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临床试验/NCT02709967
NCT02709967已完成不适用

Cluster Randomized Trial on the Effectiveness of a Girls' Empowerment Programme on Early Childbearing, Marriage and School Dropout Among Adolescent Girls in Rural Zambia

University of Bergen1 个研究点 分布在 1 个国家目标入组 4,922 人开始时间: 2016年3月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,922
试验地点
1
主要终点
Incidence of births within 8 months of the end of the intervention

研究概览

简要总结

Background Adolescent pregnancies carry risks to the young mothers and the babies. Keeping girls in school can potentially protect girls from getting pregnant. In Zambia, 35% of young rural girls have given birth by the age of 18 years, and the pregnancy rates are particularly high among girls who are out-of-school. Approximately 50% of girls never enroll in secondary school. Widespread myths and negative social norms are barriers to adolescent girls using modern contraceptives, thus contributing to high rates of early pregnancy. However, there is little robust research from Africa on how sexual and reproductive health programmes can be delivered in a way that actually affects early marriage and pregnancy rates.

Purpose To measure the effect on early childbearing rates and basic school completion in a rural Zambian context of (1) economic support to girls and their families, and (2) combining economic support with a community intervention to enhance knowledge about sexual and reproductive health and supportive community norms

Design Cluster randomized controlled trial with three arms with clusters being rural basic schools (With grades 1-9) with surrounding communities.

Study population The participant population were girls enrolled in grade 7 in January in 2016 in rural schools in twelve study districts: Kalomo, Choma, Pemba, Monze, Mazabuka, Chikankata, Kapiri Mposhi, Kabwe, Chisamba, Chibombo, Mkushi, and Luano.

Study size A total of 4922 girls and 157 clusters were recruited, that is 999 girls and 31 clusters in the control arm and 2004 and 63 clusters in the economic support arm and 1919 girls and 63 schools in the combined intervention arms. The rationale for having different numbers of clusters was that we expected larger differences between each of the intervention arms and the control arm than between the two intervention arms themselves.

Intervention One intervention arm was offered economic support in the form of monthly cash transfers to the participating girl and her parents and payment of junior secondary school fees in 2017 and 2018. The second intervention arm was offered the same economic support combined with a community component comprising community meetings about the value of education for adolescent girls and the risks related to early childbearing, and a youth club covering comprehensive sexuality education for girls and boys (both in- and out-of-school).

详细描述

Background Adolescent pregnancies carry risks to the young mothers and their babies. Keeping girls in school can potentially protect girls from getting pregnant. In Zambia, 35% of young rural girls have given birth by the age of 18 years, and the pregnancy rates are particularly high among girls who are out-of-school. Approximately 50% of girls never enroll in secondary school. A number of studies have found that economic support to girls and/or their families can increase school enrolment and attendance, and three trials have found effects on postponement of childbearing and marriage. Other studies indicate that widespread myths and negative social norms are barriers to adolescent girls using modern contraceptives, thus contributing to high rates of early pregnancy. However, there is little robust research from Africa on how sexual and reproductive health programmes can be delivered in a way that actually affects early marriage and pregnancy rates.

Purpose To measure the effect on early childbearing rates and basic school completion in a rural Zambian context of (1) providing economic support to girls and their families, and (2) combining economic support with a community intervention to enhance knowledge about sexual and reproductive health and supportive community norms.

Design Cluster randomized controlled trial with three arms with clusters being rural basic schools (With grades 1-9) with surrounding communities.

Study population The participant population will be girls enrolled in grade 7 in January in 2016 in rural schools in twelve study districts: Kalomo, Choma, Pemba, Monze, Mazabuka, Chikankata, Kapiri Mposhi, Kabwe, Chisamba, Chibombo, Mkushi, and Luano.

Study size A total of 4922 girls and 157 clusters were recruited, that is 999 girls and 31 clusters in the control arm and 2004 and 63 clusters in the economic support arm and 1919 girls and 63 schools in the combined intervention arms. The rationale for having different numbers of clusters was that we expected larger differences between each of the intervention arms and the control arm than between the two intervention arms themselves.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
9 Years 至 25 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Enrolled in grade 7

排除标准

  • Moved permanently away from catchment area of school

结局指标

主要结局

Incidence of births within 8 months of the end of the intervention

时间窗: 44 months after recruitment

Will be measured using follow up questionnaire, validated against measurement with final survey questionnaire

Incidence of births before girls' 18th birthday

时间窗: 56 months after recruitment

Will be measured using final survey questionnaire

Proportion of girls who sit for grade 9 exam

时间窗: 56 months after recruitment

Will be measured using final survey questionnaire, validated against exam register

次要结局

  • Socioeconomic inequality in incidence of births before girls' 18th birthday(56 months after recruitment)
  • Perceived community norms regarding modern contraceptive use among unmarried adolescent girls(32 months after recruitment)
  • Perceived community norms regarding early marriage(32 months after recruitment)
  • Incidence of marriage/ cohabitation before girls' 16th birthday(56 months after recruitment)
  • Socioeconomic inequality in incidence of marriage/ cohabitation before girls' 18th birthday(56 months after recruitment)
  • Incidence of births before girls' 16th birthday(56 months after recruitment)
  • Proportion currently using modern contraceptives(32 months after recruitment)
  • Proportion of adolescent girls who have been sexually active in last 4 weeks(32 months after recruitment)
  • School attendance of girls in grade 9(24 and 30 months after recruitment)
  • Incidence of marriage/ cohabitation before girls' 18th birthday(56 months after recruitment)
  • Incidence of births among girls within 2 years of the end of the interventions(56 months after recruitment)
  • Proportion of girls currently employed or self-employed(56 months after recruitment)
  • Incidence of pregnancies among girls within 2 years of the end of the interventions(56 months after recruitment)
  • Incidence of pregnancies before girls' 16th birthday(56 months after recruitment)
  • Incidence of pregnancies before girls' 18th birthday(56 months after recruitment)
  • Proportion of girls enrolled in grade 8(12 months after recruitment)
  • Average examination scores of girls from grade 9 in English, mathematics and science(34 months after recruitment)
  • Proportion of girls who enrol in grade 10(38 months after recruitment)
  • Knowledge of modern contraceptives among adolescent girls(32 months after recruitment)
  • Perceived community norms regarding adolescent pregnancy(32 months after recruitment)
  • Socioeconomic inequality in participation in grade 9 exam among girls(56 months after recruitment)
  • Perceived community norms regarding education among girls(32 months after recruitment)
  • School attendance of girls in grade 8(12 and 18 months after recruitment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

IFSandoey

Professor

University of Bergen

研究点 (1)

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