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Trial Outcomes & Findings for Youth-friendly Sexual and Reproductive Healthcare Pilot in Mumbai, India (NCT NCT04307849)

NCT ID: NCT04307849

Last Updated: 2024-11-06

Results Overview

Change from baseline to end of intervention (\~10 weeks) will be measured using the subscale "Sexual and Reproductive Health Knowledge" subscale of the "Illustrative Questionnaire for Interview-Surveys with Young People" \[Cleland, et al. 2001(1)\], which has been validated and used to assess adolescent and young adult knowledge about sexual and reproductive health and rights. The survey consists of a subset of 22 questions, and takes approximately 20 minutes to complete. Each correct answer receives 1 point, while wrong answers and "I don't know" responses receive 0 points. The total score is the sum of responses and ranges from 0-22. Higher scores suggest better sexual and reproductive health and rights knowledge.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

Pre-Test (Baseline), Week 10 Post-Initiation of Intervention

Results posted on

2024-11-06

Participant Flow

Note that parents of participants were not enrolled in the study.

Participant milestones

Participant milestones
Measure
Group A
Participants in Group A receive the intervention during Intervention Period 1 and do not have wait list control data collected.
Group B
Participants in Group B have wait list control data collected during Intervention Period 1, and receive the intervention during Intervention Period 2.
Group C
Participants in Group C have wait list control data collected during Intervention Period 2, and receive the intervention during Intervention Period 3.
Group D
Participants in Group D have wait list control data collected during Intervention Period 3 and receive the intervention during Intervention Period 4.
Physician Workshop Participants
Physicians who participate in the facility-based intervention
Community Health Volunteers (CHV) Workshop Participants
CHVs who participate in the intervention sessions.
Overall Study
STARTED
25
25
25
25
41
20
Overall Study
# Participants Started Intervention Period 1:
25
25
0
0
0
0
Overall Study
# Participants Completed Intervention Period 1:
23
25
0
0
0
0
Overall Study
# Participants Started Intervention Period 2:
0
25
25
0
23
20
Overall Study
# Participants Completed Intervention Period 2:
0
23
25
0
21
19
Overall Study
# Participants Started Intervention Period 3:
0
0
25
25
0
0
Overall Study
# Participants Completed Intervention Period 3:
0
0
19
25
0
0
Overall Study
# Participants Started Intervention Period 4:
0
0
0
25
18
0
Overall Study
# Participants Completed Intervention Period 4:
0
0
0
22
16
0
Overall Study
COMPLETED
23
23
19
22
37
19
Overall Study
NOT COMPLETED
2
2
6
3
4
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Group A
Participants in Group A receive the intervention during Intervention Period 1 and do not have wait list control data collected.
Group B
Participants in Group B have wait list control data collected during Intervention Period 1, and receive the intervention during Intervention Period 2.
Group C
Participants in Group C have wait list control data collected during Intervention Period 2, and receive the intervention during Intervention Period 3.
Group D
Participants in Group D have wait list control data collected during Intervention Period 3 and receive the intervention during Intervention Period 4.
Physician Workshop Participants
Physicians who participate in the facility-based intervention
Community Health Volunteers (CHV) Workshop Participants
CHVs who participate in the intervention sessions.
Overall Study
Took a paid position and/or work schedule no longer allowed participation
2
2
1
2
4
1
Overall Study
Travelled out of Mumbai to natal place/village
0
0
3
0
0
0
Overall Study
Family member did not want them to continue
0
0
1
0
0
0
Overall Study
Medical reason (gave birth, became ill)
0
0
1
1
0
0

