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| Name | Class |
|---|---|
| University of Mississippi Medical Center | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MySTYLE | Experimental | 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. |
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| Waitlist Control | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MySTYLE | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 months post-baseline |
| 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. | 4-months post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4-months post-baseline |
| Parent Adolescent Sexual Communication Scale |
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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.
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Exclusion Criteria: Exclusion criteria will be: a) not able to provide meaningful assent as determined by research staff, b) known HIV-infection (staff will facilitate entry into care if needed). Although we expect that most enrolled youth with be non-heterosexual Black adolescent males, heterosexual youth who enroll will be able to complete all intervention activities.
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Adolescents must identify as biological male. Parent/caregiver may be male or female.
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| Name | Affiliation | Role |
|---|---|---|
| Larry K Brown, MD | Rhode Island Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mississippi Medical Center | Jackson | Mississippi | 39213 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Notes: Baseline data is missing for one Waitlist Control Trusted Adult.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Count of Participants | Participants | 4 months post-baseline |
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Data on adverse effects was collection from time of enrollment to end of follow-up, 4-months post-baseline.
Adverse events as described in the study protocol were reported by study staff to the principle investigator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Larry K. Brown, MD | Rhode Island Hospital | (401) 793-8808 | lkbrown@lifespan.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 6, 2021 | Oct 20, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D000294 | Adolescent Behavior |
| D012725 | Sexual Behavior |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Waitlist Control | Other | 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. |
|
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. |
| Baseline, 2- and 4-months post-baseline |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Sex/Gender Identity, customized | Count of Participants | Participants |
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| Sex: Female, Male | Sex at Birth Reported as female or male. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Most Recent Grade Completed | 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. | Count of Participants | Participants |
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| Sexual Orientation | Self-identified sexual orientation | Adults were not asked this question. | Count of Participants | Participants |
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| OG001 | 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. |
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| 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. | Only adolescents who completed the 4 month follow-up assessment were included. | Posted | Mean | Standard Deviation | condomless anal sex acts | 4-months post-baseline |
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| 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. | Missing data and lost to follow-up account for the discrepancy in the analysis population. | Posted | Mean | Standard Deviation | score on a scale | 4-months post-baseline |
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| 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. | Adolescents who completed 4 month follow-up assessment are analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2- and 4-months post-baseline |
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| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | 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. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG002 | 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. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG003 | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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