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Evaluation of an Intervention for Adolescent Girls in Karnataka (Samata)

Primary Purpose

Secondary School Entry and Completion, Child Marriage

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Multi-level, structural and norms-based intervention
Sponsored by
Karnataka Health Promotion Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Secondary School Entry and Completion focused on measuring adolescent girls, female sex work, age at marriage, retention in school, sexual debut, India, Karnataka

Eligibility Criteria

13 Years - 15 Years (Child)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Adolescent girls in Standard 7

Exclusion Criteria:

  • None

Sites / Locations

  • Bagalkot and Bijapur Districts

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Village Clusters

Control Village Clusters

Arm Description

Receive multi-level, structural and norms-based intervention

No multi-level, structural and norms-based intervention

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
November 16, 2013
Last Updated
October 2, 2019
Sponsor
Karnataka Health Promotion Trust
Collaborators
University of Manitoba, London School of Hygiene and Tropical Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01996241
Brief Title
Evaluation of an Intervention for Adolescent Girls in Karnataka
Acronym
Samata
Official Title
Evaluation of an Intervention Supporting Adolescent Girls From Marginalized Communities to Complete Secondary Schooling
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karnataka Health Promotion Trust
Collaborators
University of Manitoba, London School of Hygiene and Tropical Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary School Entry and Completion, Child Marriage
Keywords
adolescent girls, female sex work, age at marriage, retention in school, sexual debut, India, Karnataka

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2457 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Village Clusters
Arm Type
Experimental
Arm Description
Receive multi-level, structural and norms-based intervention
Arm Title
Control Village Clusters
Arm Type
No Intervention
Arm Description
No multi-level, structural and norms-based intervention
Intervention Type
Behavioral
Intervention Name(s)
Multi-level, structural and norms-based intervention
Intervention Description
Receive multi-level, structural and norms-based intervention
Primary Outcome Measure Information:
Title
Number of Participants Completing Secondary School [Sit 10th Standard Exam]
Description
This outcome will be assessed using data collected from all study participants at end-line, using the face-to-face questionnaire.
Time Frame
May-August 2016 (cohort one) and May-August 2017 (cohort two)
Title
Number of Participants Married [by Trial End Line]
Description
This outcome will be assessed using data collected from all study participants at end-line, using the face-to-face questionnaire.
Time Frame
May-August 2016 (cohort one) and May-August 2017 (cohort two)
Secondary Outcome Measure Information:
Title
Number of Participants Entering Into 8th Standard [Start Secondary School]
Description
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.
Time Frame
March-May 2014
Title
Number of Participants Passing 10th Standard [Pass 10th Standard Exam]
Description
This outcome will be assessed using data collected from all study participants at end-line, using the face-to-face questionnaire.
Time Frame
May-August 2016 (cohort one) and May-August 2017 (cohort two)
Title
Number of Participants Having Sexual Debut [by Trial End Line]
Description
This outcome will be assessed using data collected from all study participants at end-line, using the self-completed questionnaire.
Time Frame
May-August 2016 (cohort one) and May-August 2017 (cohort two)
Title
Number of Participants Married and Co-habiting With Husband [by Trial End Line]
Description
This outcome will be assessed using data collected from all study participants at end-line, using the face-to-face questionnaire.
Time Frame
May-August 2016 (cohort one) and May-August 2017 (cohort two)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adolescent girls in Standard 7 Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shajy Isac, PhD
Organizational Affiliation
Karnataka Health Promotion Trust
Official's Role
Study Director
Facility Information:
Facility Name
Bagalkot and Bijapur Districts
City
Bagalkot
State/Province
Karnataka
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be anonymised and made available for secondary analyses on request, following publication of trial findings.
Citations:
PubMed Identifier
25881037
Citation
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.
Results Reference
background
PubMed Identifier
30183747
Citation
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.
Results Reference
background
PubMed Identifier
30113275
Citation
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.
Results Reference
background
PubMed Identifier
28968543
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
32720188
Citation
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.
Results Reference
derived
PubMed Identifier
31448111
Citation
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.
Results Reference
derived
PubMed Identifier
30630455
Citation
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.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4391662/pdf/12889_2015_Article_1623.pdf
Description
Link to Samata Trial Protocol Paper

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Evaluation of an Intervention for Adolescent Girls in Karnataka

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