Trial Outcomes & Findings for Development of a Tailored HIV Prevention Intervention for Young Men (NCT NCT02842060)
NCT ID: NCT02842060
Last Updated: 2019-07-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
180 participants
Primary outcome timeframe
Count of participants from baseline to 90-day follow-up reported
Results posted on
2019-07-16
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
60
|
|
Overall Study
COMPLETED
|
120
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development of a Tailored HIV Prevention Intervention for Young Men
Baseline characteristics by cohort
| Measure |
myDEx Intervention
n=120 Participants
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.
|
Non-tailored HIV Prevention
n=60 Participants
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.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.57 years
STANDARD_DEVIATION 1.81 • n=99 Participants
|
21.87 years
STANDARD_DEVIATION 1.78 • n=107 Participants
|
21.67 years
STANDARD_DEVIATION 1.81 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
126 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
20 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
120 participants
n=99 Participants
|
60 participants
n=107 Participants
|
180 participants
n=206 Participants
|
|
Current PrEP Use
|
17 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Receptive Anal Sex (past 30 days)
|
70 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
|
Alcohol use before/during sex (past 30 days)
|
43 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Count of participants from baseline to 90-day follow-up reportedThe investigators estimated the change in the total number of participants who reported engaging in condomless anal intercourse from baseline to 90-day follow-up.
Outcome measures
| Measure |
myDEx Intervention
n=120 Participants
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.
|
Non-tailored HIV Prevention
n=60 Participants
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.
|
|---|---|---|
|
Number of Participants With Change in Number of Risky Sexual Partnerships
Engaged in Condomless Receptive Anal Sex
|
32 Participants
|
24 Participants
|
|
Number of Participants With Change in Number of Risky Sexual Partnerships
No Condomless Receptive Anal Sex
|
88 Participants
|
36 Participants
|
PRIMARY outcome
Timeframe: Count of participants from baseline to 90-day follow-up reportedThe investigators estimated the number of participants who reported testing for HIV from baseline to 90-day follow-up.
Outcome measures
| Measure |
myDEx Intervention
n=120 Participants
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.
|
Non-tailored HIV Prevention
n=60 Participants
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.
|
|---|---|---|
|
Number of Participants With Change in HIV Testing Behavior
|
56 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Baseline to 90-day follow-up periodThe 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.
Outcome measures
| Measure |
myDEx Intervention
n=95 Participants
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.
|
Non-tailored HIV Prevention
n=51 Participants
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.
|
|---|---|---|
|
Change in Self-efficacy Motivations to Engage in HIV Prevention Behaviors
|
1.93 score on a scale
Standard Deviation .56
|
1.99 score on a scale
Standard Deviation .49
|
SECONDARY outcome
Timeframe: Baseline to 90-day follow-up periodThe 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.
Outcome measures
| Measure |
myDEx Intervention
n=94 Participants
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.
|
Non-tailored HIV Prevention
n=51 Participants
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.
|
|---|---|---|
|
Changes in Psychological Well-being
|
1.84 score on a scale
Standard Deviation .58
|
1.93 score on a scale
Standard Deviation .66
|
Adverse Events
myDEx Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-tailored HIV Prevention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place