Leveraging Chatbot to Improve PrEP in the Southern United States

NCT05968755 | Not Yet Recruiting

• 2 other identifiers: 2000035242000
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

HIV Prevention; PrEP Awareness; PrEP Uptake

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Change in Usability score

  At baseline, 30 days, 60 days, and 90 days

• Change in Recommendation score

  At baseline, 30 days, 60 days, and 90 days

• Change in Acceptability score

  At baseline, 30 days, 60 days, and 90 days

• Change in Practicality score

  At baseline, 30 days, 60 days, and 90 days

• Change in Demand score

  At baseline, 30 days, 60 days, and 90 days

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

Other: General educational messages

Interventions

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.

Control group

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Gilead Sciences: collaborator
• Yale University: lead

Study Sites (4)

Care 4 U Community Health Center

Miami, Florida, 33127, United States

Location

Community Care Resources of FL (CCRSFL)

Pembroke Pines, Florida, 33027, United States

Location

NAESM, Inc

Atlanta, Georgia, 30318, United States

Location

RAO Community Health

Charlotte, North Carolina, 28202, United States

Location

Related Publications (3)

• 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.

  BACKGROUND

• 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.

  PMID: 34574652 BACKGROUND

• 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.

  PMID: 31606770 BACKGROUND

Study Officials

• Zhao Ni

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao Ni

CONTACT

203-737-3039; Zhao.ni@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: August 1, 2023
• Study Start: March 28, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)