- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05968755
Leveraging Chatbot to Improve PrEP in the Southern United States
April 17, 2024 updated by: Yale University
Leveraging Chatbot Technology to Improve PrEP Awareness and Uptake Among Black MSM 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.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
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).
Study Type
Interventional
Enrollment (Estimated)
145
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhao Ni
- Phone Number: 203-737-3039
- Email: Zhao.ni@yale.edu
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33127
- Care 4 U Community Health Center
-
Pembroke Pines, Florida, United States, 33027
- Community Care Resources of FL (CCRSFL)
-
-
Georgia
-
Atlanta, Georgia, United States, 30318
- NAESM, Inc
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28202
- RAO Community Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
|
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.
|
Placebo Comparator: Control group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At baseline, 30 days, 60 days, and 90 days
|
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.
|
At baseline, 30 days, 60 days, and 90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At baseline, 30 days, 60 days, and 90 days
|
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.
|
At baseline, 30 days, 60 days, and 90 days
|
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?"
|
At baseline, 30 days, 60 days, and 90 days
|
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?"
|
At baseline, 30 days, 60 days, and 90 days
|
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.
|
At baseline, 30 days, 60 days, and 90 days
|
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?"
|
At baseline, 30 days, 60 days, and 90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Zhao Ni, Yale University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Centers for Disease Control and Prevention. HIV and African American Gay and Bisexual Men. [cited 2022 August 4]; Available from: https://www.cdc.gov/hiv/group/msm/bmsm.html.
- Adeagbo O, Harrison S, Qiao S, Li X. Pre-Exposure Prophylaxis (PrEP) Uptake among Black Men Who Have Sex with Men (BMSM) in the Southern U.S. Int J Environ Res Public Health. 2021 Sep 15;18(18):9715. doi: 10.3390/ijerph18189715.
- Watson RJ, Eaton LA, Maksut JL, Rucinski KB, Earnshaw VA. Links Between Sexual Orientation and Disclosure Among Black MSM: Sexual Orientation and Disclosure Matter for PrEP Awareness. AIDS Behav. 2020 Jan;24(1):39-44. doi: 10.1007/s10461-019-02696-1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2024
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
May 22, 2023
First Submitted That Met QC Criteria
July 27, 2023
First Posted (Actual)
August 1, 2023
Study Record Updates
Last Update Posted (Actual)
April 19, 2024
Last Update Submitted That Met QC Criteria
April 17, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2000035242
- 000 (Other Identifier: CTGTY)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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