- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04378439
격차를 줄이기 위한 애팔래치아 파트너십(목표 2)
피어 내비게이션 및 mHealth의 힘을 활용하여 애팔래치아의 건강 격차 감소
By combining two strategies (i.e., peer navigation and mHealth) into a complete, culturally compatible, bilingual intervention to increase the use of needed HIV, STI, and HCV prevention and care services among racially/ethnically diverse GBMSM and transgender women in rural Appalachia.
Study Investigators anticipate that participants in the intervention group, relative to counterparts in the delayed-intervention group, will demonstrate increased HIV, STI, and HCV testing.
연구 개요
상세 설명
This CBPR study will advance prevention science and practice through testing an innovative intervention to promote and support the use of needed HIV, STI, and HCV prevention and care services among GBMSM and transgender women; and developing priorities and recommendations to improve their health that will be disseminated to inform public health practice, research, and policy. By integrating peer navigation and mHealth strategies, the proposed study provides a unique opportunity to improve health among vulnerable, hidden, and neglected populations living in rural Appalachia. Findings from this research may inform strategies and approaches to address other health disparities in other rural populations.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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North Carolina
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Winston-Salem, North Carolina, 미국, 27157
- Wake Forest University Health Sciences
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- reside in one of the rural Appalachian catchment counties
- be ≥18 years of age
- report being assigned male sex at birth and having had sex with at least 1 man in past 12 months
- provide informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: intervention group
7 community health leaders; 56 social network members |
First, as health advisors, community health leaders will raise awareness of HIV, STIs, and HCV and local prevention and care services and help social network members access services. Thus, the community health leader will describe to the process for HCV testing, and how providers are required to maintain confidentiality. As opinion leaders, community health leaders will reframe health-compromising and bolster health-promoting norms and expectations about testing and use of other prevention and care services. Each community health leader will also conduct formal in-person group activities with their social network members. Our partnership decided that each community health leader will also hold at least 4 formal group sessions during the 12 months of intervention In addition to in-person individual and group activities, community health leaders will use mHealth platforms preferred by each social network member (i.e., Facebook , Instagram, testing, and/or GPS-based mobile apps) to communicate with them during the intervention. They will use social media to plan activities and to support use of needed prevention and care services. For example, when planning a group activity (described above), the community health leader will use social media to remind social network members about the activity and help them problem solve barriers to attending. A community health leader and social network member may also communicate "in-real-time" via social media about the process of participating in a syringe services program or accessing PrEP. |
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활성 비교기: delayed-intervention
7 community health leaders; 56 social network members |
First, as health advisors, community health leaders will raise awareness of HIV, STIs, and HCV and local prevention and care services and help social network members access services. Thus, the community health leader will describe to the process for HCV testing, and how providers are required to maintain confidentiality. As opinion leaders, community health leaders will reframe health-compromising and bolster health-promoting norms and expectations about testing and use of other prevention and care services. Each community health leader will also conduct formal in-person group activities with their social network members. Our partnership decided that each community health leader will also hold at least 4 formal group sessions during the 12 months of intervention In addition to in-person individual and group activities, community health leaders will use mHealth platforms preferred by each social network member (i.e., Facebook , Instagram, testing, and/or GPS-based mobile apps) to communicate with them during the intervention. They will use social media to plan activities and to support use of needed prevention and care services. For example, when planning a group activity (described above), the community health leader will use social media to remind social network members about the activity and help them problem solve barriers to attending. A community health leader and social network member may also communicate "in-real-time" via social media about the process of participating in a syringe services program or accessing PrEP. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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인간 면역결핍 바이러스(HIV) 검사를 받은 참가자 수
기간: 기준선
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기준선
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성병(STI) 검사를 받은 참가자 수
기간: 기준선
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기준선
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C형 간염 바이러스(HCV) 검사를 받은 참가자 수
기간: 기준선
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기준선
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HIV 검사를 받은 참가자 수
기간: 개입 직후(기준선 이후 12개월)
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개입 직후(기준선 이후 12개월)
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STI 검사를 받은 참가자 수
기간: 개입 직후(기준선 이후 12개월)
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개입 직후(기준선 이후 12개월)
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HCV 검사를 받은 참가자 수
기간: 개입 직후(기준선 이후 12개월)
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개입 직후(기준선 이후 12개월)
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HIV 검사를 받은 참가자 수
기간: 12개월 후속 조치(기준선 이후 24개월)
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12개월 후속 조치(기준선 이후 24개월)
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STI 검사를 받은 참가자 수
기간: 12개월 후속 조치(기준선 이후 24개월)
|
12개월 후속 조치(기준선 이후 24개월)
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HCV 검사를 받은 참가자 수
기간: 12개월 후속 조치(기준선 이후 24개월)
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12개월 후속 조치(기준선 이후 24개월)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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예방을 사용하는 참가자 수--Pre-exposure prophylaxis (PrEP)
기간: 기준선, 개입 직후(기준선 후 12개월) 및 12개월 후속 조치(기준선 후 24개월).
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기준선, 개입 직후(기준선 후 12개월) 및 12개월 후속 조치(기준선 후 24개월).
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예방-주사기 서비스를 사용하는 참가자 수
기간: 기준선, 개입 직후(기준선 후 12개월) 및 12개월 후속 조치(기준선 후 24개월).
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기준선, 개입 직후(기준선 후 12개월) 및 12개월 후속 조치(기준선 후 24개월).
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Number of participants who use HIV care services
기간: baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
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Measured through self-report and medical chart abstraction |
baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
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Number of participants who use STI treatment services
기간: baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
|
Measured through self-report and medical chart abstraction |
baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
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Number of participants who use HCV treatment services
기간: baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
|
Measured through self-report and medical chart abstraction |
baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
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Number of participants who use gender-affirming care services
기간: baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
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Measured through self-report and medical chart abstraction |
baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Scott D. Rhodes, Ph.D, MPH, Wake Forest University Health Sciences
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB00065116
- R01NR019512 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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