ANCHORS Study: UH2 Project

University of Florida

Status: Completed

Conditions: HIV-1-infection

Treatments: Other: Survey; Other: Focus Group; Other: Usability study

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03360422

UH2AA026214-01 (U.S. NIH Grant/Contract)

IRB201701367 N

Details and patient eligibility

About

According to the National HIV/AIDS Strategy, men who have sex with men (MSM), young adults, Black and Latino men and people in the Southern U.S. are at highest HIV risk and should be targeted with cost-effective, scalable interventions. The study team propose a synergistic mobile intervention to reduce alcohol and HIV risk in young adult MSM that combines 3 efficacious approaches.

Full description

New prevention efforts must address alcohol and HIV and be directed to the highest-risk groups. While interventions have targeted MSM, few have targeted young MSM specifically. Young people and MSM bring particular challenges. Thus, it is important that prevention be targeted to them and developed with their input. To that end, the goal of this project is to lay the groundwork for a synergistic, mobile intervention to reduce alcohol use and risky sex and prevent HIV among young adult MSM. This research study is made up of three related sub-projects: 1) a web-based survey; 2) a series of focus groups and 3) a small, preliminary acceptability and usability to study to test the mobile intervention. The proposed intervention to be tested on a preliminary basis in this study combines brief motivational intervention with daily interactive voice response (IVR) monitoring including personalized feedback. Ultimately, this combined intervention will also include pre-exposure prophylaxis (PrEP), however there will be no medication in this particular study. Each of these components has efficacy in enhancing treatment adherence, reducing alcohol and/or HIV risk but requires other interventions to maximize its potential benefit. Combining them will capitalize on the strength of each, leading to a higher impact alcohol and HIV preventive intervention.

Enrollment: 673 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Web-survey:

• Male sex
• Ages 18-30
• Ability to read and write English
• 1 or more instances of sexual activity with another man in the past 3 months
• HIV Negative

Focus group:

• 18-35
• All other inclusion criteria will be the same as the web survey

Usability phase:

• 5 or more drinks in a day in the past month
• Past-month intercourse with another man without a condom
• Willingness to try PrEP, but have never tried it before

Exclusion criteria

Web Screen:

• No subject may have lifetime use of PrEP

Focus group:

• A current undergraduate or graduate student at any level in one of the 3 departments that make up the College of Health and Human Performance (HHP) at the University of Florida (UF), where Dr. Leeman's faculty appointment is.
• Do not want to engage in open discussion regarding substance use or sexual activity/orientation in a group setting. It will be possible for participants to contribute to focus group discussions without providing detailed information about their own substance use or sexual activity, however focus group participants must have a degree of openness to discussing these topics with others. These groups will take place with 6-7 other people and some people may be made uncomfortable by the discussions that may take place with regard to participants' drinking, substance use or sexual behavior.
• Not willing to be recorded via an electronic recording device

Usability phase:

• No subject may have lifetime use of PrEP
• Those who do not wish to provide a reliable phone number will be excluded

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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673 participants in 3 patient groups

Survey group

Active Comparator group

Description:

Collect alcohol and sexual activity data via web survey from 683 young MSM to yield normative data for the alcohol and HIV preventive intervention in a follow-up study

Treatment:

Other: Survey

Focus Group

Active Comparator group

Description:

30 young MSM who drink regularly to inform the content of the alcohol and HIV preventive intervention tested in the UH3 phase and ensure the intervention is culturally appropriate for MSM.

Treatment:

Other: Focus Group

Other: Survey

Usability Study

Active Comparator group

Description:

10 young adult MSM will test the mobile intervention in development for 30 days in order to establish usability, acceptability and correct any functionality issues.

Treatment:

Other: Usability study

Other: Survey