Clinical trial NCT03360422: ANCHORS Study: UH2 Project
Official title: Advancing New Computer-based Health Outcomes Regarding Sexual Behavior(ANCHORS) Study: UH2 Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV-1-infection
Keywords: MSM, young adult
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2017-12-04
Enrollment: 673
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quantity of Alcohol Consumption
timeFrame: Retrospective self-report over the past month
measure: High-risk Sexual Behavior: Condomless Sex
timeFrame: Retrospective self-report from past month on web survey
measure: Study Participant Opinions on Acceptability of Intervention Content
timeFrame: Up to one month
measure: Study Participant Opinions on Usability of Intervention Content
timeFrame: Up to 1 month
measure: High-risk Sexual Behavior: Sexual Activity During/After Alcohol Use
timeFrame: Past month on a self-report survey
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Robert Leeman, PhD
role: PRINCIPAL_INVESTIGATOR
References: