Trial Outcomes & Findings for Evaluation of an Intervention for Adolescent Girls in Karnataka (NCT NCT01996241)
NCT ID: NCT01996241
Last Updated: 2019-10-15
Results Overview
This outcome will be assessed using data collected from all study participants at end-line, using the face-to-face questionnaire.
COMPLETED
NA
2457 participants
May-August 2016 (cohort one) and May-August 2017 (cohort two)
2019-10-15
Participant Flow
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.
Unit of analysis: Village cluster
Participant milestones
| Measure |
Intervention Village Cluster
All SC/ST girls in final year of primary school living in intervention villages eligible for study enrolment.
|
Control Village Cluster
All SC/ST girls in final year of primary school living in control villages eligible for study enrolment
|
|---|---|---|
|
Overall Study
STARTED
|
1164 40
|
1111 40
|
|
Overall Study
COMPLETED
|
912 40
|
876 40
|
|
Overall Study
NOT COMPLETED
|
252 0
|
235 0
|
Reasons for withdrawal
| Measure |
Intervention Village Cluster
All SC/ST girls in final year of primary school living in intervention villages eligible for study enrolment.
|
Control Village Cluster
All SC/ST girls in final year of primary school living in control villages eligible for study enrolment
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
252
|
235
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Village Cluster
n=1164 Participants
All SC/ST girls in final year of primary school living in intervention villages eligible for study enrolment.
|
Control Village Cluster
n=1111 Participants
All SC/ST girls in final year of primary school living in control villages eligible for study enrolment
|
Total
n=2275 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.0 years
n=1164 Participants
|
13.0 years
n=1111 Participants
|
13.0 years
n=2275 Participants
|
|
Sex: Female, Male
Female
|
1164 Participants
n=1164 Participants
|
1111 Participants
n=1111 Participants
|
2275 Participants
n=2275 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1164 Participants
|
0 Participants
n=1111 Participants
|
0 Participants
n=2275 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
India
|
1164 participants
n=1164 Participants
|
1111 participants
n=1111 Participants
|
2275 participants
n=2275 Participants
|
|
District
Bagalkote
|
639 Participants
n=1164 Participants
|
620 Participants
n=1111 Participants
|
1259 Participants
n=2275 Participants
|
|
District
Vijapura
|
525 Participants
n=1164 Participants
|
491 Participants
n=1111 Participants
|
1016 Participants
n=2275 Participants
|
|
Caste (ST vs. SC)
Scheduled Tribe
|
278 Participants
n=1164 Participants
|
209 Participants
n=1111 Participants
|
487 Participants
n=2275 Participants
|
|
Caste (ST vs. SC)
Schedued Caste
|
886 Participants
n=1164 Participants
|
902 Participants
n=1111 Participants
|
1788 Participants
n=2275 Participants
|
|
Non-literate Household Head
|
748 Participants
n=1164 Participants
|
667 Participants
n=1111 Participants
|
1415 Participants
n=2275 Participants
|
|
Village Type (Feeder vs. Main)
Feeder Village
|
321 Participants
n=1164 Participants
|
346 Participants
n=1111 Participants
|
667 Participants
n=2275 Participants
|
|
Village Type (Feeder vs. Main)
Main Village
|
843 Participants
n=1164 Participants
|
765 Participants
n=1111 Participants
|
1608 Participants
n=2275 Participants
|
|
Household wealth quintile (Poorest)
|
228 Participants
n=1164 Participants
|
227 Participants
n=1111 Participants
|
455 Participants
n=2275 Participants
|
|
Devadasi Family
|
65 Participants
n=1164 Participants
|
47 Participants
n=1111 Participants
|
112 Participants
n=2275 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
SC/ST Girls in Intervention Village Cluster
n=912 Participants
All SC/ST girls in final year of primary school living in intervention villages eligible for study enrolment.
|
SC/ST Girls in Control Village Cluster
n=876 Participants
All SC/ST girls in final year of primary school living in control villages eligible for study enrolment
|
|---|---|---|
|
Number of Participants Completing Secondary School [Sit 10th Standard Exam]
|
680 Participants
|
658 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
SC/ST Girls in Intervention Village Cluster
n=912 Participants
All SC/ST girls in final year of primary school living in intervention villages eligible for study enrolment.
|
SC/ST Girls in Control Village Cluster
n=876 Participants
All SC/ST girls in final year of primary school living in control villages eligible for study enrolment
|
|---|---|---|
|
Number of Participants Married [by Trial End Line]
|
92 Participants
|
84 Participants
|
SECONDARY outcome
Timeframe: March-May 2014Population: outcome assessed using data from cohort two girls only, using the baseline face-to-face questionnaire.
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.
Outcome measures
| Measure |
SC/ST Girls in Intervention Village Cluster
n=625 Participants
All SC/ST girls in final year of primary school living in intervention villages eligible for study enrolment.
|
SC/ST Girls in Control Village Cluster
n=566 Participants
All SC/ST girls in final year of primary school living in control villages eligible for study enrolment
|
|---|---|---|
|
Number of Participants Entering Into 8th Standard [Start Secondary School]
|
580 Participants
|
516 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
SC/ST Girls in Intervention Village Cluster
n=912 Participants
All SC/ST girls in final year of primary school living in intervention villages eligible for study enrolment.
|
SC/ST Girls in Control Village Cluster
n=876 Participants
All SC/ST girls in final year of primary school living in control villages eligible for study enrolment
|
|---|---|---|
|
Number of Participants Passing 10th Standard [Pass 10th Standard Exam]
|
518 Participants
|
530 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
SC/ST Girls in Intervention Village Cluster
n=912 Participants
All SC/ST girls in final year of primary school living in intervention villages eligible for study enrolment.
|
SC/ST Girls in Control Village Cluster
n=876 Participants
All SC/ST girls in final year of primary school living in control villages eligible for study enrolment
|
|---|---|---|
|
Number of Participants Having Sexual Debut [by Trial End Line]
|
64 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
SC/ST Girls in Intervention Village Cluster
n=912 Participants
All SC/ST girls in final year of primary school living in intervention villages eligible for study enrolment.
|
SC/ST Girls in Control Village Cluster
n=876 Participants
All SC/ST girls in final year of primary school living in control villages eligible for study enrolment
|
|---|---|---|
|
Number of Participants Married and Co-habiting With Husband [by Trial End Line]
|
43 Participants
|
46 Participants
|
Adverse Events
SC/ST Girls in Intervention Village Cluster
SC/ST Girls in Control Village Cluster
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Tara Beattie
London School of Hygiene and Tropical Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place