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

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ClinicalTrials.gov Identifier: NCT01996241
Recruitment Status : Completed
First Posted : November 27, 2013
Results First Posted : September 25, 2019
Last Update Posted : October 15, 2019
Sponsor:
Collaborators:
University of Manitoba
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Karnataka Health Promotion Trust

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.


Condition or disease Intervention/treatment Phase
Secondary School Entry and Completion Child Marriage Behavioral: Multi-level, structural and norms-based intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2457 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of an Intervention Supporting Adolescent Girls From Marginalized Communities to Complete Secondary Schooling
Study Start Date : January 2014
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Arm Intervention/treatment
Experimental: Intervention Village Clusters
Receive multi-level, structural and norms-based intervention
Behavioral: Multi-level, structural and norms-based intervention
Receive multi-level, structural and norms-based intervention

No Intervention: Control Village Clusters
No multi-level, structural and norms-based intervention



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Number of Participants Entering Into 8th Standard [Start Secondary School] [ Time Frame: March-May 2014 ]
    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.

  2. Number of Participants Passing 10th Standard [Pass 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.

  3. Number of Participants Having Sexual Debut [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 self-completed questionnaire.

  4. 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) ]
    This outcome will be assessed using data collected from all study participants at end-line, using the face-to-face questionnaire.



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Ages Eligible for Study:   13 Years to 15 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adolescent girls in Standard 7

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996241


Locations
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India
Bagalkot and Bijapur Districts
Bagalkot, Karnataka, India
Sponsors and Collaborators
Karnataka Health Promotion Trust
University of Manitoba
London School of Hygiene and Tropical Medicine
Investigators
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Study Director: Shajy Isac, PhD Karnataka Health Promotion Trust
  Study Documents (Full-Text)

Documents provided by Karnataka Health Promotion Trust:
Statistical Analysis Plan  [PDF] November 20, 2017
Study Protocol  [PDF] November 18, 2014


Additional Information:
Publications:
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Karnataka Health Promotion Trust
ClinicalTrials.gov Identifier: NCT01996241     History of Changes
Other Study ID Numbers: 111/2013
First Posted: November 27, 2013    Key Record Dates
Results First Posted: September 25, 2019
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be anonymised and made available for secondary analyses on request, following publication of trial findings.
Keywords provided by Karnataka Health Promotion Trust:
adolescent girls
female sex work
age at marriage
retention in school
sexual debut
India
Karnataka
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes