- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02882607
Peer Groups for Healthy Pregnancy & HIV Prevention for Young Malawian Women
연구 개요
상세 설명
Maintaining optimal reproductive health in the context of high HIV prevalence is a serious dilemma facing young women in Malawi and other high HIV prevalence countries. Optimal reproductive health requires practicing preconception behaviors to promote overall health including avoiding HIV infection. These healthy preconception behaviors include: practicing safer sex (abstaining or using condoms) to prevent sexually transmitted infections (STIs), including HIV infection; obtaining treatment for STIs; maintaining good health habits such as diet, exercise and avoiding substance use; using an effective family planning method to prevent unintended pregnancy; and having an HIV test periodically and with the partner when conception is intended. However the Malawi Demographic and Health Survey provides evidence that few women ages 15-20 in Malawi currently practice these healthy preconception behaviors. Currently, no programs in Malawi offer an integrated approach to optimal reproductive health.
To fill this gap, this study developed an innovative, culturally relevant, community-based peer group intervention to increase young rural Malawian women's preconception behaviors to optimize their reproductive health. The intervention is called Mzanga Samala Moyo Wako ([Mzanga] Sharing Responsibility for Pregnancy Planning and HIV Prevention). Mzanga builds on the investigators' previous research in Malawi, which tested a culturally relevant HIV prevention peer group intervention that changed HIV prevention-related knowledge, attitudes, and safer sex behaviors for rural adults and adolescents. This study integrated that prior HIV prevention content with new content on maintaining health, family planning, and preconception HIV testing.
The purpose of this study is to test Mzanga's efficacy using a longitudinal, two group (two arm) design: intervention group and delayed control group. Because Mzanga is expected to diffuse widely, we randomize at the community rather than the individual level. Eighteen geographically separate rural communities stratified by size and distance from the main paved road and then randomly assigned to Mzanga or the delayed control condition. We implement Mzanga in 9 waves. A final sample of 345 per group after attrition provides adequate power (80%) to detect small-to-medium effects. After baseline data collection, the Mzanga group receives the eight-session intervention. Outcomes are measured at 9 months post-baseline (6 months post-intervention), followed by a booster session for the Mzanga group, and final evaluation at 15 months post-baseline. After the 15-month data collection, Mzanga is offered to the delayed control group.
The study aims and hypotheses are:
Aim 1. To test the efficacy of the Mzanga intervention for improving reproductive health outcome mediating and behavioral variables for Malawian rural young women at 9 and 15 months post-baseline.
H1.Controlling for baseline differences and group effects, compared to the delayed control group, the intervention group will show more positive mediating and behavioral outcomes:
- Practice safer sex,
- Obtain prompt treatment for STI symptoms;
- Maintain good health habits (diet, exercise, substance use);
- Use an effective family planning method except when pregnancy is intended;
- Have an HIV test periodically, with partner when conception is intended; and
- More positive scores for the mediating variables of knowledge, attitudes, perceived norms, self-efficacy, and intentions for each of these behaviors.
Aim 2. To test a theoretical model of the mechanisms through which the Mzanga intervention changes preconception health behaviors of young women in rural Malawi.
H2. Mzanga's effects on healthy preconception behaviors (a-e above) will be mediated by knowledge, attitudes, perceived norms, self-efficacy, and intention scores.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- lives in designated community
Exclusion Criteria:
- cognitive or other condition that makes the participant unable to converse in a group or answer questions
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 |
---|---|
간섭 없음: 대조군
간섭 없음
|
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실험적: Intervention group
Reproductive Health Peer Groups
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8 small group sessions led by community young women, focused on reproductive health, including HIV, STI and unintended pregnancy prevention; includes skill-building for self-efficacy
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
change in unprotected sex
기간: Change from baseline to 15 months post-baseline
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Change in having sex without a condom (n the last 2 months) from baseline to 15-months post-baseline, measured by 2 questions, have you had sex in the last 2 months, and (for those who had sex) have you used a condom 'always, sometimes or never'; if had sex and have not used a condom always are coded 'yes', had unprotected sex; all other responses are coded no.
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Change from baseline to 15 months post-baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in having had an HIV test
기간: Change in having had an HIV test from baseline to 15 months post-baseline
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change in whether had a recent HIV test (within the last 12 months) from baseline to 15-months post-baseline
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Change in having had an HIV test from baseline to 15 months post-baseline
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change in having sexually transmitted infection (STI) symptoms
기간: baseline to 15 months post-baseline
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change in reported STI symptoms between baseline and 9-month and 15-month survey
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baseline to 15 months post-baseline
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Change in unintended pregnancy
기간: Change in unintended pregnancy from baseline to 15 months post-intervention
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Change in reported unintended pregnancy between baseline and 15-months post-baseline; measured by whether pregnant, confirmed visually and by pregnancy test, and whether reported in intending to become pregnant
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Change in unintended pregnancy from baseline to 15 months post-intervention
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kathleen F. Norr, PhD, University of Illinois at Chicago
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
임신에 대한 임상 시험
-
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