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

NCT04307849 | Completed Results

• 2 other identifiers: 24-002401K01TW011480-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study will systematically adapt, pilot test, and evaluate an integrated community/facility intervention to improve the uptake of adolescent-friendly services for married and unmarried adolescent girls and young women (AGYW; ages 15-25) in a low-income area with a population of approximately 700,000 in Mumbai, India

Conditions

Reproductive Health

Outcome Measures

Primary Outcomes (1)

• Change in Sexual and Reproductive Health and Rights Knowledge Survey Score

  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.

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

Secondary Outcomes (11)

• Change in Clinic Service Uptake/Use: Change in Number of Requests for Contraception

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

• Change in Clinic Service Uptake/Use: Change in Number of Requests for Menstrual Health Materials/Support (MHM/S)

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

• Change in Clinic Service Uptake/Use: Change in Number of Requests for STI/HIV Tests

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

• Change in Personal and Community Safety

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

• Change in Gender Norms

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

Study Arms (2)

Adolescent Health Club

EXPERIMENTAL

A systematic approach for the adaptation of sexual health/HIV-related evidence-based interventions

Behavioral: Adolescent Health Club

Wait-list Control

PLACEBO COMPARATOR

Behavioral: Adolescent Health Club; Other: Wait-list Control

Interventions

Adolescent Health Club BEHAVIORAL

Sexual health/HIV-related evidence-based interventions

Adolescent Health Club; Wait-list Control

Wait-list Control OTHER

The wait-listed group will begin the intervention after the intervention group

Wait-list Control

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• AGYW between the ages of 15-25 years old
• Provide consent or assent,
• Living in the study area for one year or more,

You may not qualify if:

• AGYW who are unable to give consent due to psychological or mental limitations,
• If unmarried and under the age of 18 do not have parental consent to participate.

Sponsors & Collaborators

• NYU Langone Health: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Apnalaya

Mumbai, Maharashtra, India

Location

Related Publications (8)

• Wingood GM, DiClemente RJ. The ADAPT-ITT model: a novel method of adapting evidence-based HIV Interventions. J Acquir Immune Defic Syndr. 2008 Mar 1;47 Suppl 1:S40-6. doi: 10.1097/QAI.0b013e3181605df1.

  PMID: 18301133 BACKGROUND

• Hunsley J. Development of the treatment acceptability questionnaire. Journal of Psychopathology and Behavioral Assessment. 1992;14(1):55-64.

  BACKGROUND

• Cleland J, Ingham R, Stone N. Asking young people about sexual and reproductive behaviours: Illustrative Core Instruments. World Health Organization, 2001.

  BACKGROUND

• Bhatla N, Achyut P, Ghosh S, Gautam A, Verma R. Safe Cities Free From Violence Against Women and Girls: Baseline Finding from the

  BACKGROUND

• Achyut P, Bhatia N, Singh A, Verma R, Khandekar S, Pallav P, et al. Building support for gender equality among young adolescents in school: findings from Mumbai India. 2011.

  BACKGROUND

• Brault MA, Schensul SL, Bankar S. The role of pre-marital agency in delaying marriage and reproductive decision-making in urban India. In: Erausquin MWaJT, editor. Global Perspectives on Women's Reproductive and Sexual Health Across the Lifespan: Springer Press Publishers; 2017.

  BACKGROUND

• Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, Walters EE, Zaslavsky AM. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002 Aug;32(6):959-76. doi: 10.1017/s0033291702006074.

  PMID: 12214795 BACKGROUND

• Lewis CC, Fischer S, Weiner BJ, Stanick C, Kim M, Martinez RG. Outcomes for implementation science: an enhanced systematic review of instruments using evidence-based rating criteria. Implement Sci. 2015 Nov 4;10:155. doi: 10.1186/s13012-015-0342-x.

  PMID: 26537706 BACKGROUND

Results Point of Contact

• Title: Marie Brault, PhD
• Organization: NYU Langone Health

Marie.Brault@nyulangone.org

210-276-9012

Study Officials

• Marie Brault, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: March 13, 2020
• Study Start: September 15, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: November 6, 2024
• Results First Posted: November 6, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)