Baseline Characteristics

Youth-friendly Sexual and Reproductive Healthcare Pilot in Mumbai, India

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group A
n=23 Participants
Participants in Group A receive the intervention during Intervention Period 1 and do not have wait list control data collected.
Group B
n=23 Participants
Participants in Group B have wait list control data collected during Intervention Period 1, and receive the intervention during Intervention Period 2.
Group C
n=19 Participants
Participants in Group C have wait list control data collected during Intervention Period 2, and receive the intervention during Intervention Period 3.
Group D
n=22 Participants
Participants in Group D have wait list control data collected during Intervention Period 3 and receive the intervention during Intervention Period 4.
Physician Workshop Participants
n=37 Participants
Physicians who participated in the intervention.
CHV Workshop Participants
CHVs who participated in the intervention.
Total
n=124 Participants
Total of all reporting groups
Age, Continuous
18.04 years
n=99 Participants
18.52 years
n=107 Participants
17.58 years
n=206 Participants
18.91 years
n=157 Participants
45.2 years
n=390 Participants
—
23.65 years
n=3 Participants
Sex: Female, Male
Female
23 Participants
n=99 Participants
23 Participants
n=107 Participants
19 Participants
n=206 Participants
22 Participants
n=157 Participants
18 Participants
n=390 Participants
—
105 Participants
n=3 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=157 Participants
19 Participants
n=390 Participants
—
19 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=157 Participants
0 Participants
n=390 Participants
—
0 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
23 Participants
n=99 Participants
23 Participants
n=107 Participants
19 Participants
n=206 Participants
22 Participants
n=157 Participants
37 Participants
n=390 Participants
—
124 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=157 Participants
0 Participants
n=390 Participants
—
0 Participants
n=3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=157 Participants
0 Participants
n=390 Participants
—
0 Participants
n=3 Participants
Race (NIH/OMB)
Asian
23 Participants
n=99 Participants
23 Participants
n=107 Participants
19 Participants
n=206 Participants
22 Participants
n=157 Participants
37 Participants
n=390 Participants
—
124 Participants
n=3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=157 Participants
0 Participants
n=390 Participants
—
0 Participants
n=3 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=157 Participants
0 Participants
n=390 Participants
—
0 Participants
n=3 Participants
Race (NIH/OMB)
White
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=157 Participants
0 Participants
n=390 Participants
—
0 Participants
n=3 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=157 Participants
0 Participants
n=390 Participants
—
0 Participants
n=3 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=157 Participants
0 Participants
n=390 Participants
—
0 Participants
n=3 Participants
Region of Enrollment
India
23 participants
n=99 Participants
23 participants
n=107 Participants
19 participants
n=206 Participants
22 participants
n=157 Participants
37 participants
n=390 Participants
—
87 participants
n=3 Participants

PRIMARY outcome

Timeframe: Pre-Test (Baseline), Week 10 Post-Initiation of Intervention

Change from baseline to end of intervention (\~10 weeks) will be measured using the subscale "Sexual and Reproductive Health Knowledge" subscale of the "Illustrative Questionnaire for Interview-Surveys with Young People" \[Cleland, et al. 2001(1)\], which has been validated and used to assess adolescent and young adult knowledge about sexual and reproductive health and rights. The survey consists of a subset of 22 questions, and takes approximately 20 minutes to complete. Each correct answer receives 1 point, while wrong answers and "I don't know" responses receive 0 points. The total score is the sum of responses and ranges from 0-22. Higher scores suggest better sexual and reproductive health and rights knowledge.

Outcome measures

Outcome measures
Measure
Group A
n=23 Participants
Participants in Group A receive the intervention during Intervention Period 1 and do not have wait list control data collected.
Group B
n=23 Participants
Participants in Group B have wait list control data collected during Intervention Period 1, and receive the intervention during Intervention Period 2.
Group C
n=19 Participants
Participants in Group C have wait list control data collected during Intervention Period 2, and receive the intervention during Intervention Period 3.
Group D
n=22 Participants
Participants in Group D have wait list control data collected during Intervention Period 3 and receive the intervention during Intervention Period 4.
Change in Sexual and Reproductive Health and Rights Knowledge Survey Score
0.45 score on a scale
Standard Deviation 0.02
0.44 score on a scale
Standard Deviation 0.03
0.47 score on a scale
Standard Deviation 0.04
0.49 score on a scale
Standard Deviation 0.04

SECONDARY outcome

Timeframe: Pre-Test (Baseline), Week 10 Post-Initiation of Intervention

The change from baseline to end of intervention (\~10 weeks) will be measured asking AGYW about their most recent healthcare usage (where they went for healthcare, the reason they went, and what services and referrals they requested). This outcome measures the change in the number of requests for contraception, and is measured across all participants.

