Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Research Initiative to Support the Empowerment of Girls (RISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02709967
Recruitment Status : Active, not recruiting
First Posted : March 16, 2016
Last Update Posted : October 16, 2018
Sponsor:
Collaborators:
University of Zambia
Chr. Michelsen Institutt
Norwegian School of Economics
Information provided by (Responsible Party):
IFSandoey, University of Bergen

Brief Summary:

Background Adolescent pregnancies carry risks to the young mothers and the baby. 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 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 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 Approximately 5000 girls and 157 clusters, that is 1000 girls and 31 clusters in the control arm and 2000 girls and 63 clusters in each of the intervention arms. The rationale for having different numbers of clusters is that we expect larger differences between each of the intervention arms and the control arm than between the two intervention arms themselves.

Intervention One intervention arm will be offered economic support in the form of monthly cash transfers to the participating girl and her parents and payment of school fees in 2017 and 2018 if the girl attends junior secondary school. The second intervention arm will be 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 for girls and boys (both in- and out-of-school).


Condition or disease Intervention/treatment Phase
Pregnancy in Adolescence Other: Material support Other: Economic Behavioral: Community dialogue Not Applicable

Detailed Description:

Background Adolescent pregnancies carry risks to the young mothers and the baby. 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 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 Approximately 5000 girls and 157 clusters, that is 1000 girls and 31 clusters in the control arm and 2000 girls and 63 clusters in each of the intervention arms. The rationale for having different numbers of clusters is that we expect larger differences between each of the intervention arms and the control arm than between the two intervention arms themselves.

Intervention The control group (31 schools) will receive writing materials. One intervention group (63 schools) will be offered writing materials and economic support in the form of monthly cash transfers to the participating girl and her parents and payment of school fees in 2017 and 2018 if the girl attends junior secondary school. The second intervention group (63 schools) will be offered writing materials, economic support, and a community component. The community component will comprise of community meetings about the value of education for adolescent girls and the risks related to early childbearing, and a youth club for girls and boys (both in- and out-of-school).

Duration and Follow-up The duration of the trial, from recruitment to the last follow-up survey will be 4.5 years. A baseline survey will be conducted just after recruitment, and a final survey will be conducted after approximately 4.5 years. In between there will be short phone-based follow-up contacts with all the participants every six months.

Primary objectives

  1. To measure the effectiveness of a combined economic and community intervention on childbearing within 8 months of the end of the intervention period
  2. To measure the effectiveness of economic support alone and of a combined economic and community intervention on childbearing before the 18th birthday among girls.
  3. To measure the effectiveness of economic support alone and of a combined economic and community intervention on the proportion of girls who sit for the grade 9 exam.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : March 4, 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: Material support
Writing materials
Other: Material support
Writing materials

Experimental: Economic support
Writing materials and economic support (monthly cash transfer to girls, annual grant to guardians, and payment of school fees in grade 8 and 9).
Other: Material support
Writing materials

Other: Economic
Economic support (monthly cash transfer to girls, annual grant to guardians, and payment of school fees in grade 8 and 9)

Experimental: Combined intervention
Writing materials, economic support (monthly cash transfer to girls, annual grant to guardians, and payment of school fees in grade 8 and 9) and community dialogue (youth club meetings, community and parent meetings)
Other: Material support
Writing materials

Other: Economic
Economic support (monthly cash transfer to girls, annual grant to guardians, and payment of school fees in grade 8 and 9)

Behavioral: Community dialogue
Community dialogue (youth club meetings, community and parent meetings)




Primary Outcome Measures :
  1. Incidence of births within 8 months of the end of the intervention [ Time Frame: 44 months after recruitment ]
    Will be measured using follow up questionnaire, validated against measurement with final survey questionnaire

  2. Incidence of births before girls' 18th birthday [ Time Frame: 56 months after recruitment ]
    Will be measured using final survey questionnaire

  3. Proportion of girls who sit for grade 9 exam [ Time Frame: 56 months after recruitment ]
    Will be measured using final survey questionnaire, validated against exam register


