Trial Outcomes & Findings for MySTYLE: Online Family-based HIV Prevention for Non-heterosexual Black Adolescent Males in the South (NCT NCT03487796)
NCT ID: NCT03487796
Last Updated: 2021-12-29
Results Overview
Behavioral outcome: acceptance of a rapid, point of care HIV test at study completion. This will be assessed via electronic medical chart extraction.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
4 months post-baseline
Results posted on
2021-12-29
Participant Flow
This was a dyad study. Adolescent participants were given the opportunity to invite a trusted adult to join them in the study; however, having a parent/guardian/trusted adult enroll was not mandatory. Only 7 trusted adults were enrolled. All enrollment values below indicate number of dyads, not individuals, unless otherwise stated.
Participant milestones
| Measure |
MySTYLE
MySTYLE is online, brief and encourages parent-adolescent communication about sex and HIV prevention. Participants (non-heterosexual Black adolescent males and parents/caregivers) will receive two texts per week (for eight weeks) with links to intervention content that includes video, games and graphics to improve knowledge, motivation and skills for HIV prevention. Topics include assertive communication, sexual safety, goal setting, and resilience.
MySTYLE: Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
Waitlist Control
Participants randomized to the waitlist control will be eligible to receive the eight-week MySTYLE intervention after the completion of the 4-month follow-up assessment. During their first four months of participation, waitlist control participants will not receive any intervention materials.
Waitlist Control: Youth and parents will not receive intervention materials for the first four months of participation. At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
31
|
|
Overall Study
2 Month Follow-up
|
24
|
26
|
|
Overall Study
COMPLETED
|
23
|
25
|
|
Overall Study
NOT COMPLETED
|
18
|
6
|
Reasons for withdrawal
| Measure |
MySTYLE
MySTYLE is online, brief and encourages parent-adolescent communication about sex and HIV prevention. Participants (non-heterosexual Black adolescent males and parents/caregivers) will receive two texts per week (for eight weeks) with links to intervention content that includes video, games and graphics to improve knowledge, motivation and skills for HIV prevention. Topics include assertive communication, sexual safety, goal setting, and resilience.
MySTYLE: Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
Waitlist Control
Participants randomized to the waitlist control will be eligible to receive the eight-week MySTYLE intervention after the completion of the 4-month follow-up assessment. During their first four months of participation, waitlist control participants will not receive any intervention materials.
Waitlist Control: Youth and parents will not receive intervention materials for the first four months of participation. At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
18
|
6
|
Baseline Characteristics
Only adolescents, and not parents/caregivers, were asked this question. One waitlist control adolescent is missing data on this variable; therefore, only 30 were analyzed from this groups' 31 participants.
Baseline characteristics by cohort
| Measure |
MySTYLE Adolescents
n=41 Participants
MySTYLE is online, brief and encourages parent-adolescent communication about sex and HIV prevention. Participants (non-heterosexual Black adolescent males and parents/caregivers) will receive two texts per week (for eight weeks) with links to intervention content that includes video, games and graphics to improve knowledge, motivation and skills for HIV prevention. Topics include assertive communication, sexual safety, goal setting, and resilience.
MySTYLE: Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
Waitlist Control Adolescents
n=31 Participants
Participants randomized to the waitlist control will be eligible to receive the eight-week MySTYLE intervention after the completion of the 4-month follow-up assessment. During their first four months of participation, waitlist control participants will not receive any intervention materials.
Waitlist Control: Youth and parents will not receive intervention materials for the first four months of participation. At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
MySTYLE Trusted Adults
n=5 Participants
MySTYLE is online, brief and encourages parent-adolescent communication about sex and HIV prevention. Participants (non-heterosexual Black adolescent males and parents/caregivers) will receive two texts per week (for eight weeks) with links to intervention content that includes video, games and graphics to improve knowledge, motivation and skills for HIV prevention. Topics include assertive communication, sexual safety, goal setting, and resilience.
MySTYLE: Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
Waitlist Control Trusted Adults
n=1 Participants
Participants randomized to the waitlist control will be eligible to receive the eight-week MySTYLE intervention after the completion of the 4-month follow-up assessment. During their first four months of participation, waitlist control participants will not receive any intervention materials.
