NCT05968755 · Yale University
Leveraging Chatbot to Improve PrEP in the Southern United States
What this study is about
The purpose of this study is to develop a chatbot intervention to promote PrEP awareness and uptake among Black men who have sex with men (MSM) in the Southern United States.
View original scientific description
The purpose of this study is to develop a chatbot intervention to promote PrEP awareness and uptake among Black men who have sex with men (MSM) in the Southern United States.
Interventions
DEVICE
A chatbot designed to promote PrEP awareness and uptake for Black MSM
Participants in the intervention group will have access to a theory-informed (Self-Determination Theory) chatbot and receive an automated personalized question message (root-node message) from the chatbot. The root-node messages are questions written into the chatbot algorithms to initiate interactive communication with participants. In each round of the interactive communication, the chatbot will provide automated personalized PrEP-related information, autonomous motivation, and psychological needs based on Self-Determination Theory constructs.
OTHER
General educational messages
Participants in the control group will received general education messages from a research assistant including healthy diet, exercise, and COVID-19 prevention. The frequency of contact will be pre-specified by participants in interviews prior to the RCT.
Primary outcome measures
Change from baseline PrEP awareness in 90 days
Time frame: At the baseline, 30, 60, and 90 days
PrEP awareness will be measured as the proportion of participants who are aware of PrEP. Specifically, the investigators will collect PrEP awareness by asking participants standardized questions through a Qualtrics survey.
Change from baseline PrEP uptake in 90 days
Time frame: At the baseline, 30, 60, and 90 days
PrEP uptake will be measured as the mean of the frequency of taking PrEP medication. Specifically, the investigators will collect PrEP uptake by asking participants through a Qualtrics survey if they have been taken PrEP at baseline and every 30 days. If participants respond that they have taken PrEP, the investigators will ask them the date and frequency of taking it and ask them to upload a photo of their PrEP for verification to reduce social desirability bias in responses.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Being cisgender Black male
- Being aged ≥ 18 years
- Having Internet access
- Speaking English
- Self-reporting condomless sex with another man in the past 6 months
- Living in the U.S. South
- HIV negative or untested.
Exclusion criteria
- Not residing in a U.S. Census Bureau-defined Southern state: AL, AR, DE, FL, GA, KY, LA, MD, MS, NC, OK, SC, TN, TX, VA, WV.
- Having received antiretroviral therapy (ART) treatment.
Where
- Miami, Florida
- Pembroke Pines, Florida
- Atlanta, Georgia
- Charlotte, North Carolina
Collaborators
Gilead Sciences
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 23, 2026 · Source of record for eligibility and locations