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Trial · NCT01996241

Evaluation of an Intervention for Adolescent Girls in Karnataka

NCT01996241, Not applicable, Completed, Karnataka Health Promotion Trust; results first posted 2019-09-25

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Evaluation of an Intervention for Adolescent Girls in Karnataka. Trials, record NCT01996241. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01996241

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Evaluation of an Intervention for Adolescent Girls in Karnataka
NCT number
NCT01996241
Status
Completed
Phases
Not applicable
Enrollment
2,457 participants, actual
Lead sponsor
Karnataka Health Promotion Trust
Conditions
Secondary School Entry and Completion, Child Marriage
Interventions
Multi-level, structural and norms-based intervention
First posted
2013-11-27
Last updated
2019-10-15
Results first posted
2019-09-25
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.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber 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.
PrimaryNumber 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.
SecondaryNumber of Participants Entering Into 8th Standard [Start Secondary School]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.
SecondaryNumber 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.
SecondaryNumber 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.
SecondaryNumber 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.

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants Completing Secondary School [Sit 10th Standard Exam]May-August 2016 (cohort one) and May-August 2017 (cohort two)ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants Married [by Trial End Line]May-August 2016 (cohort one) and May-August 2017 (cohort two)ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Entering Into 8th Standard [Start Secondary School]March-May 2014outcome assessed using data from cohort two girls only, using the baseline face-to-face questionnaire.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Passing 10th Standard [Pass 10th Standard Exam]May-August 2016 (cohort one) and May-August 2017 (cohort two)ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Having Sexual Debut [by Trial End Line]May-August 2016 (cohort one) and May-August 2017 (cohort two)ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Married and Co-habiting With Husband [by Trial End Line]May-August 2016 (cohort one) and May-August 2017 (cohort two)ParticipantsCOUNT_OF_PARTICIPANTS

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Number of Participants Completing Secondary School [Sit 10th Standard Exam]SC/ST Girls in Intervention Village Cluster680Participants
Number of Participants Completing Secondary School [Sit 10th Standard Exam]SC/ST Girls in Control Village Cluster658Participants
Number of Participants Married [by Trial End Line]SC/ST Girls in Intervention Village Cluster92Participants
Number of Participants Married [by Trial End Line]SC/ST Girls in Control Village Cluster84Participants
Number of Participants Entering Into 8th Standard [Start Secondary School]SC/ST Girls in Intervention Village Cluster580Participants
Number of Participants Entering Into 8th Standard [Start Secondary School]SC/ST Girls in Control Village Cluster516Participants
Number of Participants Passing 10th Standard [Pass 10th Standard Exam]SC/ST Girls in Intervention Village Cluster518Participants
Number of Participants Passing 10th Standard [Pass 10th Standard Exam]SC/ST Girls in Control Village Cluster530Participants
Number of Participants Having Sexual Debut [by Trial End Line]SC/ST Girls in Intervention Village Cluster64Participants
Number of Participants Having Sexual Debut [by Trial End Line]SC/ST Girls in Control Village Cluster53Participants

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDIntervention Village Cluster1,16440
Overall StudySTARTEDControl Village Cluster1,11140
Overall StudyCOMPLETEDIntervention Village Cluster91240
Overall StudyCOMPLETEDControl Village Cluster87640
Overall StudyNOT COMPLETEDIntervention Village Cluster2520
Overall StudyNOT COMPLETEDControl Village Cluster2350

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalitySC/ST Girls in Intervention Village Cluster01,265
Total, all-cause mortalitySC/ST Girls in Control Village Cluster01,192
Total, other adverse eventsSC/ST Girls in Intervention Village Cluster01,265
Total, other adverse eventsSC/ST Girls in Control Village Cluster01,192
Total, serious adverse eventsSC/ST Girls in Intervention Village Cluster01,265
Total, serious adverse eventsSC/ST Girls in Control Village Cluster01,192

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
25881037BACKGROUNDPubMed
28968543BACKGROUNDPubMed
30113275BACKGROUNDPubMed
30183747BACKGROUNDPubMed
30630455DERIVEDPubMed
31448111DERIVEDPubMed
32720188DERIVEDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons8

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
SC/ST Girls in Intervention Village Cluster vs SC/ST Girls in Control Village Cluster: Number of Participants Entering Into 8th Standard [Start Secondary School]Trial comparisons
SC/ST Girls in Intervention Village Cluster vs SC/ST Girls in Control Village Cluster: Number of Participants Married and Co-habiting With Husband [by Trial End Line]Trial comparisons
SC/ST Girls in Intervention Village Cluster vs SC/ST Girls in Control Village Cluster: Number of Participants Passing 10th Standard [Pass 10th Standard Exam]Trial comparisons
SC/ST Girls in Intervention Village Cluster vs SC/ST Girls in Control Village Cluster: Number of Participants Married [by Trial End Line]Trial comparisons
SC/ST Girls in Intervention Village Cluster vs SC/ST Girls in Control Village Cluster: Number of Participants Completing Secondary School [Sit 10th Standard Exam]Trial comparisons
SC/ST Girls in Intervention Village Cluster vs SC/ST Girls in Control Village Cluster: deaths from any causeTrial comparisons
SC/ST Girls in Intervention Village Cluster vs SC/ST Girls in Control Village Cluster: Number of Participants Having Sexual Debut [by Trial End Line]Trial comparisons
SC/ST Girls in Intervention Village Cluster vs SC/ST Girls in Control Village Cluster: serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01996241

GET https://conductscience.org/api/trials/v1/NCT01996241/registered