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Completed

NCT Number: NCT01996241

Evaluation of an Intervention for Adolescent Girls in Karnataka

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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Key information

Conditions

Secondary School Entry and Completion Child Marriage

Age range

13 year–15 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bagalkot and Bijapur Districts

Bagalkot, Karnataka, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adolescent girls in Standard 7

Exclusion criteria

  • None

Treatment and study plan

Multi-level, structural and norms-based intervention

Behavioral

Receive multi-level, structural and norms-based intervention

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Karnataka Health Promotion Trust

Other

Collaborators

  • London School of Hygiene and Tropical Medicine
  • University of Manitoba

Registry information

Official study title

Evaluation of an Intervention Supporting Adolescent Girls From Marginalized Communities to Complete Secondary Schooling

Acronym: Samata

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 27, 2013
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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