Leveraging Chatbot to Improve PrEP in the Southern United States

HIV Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05968755
• Other study ID #: 2000035242
• Secondary ID: 000
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: Yale University
• Contact: Zhao Ni
• Phone: 203-737-3039
• Email: Zhao.ni[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 145
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Prevention
• PrEP Uptake

Intervention

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.

Locations

Country	Name	City	State
United States	NAESM, Inc	Atlanta	Georgia
United States	RAO Community Health	Charlotte	North Carolina
United States	Care 4 U Community Health Center	Miami	Florida
United States	Community Care Resources of FL (CCRSFL)	Pembroke Pines	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Gilead Sciences

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline PrEP awareness in 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
Primary	Change from baseline PrEP uptake in 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	Change in Usability score	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
Secondary	Change in Recommendation score	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
Secondary	Change in Acceptability score	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
Secondary	Change in Practicality score	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
Secondary	Change in Demand score	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
Secondary	Change in Adaptation score	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