- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03307226
Suubi4Her: A Combination Intervention Addressing HIV Risk Behaviors Among Older Adolescent Girls Transitioning Into Adulthood in Uganda
연구 개요
상태
정황
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Masaka, 우간다, 256
- International Center for Child Health and Development
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Masaka, 우간다
- International Center for Child Health and Development
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
(1) female; (2) enrolled in first year of secondary school in Rakai, Masaka, Lwengo or Kalungu districts; (3) age 14-17 years; (4) living within a family (broadly defined and not an institution or orphanage, as those in institutions have different familial needs)
Exclusion Criteria:
(5) they have a cognitive or severe psychiatric impairment that would prevent comprehension of study procedures as assessed during the Informed Consent process or; (6) they are unwilling or unable to commit to completing the study.
We will not exclude girls because of their HIV, STI and/or pregnancy status. Analysis will be adjusted to account for these baseline factors. Girls testing positive for HIV, STI or pregnancy will be referred for care and support.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Youth Development Accounts (YDA)
Youth Development Accounts (YDA)
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Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs) Behavioral: Youth Development Accounts (YDA)
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실험적: YDA + Multiple Family Groups (MFG)
YDA + Multiple Family Groups (MFG)
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Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development 12 Financial Management workshops on asset-building, saving and investing in Income Generating Activities (IGAs) 18 Multiple Family Groups sessions focused on strengthening family relationships and mental health
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간섭 없음: Usual Care
Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in proportion of STIs from baseline to follow-up assessments
기간: Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
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Change in proportion of girls biologically confirmed STIs (Gonorrhea, Tirchomonas, and Chlamydia) at each assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
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Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in proportion of new HIV infections
기간: Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
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Change in the proportion of new HIV infections at each assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
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Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
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Change in adherence to HIV treatment from baseline to follow-up assessments
기간: Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
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For HIV+ participants, adherence to HIV treatment regimen outcomes as measured through viral load and CD4 counts
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Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
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Cost-Effectiveness Analyses
기간: Every year for five years
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Cost-effectiveness analyses measuring the cost of achieving an agreed upon benefit, such as an additional year of schooling, employment, or a reduction in a disease.
Costs will be measured on a per person basis.
The costs of the intervention will include all program costs.
Research costs will not be included.
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Every year for five years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Fred Ssewamala, PhD, Washington University School of Medicine
간행물 및 유용한 링크
일반 간행물
- Byansi W, Ssewamala FM, Neilands TB, Sensoy Bahar O, Nabunya P, Namuwonge F, McKay MM. The Short-Term Impact of a Combination Intervention on Depressive Symptoms Among School-Going Adolescent Girls in Southwestern Uganda: The Suubi4Her Cluster Randomized Trial. J Adolesc Health. 2022 Sep;71(3):301-307. doi: 10.1016/j.jadohealth.2022.04.008. Epub 2022 Jun 1.
- Nabunya P, Damulira C, Byansi W, Muwanga J, Bahar OS, Namuwonge F, Ighofose E, Brathwaite R, Tumwesige W, Ssewamala FM. Prevalence and correlates of depressive symptoms among high school adolescent girls in southern Uganda. BMC Public Health. 2020 Nov 25;20(1):1792. doi: 10.1186/s12889-020-09937-2.
- Ssewamala FM, Bermudez LG, Neilands TB, Mellins CA, McKay MM, Garfinkel I, Sensoy Bahar O, Nakigozi G, Mukasa M, Stark L, Damulira C, Nattabi J, Kivumbi A. Suubi4Her: a study protocol to examine the impact and cost associated with a combination intervention to prevent HIV risk behavior and improve mental health functioning among adolescent girls in Uganda. BMC Public Health. 2018 Jun 5;18(1):693. doi: 10.1186/s12889-018-5604-5.
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
- 201703102
- 1R01MH113486-01 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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