Clinical trial NCT05968755: Leveraging Chatbot to Improve PrEP in the Southern United States
Official title: Leveraging Chatbot Technology to Improve PrEP Awareness and Uptake Among Black MSM in the Southern United States
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV Prevention
PrEP Awareness
PrEP Uptake
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2023-08-01
Enrollment: 145
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

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.

Primary outcomes:
measure: Change from baseline PrEP awareness in 90 days
timeFrame: At baseline, 30 days, 60 days, and 90 days
measure: Change from baseline PrEP uptake in 90 days
timeFrame: At baseline, 30 days, 60 days, and 90 days
Secondary outcomes:
measure: Change in Usability score
timeFrame: At baseline, 30 days, 60 days, and 90 days
measure: Change in Recommendation score
timeFrame: At baseline, 30 days, 60 days, and 90 days
measure: Change in Acceptability score
timeFrame: At baseline, 30 days, 60 days, and 90 days
measure: Change in Practicality score
timeFrame: At baseline, 30 days, 60 days, and 90 days
measure: Change in Demand score
timeFrame: At baseline, 30 days, 60 days, and 90 days
measure: Change in Adaptation score
timeFrame: At baseline, 30 days, 60 days, and 90 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Care 4 U Community Health Center
state: Florida
city: Pembroke Pines
country: United States
facility: Community Care Resources of FL (CCRSFL)
state: Florida
city: Atlanta
country: United States
facility: NAESM, Inc
state: Georgia
city: Charlotte
country: United States
facility: RAO Community Health
state: North Carolina
Study officials:
affiliation: Yale University
name: Zhao Ni
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.