Trial Outcomes & Findings for Reducing HIV Vulnerability Through A Multilevel Life Skills Intervention For Adolescent Men (NCT NCT03155841)
NCT ID: NCT03155841
Last Updated: 2023-05-06
Results Overview
The investigators will measure HIV prevention self-efficacy over time, using a 4-point scale (1=Very Easily; 2=Easily; 3=Somewhat Easily; 4=Not Easily) where lower scores indicate a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
600 participants
Primary outcome timeframe
6-month, 12-month
Results posted on
2023-05-06
Participant Flow
Participant milestones
| Measure |
Life Skills Coaching
Participants in the experimental arm will receive access to HIV prevention and life skills content, including opportunities for goal setting, a directory of local resources in their community, and the ability to discuss their goals with Youth Navigators through a video-chat function.
Life Skills Coaching: The investigators designed the intervention to help participants increase their HIV risk awareness, promote self-appraisal and increase motivation for engaging in prevention services, problem solving barriers to accessing care, and locating culturally-sensitive providers. Intervention content is customized based on participants' socio-demographic characteristics and geographic location.
|
Community Resources
Participants in the control arm will receive access to a directory of local resources in their community.
Community Resources: The investigators will provide a resource locator as the attention-control condition. The resource locator provides a list of health (e.g., HIV testing) and social (e.g., support groups) resources across study regions.
|
|---|---|---|
|
Overall Study
STARTED
|
300
|
300
|
|
Overall Study
COMPLETED
|
297
|
296
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Life Skills Coaching
Participants in the experimental arm will receive access to HIV prevention and life skills content, including opportunities for goal setting, a directory of local resources in their community, and the ability to discuss their goals with Youth Navigators through a video-chat function.
Life Skills Coaching: The investigators designed the intervention to help participants increase their HIV risk awareness, promote self-appraisal and increase motivation for engaging in prevention services, problem solving barriers to accessing care, and locating culturally-sensitive providers. Intervention content is customized based on participants' socio-demographic characteristics and geographic location.
|
Community Resources
Participants in the control arm will receive access to a directory of local resources in their community.
Community Resources: The investigators will provide a resource locator as the attention-control condition. The resource locator provides a list of health (e.g., HIV testing) and social (e.g., support groups) resources across study regions.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
4
|
Baseline Characteristics
Reducing HIV Vulnerability Through A Multilevel Life Skills Intervention For Adolescent Men
Baseline characteristics by cohort
| Measure |
Life Skills Coaching
n=300 Participants
Participants in the experimental arm will receive access to HIV prevention and life skills content, including opportunities for goal setting, a directory of local resources in their community, and the ability to discuss their goals with Youth Navigators through a video-chat function.
Life Skills Coaching: The investigators designed the intervention to help participants increase their HIV risk awareness, promote self-appraisal and increase motivation for engaging in prevention services, problem solving barriers to accessing care, and locating culturally-sensitive providers. Intervention content is customized based on participants' socio-demographic characteristics and geographic location.
|
Community Resources
n=300 Participants
Participants in the control arm will receive access to a directory of local resources in their community.
Community Resources: The investigators will provide a resource locator as the attention-control condition. The resource locator provides a list of health (e.g., HIV testing) and social (e.g., support groups) resources across study regions.
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Ages 13-14
|
41 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Age, Customized
Ages 15-16
|
136 Participants
n=99 Participants
|
128 Participants
n=107 Participants
|
264 Participants
n=206 Participants
|
|
Age, Customized
Ages 17-18
|
123 Participants
n=99 Participants
|
135 Participants
n=107 Participants
|
258 Participants
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
|
300 Participants
n=99 Participants
|
300 Participants
n=107 Participants
|
600 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
120 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
224 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
180 Participants
n=99 Participants
|
196 Participants
n=107 Participants
|
376 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
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
28 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
62 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
121 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
230 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
54 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Same-sex sexual behaviors
|
139 Participants
n=99 Participants
|
136 Participants
n=107 Participants
|
275 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6-month, 12-monthPopulation: Number analyzed in follow-up periods differ from the enrolled sample due to missing data resulting from attrition in follow-up periods. Only those participants who were measured at a given follow-up period contributed to the data reported in the table.
The investigators will measure HIV prevention self-efficacy over time, using a 4-point scale (1=Very Easily; 2=Easily; 3=Somewhat Easily; 4=Not Easily) where lower scores indicate a better outcome.
Outcome measures
| Measure |
Life Skills Coaching
n=240 Participants
Participants in the experimental arm will receive access to HIV prevention and life skills content, including opportunities for goal setting, a directory of local resources in their community, and the ability to discuss their goals with Youth Navigators through a video-chat function.
Life Skills Coaching: The investigators designed the intervention to help participants increase their HIV risk awareness, promote self-appraisal and increase motivation for engaging in prevention services, problem solving barriers to accessing care, and locating culturally-sensitive providers. Intervention content is customized based on participants' socio-demographic characteristics and geographic location.
|
Community Resources
n=257 Participants
Participants in the control arm will receive access to a directory of local resources in their community.
Community Resources: The investigators will provide a resource locator as the attention-control condition. The resource locator provides a list of health (e.g., HIV testing) and social (e.g., support groups) resources across study regions.
|
|---|---|---|
|
Confidence to Engage in HIV Prevention Behaviors When Engaging in Receptive Anal Sex Over Time
6 Month Follow-up
|
1.72 units on a scale
Standard Deviation .69
|
1.71 units on a scale
Standard Deviation .69
|
|
Confidence to Engage in HIV Prevention Behaviors When Engaging in Receptive Anal Sex Over Time
12 Month Follow-up
|
1.73 units on a scale
Standard Deviation .72
|
1.72 units on a scale
Standard Deviation .71
|
PRIMARY outcome
Timeframe: 6-month, 12-monthPopulation: Number analyzed in follow-up periods differ from the enrolled sample due to missing data resulting from attrition in follow-up periods. Only those participants who were measured at a given follow-up period contributed to the data reported in the table.
