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Completed

NCT Number: NCT03360422

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey

Other

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

Focus Group

Other

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.

Usability study

Other

After informed consent, participants will utilize the mobile intervention in development for 30 days to establish usability, acceptability and correct any functionality issues.

Primary outcomes

  1. Quantity of Alcohol Consumption

    Time frame: Retrospective self-report over the past month

    Determine levels of alcohol consumption in study population

  2. High-risk Sexual Behavior: Condomless Sex

    Time frame: Retrospective self-report from past month on web survey

    Past month frequency of condomless sex

  3. Study Participant Opinions on Acceptability of Intervention Content

    Time frame: 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.

  4. Study Participant Opinions on Usability of Intervention Content

    Time frame: 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.

  5. High-risk Sexual Behavior: Sexual Activity During/After Alcohol Use

    Time frame: Past month on a self-report survey

    Past month frequency of alcohol use before or during oral, anal and/or vaginal sex

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Acronym: ANCHORS

Important dates

Study start
2017
Primary completion
2020
Study completion
2023
First posted
Dec 4, 2017
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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