Trial Outcomes & Findings for Digital Star: HIV Prevention for Youth in Mental Health Treatment (NCT NCT02921841)
NCT ID: NCT02921841
Last Updated: 2020-01-27
Results Overview
HIV Knowledge Questionnaire. A 18-item (true, false, uncertain) scale surveys routes of transmission, casual contact misconceptions, general information and course of illness. Scores range from 0-18 with higher scores indicating greater HIV knowledge.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
125 participants
Primary outcome timeframe
3 months post-intervention
Results posted on
2020-01-27
Participant Flow
Participant milestones
| Measure |
DSTAR
Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education.
|
DHEALTH
Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
57
|
|
Overall Study
COMPLETED
|
52
|
44
|
|
Overall Study
NOT COMPLETED
|
16
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Digital Star: HIV Prevention for Youth in Mental Health Treatment
Baseline characteristics by cohort
| Measure |
DSTAR
n=68 Participants
Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education.
|
DHEALTH
n=57 Participants
Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.9 years
STANDARD_DEVIATION 1.4 • n=99 Participants
|
15.8 years
STANDARD_DEVIATION 1.3 • n=107 Participants
|
15.8 years
STANDARD_DEVIATION 1.4 • n=206 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
42 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
23 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Gender · Other
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Gender · Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
18 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=99 Participants
|
57 participants
n=107 Participants
|
125 participants
n=206 Participants
|
|
History of Arrest
No
|
35 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
History of Arrest
Yes
|
33 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Sexual Orientation
Heterosexual
|
50 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Sexual Orientation
Homosexual
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sexual Orientation
Bisexual
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sexual Orientation
Undecided/Questioning
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sexual Orientation
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
School Lunch Price
Full Price
|
21 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
School Lunch Price
Reduced Price or Free
|
45 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
School Lunch Price
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 months post-interventionPopulation: Missing data accounts for the discrepancy in the analytic sample for this measure.
HIV Knowledge Questionnaire. A 18-item (true, false, uncertain) scale surveys routes of transmission, casual contact misconceptions, general information and course of illness. Scores range from 0-18 with higher scores indicating greater HIV knowledge.
Outcome measures
| Measure |
DSTAR
n=52 Participants
Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education.
|
DHEALTH
n=43 Participants
Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.
|
|---|---|---|
|
HIV Knowledge
|
11.10 score on a scale
Standard Deviation 3.32
|
10.98 score on a scale
Standard Deviation 3.18
|
PRIMARY outcome
Timeframe: 3 months post-interventionPopulation: Missing data accounts for the discrepancy in the analytic sample for this measure.
The scale contains 13 items that reflect the context of condom use, such as "could use a condom when I'm very upset". Scores range from 13 to 52 with higher scores indicated lower self-efficacy for HIV prevention.
Outcome measures
| Measure |
DSTAR
n=52 Participants
Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education.
|
DHEALTH
n=43 Participants
Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.
|
|---|---|---|
|
Self-efficacy for HIV Prevention
|
37.83 score on a scale
Standard Deviation 9.76
|
37.37 score on a scale
Standard Deviation 8.63
|
PRIMARY outcome
Timeframe: 3-months post-interventionLifetime oral, vaginal, and/or anal sex
Outcome measures
| Measure |
DSTAR
n=52 Participants
Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education.
|
DHEALTH
n=44 Participants
Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.
|
|---|---|---|
|
Lifetime Sexual Intercourse
No
|
23 Participants
|
15 Participants
|
|
Lifetime Sexual Intercourse
Yes
|
29 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: 3-months post-interventionPopulation: Missing data accounts for the discrepancies in the analytic sample for this measure.
Oral, vaginal, and/or anal sex in the past 3 months
Outcome measures
| Measure |
DSTAR
n=52 Participants
Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education.
|
DHEALTH
n=43 Participants
Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.
|
|---|---|---|
|
Recent Oral, Vaginal, and/or Anal Sex
No
|
34 Participants
|
27 Participants
|
|
Recent Oral, Vaginal, and/or Anal Sex
Yes
|
18 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: 3-months post-interventionPopulation: Restricted to those that were sexually active in the past 3 months at the 3-month post-intervention follow-up. Missing data also accounts for the discrepancy in analytic sample for this measure.
Number of oral, vaginal, and/or anal sexual occurrences in the past 3 months.
Outcome measures
| Measure |
DSTAR
n=16 Participants
Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education.
|
DHEALTH
n=10 Participants
Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.
|
|---|---|---|
|
Frequency of Sexual Intercourse
|
13.75 sexual acts
Standard Deviation 18.11
|
9.40 sexual acts
Standard Deviation 15.61
|
PRIMARY outcome
Timeframe: 3-months post-interventionPopulation: Restricted to those that were sexually active in the past 3 months at the 3-month post-intervention follow-up. Missing data also accounts for the discrepancy in the analytic sample for this measure.
Number of sexual partners in the past 3 months.
