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임상시험 NCT05852600은(는) 인체 면역 결핍 바이러스 (HIV), 성 건강에 대해 진행중, 모집종료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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카드 뷰

Parent-focused Intervention to Reduce HIV Risk in Gay and Bisexual Adolescents 393 무작위 배정 청소년 예방

진행중, 모집종료
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임상시험 NCT05852600은(는) 인체 면역 결핍 바이러스 (HIV), 성 건강에 대해 알아보는 중재연구입니다. 현재 상태는 진행중, 모집종료이며, 연구는 2023년 4월 24일에 시작되어 393명의 참여자를 모집하고 있습니다. 조지 워싱턴 대학교이(가) 진행하며, 2026년 11월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 2월 17일에 갱신되었습니다.
간단한 개요
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...더 보기
공식 제목

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

질환명
인체 면역 결핍 바이러스 (HIV)성 건강
기타 연구 식별자
  • MH129169
NCT 번호
실제 연구 시작일
2023-04-24
최신 업데이트 게시
2026-02-17
예상 연구 완료일
2026-11-01
계획된 등록 인원
393
연구종류
중재연구
단계/상
해당 없음
상태
진행중, 모집종료
키워드
randomized controlled trial
parenting
sexual minority youth
주요 목적
예방
설계 할당
무작위배정
중재 모델
교차 설계
맹검 (마스킹)
단일맹검
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적Intervention
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...더 보기
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 ...더 보기
활성 대조군Waitlist 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...더 보기
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...더 보기
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 ...더 보기
주요결과변수
결과변수측정값 설명시간 범위
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.
이차결과변수
결과변수측정값 설명시간 범위
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.
참여 도우미
적격성 기준

연령대
어린이, 성인, 노인
최소 연령
14 Years
참여 가능한 성별
전체
건강한 참가자 허용

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 logo조지 워싱턴 대학교
연구 책임자
David Huebner, 책임연구자, Professor, George Washington University
연락처 정보가 없습니다.
1 1개국에 임상시험 장소

District of Columbia

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