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Clinical Trials/NCT04307849
NCT04307849CompletedNot Applicable

Engaging Providers, Community Members, and Young Women to Adapt and Pilot a Youth-friendly Sexual and Reproductive Health Package in Low-income Communities in India

NYU Langone Health1 site in 1 country100 target enrollmentStarted: September 15, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Change in Sexual and Reproductive Health and Rights Knowledge Survey Score

Study Overview

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

Detailed Description

Aim 1: Adapt the health club curriculum and provider/staff sensitization training using Assessment, Decision, Administration, Production, discussion with Topical experts, Integration, Training, and Testing (ADAPT-ITT) Formative mixed methods data will be collected from stakeholders to assess the landscape of adolescent-friendly care and gaps to adapt the intervention. Intervention sessions will be presented to groups of stakeholders to elicit feedback on adaptations.

The formative research entails a mixed methods assessment of the adolescent sexual reproductive health landscape in the study area, and adaptation of the intervention components through interactive sessions, consistent with ADAPT-ITT.

ADAPT-ITT Assessment Phase

Key informant interviews (KIIs) - Qualitative key informant interviews (N=35) will be conducted with both public and private community-based health providers, NGO workers, community health workers (CHWs), and parents of young women. Interviews will also be conducted with government officials at the community and M Ward levels (wards are the smallest administrative unit of governmental ministries). These interviews will focus on qualitative mapping of adolescent health and treatment-seeking pathways and providers in the study area, and factors in the family, community, and elsewhere that influence adolescent girls' and young women's health. The KIIs will also provide insight into aspects of the intervention and evaluation tools requiring modification. KIIs will also be invited to join a community advisory board (CAB) for the duration of the project. This CAB will provide a forum for AGYW to present their learnings from the adolescent club, and serve as a resource should community members have questions or concerns about the intervention.

In-depth interviews with adolescent girls and young women (IDIs) - Qualitative in-depth interviews will be conducted with 20 AGYW (aged 15-25 years old) to understand their experiences with healthcare in the study area, treatment-seeking patterns, and factors in the family, community and elsewhere that influence their health. Young women will also be asked to comment on the proposed intervention's feasibility and acceptability, and provide input on aspects of the intervention and evaluation tools that need modification. Roughly equal numbers of married and unmarried young women will be recruited for participation. Young women will be recruited with assistance from NGO programs, CHWs, and referrals from other participants.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
15 Years to 25 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • AGYW between the ages of 15-25 years old
  • Provide consent or assent,
  • Living in the study area for one year or more,
  • If unmarried and under the age of 18, have parental consent to participate. Married AGYW and/or those age 18 or over will be recruited if they meet inclusion criteria and provide informed consent.

Exclusion Criteria

  • 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.

Arms & Interventions

Adolescent Health Club

Experimental

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

Intervention: Adolescent Health Club (Behavioral)

Wait-list Control

Placebo Comparator

Intervention: Adolescent Health Club (Behavioral)

Wait-list Control

Placebo Comparator

Intervention: Wait-list Control (Other)

Outcomes

Primary Outcomes

Change in Sexual and Reproductive Health and Rights Knowledge Survey Score

Time Frame: 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.

Secondary Outcomes

  • 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)
  • Change in Perceived Self-efficacy and Agency(Pre-Test (Baseline), Week 10 Post-Initiation of Intervention)
  • Change in Mental Health as Measured Using GAD-7(Pre-Test (Baseline), Week 10 Post-Initiation of Intervention)
  • Change in Mental Health as Measured Using PHQ-8(Pre-Test (Baseline), Week 10 Post-Initiation of Intervention)
  • Intervention Acceptability as Rated by AGYW(Week 10 Post-Initiation of Intervention)
  • Satisfaction With Intervention/Services as Rated by AGYW(Week 10 Post-Initiation of Intervention)
  • Intervention Feasibility as Rated by AGYW(Week 10 Post-Initiation of Intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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