רדאר קליני AI | ||
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הניסוי הקליני NCT05852600 עבור HIV (נגיף הכשל החיסוני האנושי), בריאות מינית הוא פעיל, לא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
Parent-focused Intervention to Reduce HIV Risk in Gay and Bisexual Adolescents 393 אקראי מתבגרים מניעה
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT05852600 הוא מחקר מסוג התערבותי עבור HIV (נגיף הכשל החיסוני האנושי), בריאות מינית, שנמצא כעת במצב פעיל, לא מגייס. המחקר התחיל ב-24 באפריל 2023 ומתוכנן לכלול 393 משתתפים. המחקר מנוהל על ידי אוניברסיטת ג'ורג' וושינגטון וצפוי להסתיים ב-1 בנובמבר 2026. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-17 בפברואר 2026.
סיכום קצר
Gay and bisexual youth make up 80% of all new HIV infections among adolescents ages 14-19 in the United States, yet interventions to improve sexual health outcomes in these youth are extremely limited. Our team has developed an intervention -- Parents and Adolescents Talking about Healthy Sexuality (PATHS) -- to reduce HIV risk for gay and bisexual youth by working with their parents to improve the ways parents commu...הצג עוד
כותרת רשמית
Randomized-controlled Trial of a Parent-focused Intervention to Reduce HIV Risk in Gay and Bisexual Adolescents
מצבים רפואיים
HIV (נגיף הכשל החיסוני האנושי)בריאות מיניתמזהי מחקר נוספים
- MH129169
מספר NCT
תחילת המחקר (בפועל)
2023-04-24
עדכון אחרון שפורסם
2026-02-17
סיום המחקר (מוערך)
2026-11-01
משתתפים (מתוכנן)
393
סוג המחקר
התערבותי
שלב
לא ישים
סטטוס
פעיל, לא מגייס
מילות מפתח
randomized controlled trial
parenting
sexual minority youth
parenting
sexual minority youth
מטרה ראשית
מניעה
הקצאת טיפול
אקראי
דגם מתערב
מחקר מוצלב
עיוורון
יחיד
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיIntervention Participants assigned to the intervention arm are immediately given the opportunity to view Lead with Love, and then to complete the PATHS toolkit. One month after completing PATHS, they complete a "refresher" module that is designed to boost the initial effects of PATHS. | Parents and Adolescents Talking about Healthy Sexuality (PATHS) PATHS is an intervention delivered to parents of AMSM that aims to increase parent communication about sexuality and HIV, as well as other parent behaviors supportive of sexual risk reduction. PATHS can all be accessed online, is self-paced, and typically takes parents 40-60 minutes to complete. The toolkit is comprised of 7 modules, covering a range of topics relevant to increasing parents' motivation, self-efficacy...הצג עוד Lead with Love (LWL) Lead with Love is a 35-minute "education entertainment" film created to provide support, information, and behavioral guidance to parents of lesbian, gay, or bisexual (LGB) children. Drawing from stage-based models of behavior change, and social cognitive theory, it aims to help parents progress through the process of coming to accept their child's sexual orientation, recognizing the importance of their behaviors and ...הצג עוד |
משווה פעילWaitlist Control Participants assigned to the waitlist control arm are immediately given the opportunity to view Lead with Love. One month after viewing the film, they complete a "refresher" module that reviews the most important lessons from the film. Six months after being randomized, participants are then given access to the PATHS toolkit. One month after completing the PATHS toolkit, they complete a "refresher" module that is des...הצג עוד | Parents and Adolescents Talking about Healthy Sexuality (PATHS) PATHS is an intervention delivered to parents of AMSM that aims to increase parent communication about sexuality and HIV, as well as other parent behaviors supportive of sexual risk reduction. PATHS can all be accessed online, is self-paced, and typically takes parents 40-60 minutes to complete. The toolkit is comprised of 7 modules, covering a range of topics relevant to increasing parents' motivation, self-efficacy...הצג עוד Lead with Love (LWL) Lead with Love is a 35-minute "education entertainment" film created to provide support, information, and behavioral guidance to parents of lesbian, gay, or bisexual (LGB) children. Drawing from stage-based models of behavior change, and social cognitive theory, it aims to help parents progress through the process of coming to accept their child's sexual orientation, recognizing the importance of their behaviors and ...הצג עוד |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Change in condom use self-efficacy | 15-item scale assessing youth's confidence in their ability to correctly use and acquire condoms. | Youth will complete this measure at baseline (pre-randomization) and at 3, 6, 9, and 12-months post randomization. The primary outcome will be the 6-month post-randomization assessment, adjusted for baseline values. |
Change in condom access | Youth report (yes/no) whether they have a condom that they could access in one of five different locations (e.g., their bedroom, somewhere else in their home, their locker at school). Having a condom available in any of this locations will count as "access." | Youth will complete this measure at baseline (pre-randomization) and at 3, 6, 9, and 12-months post randomization. The primary outcome will be the 6-month post-randomization assessment, adjusted for baseline values. |
Change in condom use intentions | Youth will complete two items assessing their intentions to use condoms for insertive and receptive anal intercourse over the next several months. | Youth will complete this measure at baseline (pre-randomization) and at 3, 6, 9, and 12-months post randomization. The primary outcome will be the 6-month post-randomization assessment, adjusted for baseline values. |
