Evaluation of an Intervention for Adolescent Girls in Karnataka

Child Marriage Clinical Trial

— Samata  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01996241
• Other study ID #: 111/2013
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: October 2019
• Source: Karnataka Health Promotion Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2457
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 15 Years

Eligibility

Inclusion Criteria:

• Adolescent girls in Standard 7

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Child Marriage
• Neoplasm Metastasis
• Secondary School Entry and Completion

Intervention

Behavioral:
• Multi-level, structural and norms-based intervention
Receive multi-level, structural and norms-based intervention

Locations

Country	Name	City	State
India	Bagalkot and Bijapur Districts	Bagalkot	Karnataka

Sponsors (3)

Lead Sponsor	Collaborator
Karnataka Health Promotion Trust	London School of Hygiene and Tropical Medicine, University of Manitoba

Country where clinical trial is conducted

India, 

References & Publications (5)

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. — View 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

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	May-August 2016 (cohort one) and May-August 2017 (cohort two)
Primary	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.	May-August 2016 (cohort one) and May-August 2017 (cohort two)
Secondary	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.	March-May 2014
Secondary	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.	May-August 2016 (cohort one) and May-August 2017 (cohort two)
Secondary	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.	May-August 2016 (cohort one) and May-August 2017 (cohort two)
Secondary	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.	May-August 2016 (cohort one) and May-August 2017 (cohort two)

External Links

•   Link to Samata Trial Protocol Paper