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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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
Read more
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
- To measure the effectiveness of a combined economic and community intervention on childbearing within 8 months of the end of the intervention period
- To measure the effectiveness of economic support alone and of a combined economic and community intervention on childbearing before the 18th birthday among girls.
- 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.
- Conditions
- Pregnancy in Adolescence
- 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 group | Role | What they receive |
|---|---|---|
| Material support | Active comparator | Writing materials Receives: 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). Receives: Other: Material support; Other: 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) 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.
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
Incidence of births before girls' 18th birthday
Will be measured using final survey questionnaire
Measured: 56 months after recruitment
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)
Incidence of marriage/ cohabitation before girls' 16th birthday
Will be measured using final survey questionnaire
Measured: 56 months after recruitment
Incidence of marriage/ cohabitation before girls' 18th birthday
Will be measured using final survey questionnaire
Measured: 56 months after recruitment
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
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
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
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
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
Incidence of pregnancies before girls' 18th birthday
Will be measured using final survey questionnaire
Measured: 56 months after recruitment
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
Proportion of girls enrolled in grade 8
will be measured using follow-up questionnaire, validated against school registers
Measured: 12 months after recruitment
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
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
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
Proportion currently using modern contraceptives
Will be measured using final survey questionnaire
Measured: 32 months after recruitment
Knowledge of modern contraceptives among adolescent girls
Will be measured using final survey questionnaire
Measured: 32 months after recruitment
Perceived community norms regarding modern contraceptive use among unmarried adolescent girls
Will be measured using final survey questionnaire
Measured: 32 months after recruitment
Perceived community norms regarding early marriage
Will be measured using final survey questionnaire
Measured: 32 months after recruitment
Perceived community norms regarding adolescent pregnancy
Will be measured using final survey questionnaire
Measured: 32 months after recruitment
Perceived community norms regarding education among girls
Will be measured using final survey questionnaire
Measured: 32 months after recruitment
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
Proportion of girls currently employed or self-employed
Will be measured using final survey questionnaire
Measured: 56 months after recruitment
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
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.
- First posted16 Mar 2016 (estimated)
- Study start4 Mar 2016
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy in AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zambia, Chr. Michelsen Institutt, Norwegian School of Economics
- Responsible party
- Principal investigator, IFSandoey, University of Bergen
- Investigators
- Ingvild F Sandøy, PhD, Principal investigator, University of Bergen
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 38741917Mori 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02709967
- Acronym / sponsor ID
- RISE / 2015/895
- Conditions
- Pregnancy in Adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,922 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- University of Zambia, Chr. Michelsen Institutt, Norwegian School of Economics
- Study start
- 4 Mar 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 16 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To measure the effectiveness of a combined economic and community intervention on childbearing within 8 months of the end of the intervention period
- To measure the effectiveness of economic support alone and of a combined economic and community intervention on childbearing before the 18th birthday among girls.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Material support | Active comparator | Other: Material supportWriting materials |
| Economic support | Experimental | Other: Material support, Other: EconomicWriting materials and economic support (monthly cash transfer to girls, annual grant to guardians, and payment of school fees in grade 8 and 9). |
| Combined intervention | Experimental | Other: Material support, Other: Economic, Behavioral: Community dialogueWriting 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) |
Who may qualify
- Ages
- 9 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Female
- Enrolled in grade 7
Key exclusion criteria (1 listed)
- Moved permanently away from catchment area of school
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Material supportWriting materials | Other | Combined intervention, Economic support, Material support |
| EconomicEconomic support (monthly cash transfer to girls, annual grant to guardians, and payment of school fees in grade 8 and 9) | Other | Combined intervention, Economic support |
| Community dialogueCommunity dialogue (youth club meetings, community and parent meetings) | Behavioural | Combined intervention |
Primary outcome
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
Incidence of births before girls' 18th birthday
Time frame: 56 months after recruitment
Will be measured using final survey questionnaire
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
23 secondary outcomes
Incidence of marriage/ cohabitation before girls' 16th birthday
Time frame: 56 months after recruitment
Incidence of marriage/ cohabitation before girls' 18th birthday
Time frame: 56 months after recruitment
Socioeconomic inequality in incidence of marriage/ cohabitation before girls' 18th birthday
Time frame: 56 months after recruitment
Incidence of pregnancies among girls within 2 years of the end of the interventions
Time frame: 56 months after recruitment
Incidence of births among girls within 2 years of the end of the interventions
Time frame: 56 months after recruitment
Incidence of pregnancies before girls' 16th birthday
Time frame: 56 months after recruitment
Incidence of births before girls' 16th birthday
Time frame: 56 months after recruitment
Incidence of pregnancies before girls' 18th birthday
Time frame: 56 months after recruitment
Socioeconomic inequality in incidence of births before girls' 18th birthday
Time frame: 56 months after recruitment
Proportion of girls enrolled in grade 8
Time frame: 12 months after recruitment
Average examination scores of girls from grade 9 in English, mathematics and science
Time frame: 34 months after recruitment
Proportion of girls who enrol in grade 10
Time frame: 38 months after recruitment
Socioeconomic inequality in participation in grade 9 exam among girls
Time frame: 56 months after recruitment
Proportion currently using modern contraceptives
Time frame: 32 months after recruitment
Knowledge of modern contraceptives among adolescent girls
Time frame: 32 months after recruitment
Perceived community norms regarding modern contraceptive use among unmarried adolescent girls
Time frame: 32 months after recruitment
Perceived community norms regarding early marriage
Time frame: 32 months after recruitment
Perceived community norms regarding adolescent pregnancy
Time frame: 32 months after recruitment
Perceived community norms regarding education among girls
Time frame: 32 months after recruitment
Proportion of adolescent girls who have been sexually active in last 4 weeks
Time frame: 32 months after recruitment
Proportion of girls currently employed or self-employed
Time frame: 56 months after recruitment
School attendance of girls in grade 8
Time frame: 12 and 18 months after recruitment
School attendance of girls in grade 9
Time frame: 24 and 30 months after recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Derived from this study: PubMed 38741917Mori 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.
- Derived from this study: PubMed 29258591Mori 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.
- Individual participant dataSharing planned: Undecided. not yet determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingvild F Sandøy, PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
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.