HIV Infections
Conditions
Keywords
Prevention & Control, Young Adult, Internet
Brief summary
This study uses an interactive design and development process to develop tailored messages that align YMSM's relationship experiences and desires with HIV prevention strategies. The study includes a tailored online prevention, intervention, as well as an attention control non--tailored HIV prevention (NTHP) comparison intervention. The pilot RCT will compare the intervention (N=120) to NTHP (N=60) to assess intervention feasibility and acceptability, and gather preliminary behavioral data to inform a subsequent application. Follow-up assessments will be collected at thirty (30), sixty (60), and ninety (90) days post-intervention.
Detailed description
A resurgence of new HIV cases among young men who have sex with men (YMSM; ages 18--24) has underscored the importance of developing culturally- and developmentally- informed HIV programs for YMSM. The investigators are developing and pilot testing a tailored, web- based intervention called myDEx that focuses on delivering HIV prevention messages based on single YMSM's relationship expectations and partner--seeking behaviors. To maximize intervention appeal and appropriateness, the investigators have convened a youth advisory board (YAB) to provide insight and feedback during the 3--stage intervention development process. Using an iterative design and development process, they have developed tailored messages that align YMSM's relationship experiences and desires with HIV prevention strategies. The investigators designed and developed the myDEx tailored online prevention intervention, as well as an attention- control non--tailored HIV/AIDS prevention (NTHP) comparison intervention. After developing both interventions, the investigators used usability testing procedures to collect preliminary data from 16 YMSM on the proposed intervention's design and acceptability. Recommended changes were added to the intervention prior to launching a small pilot randomized controlled trial (RCT). The pilot RCT will compare myDEx (N=120) to NTHP (N=60) to assess intervention feasibility and acceptability, and gather preliminary behavioral data to inform a subsequent application. Assessments will be collected at 30, 60, and 90 days follow--up. Specific Aims include: 1. To develop a tailored (myDEx) and non-tailored (NTHP) HIV prevention intervention focused on addressing HIV risk behaviors among single YMSM; 2. To collect preliminary data on the feasibility, acceptability, and intervention content of the myDEx (N=16) in preparation for a small pilot RCT; and, 3. To implement a small pilot RCT of the refined myDEx (N=120) as compared to the NTHP (N=60) intervention, in order to evaluate its feasibility and acceptability and gather preliminary efficacy results in reducing sexual risk behaviors.
Interventions
BEHAVIORALmyDEx
myDEx will consist of a 6-session online program. Cognizant of challenges maintaining users' attention in a web application and to facilitate delivery through a smartphone, the investigators will design each session to be no more than 20 minutes in length. In the course of these 6 sessions, participants will have a total of 120 minutes of intervention exposure. Across sessions, the investigators will emphasize the importance of sexual decision-making across different partner types, help men consider what type of relationship(s) they want, and align these relationship desires with safer sex practices.
BEHAVIORALNTHP
The investigators will create a 6-session attention-control comparison to match the intervention in time and attention yet have non-tailored and non-interactive content (NTHP). NTHP will include HIV/STI information currently available on sex education websites. The attention-control condition allows the investigators to avoid confounding due to content and ensures that all participants receive some HIV prevention content given their high vulnerability to HIV. Further, this comparison will help critically examine the extent to which tailoring increases the acceptability to the program, above and beyond having a non-tailored, non-interactive intervention.
Sponsors
University of Michigan
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* Cis-gender male * Self-report as being single * Self report as HIV-negative at baseline * Speak and read English * Report unprotected anal intercourse with a male partner in prior six (6) months * Have access to computer or smartphone device
Exclusion criteria
* Transgender identity * HIV positive diagnosis * Not residing in the United States * Does not engage in male-to-male sexual behavior
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Change in Number of Risky Sexual Partnerships | Count of participants from baseline to 90-day follow-up reported | The investigators estimated the change in the total number of participants who reported engaging in condomless anal intercourse from baseline to 90-day follow-up. |
| Number of Participants With Change in HIV Testing Behavior | Count of participants from baseline to 90-day follow-up reported | The investigators estimated the number of participants who reported testing for HIV from baseline to 90-day follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-efficacy Motivations to Engage in HIV Prevention Behaviors | Baseline to 90-day follow-up period | The investigators will measure the change in safer sex self-efficacy over time using the HIV Risk Behavior Self-Efficacy Scale by Fisher, Fisher, Misovich, Kimble & Malloy (1996). The scale is measured on a 4-point scale (range 1-4), where higher scores mean less self-efficacy to negotiate safer sex with partners met online. |
| Changes in Psychological Well-being | Baseline to 90-day follow-up period | The investigators will measure symptoms of depression and anxiety using the Brief Symptom Inventory by Derogatis & Spencer (1982). Higher mean scores (scale 1-4) indicate greater symptoms of psychological distress. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| myDEx Intervention The proposed intervention will consist of a 6-session web-based program. Across sessions, the investigators will emphasize the importance of sexual decision-making across different partner types, help YMSM consider what type of relationship(s) they want, and align these relationship desires with safer sex practices.
myDEx: myDEx will consist of a 6-session online program. Cognizant of challenges maintaining users' attention in a web application and to facilitate delivery through a smartphone, the investigators will design each session to be no more than 20 minutes in length. In the course of these 6 sessions, participants will have a total of 120 minutes of intervention exposure. Across sessions, the investigators will emphasize the importance of sexual decision-making across different partner types, help men consider what type of relationship(s) they want, and align these relationship desires with safer sex practices. | 120 |
| Non-tailored HIV Prevention The investigators will create a 6-session web-based attention-control comparison to match myDEx in time and attention yet have non-tailored and non-interactive content (NTHP). NTHP will include HIV/STI information currently available on sex education websites.
