ANCHORS Study: UH2 Project

HIV-1-infection Clinical Trial

— ANCHORS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03360422
• Other study ID #: IRB201701367 N
• Secondary ID: UH2AA026214-01
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: July 1, 2023

Study information

• Verified date: April 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 1, 2023
• Est. primary completion date: June 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

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
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity of alcohol consumption	Determine levels of alcohol consumption in study population	Retrospective self-report from past 1-3 months on web survey
Primary	High-risk sexual behavior	Determine levels of unprotected sex during and outside of drinking occasions in study population	Retrospective self-report from past 1-3 months on web survey
Primary	Study participant opinions on intervention content	Interactive Voice Response System Questions are Yes no responses to focusing on the degree to which it is culturally appropriate for study population.	Up to one month