Outcome measures

Outcome measures
Measure
Group A
n=23 Participants
Participants in Group A receive the intervention during Intervention Period 1 and do not have wait list control data collected.
Group B
n=23 Participants
Participants in Group B have wait list control data collected during Intervention Period 1, and receive the intervention during Intervention Period 2.
Group C
n=19 Participants
Participants in Group C have wait list control data collected during Intervention Period 2, and receive the intervention during Intervention Period 3.
Group D
n=22 Participants
Participants in Group D have wait list control data collected during Intervention Period 3 and receive the intervention during Intervention Period 4.
Change in Clinic Service Uptake/Use: Change in Number of Requests for Contraception
-1 Number of requests for contraception
0 Number of requests for contraception
-2 Number of requests for contraception
1 Number of requests for contraception

SECONDARY outcome

Timeframe: Pre-Test (Baseline), Week 10 Post-Initiation of Intervention

The change from baseline to end of intervention (\~10 weeks) will be measured asking AGYW about their most recent healthcare usage (where they went for healthcare, the reason they went, and what services and referrals they requested). This outcome measures the change in the number of requests for menstrual health materials/support (MHM/S), and is measured across all participants.

Outcome measures

Outcome measures
Measure
Group A
n=23 Participants
Participants in Group A receive the intervention during Intervention Period 1 and do not have wait list control data collected.
Group B
n=23 Participants
Participants in Group B have wait list control data collected during Intervention Period 1, and receive the intervention during Intervention Period 2.
Group C
n=19 Participants
Participants in Group C have wait list control data collected during Intervention Period 2, and receive the intervention during Intervention Period 3.
Group D
n=22 Participants
Participants in Group D have wait list control data collected during Intervention Period 3 and receive the intervention during Intervention Period 4.
Change in Clinic Service Uptake/Use: Change in Number of Requests for Menstrual Health Materials/Support (MHM/S)
-1 Number of requests for MHM/S
0 Number of requests for MHM/S
-4 Number of requests for MHM/S
-3 Number of requests for MHM/S

SECONDARY outcome

Timeframe: Pre-Test (Baseline), Week 10 Post-Initiation of Intervention

The change from baseline to end of intervention (\~10 weeks) will be measured asking AGYW about their most recent healthcare usage (where they went for healthcare, the reason they went, and what services and referrals they requested). This outcome measures the change in the number of requests for STI/HIV tests, and is measured across all participants.

Outcome measures

Outcome measures
Measure
Group A
n=23 Participants
Participants in Group A receive the intervention during Intervention Period 1 and do not have wait list control data collected.
Group B
n=23 Participants
Participants in Group B have wait list control data collected during Intervention Period 1, and receive the intervention during Intervention Period 2.
Group C
n=19 Participants
Participants in Group C have wait list control data collected during Intervention Period 2, and receive the intervention during Intervention Period 3.
Group D
n=22 Participants
Participants in Group D have wait list control data collected during Intervention Period 3 and receive the intervention during Intervention Period 4.
Change in Clinic Service Uptake/Use: Change in Number of Requests for STI/HIV Tests
-2 Number of requests for STI/HIV tests
0 Number of requests for STI/HIV tests
-4 Number of requests for STI/HIV tests
0 Number of requests for STI/HIV tests

SECONDARY outcome

Timeframe: Pre-Test (Baseline), Week 10 Post-Initiation of Intervention

The change from baseline to end of intervention (\~10 weeks) will be measured asking AGYW about their perceptions of personal and community safety. These questions were developed and validated for use in India by Bhatla, et al. 2013 (2). This consists of 7 questions, and takes approximately 7 minutes to complete. Score range from 0 - 4, higher scores suggest greater feelings of safety.

Outcome measures

Outcome measures
Measure
Group A
n=23 Participants
Participants in Group A receive the intervention during Intervention Period 1 and do not have wait list control data collected.
Group B
n=23 Participants
Participants in Group B have wait list control data collected during Intervention Period 1, and receive the intervention during Intervention Period 2.
Group C
n=19 Participants
Participants in Group C have wait list control data collected during Intervention Period 2, and receive the intervention during Intervention Period 3.
Group D
n=22 Participants
Participants in Group D have wait list control data collected during Intervention Period 3 and receive the intervention during Intervention Period 4.
Change in Personal and Community Safety
-0.14 score on a scale
Standard Deviation 0.09
-0.16 score on a scale
Standard Deviation 0.15
-0.43 score on a scale
Standard Deviation 0.16
-0.38 score on a scale
Standard Deviation 0.18

SECONDARY outcome

Timeframe: Pre-Test (Baseline), Week 10 Post-Initiation of Intervention

The change from baseline to end of intervention (\~10 weeks) will be measured asking AGYW about their perceptions regarding what are acceptable behaviors for young men and women in their community. These questions were developed and validated for use in India by Achyut, et al. 2011 (3). This consists of 40 questions, and takes approximately 30 minutes to complete. Score ranges from 1-4, higher scores suggest more gender equitable norms.

