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Not yet recruiting NCT05968755

Leveraging Chatbot to Improve PrEP in the Southern United States

No phase Interventional HIV Prevention PrEP Awareness PrEP Uptake

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: A chatbot designed to promote PrEP awareness and uptake for Black MSM, General educational messages.
Who it may be relevant to
Registry conditions: HIV Prevention, PrEP Awareness, PrEP Uptake. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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).

Interventions

  • 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 n
  • 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.

Primary outcome measures

  • Change from baseline PrEP awareness in 90 days [Time frame: 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]
Secondary outcome measures (6)
  • Change in Usability score [Time frame: At baseline, 30 days, 60 days, and 90 days]
  • Change in Recommendation score [Time frame: At baseline, 30 days, 60 days, and 90 days]
  • Change in Acceptability score [Time frame: At baseline, 30 days, 60 days, and 90 days]
  • Change in Practicality score [Time frame: At baseline, 30 days, 60 days, and 90 days]
  • Change in Demand score [Time frame: At baseline, 30 days, 60 days, and 90 days]
  • Change in Adaptation score [Time frame: At baseline, 30 days, 60 days, and 90 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 4 centers
  • Care 4 U Community Health Center — Miami
  • Community Care Resources of FL (CCRSFL) — Pembroke Pines
  • NAESM, Inc — Atlanta
  • RAO Community Health — Charlotte

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. PMID 34574652
  • 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

Identifiers

NCT: NCT05968755 · 2000035242 · 000

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