ANCHORS Study: UH2 Project

Not Applicable

Completed

• Conditions: HIV-1-infection
• Interventions: Other: Survey; Other: Focus Group; Other: Usability study

• Registration Number: NCT03360422
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-11-27
• Study Start: 2017-12-01
• Study First Posted: 2017-12-04
• Primary Completion: 2020-06-19
• Study Completion: 2023-07-01
• Results First Submitted: 2024-04-15
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-17
• Last Update Submitted: 2024-06-17
• Results First Posted: 2024-07-11
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 673

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Focus Group	Survey	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.
Usability Study	Survey	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.
Survey group	Survey	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
Focus Group	Focus Group	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.
Usability Study	Usability study	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.

Primary Outcome Measures

Name	Time	Method
High-risk Sexual Behavior: Condomless Sex	Retrospective self-report from past month on web survey	Past month frequency of condomless sex
Quantity of Alcohol Consumption	Retrospective self-report over the past month	Determine levels of alcohol consumption in study population
High-risk Sexual Behavior: Sexual Activity During/After Alcohol Use	Past month on a self-report survey	Past month frequency of alcohol use before or during oral, anal and/or vaginal sex
Study Participant Opinions on Acceptability of Intervention Content	Up to one month	Participants in the usability study will report on the acceptability of the interactive voice response (IVR) system and the personalized feedback produced based on their IVR responses.; On a modified System Usability Scale, participants in the usability study will report on the acceptability (i.e., perceived value, liking) of the interactive voice response (IVR) system and the personalized feedback produced based on their IVR responses. Items were rated on a 1-7 scale with higher scores indicating greater usability. The acceptability subscale is made up of 5 items. The score reported below is the mean of these five items.
Study Participant Opinions on Usability of Intervention Content	Up to 1 month	On a modified System Usability Scale, participants in the usability study will report on the usability of the interactive voice response (IVR) system and the personalized feedback produced based on their IVR responses. Items were rated on a 1-7 scale with higher scores indicating greater usability. The usability subscale is made up of 4 items. The score reported below is the mean of these four items.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States