- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01501864
School Support as Structural HIV Prevention for Adolescent Orphans in Kenya
연구 개요
상세 설명
This study examines the impact of school support as a structural intervention, tested among adolescent orphans in Siaya District, Nyanza Province, Kenya.
Aims for the proposed study are: 1) To experimentally test whether providing comprehensive school support to Kenyan orphaned boys and girls will reduce school dropout, reduce sexual risk behaviors, and prevent HIV/HSV-2 infection; 2) To conduct a process evaluation of the implementation of the program; and 3) To conduct comparative cost effectiveness analyses, specifying the intervention's cost and return on investment as evidenced by cost per unit improvement in the primary outcomes of school enrollment, delay of sexual debut and prevention of risk behaviors and HIV/HSV-2 infection, as well as by gains in health-related quality of life.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Orphan (one or both parents deceased)
- In Grade 7 or 8 in a primary school participating in the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: School Support Group
School Support Intervention
|
Comprehensive school support is provided that includes payment of school fees, school uniform, and a nurse researcher who monitors attendance and addresses problems that may lead to school absence and dropout.
|
|
간섭 없음: Control
No school support
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Dropped out of school
기간: From date of randomization until drop out from school, up to 3 years
|
From date of randomization until drop out from school, up to 3 years
|
|
Change from baseline in ever had sexual intercourse at 1 year
기간: Baseline and 1 year
|
Baseline and 1 year
|
|
Change from baseline in ever had sexual intercourse at 2 years
기간: Baseline and 2 years
|
Baseline and 2 years
|
|
Change from baseline in ever had sexual intercourse at 3 years
기간: Baseline and 3 years
|
Baseline and 3 years
|
|
HIV Incidence
기간: 3 years
|
3 years
|
|
HSV-2 Incidence
기간: 3 years
|
3 years
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Ever married or ever pregnant
기간: From date of randomization until marriage or preganancy, up to 3 years
|
From date of randomization until marriage or preganancy, up to 3 years
|
|
Health-related quality of life
기간: Baseline and 1 year
|
Baseline and 1 year
|
|
Health-related quality of life
기간: Baseline and 2 years
|
Baseline and 2 years
|
|
Health-related quality of life
기간: Baseline and 3 years
|
Baseline and 3 years
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Hyunsan Cho, Ph.D., Pacific Institute for Research and Evaluation
간행물 및 유용한 링크
일반 간행물
- Cho H, Mbai I, Luseno WK, Hobbs M, Halpern C, Hallfors DD. School Support as Structural HIV Prevention for Adolescent Orphans in Western Kenya. J Adolesc Health. 2018 Jan;62(1):44-51. doi: 10.1016/j.jadohealth.2017.07.015. Epub 2017 Nov 6.
- Hallfors DD, Cho H, Mbai II, Millimo BW, Atieno C, Okumu D, Luseno WK, Hartman S, Halpern CT, Hobbs MM. Disclosure of HSV-2 serological test results in the context of an adolescent HIV prevention trial in Kenya. Sex Transm Infect. 2015 Sep;91(6):395-400. doi: 10.1136/sextrans-2015-052025. Epub 2015 Jul 2.
- Cho H, Luseno W, Halpern C, Zhang L, Mbai I, Milimo B, Hallfors DD. Discordance of HIV and HSV-2 biomarkers and self-reported sexual behaviour among orphan adolescents in Western Kenya. Sex Transm Infect. 2015 Jun;91(4):260-5. doi: 10.1136/sextrans-2014-051720. Epub 2014 Nov 6.
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 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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