Secondary School Entry and CompletionSamataNCT01996241
Evaluation of an Intervention for Adolescent Girls in Karnataka
A study testing Multi-level, structural and norms-based intervention in people with Secondary School Entry and Completion and Child Marriage, run by Karnataka Health Promotion Trust at 1 site in India.
Trial summary
This cluster Randomised Control Trial is evaluating an intervention to support adolescent girls from marginalised communities in northern Karnataka State, South India to complete secondary school, thereby reducing their vulnerability to HIV infection from early marriage and entry into sex work at young ages. Read more about this study
- Who is it for?
- Ages 13 to 15 years, women only
- Conditions the study is for
- Secondary School Entry and Completion, Child Marriage
- What is being tested?
- Multi-level, structural and norms-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,457 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2014to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 15 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Adolescent girls in Standard 7
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Intervention Supporting Adolescent Girls From Marginalized Communities to Complete Secondary Schooling
This cluster Randomised Control Trial is evaluating an intervention to support adolescent girls from marginalised communities in northern Karnataka State, South India to complete secondary school, thereby reducing their vulnerability to HIV infection from early marriage and entry into sex work at young ages. The intervention will test innovations to address both supply and demand side barriers to girls' completion of secondary school, and will have long-term educational and livelihood benefits, in addition to reducing vulnerability to HIV.
School-based constraints will be addressed by improving academic outcomes through teacher training and academic support to students; addressing gender-related and skill-based gaps among teachers; training of local female teachers; and increasing the content knowledge of secondary school teachers. Demand side barriers will be addressed by reducing economic pressures that households face to withdraw girls' from school; building appreciation and value of girls' education; building family and community accountability for school attendance; creating safe spaces for girls and strengthening their agency; and engaging boys in promoting and supporting girls' education.
Primary stakeholders will include teachers and students, especially adolescent girls in the school (7th to 10 the standard) from marginalized communities. Secondary stakeholders will include school development and management committees (SDMCs), families, boys and the communities that are served by the schools. 80 village clusters (40 intervention; 40 control) were randomly selected from 125 village clusters in Bagalkote and Vijayapura districts. The intervention will be implemented with village communities and high schools in 40 village clusters in Bagalkote and Vijayapura districts. The intervention will be implemented in collaboration with the Department of State Educational Research and Training (DSERT), Karnataka; the Adolescent Education Cell, Government College of Teachers' Education (CTE), Jamkhandi; and the Institute for Advanced Studies in Education (IASE), Gulbarga.
- Being tested
- Multi-level, structural and norms-based intervention
- Keywords
- adolescent girls, female sex work, age at marriage, retention in school, sexual debut, India, Karnataka
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-level, structural and norms-based interventionBehavioural
Receive multi-level, structural and norms-based intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention Village Clusters | Experimental | Receive multi-level, structural and norms-based intervention Receives: Behavioral: Multi-level, structural and norms-based intervention |
| Control Village Clusters | No intervention | No multi-level, structural and norms-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Completing Secondary School [Sit 10th Standard Exam]
This outcome will be assessed using data collected from all study participants at end-line, using the face-to-face questionnaire.
Measured: May-August 2016 (cohort one) and May-August 2017 (cohort two)
Number of Participants Married [by Trial End Line]
This outcome will be assessed using data collected from all study participants at end-line, using the face-to-face questionnaire.
Measured: May-August 2016 (cohort one) and May-August 2017 (cohort two)
Secondary outcomes (4)
Number of Participants Entering Into 8th Standard [Start Secondary School]
Due to delays at the start of the cluster-Randomized Controlled Trial, the intervention had not started when cohort one girls were interviewed. This outcome will be assessed using data from cohort two girls only, using the face-to-face questionnaire. To reduce recall bias, we will use data collected at the first interview (baseline) to measure this outcome.
Measured: March-May 2014
Number of Participants Passing 10th Standard [Pass 10th Standard Exam]
This outcome will be assessed using data collected from all study participants at end-line, using the face-to-face questionnaire.
Measured: May-August 2016 (cohort one) and May-August 2017 (cohort two)
Number of Participants Having Sexual Debut [by Trial End Line]
This outcome will be assessed using data collected from all study participants at end-line, using the self-completed questionnaire.
