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| Name | Class |
|---|---|
| University of Manitoba | OTHER |
| London School of Hygiene and Tropical Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Village Clusters | Experimental | Receive multi-level, structural and norms-based intervention |
|
| Control Village Clusters | No Intervention | No multi-level, structural and norms-based intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-level, structural and norms-based intervention | Behavioral | Receive multi-level, structural and norms-based intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | May-August 2016 (cohort one) and May-August 2017 (cohort two) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shajy Isac, PhD | Karnataka Health Promotion Trust | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bagalkot and Bijapur Districts | Bagalkot | Karnataka | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25881037 | Background | 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. | |
| 30183747 |
| Label | URL |
|---|---|
| Link to Samata Trial Protocol Paper | View source |
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Data will be anonymised and made available for secondary analyses on request, following publication of trial findings.
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80 of 121 village clusters in Vijayapura and Bagalkote districts, Karnataka State, were randomly selected (40 intervention; 40 control). Girls were recruited from two successive academic years (cohorts 1 and 2) to increase study power and achieve required sample size. Analysis was planned by trial arm rather than separately for two study cohorts.
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Village Cluster | All SC/ST girls in final year of primary school living in intervention villages eligible for study enrolment. |
| FG001 | Control Village Cluster | All SC/ST girls in final year of primary school living in control villages eligible for study enrolment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Of the total population of SC/ST girls in the final year of primary school who were eligible for this study, 1164/1265 in the intervention arm and 1111/1192 in the control arm participated in the baseline survey. 101 girls from the intervention and 81 from the control were not surveyed at baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Village Cluster | All SC/ST girls in final year of primary school living in intervention villages eligible for study enrolment. |
| BG001 | Control Village Cluster | All SC/ST girls in final year of primary school living in control villages eligible for study enrolment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | May-August 2016 (cohort one) and May-August 2017 (cohort two) |
|
3 years, 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SC/ST Girls in Intervention Village Cluster | All SC/ST girls in final year of primary school living in intervention villages eligible for study enrolment. |
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Due to funding delays at the start of the trial, the intervention started later than planned, when girls in cohort 1 were in second year of secondary school and girls in cohort 2 were in first term of secondary school.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Tara Beattie | London School of Hygiene and Tropical Medicine | 0044 (0)2079272613 | tara.beattie@lshtm.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 20, 2017 | Jan 7, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Nov 18, 2014 | May 14, 2019 | Prot_001.pdf |
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| 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. | 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. | 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. | May-August 2016 (cohort one) and May-August 2017 (cohort two) |
| Background |
| Ramanaik 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. |
| 30113275 | Background | Mazzuca 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. |
| 28968543 | Background | Prakash 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. |
| Background | Bhagavatheeswaran 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 |
| 32720188 | Derived | 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. |
| 31448111 | Derived | Prakash 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. |
| 30630455 | Derived | Beattie 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| District | Count of Participants | Participants |
|
| Caste (ST vs. SC) | Count of Participants | Participants |
|
| Non-literate Household Head | Count of Participants | Participants |
|
| Village Type (Feeder vs. Main) | Count of Participants | Participants |
|
| Household wealth quintile (Poorest) | Count of Participants | Participants |
|
| Devadasi Family | Count of Participants | Participants |
|
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | May-August 2016 (cohort one) and May-August 2017 (cohort two) |
|
|
|
|
| Secondary | 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. | outcome assessed using data from cohort two girls only, using the baseline face-to-face questionnaire. | Posted | Count of Participants | Participants | March-May 2014 |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | May-August 2016 (cohort one) and May-August 2017 (cohort two) |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | May-August 2016 (cohort one) and May-August 2017 (cohort two) |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | May-August 2016 (cohort one) and May-August 2017 (cohort two) |
|
|
|
|
| 0 |
| 1,265 |
| 0 |
| 1,265 |
| 0 |
| 1,265 |
| EG001 | SC/ST Girls in Control Village Cluster | All SC/ST girls in final year of primary school living in control villages eligible for study enrolment | 0 | 1,192 | 0 | 1,192 | 0 | 1,192 |
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