HIV-1-infection
Conditions
Keywords
MSM, young adult
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.
Interventions
OTHERSurvey
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
OTHERFocus 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.
OTHERUsability study
After informed consent, participants will utilize the mobile intervention in development for 30 days to establish usability, acceptability and correct any functionality issues.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantity of Alcohol Consumption | Retrospective self-report over the past month | Determine levels of alcohol consumption in study population |
| High-risk Sexual Behavior: Condomless Sex | Retrospective self-report from past month on web survey | Past month frequency of condomless sex |
| Study Participant Opinions on Acceptability of Intervention Content | 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. |
| Study Participant Opinions on Usability of Intervention Content | 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. |
| High-risk Sexual Behavior: Sexual Activity During/After Alcohol Use | Past month on a self-report survey | Past month frequency of alcohol use before or during oral, anal and/or vaginal sex |
Countries
United States
Participant flow
Recruitment details
Participants who enrolled in a focus group/individual interview and the usability study were a subset of those who completed the survey
Pre-assignment details
Provision of insufficient data to be considered a valid participant
Participants by arm
| Arm | Count |
|---|---|
| Young Adult Men Who Have Sex With Men 18-30 year old men who have sex with men residing in the Southern United States | 673 |
| Total | 673 |
Baseline characteristics
| Characteristic | Young Adult Men Who Have Sex With Men |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 673 Participants |
| Age, Continuous | 24.77 years STANDARD_DEVIATION 3.29 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 153 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 509 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 10 Participants |
| Race (NIH/OMB) Asian | 23 Participants |
| Race (NIH/OMB) Black or African American | 117 Participants |
| Race (NIH/OMB) More than one race | 41 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 24 Participants |
| Race (NIH/OMB) White | 458 Participants |
| Region of Enrollment United States | 673 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 673 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 10 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 10 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 10 |
Outcome results
Primary
High-risk Sexual Behavior: Condomless Sex
Past month frequency of condomless sex
Time frame: Retrospective self-report from past month on web survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Survey Group | High-risk Sexual Behavior: Condomless Sex | 4.12 events | Standard Deviation 6.92 |
| Focus Group/Individual Interview | High-risk Sexual Behavior: Condomless Sex | 2.22 events | Standard Deviation 3.23 |
| Usability Study | High-risk Sexual Behavior: Condomless Sex | 7.17 events | Standard Deviation 9.39 |
Primary
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
Time frame: Past month on a self-report survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Survey Group | High-risk Sexual Behavior: Sexual Activity During/After Alcohol Use | 2.88 events | Standard Deviation 5.16 |
| Focus Group/Individual Interview | High-risk Sexual Behavior: Sexual Activity During/After Alcohol Use | 2.13 events | Standard Deviation 3.49 |
| Usability Study | High-risk Sexual Behavior: Sexual Activity During/After Alcohol Use | 1.50 events | Standard Deviation 1.05 |
Primary
Quantity of Alcohol Consumption
Determine levels of alcohol consumption in study population
Time frame: Retrospective self-report over the past month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Survey Group | Quantity of Alcohol Consumption | 11.38 drinks | Standard Deviation 20.05 |
| Focus Group/Individual Interview | Quantity of Alcohol Consumption | 7.81 drinks | Standard Deviation 7.8 |
| Usability Study | Quantity of Alcohol Consumption | 4.78 drinks | Standard Deviation 2.78 |
Primary
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.
Time frame: Up to one month
Population: Acceptability was assessed only among participants in the usability study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usability Study | Study Participant Opinions on Acceptability of Intervention Content | 5.50 score on a scale | Standard Deviation 1.51 |
Primary
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.
Time frame: Up to 1 month
Population: Acceptability and usability data were collected only from the usability study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usability Study | Study Participant Opinions on Usability of Intervention Content | 6.40 score on a scale | Standard Deviation 0.7 |