Measured: May-August 2016 (cohort one) and May-August 2017 (cohort two)
Number of Participants Married and Co-habiting With Husband [by Trial End Line]
This outcome will be assessed using data collected from all study participants at end-line, using the face-to-face questionnaire.
Measured: May-August 2016 (cohort one) and May-August 2017 (cohort two)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startJan 2014
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Secondary School Entry and CompletionStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karnataka Health Promotion Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manitoba, London School of Hygiene and Tropical Medicine
- Responsible party
- Sponsor
- Investigators
- Shajy Isac, PhD, Study director, Karnataka Health Promotion Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996241
- Sponsor's protocol ID
- 111/2013
- Acronym
- Samata
- Status last verified
- Oct 2019
- First submitted
- 16 Nov 2013
- Last updated
- 15 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be anonymised and made available for secondary analyses on request, following publication of trial findings.
Publications
Beattie TS, Bhattacharjee P, Isac S, Davey C, Javalkar P, Nair S, Thalinja R, Sudhakar G, Collumbien M, Blanchard JF, Watts C, Moses S, Heise L. Supporting adolescent girls to stay in school, reduce child marriage and reduce entry into sex work as HIV risk prevention in north Karnataka, India: protocol for a cluster randomised controlled trial. BMC Public Health. 2015 Mar 25;15:292. doi: 10.1186/s12889-015-1623-7.
PubMed 25881037Ramanaik S, Collumbien M, Prakash R, Howard-Merrill L, Thalinja R, Javalkar P, Murthy S, Cislaghi B, Beattie T, Isac S, Moses S, Heise L, Bhattacharjee P. Education, poverty and "purity" in the context of adolescent girls' secondary school retention and dropout: A qualitative study from Karnataka, southern India. PLoS One. 2018 Sep 5;13(9):e0202470. doi: 10.1371/journal.pone.0202470. eCollection 2018.
PubMed 30183747Mazzuca A, Nagarchi D, Ramanaik S, Raghavendra T, Javalkar P, Rotti S, Bhattacharjee P, Isac S, Cohen A, Beattie T. Developing a Mental Health Measurement Strategy to Capture Psychological Problems among Lower Caste Adolescent Girls in Rural, South India. Transcult Psychiatry. 2019 Feb;56(1):24-47. doi: 10.1177/1363461518789540. Epub 2018 Aug 16.
PubMed 30113275Prakash R, Beattie T, Javalkar P, Bhattacharjee P, Ramanaik S, Thalinja R, Murthy S, Davey C, Blanchard J, Watts C, Collumbien M, Moses S, Heise L, Isac S. Correlates of school dropout and absenteeism among adolescent girls from marginalized community in north Karnataka, south India. J Adolesc. 2017 Dec;61:64-76. doi: 10.1016/j.adolescence.2017.09.007. Epub 2017 Sep 29.
PubMed 28968543Bhagavatheeswaran L, Nair S, Stone H, Isac S, Hiremath T, Thalinda R, Vadde K, Doddamane M, Srikantamurthy HS, Heise L, Watts C, Schweisfurth M, Bhattacharjee P, Beattie TS. The barriers and enablers to education among scheduled caste and scheduled tribe adolescent girls in northern Karnataka, South India: A qualitative study. Int J Edu Dev. 2016. 49 262-270
Prakash R, Beattie TS, Cislaghi B, Bhattacharjee P, Javalkar P, Ramanaik S, Thalinja R, Davey C, Gafos M, Watts C, Collumbien M, Moses S, Isac S, Heise L. Changes in Family-Level Attitudes and Norms and Association with Secondary School Completion and Child Marriage Among Adolescent Girls: Results from an Exploratory Study Nested Within a Cluster-Randomised Controlled Trial in India. Prev Sci. 2020 Nov;21(8):1065-1080. doi: 10.1007/s11121-020-01143-1.
PubMed 32720188Prakash R, Beattie TS, Javalkar P, Bhattacharjee P, Ramanaik S, Thalinja R, Murthy S, Davey C, Gafos M, Blanchard J, Watts C, Collumbien M, Moses S, Heise L, Isac S. The Samata intervention to increase secondary school completion and reduce child marriage among adolescent girls: results from a cluster-randomised control trial in India. J Glob Health. 2019 Jun;9(1):010430. doi: 10.7189/jogh.09.010430.