Waitlist Control: Youth and parents will not receive intervention materials for the first four months of participation. At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
18.1 years
STANDARD_DEVIATION 1.7 • n=41 Participants
|
18.4 years
STANDARD_DEVIATION 1.5 • n=31 Participants
|
38.0 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
44.0 years
STANDARD_DEVIATION NA • n=1 Participants
|
18.2 years
STANDARD_DEVIATION 1.6 • n=78 Participants
|
|
Sex/Gender, Customized
Male
|
38 Participants
n=41 Participants
|
31 Participants
n=31 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
70 Participants
n=78 Participants
|
|
Sex/Gender, Customized
Female
|
1 Participants
n=41 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
5 Participants
n=78 Participants
|
|
Sex/Gender, Customized
Trans male/trans man
|
1 Participants
n=41 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=78 Participants
|
|
Sex/Gender, Customized
Genderqueer/non-comforming
|
1 Participants
n=41 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=78 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=41 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=1 Participants
|
6 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=41 Participants
|
31 Participants
n=31 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
72 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=41 Participants
|
30 Participants
n=31 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=1 Participants
|
77 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Black or African American
|
39 Participants
n=41 Participants
|
28 Participants
n=31 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=1 Participants
|
72 Participants
n=78 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=41 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=78 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=41 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
4 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=78 Participants
|
|
Most Recent Grade Completed
8th grade
|
0 Participants
n=41 Participants • Only adolescents, and not parents/caregivers, were asked this question. One waitlist control adolescent is missing data on this variable; therefore, only 30 were analyzed from this groups' 31 participants.
|
1 Participants
n=30 Participants • Only adolescents, and not parents/caregivers, were asked this question. One waitlist control adolescent is missing data on this variable; therefore, only 30 were analyzed from this groups' 31 participants.
|
—
|
—
|
1 Participants
n=71 Participants • Only adolescents, and not parents/caregivers, were asked this question. One waitlist control adolescent is missing data on this variable; therefore, only 30 were analyzed from this groups' 31 participants.
|
|
Most Recent Grade Completed
9th grade
|
1 Participants
n=41 Participants • Only adolescents, and not parents/caregivers, were asked this question. One waitlist control adolescent is missing data on this variable; therefore, only 30 were analyzed from this groups' 31 participants.
|
1 Participants
n=30 Participants • Only adolescents, and not parents/caregivers, were asked this question. One waitlist control adolescent is missing data on this variable; therefore, only 30 were analyzed from this groups' 31 participants.
|
—
|
—
|
2 Participants
n=71 Participants • Only adolescents, and not parents/caregivers, were asked this question. One waitlist control adolescent is missing data on this variable; therefore, only 30 were analyzed from this groups' 31 participants.
|
|
Most Recent Grade Completed
10th grade
|
6 Participants
n=41 Participants • Only adolescents, and not parents/caregivers, were asked this question. One waitlist control adolescent is missing data on this variable; therefore, only 30 were analyzed from this groups' 31 participants.
|
2 Participants
n=30 Participants • Only adolescents, and not parents/caregivers, were asked this question. One waitlist control adolescent is missing data on this variable; therefore, only 30 were analyzed from this groups' 31 participants.
|
—
|
—
|
8 Participants
n=71 Participants • Only adolescents, and not parents/caregivers, were asked this question. One waitlist control adolescent is missing data on this variable; therefore, only 30 were analyzed from this groups' 31 participants.
|
|
Most Recent Grade Completed
11th grade
|
3 Participants
n=41 Participants • Only adolescents, and not parents/caregivers, were asked this question. One waitlist control adolescent is missing data on this variable; therefore, only 30 were analyzed from this groups' 31 participants.
|
1 Participants
n=30 Participants • Only adolescents, and not parents/caregivers, were asked this question. One waitlist control adolescent is missing data on this variable; therefore, only 30 were analyzed from this groups' 31 participants.
