Recruiting

Chatbot Intervention

Sponsor:

Yale University

Code:

NCT05968755

Conditions

HIV Prevention

PrEP Awareness

PrEP Uptake

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

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

General educational messages

Study Details

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

Study ID

NCT05968755

Start date

Jul 13, 2026

Status verified date

Sep, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

145 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention group

placebo comparator: Control group

Interventions

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.

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 measure

  • Change from baseline PrEP awareness in 90 days [ Time Frame: At the baseline, 30, 60, and 90 days ]
  • Change from baseline PrEP uptake in 90 days [ Time Frame: At the baseline, 30, 60, and 90 days ]

Central Contacts and Locations

Central contacts

Zhao Ni

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

Locations

Care 4 U Community Health Center

Recruiting

Miami, Florida, United States, 33127

Contacts

Chief Operating Officer

305-835-0101aichite@care4uchc.org

Community Care Resources of FL (CCRSFL)

Recruiting

Pembroke Pines, Florida, United States, 33027

Contacts

Executive Director

877-287-2520victoria@ccrsfl.com

NAESM, Inc

Recruiting

Atlanta, Georgia, United States, 30318

Contacts

Research Coordinator

404-691-8880ak@naesminc.org

RAO Community Health

Recruiting

Charlotte, North Carolina, United States, 28202

Contacts

Director of Programs

704-237-8793zharris@raoassist.org

More Information

Sponsor

Yale University

Last update posted

Sep 23, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Yale University on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.