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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02709967
Date of registration:	02/03/2016
Prospective Registration:	Yes
Primary sponsor:	University of Bergen
Public title:	Research Initiative to Support the Empowerment of Girls RISE
Scientific title:	Cluster Randomized Trial on the Effectiveness of a Girls' Empowerment Programme on Early Childbearing, Marriage and School Dropout Among Adolescent Girls in Rural Zambia
Date of first enrolment:	March 4, 2016
Target sample size:	5000
Recruitment status:	Active, not recruiting
URL:	https://clinicaltrials.gov/show/NCT02709967
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Zambia

Contacts

Name:	Ingvild F Sandøy, PhD
Address:
Telephone:
Email:
Affiliation:	University of Bergen

Key inclusion & exclusion criteria

Inclusion Criteria:

- Female

- Enrolled in grade 7

Exclusion Criteria:

- Moved permanently away from catchment area of school

Age minimum: 9 Years
Age maximum: 25 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Pregnancy in Adolescence

Intervention(s)

Behavioral: Community dialogue

Other: Material support

Other: Economic

Primary Outcome(s)

Proportion of girls who sit for grade 9 exam [Time Frame: 56 months after recruitment]

Incidence of births before girls' 18th birthday [Time Frame: 56 months after recruitment]

Incidence of births within 8 months of the end of the intervention [Time Frame: 44 months after recruitment]

Secondary Outcome(s)

Incidence of births before girls' 16th birthday [Time Frame: 56 months after recruitment]

Incidence of marriage/ cohabitation before girls' 16th birthday [Time Frame: 56 months after recruitment]

Incidence of pregnancies among girls within 2 years of the end of the interventions [Time Frame: 56 months after recruitment]

Incidence of pregnancies before girls' 16th birthday [Time Frame: 56 months after recruitment]

Perceived community norms regarding modern contraceptive use among unmarried adolescent girls [Time Frame: 32 months after recruitment]

Proportion of girls who enrol in grade 10 [Time Frame: 38 months after recruitment]

Socioeconomic inequality in incidence of births before girls' 18th birthday [Time Frame: 56 months after recruitment]

Perceived community norms regarding education among girls [Time Frame: 32 months after recruitment]

Proportion of girls currently employed or self-employed [Time Frame: 56 months after recruitment]

School attendance of girls in grade 9 [Time Frame: 24 and 30 months after recruitment]

Socioeconomic inequality in participation in grade 9 exam among girls [Time Frame: 56 months after recruitment]

Proportion currently using modern contraceptives [Time Frame: 32 months after recruitment]

Knowledge of modern contraceptives among adolescent girls [Time Frame: 32 months after recruitment]

Proportion of girls enrolled in grade 8 [Time Frame: 12 months after recruitment]

School attendance of girls in grade 8 [Time Frame: 12 and 18 months after recruitment]

Socioeconomic inequality in incidence of marriage/ cohabitation before girls' 18th birthday [Time Frame: 56 months after recruitment]

Perceived community norms regarding early marriage [Time Frame: 32 months after recruitment]

Proportion of adolescent girls who have been sexually active in last 4 weeks [Time Frame: 32 months after recruitment]

Average examination scores of girls from grade 9 in English, mathematics and science [Time Frame: 34 months after recruitment]

Incidence of births among girls within 2 years of the end of the interventions [Time Frame: 56 months after recruitment]

Incidence of marriage/ cohabitation before girls' 18th birthday [Time Frame: 56 months after recruitment]

Incidence of pregnancies before girls' 18th birthday [Time Frame: 56 months after recruitment]

Perceived community norms regarding adolescent pregnancy [Time Frame: 32 months after recruitment]

Secondary ID(s)

2015/895

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Zambia

Norwegian School of Economics

Chr. Michelsen Institutt

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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