|
—
|
—
|
4 Participants
n=71 Participants • Only adolescents, and not parents/caregivers, were asked this question. One waitlist control adolescent is missing data on this variable; therefore, only 30 were analyzed from this groups' 31 participants.
|
|
Most Recent Grade Completed
12th grade
|
4 Participants
n=41 Participants • Only adolescents, and not parents/caregivers, were asked this question. One waitlist control adolescent is missing data on this variable; therefore, only 30 were analyzed from this groups' 31 participants.
|
3 Participants
n=30 Participants • Only adolescents, and not parents/caregivers, were asked this question. One waitlist control adolescent is missing data on this variable; therefore, only 30 were analyzed from this groups' 31 participants.
|
—
|
—
|
7 Participants
n=71 Participants • Only adolescents, and not parents/caregivers, were asked this question. One waitlist control adolescent is missing data on this variable; therefore, only 30 were analyzed from this groups' 31 participants.
|
|
Most Recent Grade Completed
Other
|
27 Participants
n=41 Participants • Only adolescents, and not parents/caregivers, were asked this question. One waitlist control adolescent is missing data on this variable; therefore, only 30 were analyzed from this groups' 31 participants.
|
22 Participants
n=30 Participants • Only adolescents, and not parents/caregivers, were asked this question. One waitlist control adolescent is missing data on this variable; therefore, only 30 were analyzed from this groups' 31 participants.
|
—
|
—
|
49 Participants
n=71 Participants • Only adolescents, and not parents/caregivers, were asked this question. One waitlist control adolescent is missing data on this variable; therefore, only 30 were analyzed from this groups' 31 participants.
|
|
Sexual Orientation
Exploring
|
3 Participants
n=41 Participants • Adults were not asked this question.
|
2 Participants
n=31 Participants • Adults were not asked this question.
|
—
|
—
|
5 Participants
n=72 Participants • Adults were not asked this question.
|
|
Sexual Orientation
Undecided
|
1 Participants
n=41 Participants • Adults were not asked this question.
|
1 Participants
n=31 Participants • Adults were not asked this question.
|
—
|
—
|
2 Participants
n=72 Participants • Adults were not asked this question.
|
|
Sexual Orientation
Questioning
|
2 Participants
n=41 Participants • Adults were not asked this question.
|
0 Participants
n=31 Participants • Adults were not asked this question.
|
—
|
—
|
2 Participants
n=72 Participants • Adults were not asked this question.
|
|
Sexual Orientation
Other
|
1 Participants
n=41 Participants • Adults were not asked this question.
|
0 Participants
n=31 Participants • Adults were not asked this question.
|
—
|
—
|
1 Participants
n=72 Participants • Adults were not asked this question.
|
|
Sexual Orientation
Gay
|
16 Participants
n=41 Participants • Adults were not asked this question.
|
16 Participants
n=31 Participants • Adults were not asked this question.
|
—
|
—
|
32 Participants
n=72 Participants • Adults were not asked this question.
|
|
Sexual Orientation
Bisexual
|
6 Participants
n=41 Participants • Adults were not asked this question.
|
4 Participants
n=31 Participants • Adults were not asked this question.
|
—
|
—
|
10 Participants
n=72 Participants • Adults were not asked this question.
|
|
Sexual Orientation
More than one endorsement
|
12 Participants
n=41 Participants • Adults were not asked this question.
|
8 Participants
n=31 Participants • Adults were not asked this question.
|
—
|
—
|
20 Participants
n=72 Participants • Adults were not asked this question.
|
PRIMARY outcome
Timeframe: 4 months post-baselinePopulation: Missing data and those lost to follow-up account for the discrepancy in the analysis population. Only adolescent participants were offered an HIV test at study completion and analyzed on this outcome (no parent/caregivers).
Behavioral outcome: acceptance of a rapid, point of care HIV test at study completion. This will be assessed via electronic medical chart extraction.
Outcome measures
| Measure |
MySTYLE
n=17 Participants
MySTYLE is online, brief and encourages parent-adolescent communication about sex and HIV prevention. Participants (non-heterosexual Black adolescent males and parents/caregivers) will receive two texts per week (for eight weeks) with links to intervention content that includes video, games and graphics to improve knowledge, motivation and skills for HIV prevention. Topics include assertive communication, sexual safety, goal setting, and resilience.
MySTYLE: Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
Waitlist Control
n=18 Participants
Participants randomized to the waitlist control will be eligible to receive the eight-week MySTYLE intervention after the completion of the 4-month follow-up assessment. During their first four months of participation, waitlist control participants will not receive any intervention materials.
Waitlist Control: Youth and parents will not receive intervention materials for the first four months of participation. At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
MySTYLE Trusted Adults
MySTYLE is online, brief and encourages parent-adolescent communication about sex and HIV prevention. Participants (non-heterosexual Black adolescent males and parents/caregivers) will receive two texts per week (for eight weeks) with links to intervention content that includes video, games and graphics to improve knowledge, motivation and skills for HIV prevention. Topics include assertive communication, sexual safety, goal setting, and resilience.
MySTYLE: Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
Waitlist Control Trusted Adults
Participants randomized to the waitlist control will be eligible to receive the eight-week MySTYLE intervention after the completion of the 4-month follow-up assessment. During their first four months of participation, waitlist control participants will not receive any intervention materials.
Waitlist Control: Youth and parents will not receive intervention materials for the first four months of participation. At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
|---|---|---|---|---|
|
Acceptance of an HIV Test at Study Completion
No
|
8 Participants
|
8 Participants
|
—
|
—
|
|
Acceptance of an HIV Test at Study Completion
Yes
|
9 Participants
|
10 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 4-months post-baselinePopulation: Only adolescents who completed the 4 month follow-up assessment were included.
Participants will be asked to report the number of condomless anal sex acts they have engaged in, in the past 90 days at baseline and at the 4 month follow-up. The change in number of condomless sex acts will be assessed.
Outcome measures
| Measure |
MySTYLE
n=23 Participants
MySTYLE is online, brief and encourages parent-adolescent communication about sex and HIV prevention. Participants (non-heterosexual Black adolescent males and parents/caregivers) will receive two texts per week (for eight weeks) with links to intervention content that includes video, games and graphics to improve knowledge, motivation and skills for HIV prevention. Topics include assertive communication, sexual safety, goal setting, and resilience.
MySTYLE: Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
Waitlist Control
n=24 Participants
Participants randomized to the waitlist control will be eligible to receive the eight-week MySTYLE intervention after the completion of the 4-month follow-up assessment. During their first four months of participation, waitlist control participants will not receive any intervention materials.
Waitlist Control: Youth and parents will not receive intervention materials for the first four months of participation. At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
MySTYLE Trusted Adults
MySTYLE is online, brief and encourages parent-adolescent communication about sex and HIV prevention. Participants (non-heterosexual Black adolescent males and parents/caregivers) will receive two texts per week (for eight weeks) with links to intervention content that includes video, games and graphics to improve knowledge, motivation and skills for HIV prevention. Topics include assertive communication, sexual safety, goal setting, and resilience.
MySTYLE: Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
Waitlist Control Trusted Adults
Participants randomized to the waitlist control will be eligible to receive the eight-week MySTYLE intervention after the completion of the 4-month follow-up assessment. During their first four months of participation, waitlist control participants will not receive any intervention materials.
Waitlist Control: Youth and parents will not receive intervention materials for the first four months of participation. At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
|---|---|---|---|---|
|
Change in Number of Condomless Anal Sex Acts at 4 Months
|
0.7 condomless anal sex acts
Standard Deviation 0.5
|
0.5 condomless anal sex acts
Standard Deviation 0.8
|
—
|
—
|
SECONDARY outcome
Timeframe: 4-months post-baselinePopulation: Missing data and lost to follow-up account for the discrepancy in the analysis population.
The HIV Knowledge Scale assesses knowledge about issues such as risks for HIV, using 5 items with "true," "false," or "do not know" response options. Total scores range from 0 to 5. Higher scores indicate greater knowledge.