NTHP: The investigators will create a 6-session attention-control comparison to match the intervention in time and attention yet have non-tailored and non-interactive content (NTHP). NTHP will include HIV/STI information currently available on sex education websites. The attention-control condition allows the investigators to avoid confounding due to content and ensures that all participants receive some HIV prevention content given their high vulnerability to HIV. Further, this comparison will help critically examine the extent to which tailoring increases the acceptability to the program, above and beyond having a non-tailored, non-interactive intervention. | 60 |
| Total | 180 |
Baseline characteristics
| Characteristic | myDEx Intervention | Non-tailored HIV Prevention | Total |
|---|---|---|---|
| Age, Continuous | 21.57 years STANDARD_DEVIATION 1.81 | 21.87 years STANDARD_DEVIATION 1.78 | 21.67 years STANDARD_DEVIATION 1.81 |
| Alcohol use before/during sex (past 30 days) | 43 Participants | 27 Participants | 70 Participants |
| Current PrEP Use | 17 Participants | 8 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 35 Participants | 19 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 85 Participants | 41 Participants | 126 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 3 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 6 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 20 Participants | 10 Participants | 30 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 81 Participants | 40 Participants | 121 Participants |
| Receptive Anal Sex (past 30 days) | 70 Participants | 40 Participants | 110 Participants |
| Region of Enrollment United States | 120 participants | 60 participants | 180 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 120 Participants | 60 Participants | 180 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 120 | 0 / 60 |
| other Total, other adverse events | 0 / 120 | 0 / 60 |
| serious Total, serious adverse events | 0 / 120 | 0 / 60 |
Outcome results
Primary
Number of Participants With Change in HIV Testing Behavior
The investigators estimated the number of participants who reported testing for HIV from baseline to 90-day follow-up.
Time frame: Count of participants from baseline to 90-day follow-up reported
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| myDEx Intervention | Number of Participants With Change in HIV Testing Behavior | 56 Participants |
| Non-tailored HIV Prevention | Number of Participants With Change in HIV Testing Behavior | 29 Participants |
Primary
Number of Participants With Change in Number of Risky Sexual Partnerships
The investigators estimated the change in the total number of participants who reported engaging in condomless anal intercourse from baseline to 90-day follow-up.
Time frame: Count of participants from baseline to 90-day follow-up reported
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| myDEx Intervention | Number of Participants With Change in Number of Risky Sexual Partnerships | No Condomless Receptive Anal Sex | 88 Participants |
| myDEx Intervention | Number of Participants With Change in Number of Risky Sexual Partnerships | Engaged in Condomless Receptive Anal Sex | 32 Participants |
| Non-tailored HIV Prevention | Number of Participants With Change in Number of Risky Sexual Partnerships | Engaged in Condomless Receptive Anal Sex | 24 Participants |
| Non-tailored HIV Prevention | Number of Participants With Change in Number of Risky Sexual Partnerships | No Condomless Receptive Anal Sex | 36 Participants |
Secondary
Change in Self-efficacy Motivations to Engage in HIV Prevention Behaviors
The investigators will measure the change in safer sex self-efficacy over time using the HIV Risk Behavior Self-Efficacy Scale by Fisher, Fisher, Misovich, Kimble & Malloy (1996). The scale is measured on a 4-point scale (range 1-4), where higher scores mean less self-efficacy to negotiate safer sex with partners met online.
Time frame: Baseline to 90-day follow-up period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| myDEx Intervention | Change in Self-efficacy Motivations to Engage in HIV Prevention Behaviors | 1.93 score on a scale | Standard Deviation 0.56 |
| Non-tailored HIV Prevention | Change in Self-efficacy Motivations to Engage in HIV Prevention Behaviors | 1.99 score on a scale | Standard Deviation 0.49 |
Secondary
Changes in Psychological Well-being
The investigators will measure symptoms of depression and anxiety using the Brief Symptom Inventory by Derogatis & Spencer (1982). Higher mean scores (scale 1-4) indicate greater symptoms of psychological distress.
Time frame: Baseline to 90-day follow-up period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| myDEx Intervention | Changes in Psychological Well-being | 1.84 score on a scale | Standard Deviation 0.58 |
| Non-tailored HIV Prevention | Changes in Psychological Well-being | 1.93 score on a scale | Standard Deviation 0.66 |