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

This study is currently recruiting participants.
Verified June 2017 by Karnataka Health Promotion Trust
Sponsor:
ClinicalTrials.gov Identifier:
NCT01996241
First Posted: November 27, 2013
Last Update Posted: June 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Manitoba
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Karnataka Health Promotion Trust
  Purpose

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 Bagalkot and Bijapur districts. The intervention will be implemented with village communities and high schools in 40 village clusters in Bagalkot and Bijapur 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 Intervention
Secondary School Entry and Completion Child Marriage Behavioral: Educational enhancement intervention

Study Type: Interventional
Study Design: 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

Further study details as provided by Karnataka Health Promotion Trust:

Primary Outcome Measures:
  • Proportion of girls who complete secondary school [sit 10th standard exam] [ Time Frame: May-August 2016 (cohort one) and May-August 2017 (cohort two) ]
    Outcomes will be measured through a cluster RCT conducted in 80 village clusters (40 intervention; 40 control) in Bijapur and Bagalkot districts in north Karnataka. All lower caste (scheduled caste/tribe) adolescent girls living in the selected village clusters and attending 7th standard (final year of primary school) will be recruited into the study in two consecutive waves, one academic year apart. Girls (n=2100) will be interviewed at baseline (year 8) and at end-line two years later (end of year 10). The interview will comprise a interviewer administered face-to-face questionnaire plus a short self-completed questionnaire (containing sensitive questions). Interviews will be conducted in private in the study participant's home. Observers assessing the outcomes will be blinded to group assignment. The primary outcomes will be an adjusted, cluster-level intention to treat analysis, comparing outcomes in intervention and control villages.

  • Proportion of girls who are married [by Trial end line] [ Time Frame: May-August 2016 (cohort one) and May-August 2017 (cohort two) ]
    See above Description regarding measurement of this outcome. This outcome will be assessed using data collected from all study participants at end-line, using the face-to-face questionnaire.


Secondary Outcome Measures:
  • Proportion of girls who enter into 8th standard [start secondary school] [ Time Frame: March-May 2014 ]
    Due to delays at the start of the cluster-RCT, 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.

  • Proportion of girls who pass 10th standard [pass 10th standard exam] [ Time Frame: May-August 2016 (cohort one) and May-August 2017 (cohort two) ]
    See above description for primary outcome 1 regarding measurement of this outcome. This outcome will be assessed using data collected from all study participants at end-line, using the face-to-face questionnaire.

  • Proportion of girls who have sexual debut [by Trial end line] [ Time Frame: May-August 2016 (cohort one) and May-August 2017 (cohort two) ]
    See above description for primary outcome 1 regarding measurement of this outcome. This outcome will be assessed using data collected from all study participants at end-line, using the self-completed questionnaire.

  • Proportion of girls married and co-habiting with husband [by Trial end line] [ Time Frame: May-August 2016 (cohort one) and May-August 2017 (cohort two) ]
    See above description for primary outcome 1 regarding measurement of this outcome. This outcome will be assessed using data collected from all study participants at end-line, using the face-to-face questionnaire.


Estimated Enrollment: 2275
Study Start Date: January 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Educational enhancement intervention
Receive educational enhancement intervention
Behavioral: Educational enhancement intervention
Receive educational enhancement intervention
No Intervention: No eduational enhancement intervention
No educational enhancement intervention

  Eligibility

Information from the National Library of Medicine

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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:

  Contacts and Locations
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


Contacts
Contact: Shajy Isac, PhD +91.9980912281 shajyisac@khpt.org

Locations
India
Bagalkot District Recruiting
Bagalkot, Karnataka, India
Principal Investigator: Shajy Isac, PhD         
Sponsors and Collaborators
Karnataka Health Promotion Trust
University of Manitoba
London School of Hygiene and Tropical Medicine
Investigators
Study Director: Shajy Isac, PhD Karnataka Health Promotion Trust
  More Information

Additional Information:
Publications:
Responsible Party: Karnataka Health Promotion Trust
ClinicalTrials.gov Identifier: NCT01996241     History of Changes
Other Study ID Numbers: 111/2013
First Submitted: November 16, 2013
First Posted: November 27, 2013
Last Update Posted: June 23, 2017
Last Verified: June 2017
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:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes