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Evaluation of an Intervention for Adolescent Girls in Karnataka

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01996241
Acronym
Samata
Enrollment
2457
Registered
2013-11-27
Start date
2014-01-31
Completion date
2017-12-31
Last updated
2019-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Marriage, Secondary School Entry and Completion

Keywords

adolescent girls, female sex work, age at marriage, retention in school, sexual debut, India, Karnataka

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.

Interventions

BEHAVIORALMulti-level, structural and norms-based intervention

Receive multi-level, structural and norms-based intervention

Sponsors

University of Manitoba
CollaboratorOTHER
London School of Hygiene and Tropical Medicine
CollaboratorOTHER
Karnataka Health Promotion Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
13 Years to 15 Years
Healthy volunteers
No

Inclusion criteria

* Adolescent girls in Standard 7

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Completing Secondary School [Sit 10th Standard Exam]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.
Number of Participants Married [by Trial End Line]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

MeasureTime frameDescription
Number of Participants Married and Co-habiting With Husband [by Trial End Line]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.
Number of Participants Entering Into 8th Standard [Start Secondary School]March-May 2014Due 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.
Number of Participants Passing 10th Standard [Pass 10th Standard Exam]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.
Number of Participants Having Sexual Debut [by Trial End Line]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.

Countries

India

Participant flow

Recruitment details

80 of 121 village clusters in Vijayapura and Bagalkote districts, Karnataka State, were randomly selected (40 intervention; 40 control). Girls were recruited from two successive academic years (cohorts 1 and 2) to increase study power and achieve required sample size. Analysis was planned by trial arm rather than separately for two study cohorts.

Participants by arm

ArmCount
Intervention Village Cluster
All SC/ST girls in final year of primary school living in intervention villages eligible for study enrolment.
1,164
Control Village Cluster
All SC/ST girls in final year of primary school living in control villages eligible for study enrolment
1,111
Total2,275

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up252235

Baseline characteristics

CharacteristicIntervention Village ClusterControl Village ClusterTotal
Age, Continuous13.0 years13.0 years13.0 years
Caste (ST vs. SC)
Schedued Caste
886 Participants902 Participants1788 Participants
Caste (ST vs. SC)
Scheduled Tribe
278 Participants209 Participants487 Participants
Devadasi Family65 Participants47 Participants112 Participants
District
Bagalkote
639 Participants620 Participants1259 Participants
District
Vijapura
525 Participants491 Participants1016 Participants
Household wealth quintile (Poorest)228 Participants227 Participants455 Participants
Non-literate Household Head748 Participants667 Participants1415 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
India
1164 participants1111 participants2275 participants
Sex: Female, Male
Female
1164 Participants1111 Participants2275 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Village Type (Feeder vs. Main)
Feeder Village
321 Participants346 Participants667 Participants
Village Type (Feeder vs. Main)
Main Village
843 Participants765 Participants1608 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1,2650 / 1,192
other
Total, other adverse events
0 / 1,2650 / 1,192
serious
Total, serious adverse events
0 / 1,2650 / 1,192

Outcome results

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.

Time frame: May-August 2016 (cohort one) and May-August 2017 (cohort two)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SC/ST Girls in Intervention Village ClusterNumber of Participants Completing Secondary School [Sit 10th Standard Exam]680 Participants
SC/ST Girls in Control Village ClusterNumber of Participants Completing Secondary School [Sit 10th Standard Exam]658 Participants
p-value: 0.9895% CI: [0.7, 1.38]Regression, Logistic
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.

Time frame: May-August 2016 (cohort one) and May-August 2017 (cohort two)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SC/ST Girls in Intervention Village ClusterNumber of Participants Married [by Trial End Line]92 Participants
SC/ST Girls in Control Village ClusterNumber of Participants Married [by Trial End Line]84 Participants
p-value: 0.9895% CI: [0.7, 1.4]Regression, Logistic
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.

Time frame: March-May 2014

Population: outcome assessed using data from cohort two girls only, using the baseline face-to-face questionnaire.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SC/ST Girls in Intervention Village ClusterNumber of Participants Entering Into 8th Standard [Start Secondary School]580 Participants
SC/ST Girls in Control Village ClusterNumber of Participants Entering Into 8th Standard [Start Secondary School]516 Participants
p-value: 0.33195% CI: [0.2, 2.31]Regression, Logistic
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.

Time frame: May-August 2016 (cohort one) and May-August 2017 (cohort two)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SC/ST Girls in Intervention Village ClusterNumber of Participants Having Sexual Debut [by Trial End Line]64 Participants
SC/ST Girls in Control Village ClusterNumber of Participants Having Sexual Debut [by Trial End Line]53 Participants
p-value: 0.7995% CI: [0.7, 1.55]Regression, Logistic
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.

Time frame: May-August 2016 (cohort one) and May-August 2017 (cohort two)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SC/ST Girls in Intervention Village ClusterNumber of Participants Married and Co-habiting With Husband [by Trial End Line]43 Participants
SC/ST Girls in Control Village ClusterNumber of Participants Married and Co-habiting With Husband [by Trial End Line]46 Participants
p-value: 0.4595% CI: [0.5, 1.34]Regression, Logistic
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.

Time frame: May-August 2016 (cohort one) and May-August 2017 (cohort two)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SC/ST Girls in Intervention Village ClusterNumber of Participants Passing 10th Standard [Pass 10th Standard Exam]518 Participants
SC/ST Girls in Control Village ClusterNumber of Participants Passing 10th Standard [Pass 10th Standard Exam]530 Participants
p-value: 0.2695% CI: [0.6, 1.15]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026