use, primarily due to systemic issues such as financial problems and logistical barriers related to clinics and pharmacies.

Behavioral factors and concerns about medication side effects also contributed to discontinuation, highlighting the need for addressing both systemic and personal factors to improve PrEP retention and engagement in care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reasons for PrEP Discontinuation After Navigation at Sexual Health Clinics: Interactions Among Systemic Barriers, Behavioral Relevance, and Medication Concerns. Unger, ZD., Golub, SA., Borges, C., et al.[2023]

In a randomized clinical trial involving 229 MSM participants, providing automated feedback through a mobile app did not reduce the number of participants with poor adherence to preexposure prophylaxis (PrEP), with 16% in the intervention group showing poor adherence compared to 11% in the control group.

However, the app feedback significantly increased the proportion of participants achieving excellent adherence (48% in the intervention group vs. 31% in the control group), indicating that while it didn't help those struggling with adherence, it did support those already adhering well to PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving adherence to daily preexposure prophylaxis among MSM in Amsterdam by providing feedback via a mobile application. van den Elshout, MAM., Hoornenborg, E., Achterbergh, RCA., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10719151/

Chatbots for HIV Prevention and Care: a Narrative Review

Chatbots in HIV prevention and care show potential; however, significant work remains in addressing associated ethical and practical concerns.

2.

chprc.org

chprc.org/publications/evaluating-ai-chatbots-for-hiv-prevention-an-assessment-of-response-quality-and-user-tailoring/

Evaluating AI chatbots for HIV prevention: An assessment ...

A new CHPRC analysis evaluates the quality of the HIV-related information provided by ChatGPT and other popular chatbots powered by artificial intelligence (AI)

3.

publichealth.berkeley.edu

publichealth.berkeley.edu/articles/spotlight/research/study-explores-effectiveness-of-ai-chatbots-in-hiv-prevention

New study explores effectiveness of AI chatbots in HIV ...

High Response Accuracy, but Variable Clarity: AI chatbots can provide HIV prevention information and guidance that is accurate and neutral in ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11239277/

Improving HIV Pre-exposure Prophylaxis Uptake with ...

The United Nations Educational, Scientific and Cultural Organization created an AI chatbot named Eli to answer questions on HIV prevention in 2020, followed by ...

5.

humanfactors.jmir.org

humanfactors.jmir.org/2025/1/e70034

Evaluating the Usability of an HIV Prevention Artificial ...

The AI chatbot demonstrated high feasibility in delivering HIV self-testing kits and providing clinical information on HIV testing, PrEP, and ...

6.

humanfactors.jmir.org

humanfactors.jmir.org/2024/1/e52055

Testing the Feasibility and Acceptability of Using an Artificial ...

Conclusions: The current AI chatbot is feasible and acceptable to promote the uptake of HIV testing and PrEP. To ensure the successful ...

7.

medrxiv.org

medrxiv.org/content/10.1101/2025.05.02.25326894v1

Protocol for chatbot implementation and evaluation

Chatbots have the potential to reduce barriers to HIV treatment and PrEP by providing anonymous and continuous support.

8.

unc.edu

unc.edu/posts/2024/09/24/chatbot-informs-women-about-hiv-prevention/

Chatbot informs women about HIV prevention

The new chatbot will help women worldwide learn about and choose their preferred HIV prevention method.