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Clinical Trials/NCT06320964
NCT06320964
Completed
Not Applicable

Feasibility and Acceptability of a Group-based Life Skills-integrated Reproductive Health Empowerment Intervention for Newly Married Women, Husbands, and Mothers-in-law

University of California, San Francisco1 site in 1 country42 target enrollmentJuly 14, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Feasibility
Sponsor
University of California, San Francisco
Enrollment
42
Locations
1
Primary Endpoint
Feasibility of the Intervention
Status
Completed
Last Updated
last year

Overview

Brief Summary

The mixed methods pilot study aims to evaluate the acceptability, feasibility, and implementation challenges of the TARANG intervention in villages in rural/tribal Rajasthan to inform the study design and operational details for a larger cluster-randomized controlled trial.

Detailed Description

Participants will participate in the single group in the TARANG intervention arm and receive the sessions that will enable them to navigate newly formed relationships (e.g. spousal communication, healthy relationships with in-laws, establishing peer network, and negotiation skills), improve participants awareness of sexual reproductive health, enable participants to challenge inequitable gender norms to reduce unintended pregnancies. Newly married women (daughters-in-law) received 17 sessions; husbands received 4 sessions and mothers-in-law received 4 sessions. The sessions are implemented by NGO partner, Vikalp Sansthan via trained facilitators/moderators who are supervised by NGO staff. In this mixed methods pilot study, we aimed to qualitatively understand the participants' acceptability, feasibility of the TARANG intervention delivery, content, modules, etc. We also aimed to capture the qualitative impact of the TARANG intervention and pilot activities in communities/villages as well as to understand the operational challenges of delivery from participants and NGO moderators (key informants) delivering the intervention. Quantitative pre- and post-surveys were conducted to understand implementation outcomes such as feasibility, acceptability, and satisfaction, among other outcomes.

Registry
clinicaltrials.gov
Start Date
July 14, 2023
End Date
January 21, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Newly married women:
  • Age 18-25 years at the time of wedding
  • Does not plan to move out of the area for the period of the intervention
  • Mother-in-law has agreed to support daughter-in-law's participation in the study
  • Mother-in-law and husband are eligible for the study participation
  • 18 years or more at the time of the wedding
  • Does not plan to move out of the village during period of the intervention
  • Mother and wife are eligible for study participation
  • Mothers-in-law:
  • Has a daughter-in-law who is eligible and willing to participate in the study

Exclusion Criteria

  • Newly married women:
  • Wanting to have a child in the next 12 months at the time of baseline
  • Cognitive ability to participate in surveys

Outcomes

Primary Outcomes

Feasibility of the Intervention

Time Frame: Post-intervention at 5 month endline survey

Proportion of participants who complete 50% of the intervention sessions

Acceptability

Time Frame: Post-intervention at 5 month endline survey

Proportion of participants who were completely or somewhat satisfied with the intervention

Usefulness

Time Frame: Post-intervention at 5 month endline survey

Proportion of participants who found the TARANG intervention sessions very useful or somewhat useful

Study Sites (1)

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