Research Initiative to Support the Empowerment of Girls

Pregnancy in Adolescence Clinical Trial

— RISE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02709967
• Other study ID #: 2015/895
• Status: Completed
• Phase: N/A
• Start date: March 4, 2016
• Est. completion date: December 2020

Study information

• Verified date: December 2021
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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. Intervention The control group (31 schools) received writing materials. One intervention group (63 schools) was offered writing materials and 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 group (63 schools) was offered writing materials, economic support, and a community component. The community component comprised of 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). Duration and Follow-up The duration of the trial, from recruitment to the last follow-up survey was 4.5 years. A baseline survey was conducted just after recruitment, and a final survey was conducted after approximately 4.5 years. In between there were short 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4922
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 25 Years

Eligibility

Inclusion Criteria:

• Female
• Enrolled in grade 7

Exclusion Criteria:

• Moved permanently away from catchment area of school

Related Conditions & MeSH terms

• Pregnancy in Adolescence

Intervention

Other:
• Material support
Writing materials
• 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)

Locations

Country	Name	City	State
Zambia	University of Zambia	Lusaka

Sponsors (4)

Lead Sponsor	Collaborator
University of Bergen	Chr. Michelsen Institutt, Norwegian School of Economics, University of Zambia

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of births within 8 months of the end of the intervention	Will be measured using follow up questionnaire, validated against measurement with final survey questionnaire	44 months after recruitment
Primary	Incidence of births before girls' 18th birthday	Will be measured using final survey questionnaire	56 months after recruitment
Primary	Proportion of girls who sit for grade 9 exam	Will be measured using final survey questionnaire, validated against exam register	56 months after recruitment
Secondary	Incidence of marriage/ cohabitation before girls' 16th birthday	Will be measured using final survey questionnaire	56 months after recruitment
Secondary	Incidence of marriage/ cohabitation before girls' 18th birthday	Will be measured using final survey questionnaire	56 months after recruitment
Secondary	Socioeconomic inequality in incidence of marriage/ cohabitation before girls' 18th birthday	Marriage/cohabitation will be measured using final survey questionnaire. We will use two measures of socioeconomic status: (i) guardian's highest level of education and (ii) household per capita consumption. Both socioeconomic measures will be categorized into tertiles of similar size.	56 months after recruitment
Secondary	Incidence of pregnancies among girls within 2 years of the end of the interventions	Will be measured using final survey questionnaire	56 months after recruitment
Secondary	Incidence of births among girls within 2 years of the end of the interventions	Will be measured using final survey questionnaire	56 months after recruitment
Secondary	Incidence of pregnancies before girls' 16th birthday	Will be measured using final survey questionnaire, validated against measurement with follow-up questionnaire at 24-48 months post-recruitment	56 months after recruitment
Secondary	Incidence of births before girls' 16th birthday	Will be measured using final survey questionnaire, validated against measurement with follow-up questionnaire at 24-48 months post-recruitment	56 months after recruitment
Secondary	Incidence of pregnancies before girls' 18th birthday	Will be measured using final survey questionnaire	56 months after recruitment
Secondary	Socioeconomic inequality in incidence of births before girls' 18th birthday	Births will be measured using final survey questionnaire. We will use two measures of socioeconomic status: (i) guardian's highest level of education and (ii) household per capita consumption. Both socioeconomic measures will be categorized into tertiles of similar size.	56 months after recruitment
Secondary	Proportion of girls enrolled in grade 8	will be measured using follow-up questionnaire, validated against school registers	12 months after recruitment
Secondary	Average examination scores of girls from grade 9 in English, mathematics and science	will be measured using grade 9 exam results obtained from District educational boards	34 months after recruitment
Secondary	Proportion of girls who enrol in grade 10	will be measured using follow-up questionnaire, validated against school registers and final survey questionnaire at 56 months post-recruitment	38 months after recruitment
Secondary	Socioeconomic inequality in participation in grade 9 exam among girls	Participation in grade 9 will be measured using final questionnaire, validated against exam register. We will use two measures of socioeconomic status: (i) guardian's highest level of education and (ii) household per capita consumption. Both socioeconomic measures will be categorized into tertiles of similar size.	56 months after recruitment
Secondary	Proportion currently using modern contraceptives	Will be measured using final survey questionnaire	32 months after recruitment
Secondary	Knowledge of modern contraceptives among adolescent girls	Will be measured using final survey questionnaire	32 months after recruitment
Secondary	Perceived community norms regarding modern contraceptive use among unmarried adolescent girls	Will be measured using final survey questionnaire	32 months after recruitment
Secondary	Perceived community norms regarding early marriage	Will be measured using final survey questionnaire	32 months after recruitment
Secondary	Perceived community norms regarding adolescent pregnancy	Will be measured using final survey questionnaire	32 months after recruitment
Secondary	Perceived community norms regarding education among girls	Will be measured using final survey questionnaire	32 months after recruitment
Secondary	Proportion of adolescent girls who have been sexually active in last 4 weeks	Will be measured using final survey questionnaire	32 months after recruitment
Secondary	Proportion of girls currently employed or self-employed	Will be measured using final survey questionnaire	56 months after recruitment
Secondary	School attendance of girls in grade 8	will be measured using follow-up questionnaire, validated against school registers. Attending 4 or more days per week on average will be categorized as high attendance, and less than 4 days on average will be categorized as low attendance.	12 and 18 months after recruitment
Secondary	School attendance of girls in grade 9	will be measured using follow-up questionnaire, validated against school registers. Attending 4 or more days per week on average will be categorized as high attendance, and less than 4 days on average will be categorized as low attendance.	24 and 30 months after recruitment