Outcome measures

Outcome measures
Measure
Group A
n=23 Participants
Participants in Group A receive the intervention during Intervention Period 1 and do not have wait list control data collected.
Group B
n=23 Participants
Participants in Group B have wait list control data collected during Intervention Period 1, and receive the intervention during Intervention Period 2.
Group C
n=19 Participants
Participants in Group C have wait list control data collected during Intervention Period 2, and receive the intervention during Intervention Period 3.
Group D
n=22 Participants
Participants in Group D have wait list control data collected during Intervention Period 3 and receive the intervention during Intervention Period 4.
Change in Gender Norms
0.16 score on a scale
Standard Deviation 0.03
0.06 score on a scale
Standard Deviation 0.06
0.07 score on a scale
Standard Deviation 0.07
0.15 score on a scale
Standard Deviation 0.08

SECONDARY outcome

Timeframe: Pre-Test (Baseline), Week 10 Post-Initiation of Intervention

This is a sub-scale asking AGYW about their perceived self-efficacy and agency will be measured at baseline. These questions were developed and validated for use by Brault, et al. 2017 (4). This consists of 9 questions, and takes approximately 5 minutes to complete. Score ranges from 1-4, higher scores suggest greater self-efficacy.

Outcome measures

Outcome measures
Measure
Group A
n=23 Participants
Participants in Group A receive the intervention during Intervention Period 1 and do not have wait list control data collected.
Group B
n=23 Participants
Participants in Group B have wait list control data collected during Intervention Period 1, and receive the intervention during Intervention Period 2.
Group C
n=19 Participants
Participants in Group C have wait list control data collected during Intervention Period 2, and receive the intervention during Intervention Period 3.
Group D
n=22 Participants
Participants in Group D have wait list control data collected during Intervention Period 3 and receive the intervention during Intervention Period 4.
Change in Perceived Self-efficacy and Agency
0.18 score on a scale
Standard Deviation 0.03
0.51 score on a scale
Standard Deviation 0.05
0.49 score on a scale
Standard Deviation 0.06
0.46 score on a scale
Standard Deviation 0.06

SECONDARY outcome

Timeframe: Pre-Test (Baseline), Week 10 Post-Initiation of Intervention

The Generalized Anxiety Disorder 7-item (GAD-7) questionnaire is an assessment of symptoms of generalized anxiety disorder. Each item is rated on a Likert scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-21; higher scores indicate greater presence of generalized anxiety disorder symptoms.

Outcome measures

Outcome measures
Measure
Group A
n=23 Participants
Participants in Group A receive the intervention during Intervention Period 1 and do not have wait list control data collected.
Group B
n=23 Participants
Participants in Group B have wait list control data collected during Intervention Period 1, and receive the intervention during Intervention Period 2.
Group C
n=19 Participants
Participants in Group C have wait list control data collected during Intervention Period 2, and receive the intervention during Intervention Period 3.
Group D
n=22 Participants
Participants in Group D have wait list control data collected during Intervention Period 3 and receive the intervention during Intervention Period 4.
Change in Mental Health as Measured Using GAD-7
0.38 score on a scale
Standard Deviation 0.35
-1.55 score on a scale
Standard Deviation 0.62
-1.92 score on a scale
Standard Deviation 0.71
-1.76 score on a scale
Standard Deviation 0.80

SECONDARY outcome

Timeframe: Pre-Test (Baseline), Week 10 Post-Initiation of Intervention

The Patient Health Questionnaire depression scale (PHQ-8) is an 8-item assessment of depressive symptomology. The questionnaire is scored by adding up the values of all eight items on the scale. Each item uses a 4-point Likert-type scale, ranging from 0 ("not at all") to 3 ("nearly every day"). The total score ranges from 0 to 24 points, with higher scores indicating greater depressive symptomology.