Outcome measures
| Measure |
MySTYLE
n=23 Participants
MySTYLE is online, brief and encourages parent-adolescent communication about sex and HIV prevention. Participants (non-heterosexual Black adolescent males and parents/caregivers) will receive two texts per week (for eight weeks) with links to intervention content that includes video, games and graphics to improve knowledge, motivation and skills for HIV prevention. Topics include assertive communication, sexual safety, goal setting, and resilience.
MySTYLE: Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
Waitlist Control
n=24 Participants
Participants randomized to the waitlist control will be eligible to receive the eight-week MySTYLE intervention after the completion of the 4-month follow-up assessment. During their first four months of participation, waitlist control participants will not receive any intervention materials.
Waitlist Control: Youth and parents will not receive intervention materials for the first four months of participation. At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
MySTYLE Trusted Adults
MySTYLE is online, brief and encourages parent-adolescent communication about sex and HIV prevention. Participants (non-heterosexual Black adolescent males and parents/caregivers) will receive two texts per week (for eight weeks) with links to intervention content that includes video, games and graphics to improve knowledge, motivation and skills for HIV prevention. Topics include assertive communication, sexual safety, goal setting, and resilience.
MySTYLE: Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
Waitlist Control Trusted Adults
Participants randomized to the waitlist control will be eligible to receive the eight-week MySTYLE intervention after the completion of the 4-month follow-up assessment. During their first four months of participation, waitlist control participants will not receive any intervention materials.
Waitlist Control: Youth and parents will not receive intervention materials for the first four months of participation. At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
|---|---|---|---|---|
|
HIV Knowledge (Adolescent) at 4 Months
|
3.4 score on a scale
Standard Deviation 0.8
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3.5 score on a scale
Standard Deviation 1.1
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SECONDARY outcome
Timeframe: Baseline, 2- and 4-months post-baselinePopulation: Adolescents who completed 4 month follow-up assessment are analyzed.
The Miller Sexual Communication Scale assesses the process and content of sexual communication between parents and adolescents. Only adolescent participants, not parent/caregivers, were asked to complete this scale. Evidence supports internal consistencies between .65 and .86. Each item is rated on a Likert scale 1 (not true) to 7 (very true) with scale scores ranging from 6-42. Higher scores indicate better communication about sexual behaviors.
Outcome measures
| Measure |
MySTYLE
n=23 Participants
MySTYLE is online, brief and encourages parent-adolescent communication about sex and HIV prevention. Participants (non-heterosexual Black adolescent males and parents/caregivers) will receive two texts per week (for eight weeks) with links to intervention content that includes video, games and graphics to improve knowledge, motivation and skills for HIV prevention. Topics include assertive communication, sexual safety, goal setting, and resilience.
MySTYLE: Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
Waitlist Control
n=24 Participants
Participants randomized to the waitlist control will be eligible to receive the eight-week MySTYLE intervention after the completion of the 4-month follow-up assessment. During their first four months of participation, waitlist control participants will not receive any intervention materials.
Waitlist Control: Youth and parents will not receive intervention materials for the first four months of participation. At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
MySTYLE Trusted Adults
MySTYLE is online, brief and encourages parent-adolescent communication about sex and HIV prevention. Participants (non-heterosexual Black adolescent males and parents/caregivers) will receive two texts per week (for eight weeks) with links to intervention content that includes video, games and graphics to improve knowledge, motivation and skills for HIV prevention. Topics include assertive communication, sexual safety, goal setting, and resilience.
MySTYLE: Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
|
Waitlist Control Trusted Adults
Participants randomized to the waitlist control will be eligible to receive the eight-week MySTYLE intervention after the completion of the 4-month follow-up assessment. During their first four months of participation, waitlist control participants will not receive any intervention materials.
Waitlist Control: Youth and parents will not receive intervention materials for the first four months of participation. At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
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Parent Adolescent Sexual Communication Scale
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20.1 score on a scale
Standard Deviation 8.8
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23.6 score on a scale
Standard Deviation 9.5
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Adverse Events
MySTYLE Adolescents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control Adolescents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MySTYLE Trusted Adults
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control Trusted Adults
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