ANCHORS Study: UH2 Project (ANCHORS)

Advancing New Computer-based Health Outcomes Regarding Sexual Behavior(ANCHORS) Study: UH2 Project

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.

Study Overview

• Status: Completed
• Conditions: HIV-1-infection
• Intervention / Treatment: Other: Survey; Other: Focus Group; Other: Usability study

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.

• Study Type: Interventional
• Enrollment (Actual): 673
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Survey group; 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	Other: Survey; Respondents meeting inclusion criteria will be informed they were selected for the longer survey and continue to the survey. Upon completion, the survey will generate a study identification (ID) that respondents will provide to study staff with additional contact information via phone, text or email to be compensated
Active Comparator: 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.	Other: Survey; Respondents meeting inclusion criteria will be informed they were selected for the longer survey and continue to the survey. Upon completion, the survey will generate a study identification (ID) that respondents will provide to study staff with additional contact information via phone, text or email to be compensated; Other: Focus Group; After informed consent, participants will complete the web-based intervention component in development. Afterward, participants will be engaged by an experienced facilitator in a discussion of aspects of the intervention they liked and disliked and suggestions they have for enhancing its cultural appropriateness to young MSM.
Active Comparator: 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.	Other: Survey; Respondents meeting inclusion criteria will be informed they were selected for the longer survey and continue to the survey. Upon completion, the survey will generate a study identification (ID) that respondents will provide to study staff with additional contact information via phone, text or email to be compensated; Other: Usability study; After informed consent, participants will utilize the mobile intervention in development for 30 days to establish usability, acceptability and correct any functionality issues.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity of Alcohol Consumption	Determine levels of alcohol consumption in study population	Retrospective self-report over the past month
High-risk Sexual Behavior: Condomless Sex	Past month frequency of condomless sex	Retrospective self-report from past month on web survey
Study Participant Opinions on Acceptability of Intervention Content	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.	Up to one month
Study Participant Opinions on Usability of Intervention Content	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.	Up to 1 month
High-risk Sexual Behavior: Sexual Activity During/After Alcohol Use	Past month frequency of alcohol use before or during oral, anal and/or vaginal sex	Past month on a self-report survey

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Robert Leeman, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): June 19, 2020
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): December 4, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: MSM, young adult
• Other Study ID Numbers: IRB201701367 N; UH2AA026214-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No