PubMed 31448111Beattie TS, Prakash R, Mazzuca A, Kelly L, Javalkar P, Raghavendra T, Ramanaik S, Collumbien M, Moses S, Heise L, Isac S, Watts C. Prevalence and correlates of psychological distress among 13-14 year old adolescent girls in North Karnataka, South India: a cross-sectional study. BMC Public Health. 2019 Jan 10;19(1):48. doi: 10.1186/s12889-018-6355-z.
PubMed 30630455
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Intervention Supporting Adolescent Girls From Marginalized Communities to Complete Secondary Schooling
- ClinicalTrials.gov ID
- NCT01996241
- Acronym / sponsor ID
- Samata / 111/2013
- Keywords
- adolescent girls, female sex work, age at marriage, retention in school, sexual debut, India, Karnataka
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,457 participants (actual)
- Lead sponsor
- Karnataka Health Promotion TrustUniversity, hospital or other
- Collaborators
- University of Manitoba, London School of Hygiene and Tropical Medicine
- Study start
- Jan 2014
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Posted 25 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This cluster Randomised Control Trial is evaluating an intervention to support adolescent girls from marginalised communities in northern Karnataka State, South India to complete secondary school, thereby reducing their vulnerability to HIV infection from early marriage and entry into sex work at young ages. The intervention will test innovations to address both supply and demand side barriers to girls' completion of secondary school, and will have long-term educational and livelihood benefits, in addition to reducing vulnerability to HIV.
School-based constraints will be addressed by improving academic outcomes through teacher training and academic support to students; addressing gender-related and skill-based gaps among teachers; training of local female teachers; and increasing the content knowledge of secondary school teachers. Demand side barriers will be addressed by reducing economic pressures that households face to withdraw girls' from school; building appreciation and value of girls' education; building family and community accountability for school attendance; creating safe spaces for girls and strengthening their agency; and engaging boys in promoting and supporting girls' education.
Primary stakeholders will include teachers and students, especially adolescent girls in the school (7th to 10 the standard) from marginalized communities. Secondary stakeholders will include school development and management committees (SDMCs), families, boys and the communities that are served by the schools. 80 village clusters (40 intervention; 40 control) were randomly selected from 125 village clusters in Bagalkote and Vijayapura districts. The intervention will be implemented with village communities and high schools in 40 village clusters in Bagalkote and Vijayapura districts. The intervention will be implemented in collaboration with the Department of State Educational Research and Training (DSERT), Karnataka; the Adolescent Education Cell, Government College of Teachers' Education (CTE), Jamkhandi; and the Institute for Advanced Studies in Education (IASE), Gulbarga.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Village Clusters | Experimental | Behavioral: Multi-level, structural and norms-based interventionReceive multi-level, structural and norms-based intervention |
| Control Village Clusters | No intervention | –No multi-level, structural and norms-based intervention |
Who may qualify
- Ages
- 13 to 15 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Adolescent girls in Standard 7
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Multi-level, structural and norms-based interventionReceive multi-level, structural and norms-based intervention | Behavioural | Intervention Village Clusters |
Primary outcome
Number of Participants Completing Secondary School [Sit 10th Standard Exam]
Time frame: May-August 2016 (cohort one) and May-August 2017 (cohort two)
This outcome will be assessed using data collected from all study participants at end-line, using the face-to-face questionnaire.
Number of Participants Married [by Trial End Line]
Time frame: May-August 2016 (cohort one) and May-August 2017 (cohort two)
This outcome will be assessed using data collected from all study participants at end-line, using the face-to-face questionnaire.
4 secondary outcomes
Number of Participants Entering Into 8th Standard [Start Secondary School]
Time frame: March-May 2014
Number of Participants Passing 10th Standard [Pass 10th Standard Exam]
Time frame: May-August 2016 (cohort one) and May-August 2017 (cohort two)
Number of Participants Having Sexual Debut [by Trial End Line]
Time frame: May-August 2016 (cohort one) and May-August 2017 (cohort two)
Number of Participants Married and Co-habiting With Husband [by Trial End Line]
Time frame: May-August 2016 (cohort one) and May-August 2017 (cohort two)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25881037Beattie TS, Bhattacharjee P, Isac S, Davey C, Javalkar P, Nair S, Thalinja R, Sudhakar G, Collumbien M, Blanchard JF, Watts C, Moses S, Heise L. Supporting adolescent girls to stay in school, reduce child marriage and reduce entry into sex work as HIV risk prevention in north Karnataka, India: protocol for a cluster randomised controlled trial. BMC Public Health. 2015 Mar 25;15:292. doi: 10.1186/s12889-015-1623-7.