Outcome measures

Outcome measures
Measure
Group A
n=23 Participants
Participants in Group A receive the intervention during Intervention Period 1 and do not have wait list control data collected.
Group B
n=23 Participants
Participants in Group B have wait list control data collected during Intervention Period 1, and receive the intervention during Intervention Period 2.
Group C
n=19 Participants
Participants in Group C have wait list control data collected during Intervention Period 2, and receive the intervention during Intervention Period 3.
Group D
n=22 Participants
Participants in Group D have wait list control data collected during Intervention Period 3 and receive the intervention during Intervention Period 4.
Change in Mental Health as Measured Using PHQ-8
0.30 score on a scale
Standard Deviation 0.29
-0.85 score on a scale
Standard Deviation 0.53
-1.23 score on a scale
Standard Deviation 0.62
-0.98 score on a scale
Standard Deviation 0.72

SECONDARY outcome

Timeframe: Week 10 Post-Initiation of Intervention

Measured at the end of the intervention (\~10 weeks). These questions assess the acceptability of the intervention, and were developed by Hunsley 1992 (6). This consists of 6 questions, and takes approximately 5 minutes to complete. Score ranges from 1- 7, higher scores suggest higher intervention acceptability.

Outcome measures

Outcome measures
Measure
Group A
n=23 Participants
Participants in Group A receive the intervention during Intervention Period 1 and do not have wait list control data collected.
Group B
n=23 Participants
Participants in Group B have wait list control data collected during Intervention Period 1, and receive the intervention during Intervention Period 2.
Group C
n=19 Participants
Participants in Group C have wait list control data collected during Intervention Period 2, and receive the intervention during Intervention Period 3.
Group D
n=22 Participants
Participants in Group D have wait list control data collected during Intervention Period 3 and receive the intervention during Intervention Period 4.
Intervention Acceptability as Rated by AGYW
6.81 score on a scale
Standard Deviation 0.36
6.64 score on a scale
Standard Deviation 0.44
6.84 score on a scale
Standard Deviation 0.28
6.89 score on a scale
Standard Deviation 0.23

SECONDARY outcome

Timeframe: Week 10 Post-Initiation of Intervention

Measured at the end of the intervention (\~10 weeks).These questions assess participant satisfaction with the intervention, and are described by Lewis, et al. 2015 (7). This consists of 11 questions, and takes approximately 10 minutes to complete. Score ranges from 1 to 12, higher scores suggest greater satisfaction with services

Outcome measures

Outcome measures
Measure
Group A
n=23 Participants
Participants in Group A receive the intervention during Intervention Period 1 and do not have wait list control data collected.
Group B
n=23 Participants
Participants in Group B have wait list control data collected during Intervention Period 1, and receive the intervention during Intervention Period 2.
Group C
n=19 Participants
Participants in Group C have wait list control data collected during Intervention Period 2, and receive the intervention during Intervention Period 3.
Group D
n=22 Participants
Participants in Group D have wait list control data collected during Intervention Period 3 and receive the intervention during Intervention Period 4.
Satisfaction With Intervention/Services as Rated by AGYW
8.58 score on a scale
Standard Deviation 0.59
8.63 score on a scale
Standard Deviation 0.90
8.48 score on a scale
Standard Deviation 0.71
8.39 score on a scale
Standard Deviation 0.69

SECONDARY outcome

Timeframe: Week 10 Post-Initiation of Intervention

Measured at the end of the intervention (\~10 weeks).These questions assess participant perceptions of the feasibility of the intervention, and are described by Lewis, et al. 2015 (7). This consists of 4 questions, and takes approximately 2 minutes to complete. Score ranges from 1 to 5, higher scores suggest higher intervention feasibility.

Outcome measures

Outcome measures
Measure
Group A
n=23 Participants
Participants in Group A receive the intervention during Intervention Period 1 and do not have wait list control data collected.
Group B
n=23 Participants
Participants in Group B have wait list control data collected during Intervention Period 1, and receive the intervention during Intervention Period 2.
Group C
n=19 Participants
Participants in Group C have wait list control data collected during Intervention Period 2, and receive the intervention during Intervention Period 3.
Group D
n=22 Participants
Participants in Group D have wait list control data collected during Intervention Period 3 and receive the intervention during Intervention Period 4.
Intervention Feasibility as Rated by AGYW
5 score on a scale
Standard Deviation 0
4.78 score on a scale
Standard Deviation 0.41
5 score on a scale
Standard Deviation 0
4.96 score on a scale
Standard Deviation 0.21

Adverse Events

Group A

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group B

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group C

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group D

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marie Brault, PhD

NYU Langone Health

Phone: 210-276-9012

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place