Change in PrEP attitudes and beliefs | Youth will complete 10-items newly created for this study, assessing their attitudes and beliefs about PrEP (e.g., whether PrEP is safe, whether it is effective, whether their parents would support them taking PrEP). Prior to analyses, psychometric tests will be conducted on this new measure to determine whether the scale assesses a single construct, or multiple domains. | Youth will complete this measure at baseline (pre-randomization) and at 3, 6, 9, and 12-months post randomization. The primary outcome will be the 6-month post-randomization assessment, adjusted for baseline values. |
Frequency of condomless anal intercourse (CAS) without protection by PrEP | Youth will self-report how frequently they have engaged in condomless anal intercourse over the past 3 months. They will also report whether they were using PrEP during that time. The frequency of anal intercourse not protected by a condom or by PrEP will be calculated. | Youth will complete this measure at baseline (pre-randomization) and at 3, 6, 9, and 12-months post randomization. The primary outcome will be the total frequency of CAS reported across both the 3- and 6-month assessments. |
Youth self-report of being "current" on HIV testing | Youth will report whether they have received an HIV test and when the most recent test occurred. Sexually active youth will be considered "current" on their HIV testing if they have received an HIV test at any point in the previous year. Youth who are not yet sexually active will be considered "current" if they have received one HIV test at any point in their lives. | Youth will complete this measure at baseline (pre-randomization) and at 3, 6, 9, and 12-months post randomization. The primary outcome will whether youth are "current" on HIV testing at the 6-month assessment. |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Demonstrated behavioral skill for using condoms correctly | We will utilize the condoms skills assessment activity as a means for verifying their self-reported self-efficacy for using condoms. While completing their 3-month and 9-month online assessments, AMSM will use an online scheduling system to sign up for a 30-minute appointment to do a condom skill assessment, which will be conducted via Zoom. Once scheduled, participants will be mailed an assessment kit that contains a travel shampoo bottle (phallically shaped) and condoms. Participants will be instructed to demonstrate the correct way to apply a condom to the shampoo bottle, beginning with opening the condom, and ending with removing and disposing of the condom. Following the session, recordings will be coded by two separate team members to determine the number of steps performed correctly (discrepancies will be resolved via discussion). | Youth will complete this activity twice: (1) between the 3 and 6-month assessment, and (2) between the 9 and 12-month assessment. The activity conducted between 3 and 6-month assessments will be the primary outcome for this measure. |
Photo of condom in youth's possession | While completing the 3, 6, 9, and 12-month online assessments, youth who self-report that they have condoms in their possession will be asked to take a photo of the condom in their hand and upload it to the survey system. Photos will viewed by members of the research team to confirm that a condom was photographed as requested. The proportion of youth who are able to upload photos across each condition will be used as a means for verifying the primary outcome of youth self-report of having access to condoms. | Photo uploads at the 6-month assessment will be compared across the study arms |
Parent-report of whether son is "current" on his HIV testing | Parents will report whether their son has, to their knowledge, received an HIV test and when that test occurred. This will be used as a reliability check for youth's self-reports of their HIV testing. Sexually active youth will be considered "current" on their HIV testing if they have received an HIV test at any point in the previous year. Youth who are not yet sexually active will be considered "current" if they have received one HIV test at any point in their lives. | Parents will complete this measure at baseline (pre-randomization) and at 3, 6, 9, and 12-months post randomization. The primary outcome will be whether youth are "current" at the 6-month assessment. |
Change in competency for sexual health | 17-item scale assessing multiple dimensions of youth's comfort engaging in activities that support sexual health (e.g., telling a sex partner you want to stop after you have started having sex; teaching a sex partner what feels good to you sexually). | Youth will complete this measure at baseline (pre-randomization) and at 3, 6, 9, and 12-months post randomization. The primary outcome will be the 6-month post-randomization assessment, adjusted for baseline values. |
עוזר השתתפות
קריטריוני זכאות
גילאים מוערכים למחקר
ילד, מבוגר, גיל שלישי
גיל מינימלי למחקר
14 Years
מגדרים מוערכים למחקר
הכל
מתנדבים בריאים מתקבלים
כן
We recruit only parent-adolescent dyads for the study. Both parent and adolescent must agree to participate in order to enroll. Only parents receive the intervention. Adolescents are included in the study only for assessment purposes.
Parent inclusion criteria: Parent or legal guardian of a child with all of the following characteristics:
- cisgender male
- age 14-19
- self-identifies as gay or bisexual
- lives in the same house with parent at least 2 days per week
- child is willing to enroll in the study and complete assessments
Adolescent inclusion criteria:
- cisgender male
- age 14-19
- self-identifies as gay or bisexual
- lives in the same house with parent at least 2 days per week
- parent is willing to enroll in the study and be randomized to one of two intervention conditions.
-- Adolescent with known HIV infection
הגורם האחראי למחקר
David Huebner, חוקר ראשי, Professor, George Washington University
אין נתוני קשר.
1 מיקומי המחקר ב-1 מדינות
District of Columbia
George Washington University, Washington D.C., District of Columbia, 20052, United States