ANCHORS Study: UH2 Project

NCT03360422 | Completed Results

• 2 other identifiers: IRB201701367 NUH2AA026214-01
• Study Type: interventional
• Target: 673
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1-infection

Keywords

MSM, young adult

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

Survey group

ACTIVE COMPARATOR

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

Focus Group

ACTIVE COMPARATOR

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; Other: Focus Group

Usability Study

ACTIVE COMPARATOR

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; Other: Usability study

Interventions

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; Survey group; Usability Study

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.

Focus Group

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.

Usability Study

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Web-survey:
• Male sex
• Ages 18-30
• Ability to read and write English
• or more instances of sexual activity with another man in the past 3 months
• HIV Negative
• Focus group:
• Usability phase:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires; Focus Groups

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Robert Leeman
• Organization: Northeastern University

r.leeman@northeastern.edu

6173736501

Study Officials

• Robert Leeman, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: December 4, 2017
• Study Start: December 1, 2017
• Primary Completion: June 19, 2020
• Study Completion: July 1, 2023
• Last Updated: July 11, 2024
• Results First Posted: July 11, 2024

Record last verified: 2024-06

Locations

US (1)