Adolescent Behavior, Family Relations, Hiv, Sexual Orientation
Conditions
Brief summary
This study will develop and test the efficacy of an online, family-based intervention (MySTYLE) tailored to the relevant sexual health needs of non-heterosexual adolescent males and their parents/caregivers compared waitlist control group. Adolescent males and their parents will be recruited from community organizations, medical clinics and schools in Jackson, MS. Interviews with youth, parents, and relevant community leaders will inform the development of the interventions. Youth and their parents/caregivers in both intervention arms will complete three assessments in the four months after enrolling. This study will provide a wealth of information about the degree to which this intervention may be disseminated for this highly vulnerable population of young people.
Detailed description
In recent years, the highest rates of HIV in the U.S. have been concentrated among young men who have sex with men (MSM), especially those of color. Unfortunately, evidenced-based intervention programs for non-heterosexual Black adolescent males (nHBAM) do not exist. Drs. Brown and Crosby have each designed, tested (in the context of NIH-funded RCTs) behavioral interventions targeting young people at-risk of HIV acquisition. Also, their previous work demonstrates that parental involvement prevents sexual risk behavior by adolescents. They will adapt key elements of STYLE, an efficacious HIV prevention program for adolescents and their parents/caregivers, to be relevant for nHBAM. A formative phase will use in-depth interviews to assess and identify the needs of nHBAM and their parents/caregivers. Work groups, composed of youth, parents/caregivers, stakeholders, and investigators, will tailor and refine the content in an iterative process with a sophisticated media company (MEE studios). MySTYLE is proposed to be a series of eight online novella episodes designed to increase relevant knowledge, attitudes, and sexual protective behaviors of nHBAM. The project will take place in Jackson MS, which has the highest prevalence of HIV among urban MSM in the U.S. and the third highest rate among Black MSM under the age of 25. Adolescents and parents will be recruited from community organizations, medical clinics and schools. The feasibility and effect sizes of MySTYLE, compared to a waitlist control group, will be tested with a cohort of 72 nHBAM and their parents. Interventions effect sizes will be determined for sexual behaviors, HIV testing, and psychosocial mediators (e.g., knowledge, attitudes, communication between adolescents and their parents/caregivers relative to sex, safer sex, and sexuality).
Interventions
BEHAVIORALMySTYLE
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.
OTHERWaitlist 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.
Sponsors
University of Mississippi Medical Center
Rhode Island Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
14 Years to 20 Years
Healthy volunteers
Yes
Inclusion criteria
Eligibility criteria for adolescents in all phases of the project will be: 1) at least 14 years of age but no more than 20; 2) stably-housed (have resided with the same adult caregiver for the past 6 months and no plans to leave the city or caregiver in the next 6 months). We understand that this will preclude homeless youth who may be at risk for HIV but MySTYLE will not be designed to address the numerous structural need of chronically homeless youth; 3) the ability to read and speak English; 4) identify as a biological male; 5) and identify racially as Black African American. Eligibility criteria for Parents/caregivers for all phases of the project will be: 1) parent/caregiver or trusted adult of an adolescent who is potentially eligible for enrollment into the study; and 2) English speaking. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptance of an HIV Test at Study Completion | 4 months post-baseline | Behavioral outcome: acceptance of a rapid, point of care HIV test at study completion. This will be assessed via electronic medical chart extraction. |
| Change in Number of Condomless Anal Sex Acts at 4 Months | 4-months post-baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV Knowledge (Adolescent) at 4 Months | 4-months post-baseline | 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. |
| Parent Adolescent Sexual Communication Scale | Baseline, 2- and 4-months post-baseline | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| MySTYLE Adolescents 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. | 41 |
| Waitlist Control Adolescents 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. | 31 |
| 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. | 5 |
| 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. | 1 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 18 | 6 |
Baseline characteristics
| Characteristic | MySTYLE Trusted Adults | Waitlist Control Trusted Adults | Total | MySTYLE Adolescents | Waitlist Control Adolescents |
|---|---|---|---|---|---|
| Age, Continuous | 38.0 years STANDARD_DEVIATION 12.6 | 44.0 years | 18.2 years STANDARD_DEVIATION 1.6 | 18.1 years STANDARD_DEVIATION 1.7 | 18.4 years STANDARD_DEVIATION 1.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 1 Participants | 77 Participants | 41 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Most Recent Grade Completed 10th grade | — | — | 8 Participants | 6 Participants | 2 Participants |
| Most Recent Grade Completed 11th grade | — | — | 4 Participants | 3 Participants | 1 Participants |
| Most Recent Grade Completed 12th grade | — | — | 7 Participants | 4 Participants | 3 Participants |
| Most Recent Grade Completed 8th grade | — | — | 1 Participants | 0 Participants | 1 Participants |
| Most Recent Grade Completed 9th grade | — | — | 2 Participants | 1 Participants | 1 Participants |
| Most Recent Grade Completed Other | — | — | 49 Participants | 27 Participants | 22 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 1 Participants | 72 Participants | 39 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 6 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 72 Participants | 40 Participants | 31 Participants |
| Sex/Gender, Customized Female | 4 Participants | 0 Participants | 5 Participants | 1 Participants | 0 Participants |
| Sex/Gender, Customized Genderqueer/non-comforming | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Sex/Gender, Customized Male | 1 Participants | 0 Participants | 70 Participants | 38 Participants | 31 Participants |
| Sex/Gender, Customized Trans male/trans man | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Sexual Orientation Bisexual | — | — | 10 Participants | 6 Participants | 4 Participants |
| Sexual Orientation Exploring | — | — | 5 Participants | 3 Participants | 2 Participants |
| Sexual Orientation Gay | — | — | 32 Participants | 16 Participants | 16 Participants |
| Sexual Orientation More than one endorsement | — | — | 20 Participants | 12 Participants | 8 Participants |
| Sexual Orientation Other | — | — | 1 Participants | 1 Participants | 0 Participants |
| Sexual Orientation Questioning | — | — | 2 Participants | 2 Participants | 0 Participants |
| Sexual Orientation Undecided | — | — | 2 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 31 | 0 / 5 | 0 / 2 |
| other Total, other adverse events | 0 / 41 | 0 / 31 | 0 / 5 | 0 / 2 |
| serious Total, serious adverse events | 0 / 41 | 0 / 31 | 0 / 5 | 0 / 2 |
Outcome results
Primary
Acceptance of an HIV Test at Study Completion
Behavioral outcome: acceptance of a rapid, point of care HIV test at study completion. This will be assessed via electronic medical chart extraction.
Time frame: 4 months post-baseline
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MySTYLE | Acceptance of an HIV Test at Study Completion | No | 8 Participants |
| MySTYLE | Acceptance of an HIV Test at Study Completion | Yes | 9 Participants |
| Waitlist Control | Acceptance of an HIV Test at Study Completion | No | 8 Participants |
| Waitlist Control | Acceptance of an HIV Test at Study Completion | Yes | 10 Participants |
Primary
Change in Number of Condomless Anal Sex Acts at 4 Months
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.
Time frame: 4-months post-baseline
Population: Only adolescents who completed the 4 month follow-up assessment were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MySTYLE | Change in Number of Condomless Anal Sex Acts at 4 Months | 0.7 condomless anal sex acts | Standard Deviation 0.5 |
| Waitlist Control | Change in Number of Condomless Anal Sex Acts at 4 Months | 0.5 condomless anal sex acts | Standard Deviation 0.8 |
Secondary
HIV Knowledge (Adolescent) at 4 Months
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.
Time frame: 4-months post-baseline
Population: Missing data and lost to follow-up account for the discrepancy in the analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MySTYLE | HIV Knowledge (Adolescent) at 4 Months | 3.4 score on a scale | Standard Deviation 0.8 |
| Waitlist Control | HIV Knowledge (Adolescent) at 4 Months | 3.5 score on a scale | Standard Deviation 1.1 |
Secondary
Parent Adolescent Sexual Communication Scale
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.
Time frame: Baseline, 2- and 4-months post-baseline
Population: Adolescents who completed 4 month follow-up assessment are analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MySTYLE | Parent Adolescent Sexual Communication Scale | 20.1 score on a scale | Standard Deviation 8.8 |
| Waitlist Control | Parent Adolescent Sexual Communication Scale | 23.6 score on a scale | Standard Deviation 9.5 |