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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06320964
Other study ID # R01HD108252_1
Secondary ID R01HD108252
Status Completed
Phase N/A
First received
Last updated
Start date July 14, 2023
Est. completion date January 21, 2024

Study information

Verified date March 2024
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 135
Est. completion date January 21, 2024
Est. primary completion date January 21, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Husbands: - 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 - Provides individual consent to participate in the study - Assents for daughter-in-law to participate in the study - Does not plan to move out of the village during period of the intervention - The son and the daughter-in-law are eligible for study participation 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

Study Design


Intervention

Behavioral:
TARANG
For newly married women, the intervention had one introductory rapport-building session, followed by 16 group sessions facilitated by trained female moderators over 5 months. The intervention aimed to empower participants by enhancing their understanding of fundamental topics such as menstruation, conception, and contraception, choice of a method among others. Sessions also covered topics to strengthen participants' sense of agency and their ability to make informed decisions regarding family planning and the timing of their first childbirth. Similarly, for husbands, a male moderator delivered sessions on four topics: Love, Relationships and Expectations; Conception and Health; Contraception Methods, and how to choose family planning methods. For MILs, a female moderator covered four sessions: Nutrition flag, Conception and Health, communication between family members, and the final session on relationships with daughter-in-law.

Locations

Country Name City State
India Vikalp Sansthan Udaipur Rajasthan

Sponsors (4)

Lead Sponsor Collaborator
University of California, San Francisco Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Network for Engineering and Economics Research and Management, Vikalp Sansthan

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of the intervention Proportion of participants who complete 50% of the intervention sessions Post-intervention at 5 month endline survey
Primary Acceptability Proportion of participants who were completely or somewhat satisfied with the intervention Post-intervention at 5 month endline survey
Primary Usefulness Proportion of participants who found the TARANG intervention sessions very useful or somewhat useful Post-intervention at 5 month endline survey
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