Clinical trial NCT02709967: Research Initiative to Support the Empowerment of Girls
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy in Adolescence
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: University of Zambia
name: Chr. Michelsen Institutt
name: Norwegian School of Economics
First posted: 2016-03-16
Enrollment: 4922
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Female
* Enrolled in grade 7

Exclusion Criteria:

* Moved permanently away from catchment area of school

Primary outcomes:
measure: Incidence of births within 8 months of the end of the intervention
timeFrame: 44 months after recruitment
measure: Incidence of births before girls' 18th birthday
timeFrame: 56 months after recruitment
measure: Proportion of girls who sit for grade 9 exam
timeFrame: 56 months after recruitment
Secondary outcomes:
measure: Incidence of marriage/ cohabitation before girls' 16th birthday
timeFrame: 56 months after recruitment
measure: Incidence of marriage/ cohabitation before girls' 18th birthday
timeFrame: 56 months after recruitment
measure: Socioeconomic inequality in incidence of marriage/ cohabitation before girls' 18th birthday
timeFrame: 56 months after recruitment
measure: Incidence of pregnancies among girls within 2 years of the end of the interventions
timeFrame: 56 months after recruitment
measure: Incidence of births among girls within 2 years of the end of the interventions
timeFrame: 56 months after recruitment
measure: Incidence of pregnancies before girls' 16th birthday
timeFrame: 56 months after recruitment
measure: Incidence of births before girls' 16th birthday
timeFrame: 56 months after recruitment
measure: Incidence of pregnancies before girls' 18th birthday
timeFrame: 56 months after recruitment
measure: Socioeconomic inequality in incidence of births before girls' 18th birthday
timeFrame: 56 months after recruitment
measure: Proportion of girls enrolled in grade 8
timeFrame: 12 months after recruitment
measure: Average examination scores of girls from grade 9 in English, mathematics and science
timeFrame: 34 months after recruitment
measure: Proportion of girls who enrol in grade 10
timeFrame: 38 months after recruitment
measure: Socioeconomic inequality in participation in grade 9 exam among girls
timeFrame: 56 months after recruitment
measure: Proportion currently using modern contraceptives
timeFrame: 32 months after recruitment
measure: Knowledge of modern contraceptives among adolescent girls
timeFrame: 32 months after recruitment
measure: Perceived community norms regarding modern contraceptive use among unmarried adolescent girls
timeFrame: 32 months after recruitment
measure: Perceived community norms regarding early marriage
timeFrame: 32 months after recruitment
measure: Perceived community norms regarding adolescent pregnancy
timeFrame: 32 months after recruitment
measure: Perceived community norms regarding education among girls
timeFrame: 32 months after recruitment
measure: Proportion of adolescent girls who have been sexually active in last 4 weeks
timeFrame: 32 months after recruitment
measure: Proportion of girls currently employed or self-employed
timeFrame: 56 months after recruitment
measure: School attendance of girls in grade 8
timeFrame: 12 and 18 months after recruitment
measure: School attendance of girls in grade 9
timeFrame: 24 and 30 months after recruitment
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: University of Zambia
Study officials:
affiliation: University of Bergen
name: Ingvild F Sandøy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mori AT, Kampata L, Musonda P, Johansson KA, Robberstad B, Sandoy I. Cost-benefit and extended cost-effectiveness analysis of a comprehensive adolescent pregnancy prevention program in Zambia: study protocol for a cluster randomized controlled trial. Trials. 2017 Dec 19;18(1):604. doi: 10.1186/s13063-017-2350-4.