The investigators will measure HIV prevention knowledge over time using 13 True or False statements (0=Incorrect; 1=Correct) regarding HIV transmission. Scores can range from 0 to 13, where higher scores indicate a better outcome.
Outcome measures
| Measure |
Life Skills Coaching
n=238 Participants
Participants in the experimental arm will receive access to HIV prevention and life skills content, including opportunities for goal setting, a directory of local resources in their community, and the ability to discuss their goals with Youth Navigators through a video-chat function.
Life Skills Coaching: The investigators designed the intervention to help participants increase their HIV risk awareness, promote self-appraisal and increase motivation for engaging in prevention services, problem solving barriers to accessing care, and locating culturally-sensitive providers. Intervention content is customized based on participants' socio-demographic characteristics and geographic location.
|
Community Resources
n=260 Participants
Participants in the control arm will receive access to a directory of local resources in their community.
Community Resources: The investigators will provide a resource locator as the attention-control condition. The resource locator provides a list of health (e.g., HIV testing) and social (e.g., support groups) resources across study regions.
|
|---|---|---|
|
HIV Knowledge Over Time
6 Month Follow-up
|
7.86 score on a scale
Standard Deviation 3.23
|
7.99 score on a scale
Standard Deviation 2.84
|
|
HIV Knowledge Over Time
12 Month Follow-up
|
8.33 score on a scale
Standard Deviation 3.00
|
8.23 score on a scale
Standard Deviation 2.98
|
SECONDARY outcome
Timeframe: 6-month, 12-monthThe investigators will estimate participants' likelihood of engaging in one or more same-sex sexual partnerships during follow-up periods.
Outcome measures
| Measure |
Life Skills Coaching
n=300 Participants
Participants in the experimental arm will receive access to HIV prevention and life skills content, including opportunities for goal setting, a directory of local resources in their community, and the ability to discuss their goals with Youth Navigators through a video-chat function.
Life Skills Coaching: The investigators designed the intervention to help participants increase their HIV risk awareness, promote self-appraisal and increase motivation for engaging in prevention services, problem solving barriers to accessing care, and locating culturally-sensitive providers. Intervention content is customized based on participants' socio-demographic characteristics and geographic location.
|
Community Resources
n=300 Participants
Participants in the control arm will receive access to a directory of local resources in their community.
Community Resources: The investigators will provide a resource locator as the attention-control condition. The resource locator provides a list of health (e.g., HIV testing) and social (e.g., support groups) resources across study regions.
|
|---|---|---|
|
Number of Participants Engaging in 1+ Same-Sex Sexual Partnerships
6 Month Follow-Up
|
78 Participants
|
84 Participants
|
|
Number of Participants Engaging in 1+ Same-Sex Sexual Partnerships
12 Month Follow-Up
|
81 Participants
|
88 Participants
|
SECONDARY outcome
Timeframe: 12-monthPopulation: Number analyzed in follow-up periods differ from the enrolled sample due to missing data resulting from attrition in follow-up periods. Only those participants who were measured at a given follow-up period contributed to the data reported in the table.
The investigators will estimate the number of participants who tested for HIV two or more times over the trial period.
Outcome measures
| Measure |
Life Skills Coaching
n=189 Participants
Participants in the experimental arm will receive access to HIV prevention and life skills content, including opportunities for goal setting, a directory of local resources in their community, and the ability to discuss their goals with Youth Navigators through a video-chat function.
Life Skills Coaching: The investigators designed the intervention to help participants increase their HIV risk awareness, promote self-appraisal and increase motivation for engaging in prevention services, problem solving barriers to accessing care, and locating culturally-sensitive providers. Intervention content is customized based on participants' socio-demographic characteristics and geographic location.
|
Community Resources
n=199 Participants
Participants in the control arm will receive access to a directory of local resources in their community.
Community Resources: The investigators will provide a resource locator as the attention-control condition. The resource locator provides a list of health (e.g., HIV testing) and social (e.g., support groups) resources across study regions.
|
|---|---|---|
|
Number of Participants Engaging in HIV Testing Behavior
|
19 Participants
|
30 Participants
|
Adverse Events
Life Skills Coaching
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Community Resources
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Life Skills Coaching
n=300 participants at risk
Participants in the experimental arm will receive access to HIV prevention and life skills content, including opportunities for goal setting, a directory of local resources in their community, and the ability to discuss their goals with Youth Navigators through a video-chat function.
Life Skills Coaching: The investigators designed the intervention to help participants increase their HIV risk awareness, promote self-appraisal and increase motivation for engaging in prevention services, problem solving barriers to accessing care, and locating culturally-sensitive providers. Intervention content is customized based on participants' socio-demographic characteristics and geographic location.
|
Community Resources
n=300 participants at risk
Participants in the control arm will receive access to a directory of local resources in their community.
Community Resources: The investigators will provide a resource locator as the attention-control condition. The resource locator provides a list of health (e.g., HIV testing) and social (e.g., support groups) resources across study regions.
|
|---|---|---|
|
Infections and infestations
HIV Infection
|
0.67%
2/300 • Number of events 2 • Adverse event data were collected over 12 months
|
1.0%
3/300 • Number of events 3 • Adverse event data were collected over 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place