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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Karnataka Health Promotion Trust
University of Manitoba
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Karnataka Health Promotion Trust Identifier:
First received: November 16, 2013
Last updated: November 25, 2016
Last verified: November 2016

This 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. The intervention will cover 125 high schools 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
Behavioral: Educational enhancement intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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:
  • Delay of entry into sex work [ Time Frame: 2 years ]
    Outcomes will be measured through two sequential cohort studies. A total of 1020 adolescent girls age 13 from 68 clusters (34 clusters each in intervention and control arms of the study) will be required. At the beginning of the first academic year, the study will recruit a cohort of 1020 girls who passed out of 7th standard in 68 study villages (about 510 from each study arm). These girls will be interviewed using an interviewer administered questionnaire. The cohort from the intervention sites will be interviewed three times during the study period, once each at the beginning of academic years 1, 2, and 4. The cohort from the control sites will be interviewed only twice during the study period, at the beginning of years 1. To measure changes in subsequent cohorts of girls exposed to intervention, we will recruit another cohort at the beginning of academic year 2 from the intervention sites only. The cohort size will be 510.

Secondary Outcome Measures:
  • Delay of sexual debut [ Time Frame: 2 years ]
    See above Description regarding measurement of this outcome.

  • Increased age at marriage [ Time Frame: 2 years ]
    See above Description regarding measurement of this outcome.

Estimated Enrollment: 1530
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


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

Inclusion Criteria:

  • Adolescent girls in Standard 7

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01996241

Contact: Shajy Isac, PhD +91.9980912281

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
Study Director: Shajy Isac, PhD Karnataka Health Promotion Trust
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Karnataka Health Promotion Trust Identifier: NCT01996241     History of Changes
Other Study ID Numbers: 111/2013
Study First Received: November 16, 2013
Last Updated: November 25, 2016
Individual Participant Data  
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

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes processed this record on May 25, 2017