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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

2,457

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 years study duration

First Submitted

Initial submission to the registry

November 16, 2013

Completed

11 days until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed

1 month until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed

4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed

1.7 years until next milestone

Results Posted

Study results publicly available

September 25, 2019

Completed

Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

4 years

First QC Date

November 16, 2013

Results QC Date

January 7, 2019

Last Update Submit

October 2, 2019

Conditions

Secondary School Entry and Completion Child Marriage

Keywords

adolescent girlsfemale sex workage at marriageretention in schoolsexual debutIndiaKarnataka

Outcome Measures

Primary Outcomes (2)

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)
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 Outcomes (4)

Number of Participants Entering Into 8th Standard [Start Secondary School]
March-May 2014
Number of Participants Passing 10th Standard [Pass 10th Standard Exam]
May-August 2016 (cohort one) and May-August 2017 (cohort two)
Number of Participants Having Sexual Debut [by Trial End Line]
May-August 2016 (cohort one) and May-August 2017 (cohort two)
Number of Participants Married and Co-habiting With Husband [by Trial End Line]
May-August 2016 (cohort one) and May-August 2017 (cohort two)

Study Arms (2)

Intervention Village Clusters

EXPERIMENTAL

Receive multi-level, structural and norms-based intervention

Behavioral: Multi-level, structural and norms-based intervention

Control Village Clusters

NO INTERVENTION

No multi-level, structural and norms-based intervention

Interventions

Multi-level, structural and norms-based interventionBEHAVIORAL

Receive multi-level, structural and norms-based intervention

Intervention Village Clusters

Eligibility Criteria

Age13 Years - 15 Years

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Adolescent girls in Standard 7

You may not qualify if:

None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Karnataka Health Promotion Trustlead
University of Manitobacollaborator
London School of Hygiene and Tropical Medicinecollaborator

Study Sites (1)

Bagalkot and Bijapur Districts

Bagalkot, Karnataka, India

Location

Related Publications (8)

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.
PMID: 25881037BACKGROUND
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.
PMID: 30183747BACKGROUND
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.
PMID: 30113275BACKGROUND
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.
PMID: 28968543BACKGROUND
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
BACKGROUND
Prakash R, Beattie TS, Cislaghi B, Bhattacharjee P, Javalkar P, Ramanaik S, Thalinja R, Davey C, Gafos M, Watts C, Collumbien M, Moses S, Isac S, Heise L. Changes in Family-Level Attitudes and Norms and Association with Secondary School Completion and Child Marriage Among Adolescent Girls: Results from an Exploratory Study Nested Within a Cluster-Randomised Controlled Trial in India. Prev Sci. 2020 Nov;21(8):1065-1080. doi: 10.1007/s11121-020-01143-1.
PMID: 32720188DERIVED
Prakash R, Beattie TS, Javalkar P, Bhattacharjee P, Ramanaik S, Thalinja R, Murthy S, Davey C, Gafos M, Blanchard J, Watts C, Collumbien M, Moses S, Heise L, Isac S. The Samata intervention to increase secondary school completion and reduce child marriage among adolescent girls: results from a cluster-randomised control trial in India. J Glob Health. 2019 Jun;9(1):010430. doi: 10.7189/jogh.09.010430.
PMID: 31448111DERIVED
Beattie TS, Prakash R, Mazzuca A, Kelly L, Javalkar P, Raghavendra T, Ramanaik S, Collumbien M, Moses S, Heise L, Isac S, Watts C. Prevalence and correlates of psychological distress among 13-14 year old adolescent girls in North Karnataka, South India: a cross-sectional study. BMC Public Health. 2019 Jan 10;19(1):48. doi: 10.1186/s12889-018-6355-z.
PMID: 30630455DERIVED

Limitations and Caveats

Due to funding delays at the start of the trial, the intervention started later than planned, when girls in cohort 1 were in second year of secondary school and girls in cohort 2 were in first term of secondary school.

Results Point of Contact

Title: Dr Tara Beattie
Organization: London School of Hygiene and Tropical Medicine

Study Officials

Shajy Isac, PhD
Karnataka Health Promotion Trust
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 16, 2013

First Posted

November 27, 2013

Study Start

January 1, 2014

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

October 15, 2019

Results First Posted

September 25, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing: Will share

Locations

IN(1)

Evaluation of an Intervention for Adolescent Girls in Karnataka

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

Intervention Village Clusters

Control Village Clusters

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (8)

Related Links

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

Intervention Village Clusters

Control Village Clusters

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (8)

Related Links

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations