NCT02709967

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,922

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

March 4, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 12, 2022

Status Verified

December 1, 2021

Enrollment Period

4.7 years

First QC Date

March 2, 2016

Last Update Submit

December 22, 2021

Conditions

Pregnancy in Adolescence

Outcome Measures

Primary Outcomes (3)

  • 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

  • Incidence of births before girls' 18th birthday

    Will be measured using final survey questionnaire

    56 months after recruitment

  • 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 Outcomes (23)

  • Incidence of marriage/ cohabitation before girls' 16th birthday

    56 months after recruitment

  • Incidence of marriage/ cohabitation before girls' 18th birthday

    56 months after recruitment

  • Socioeconomic inequality in incidence of marriage/ cohabitation before girls' 18th birthday

    56 months after recruitment

  • Incidence of pregnancies among girls within 2 years of the end of the interventions

    56 months after recruitment

  • Incidence of births among girls within 2 years of the end of the interventions

    56 months after recruitment

  • +18 more secondary outcomes

Study Arms (3)

Material support

ACTIVE COMPARATOR

Writing materials

Other: Material support

Economic support

EXPERIMENTAL

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 supportOther: Economic

Combined intervention

EXPERIMENTAL

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 supportOther: EconomicBehavioral: Community dialogue

Interventions

Material supportOTHER

Writing materials

Combined interventionEconomic supportMaterial support
EconomicOTHER

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

Combined interventionEconomic support
Community dialogueBEHAVIORAL

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

Combined intervention

Eligibility Criteria

Age9 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female
  • Enrolled in grade 7

You may not qualify if:

  • Moved permanently away from catchment area of school

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zambia

Lusaka, Zambia

Location

Related Publications (2)

  • Mori AT, Mudenda M, Robberstad B, Johansson KA, Kampata L, Musonda P, Sandoy I. Impact of cash transfer programs on healthcare utilization and catastrophic health expenditures in rural Zambia: a cluster randomized controlled trial. Front Health Serv. 2024 Apr 29;4:1254195. doi: 10.3389/frhs.2024.1254195. eCollection 2024.

    PMID: 38741917DERIVED

  • 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.

    PMID: 29258591DERIVED

MeSH Terms

Interventions

Economics

Intervention Hierarchy (Ancestors)

Health Care Economics and Organizations

Study Officials

  • Ingvild F Sandøy, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 16, 2016

Study Start

March 4, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 12, 2022

Record last verified: 2021-12

Locations

ZA(1)