Outcome measures
| Measure |
DSTAR
n=17 Participants
Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education.
|
DHEALTH
n=14 Participants
Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.
|
|---|---|---|
|
Number of Sexual Partners
|
2.06 sexual partners
Standard Deviation 1.48
|
2.00 sexual partners
Standard Deviation 1.47
|
PRIMARY outcome
Timeframe: 3-months post-interventionPopulation: Restricted to those who were sexually active in the past three months at the 3-month post-intervention follow-up. Missing data also accounts for the discrepancy in the analytic sample for this measure.
Number of times a condom was used during oral, vaginal, and/or anal sex
Outcome measures
| Measure |
DSTAR
n=15 Participants
Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education.
|
DHEALTH
n=11 Participants
Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.
|
|---|---|---|
|
Frequency of Condom Use
|
3.33 times a condom was used
Standard Deviation 6.45
|
2.36 times a condom was used
Standard Deviation 3.23
|
PRIMARY outcome
Timeframe: 3-months post-interventionPopulation: Missing data accounts for the discrepancy in the analytic sample for this measure.
On a scale of 0 to 100, participants report how likely it is that they will use a condom when they have sex in the next 3 months. Zero represented "I will not use a condom", "50" represented "I will use a condom half the time.", and "100" represented "I will use a condom all the time.".
Outcome measures
| Measure |
DSTAR
n=48 Participants
Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education.
|
DHEALTH
n=37 Participants
Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.
|
|---|---|---|
|
Condom Use Intention
|
58.75 units on a scale
Standard Deviation 42.84
|
61.84 units on a scale
Standard Deviation 45.47
|
PRIMARY outcome
Timeframe: 3-months post-interventionAlcohol use in the past 30 days (yes/no)
Outcome measures
| Measure |
DSTAR
n=52 Participants
Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education.
|
DHEALTH
n=44 Participants
Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.
|
|---|---|---|
|
Recent Alcohol Use
No
|
42 Participants
|
36 Participants
|
|
Recent Alcohol Use
Yes
|
10 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 3-months post-interventionPopulation: Restricted to those that indicated alcohol use in the past 30 days at the 3-month post-intervention follow-up. Missing data also accounts for the discrepancy in the analytic sample for this measure.
Number of days alcohol was used in the past 30 days
Outcome measures
| Measure |
DSTAR
n=7 Participants
Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education.
|
DHEALTH
n=7 Participants
Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.
|
|---|---|---|
|
Frequency of Recent Alcohol Use
|
5.71 days
Standard Deviation 10.73
|
7.57 days
Standard Deviation 10.34
|
PRIMARY outcome
Timeframe: 3-months post-interventionPopulation: Restricted to those that indicated alcohol use in the past 30 days at the 3-month post-intervention follow-up. Missing data also accounts for the discrepancy in the analytic sample for this measure.
Number of drinks reported on days that a participant drank alcohol in the past 30 days
Outcome measures
| Measure |
DSTAR
n=7 Participants
Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education.
|
DHEALTH
n=6 Participants
Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.
|
|---|---|---|
|
Quantity of Recent Alcohol Use
|
3.14 alcoholic drinks
Standard Deviation 3.53
|
10.50 alcoholic drinks
Standard Deviation 6.44
|
PRIMARY outcome
Timeframe: 3-months post-interventionPopulation: Missing data accounts for the discrepancy in analytic sample for this measure.
Marijuana use in the past 30 days (yes/no)
Outcome measures
| Measure |
DSTAR
n=47 Participants
Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education.
|
DHEALTH
n=42 Participants
Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.
|
|---|---|---|
|
Recent Marijuana Use
No
|
35 Participants
|
32 Participants
|
|
Recent Marijuana Use
Yes
|
12 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 3-months post-interventionPopulation: Restricted to those that indicated marijuana use in the past 30 days at the 3-month post-intervention follow-up.
Number of days marijuana was used in the past 30 days
Outcome measures
| Measure |
DSTAR
n=12 Participants
Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education.
|
DHEALTH
n=10 Participants
Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.
|
|---|---|---|
|
Frequency of Recent Marijuana Use
|
15.83 days
Standard Deviation 12.69
|
8.60 days
Standard Deviation 7.51
|
SECONDARY outcome
Timeframe: 3 months post-intervention (average 6 months)Population: Missing data accounts for the discrepancy in the analytic sample for this measure.
A six-item scale assessing adolescents' perceived abilities to manage emotional upset (e.g., "In the past three months, I have had trouble controlling my feelings.") in sexual situations. Scores range from 6 to 24 with higher scores indicated poorer perceived ability to manage emotional upset in sexual situations.
Outcome measures
| Measure |
DSTAR
n=51 Participants
Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education.
|
DHEALTH
n=42 Participants
Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.
|
|---|---|---|
|
Affect Dysregulation Scale
|
9.39 score on a scale
Standard Deviation 2.60
|
8.90 score on a scale
Standard Deviation 2.97
|
Adverse Events
DSTAR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DHEALTH
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