Secondary Outcome Measures :
  1. proportion of girls that are married and/or cohabiting before their 16th birthday; [ Time Frame: 56 months after recruitment ]
    Will be measured using final survey questionnaire

  2. proportion of girls that are married and/or cohabiting before their 18th birthday; [ Time Frame: 56 months after recruitment ]
    Will be measured using final survey questionnaire

  3. Socioeconomic inequality in proportion of girls that are married/cohabiting before 18th birthday [ Time Frame: 56 months after recruitment ]
    Will be measured using final survey questionnaire

  4. Incidence of pregnancies among girls within 2 years of the end of the interventions [ Time Frame: 56 months after recruitment ]
    Will be measured using final survey questionnaire

  5. Incidence of births among girls within 2 years of the end of the interventions [ Time Frame: 56 months after recruitment ]
    Will be measured using final survey questionnaire

  6. Incidence of pregnancies before girls' 16th birthday [ Time Frame: 56 months after recruitment ]
    Will be measured using final survey questionnaire, validated against measurement with follow-up questionnaire at 24-48 months post-recruitment

  7. Incidence of births before girls' 16th birthday [ Time Frame: 56 months after recruitment ]
    Will be measured using final survey questionnaire, validated against measurement with follow-up questionnaire at 24-48 months post-recruitment

  8. Incidence of pregnancies before girls' 18th birthday [ Time Frame: 56 months after recruitment ]
    Will be measured using final survey questionnaire

  9. Socioeconomic inequality in proportion of girls who have given birth before 18th birthday [ Time Frame: 56 months after recruitment ]
    Will be measured using final survey questionnaire

  10. Proportion of girls enrolled in grade 8 [ Time Frame: 12 months after recruitment ]
    will be measured using follow-up questionnaire, validated against school registers

  11. Average examination scores of girls from grade 9 in English, mathematics and science [ Time Frame: 34 months after recruitment ]
    will be measured using grade 9 exam results obtained from District educational boards

  12. Proportion of girls who enrol in grade 10 [ Time Frame: 38 months after recruitment ]
    will be measured using follow-up questionnaire, validated against school registers and final survey questionnaire at 56 months post-recruitment

  13. Socioeconomic inequality in participation in grade 9 exam among girls [ Time Frame: 56 months after recruitment ]
    will be measured using final questionnaire, validated against exam register

  14. Proportion currently using modern contraceptives [ Time Frame: 32 months after recruitment ]
    Will be measured using final survey questionnaire

  15. Knowledge of modern contraceptives among adolescent girls [ Time Frame: 32 months after recruitment ]
    Will be measured using final survey questionnaire

  16. Perceived community norms regarding modern contraceptive use among unmarried adolescent girls [ Time Frame: 32 months after recruitment ]
    Will be measured using final survey questionnaire

  17. Perceived community norms regarding early marriage [ Time Frame: 32 months after recruitment ]
    Will be measured using final survey questionnaire

  18. Perceived community norms regarding adolescent pregnancy [ Time Frame: 32 months after recruitment ]
    Will be measured using final survey questionnaire

  19. Perceived community norms regarding education among girls [ Time Frame: 32 months after recruitment ]
    Will be measured using final survey questionnaire

  20. Proportion of adolescent girls who have been sexually active in last 4 weeks [ Time Frame: 32 months after recruitment ]
    Will be measured using final survey questionnaire

  21. Proportion of girls currently employed or self-employed [ Time Frame: 56 months after recruitment ]
    Will be measured using final survey questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   9 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • Enrolled in grade 7

Exclusion Criteria:

  • Moved permanently away from catchment area of school

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709967


Locations
Layout table for location information
Zambia
University of Zambia
Lusaka, Zambia
Sponsors and Collaborators
University of Bergen
University of Zambia
Chr. Michelsen Institutt
Norwegian School of Economics
Investigators
Layout table for investigator information
Principal Investigator: Ingvild F Sandøy, PhD University of Bergen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: IFSandoey, Professor, University of Bergen
ClinicalTrials.gov Identifier: NCT02709967     History of Changes
Other Study ID Numbers: 2015/895
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: not yet determined