- Background: PubMed 30183747Ramanaik S, Collumbien M, Prakash R, Howard-Merrill L, Thalinja R, Javalkar P, Murthy S, Cislaghi B, Beattie T, Isac S, Moses S, Heise L, Bhattacharjee P. Education, poverty and "purity" in the context of adolescent girls' secondary school retention and dropout: A qualitative study from Karnataka, southern India. PLoS One. 2018 Sep 5;13(9):e0202470. doi: 10.1371/journal.pone.0202470. eCollection 2018.
- Background: PubMed 30113275Mazzuca A, Nagarchi D, Ramanaik S, Raghavendra T, Javalkar P, Rotti S, Bhattacharjee P, Isac S, Cohen A, Beattie T. Developing a Mental Health Measurement Strategy to Capture Psychological Problems among Lower Caste Adolescent Girls in Rural, South India. Transcult Psychiatry. 2019 Feb;56(1):24-47. doi: 10.1177/1363461518789540. Epub 2018 Aug 16.
- Background: PubMed 28968543Prakash R, Beattie T, Javalkar P, Bhattacharjee P, Ramanaik S, Thalinja R, Murthy S, Davey C, Blanchard J, Watts C, Collumbien M, Moses S, Heise L, Isac S. Correlates of school dropout and absenteeism among adolescent girls from marginalized community in north Karnataka, south India. J Adolesc. 2017 Dec;61:64-76. doi: 10.1016/j.adolescence.2017.09.007. Epub 2017 Sep 29.
- BackgroundBhagavatheeswaran L, Nair S, Stone H, Isac S, Hiremath T, Thalinda R, Vadde K, Doddamane M, Srikantamurthy HS, Heise L, Watts C, Schweisfurth M, Bhattacharjee P, Beattie TS. The barriers and enablers to education among scheduled caste and scheduled tribe adolescent girls in northern Karnataka, South India: A qualitative study. Int J Edu Dev. 2016. 49 262-270
- Derived from this study: PubMed 32720188Prakash R, Beattie TS, Cislaghi B, Bhattacharjee P, Javalkar P, Ramanaik S, Thalinja R, Davey C, Gafos M, Watts C, Collumbien M, Moses S, Isac S, Heise L. Changes in Family-Level Attitudes and Norms and Association with Secondary School Completion and Child Marriage Among Adolescent Girls: Results from an Exploratory Study Nested Within a Cluster-Randomised Controlled Trial in India. Prev Sci. 2020 Nov;21(8):1065-1080. doi: 10.1007/s11121-020-01143-1.
- Derived from this study: PubMed 31448111Prakash R, Beattie TS, Javalkar P, Bhattacharjee P, Ramanaik S, Thalinja R, Murthy S, Davey C, Gafos M, Blanchard J, Watts C, Collumbien M, Moses S, Heise L, Isac S. The Samata intervention to increase secondary school completion and reduce child marriage among adolescent girls: results from a cluster-randomised control trial in India. J Glob Health. 2019 Jun;9(1):010430. doi: 10.7189/jogh.09.010430.
- Derived from this study: PubMed 30630455Beattie TS, Prakash R, Mazzuca A, Kelly L, Javalkar P, Raghavendra T, Ramanaik S, Collumbien M, Moses S, Heise L, Isac S, Watts C. Prevalence and correlates of psychological distress among 13-14 year old adolescent girls in North Karnataka, South India: a cross-sectional study. BMC Public Health. 2019 Jan 10;19(1):48. doi: 10.1186/s12889-018-6355-z.
- Link to Samata Trial Protocol PaperLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be anonymised and made available for secondary analyses on request, following publication of trial findings.
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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.
Shajy Isac, PhD study director
Karnataka Health Promotion Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-level, structural and norms-based intervention in people with Secondary School Entry and Completion and Child Marriage, run by Karnataka Health Promotion Trust at 1 site in India.
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 1 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 15 Oct 2019. 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 India. 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?
Yes. Results are posted in the registry (first posted 25 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Completing Secondary School [Sit 10th Standard Exam] (time frame: May-August 2016 (cohort one) and May-August 2017 (cohort two)). The study lists 2 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 NCT01996241, which also lists 8 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 15 Oct 2019.