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临床试验 NCT05852600 针对人类免疫缺陷病毒 (HIV),性健康目前进行中(不再招募)。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情,或在此提出任何问题。
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Parent-focused Intervention to Reduce HIV Risk in Gay and Bisexual Adolescents 393 随机化 青少年 预防

进行中(不再招募)
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临床试验NCT05852600是一项针对人类免疫缺陷病毒 (HIV),性健康干预性研究试验,目前试验状态为进行中(不再招募)。试验始于2023年4月24日,计划招募393名患者。该研究由乔治·华盛顿大学主导,预计于2026年11月1日完成。试验数据来源于ClinicalTrials.gov,最后更新时间为2026年2月17日
简要概括
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...显示更多
官方标题

Randomized-controlled Trial of a Parent-focused Intervention to Reduce HIV Risk in Gay and Bisexual Adolescents

疾病
人类免疫缺陷病毒 (HIV)性健康
其他研究标识符
  • MH129169
NCT编号
实际开始日期
2023-04-24
最近更新发布
2026-02-17
预计完成日期
2026-11-01
计划入组人数
393
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
进行中(不再招募)
关键词
randomized controlled trial
parenting
sexual minority youth
主要目的
预防
分配方式
随机
干预模型
交叉设计
盲法
单盲
试验组/干预措施
参与者组/试验组干预措施/治疗方法
实验性Intervention
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...显示更多
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 ...显示更多
阳性对照Waitlist 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...显示更多
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...显示更多
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 ...显示更多
主要终点
结果指标度量标准描述时间框架
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.
次要终点
结果指标度量标准描述时间框架
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.
参与助手
资格标准

适龄参与研究
儿童, 成人, 老年人
最低年龄要求
14 Years
适龄性别
全部
接受健康志愿者

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:

  1. cisgender male
  2. age 14-19
  3. self-identifies as gay or bisexual
  4. lives in the same house with parent at least 2 days per week
  5. child is willing to enroll in the study and complete assessments

Adolescent inclusion criteria:

  1. cisgender male
  2. age 14-19
  3. self-identifies as gay or bisexual
  4. lives in the same house with parent at least 2 days per week
  5. parent is willing to enroll in the study and be randomized to one of two intervention conditions.

-- Adolescent with known HIV infection
George Washington University logo乔治·华盛顿大学
研究责任方
David Huebner, 主要研究者, Professor, George Washington University
没有联系数据。
1 位于 1 个国家/地区的研究中心

District of Columbia

George Washington University, Washington D.C., District of Columbia, 20052, United States