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NCT Number: NCT05968755

Leveraging Chatbot to Improve PrEP in the Southern United States

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.

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Key information

Conditions

HIV Prevention PrEP Awareness PrEP Uptake

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Care 4 U Community Health Center, Miami, Florida, United States

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About this study

In the United States (US), the epicenter of the HIV epidemic is in the South. The HIV-related death rate in the US South is high, but engagement with quality HIV prevention services and care is low. Although only 38% of the US population lives in the South, the region accounts for 51% of new HIV infections. Gay, bisexual, and other men who have sex with men (MSM) account for 60% of new infections among African Americans in the South. Black MSM are one of the most vulnerable groups to HIV transmission in the US. HIV testing and PrEP uptake in Black MSM, however, remain low (10%) due to multiple factors including stigma, sexual-orientation based discrimination and low PrEP awareness among Black MSM. Innovative strategies that motivate and provide guidance for PrEP among Black MSM in the US South are therefore urgently needed. Chatbot technology should be tested and implemented to help improve PrEP awareness and uptake in the US South. In this project, the investigators aim to develop and pilot test to assess the acceptability and feasibility of a chatbot for PrEP awareness and uptake relative to treatment as usual (control).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • HIV negative or untested.

Exclusion criteria

  • Having lived in the US South less than 3 months
  • Having received antiretroviral therapy (ART) treatment.

Treatment and study plan

A chatbot designed to promote PrEP awareness and uptake for Black MSM

Device

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.

General educational messages

Other

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 outcomes

  1. Change from baseline PrEP awareness in 90 days

    Time frame: At baseline, 30 days, 60 days, 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.

  2. Change from baseline PrEP uptake in 90 days

    Time frame: At baseline, 30 days, 60 days, 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.

Secondary outcomes

  1. Change in Usability score

    Time frame: At baseline, 30 days, 60 days, and 90 days

    The usability score will be measured by the System Usability Scale, which is 5-point Likert scale consisted of 10 questions. Participants' scores range from 0 to 100. A score of 68 is average, below 68 is poor, above 68 is good, and above 80.3 is excellent.

  2. Change in Recommendation score

    Time frame: At baseline, 30 days, 60 days, and 90 days

    The recommendation score will be calculated by a Net Promote Score, which measures MSM's likelihood to recommend the chatbot to other MSM friends. The score ranges from 0 to 10. The higher the score, the better the recommendation score.

  3. Change in Acceptability score

    Time frame: At baseline, 30 days, 60 days, and 90 days

    Acceptability, defined as the extent to which the chatbot is suitable and satisfactory to MSM, will be measured using the standardized Customer Satisfaction Scale "How would you rate your overall satisfaction with the chatbot?" and a 5-point Likert question "How would you rate the likelihood of continuing to use the chatbot?"

  4. Change in Practicality score

    Time frame: At baseline, 30 days, 60 days, and 90 days

    Practicality defined as the extent to which the chatbot provides real-time Self-Determination theory inputs, will be measured using a 5-point Likert question "How would you rate the overall quality of the chatbot?"

  5. Change in Demand score

    Time frame: At baseline, 30 days, 60 days, and 90 days

    Demand, defined as the level of integration to which the chatbot fits into the MSM-preferred online platform, will be measured by the number of actual use documented on developer's platform.

  6. Change in Adaptation score

    Time frame: At baseline, 30 days, 60 days, and 90 days

    Adaptation, defined as the extent to which the chatbot can be integrated into other social-networking apps, will be measured by asking "How likely would you use the chatbot if embedded on other apps?"

Study contacts

Contact information is provided by the study sponsor or research team.

Zhao Ni

CONTACT

[email protected]

203-737-3039

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

Leveraging Chatbot Technology to Improve PrEP Awareness and Uptake Among Black MSM in the Southern United States

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 1, 2023
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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