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Pregnancy in AdolescenceRISENCT02709967

Research Initiative to Support the Empowerment of Girls

A study testing Material support, Economic and Community dialogue in people with Pregnancy in Adolescence, run by University of Bergen at 1 site in Zambia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 9 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy in Adolescence
What is being tested?
Material support, Economic and Community dialogue
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,922 participants
Where
1 siteZambia
Study dates
4 Mar 2016to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 25 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Female
  • Enrolled in grade 7

Who cannot join

  • Moved permanently away from catchment area of school

Trial locations and contacts

1 site in 1 country.

Zambia1 site
  • University of Zambia

    Lusaka

Other trials in Zambia

About this study

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

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

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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).

Read the 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.
Being tested
Material support, Economic, Community dialogue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Material supportOther

    Writing materials

  • EconomicOther

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

  • Community dialogueBehavioural

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

Study groups in NCT02709967
Study groupRoleWhat they receive
Material supportActive comparatorWriting materials
Receives: Other: Material support
Economic supportExperimentalWriting materials and economic support (monthly cash transfer to girls, annual grant to guardians, and payment of school fees in grade 8 and 9).
Receives: Other: Material support; Other: Economic
Combined interventionExperimentalWriting 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)
Receives: Other: Material support; Other: Economic; Behavioral: Community dialogue

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 44 months after recruitment

  2. Incidence of births before girls' 18th birthday

    Will be measured using final survey questionnaire

    Measured: 56 months after recruitment

  3. Proportion of girls who sit for grade 9 exam

    Will be measured using final survey questionnaire, validated against exam register

    Measured: 56 months after recruitment

Secondary outcomes (23)
  1. Incidence of marriage/ cohabitation before girls' 16th birthday

    Will be measured using final survey questionnaire

    Measured: 56 months after recruitment

  2. Incidence of marriage/ cohabitation before girls' 18th birthday

    Will be measured using final survey questionnaire

    Measured: 56 months after recruitment

  3. 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.

    Measured: 56 months after recruitment

  4. Incidence of pregnancies among girls within 2 years of the end of the interventions

    Will be measured using final survey questionnaire

    Measured: 56 months after recruitment

  5. Incidence of births among girls within 2 years of the end of the interventions

    Will be measured using final survey questionnaire

    Measured: 56 months after recruitment

  6. 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

    Measured: 56 months after recruitment

  7. 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

    Measured: 56 months after recruitment

  8. Incidence of pregnancies before girls' 18th birthday

    Will be measured using final survey questionnaire

    Measured: 56 months after recruitment

  9. 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.

    Measured: 56 months after recruitment

  10. Proportion of girls enrolled in grade 8

    will be measured using follow-up questionnaire, validated against school registers

    Measured: 12 months after recruitment

  11. 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

    Measured: 34 months after recruitment

  12. 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

    Measured: 38 months after recruitment

  13. 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.

    Measured: 56 months after recruitment

  14. Proportion currently using modern contraceptives

    Will be measured using final survey questionnaire

    Measured: 32 months after recruitment

  15. Knowledge of modern contraceptives among adolescent girls

    Will be measured using final survey questionnaire

    Measured: 32 months after recruitment

  16. Perceived community norms regarding modern contraceptive use among unmarried adolescent girls

    Will be measured using final survey questionnaire

    Measured: 32 months after recruitment

  17. Perceived community norms regarding early marriage

    Will be measured using final survey questionnaire

    Measured: 32 months after recruitment

  18. Perceived community norms regarding adolescent pregnancy

    Will be measured using final survey questionnaire

    Measured: 32 months after recruitment

  19. Perceived community norms regarding education among girls

    Will be measured using final survey questionnaire

    Measured: 32 months after recruitment

  20. Proportion of adolescent girls who have been sexually active in last 4 weeks

    Will be measured using final survey questionnaire

    Measured: 32 months after recruitment

  21. Proportion of girls currently employed or self-employed

    Will be measured using final survey questionnaire

    Measured: 56 months after recruitment

  22. 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.

    Measured: 12 and 18 months after recruitment

  23. 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.

    Measured: 24 and 30 months after recruitment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2016 (estimated)
  2. Study start4 Mar 2016
  3. Primary completionDec 2020
  4. Study completionDec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
4,922 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02709967
Sponsor's protocol ID
2015/895
Acronym
RISE
Status last verified
Dec 2021
First submitted
2 Mar 2016
Last updated
12 Jan 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided: not yet determined

Publications

  • 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.

    PubMed 38741917
  • 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.

    PubMed 29258591

Questions about this trial

What is this clinical trial studying?

A study testing Material support, Economic and Community dialogue in people with Pregnancy in Adolescence, run by University of Bergen at 1 site in Zambia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of births within 8 months of the end of the intervention (time frame: 44 months after recruitment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02709967, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.

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