The TARANG Intervention (TARANGPilot)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Acceptability; Unintended Pregnancy; Family Planning; Feasibility

Treatments: Behavioral: TARANG

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06320964

R01HD108252_1

R01HD108252 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

TARANG arm

Experimental group

Description:

The newly married women received 16 weekly group sessions and one rapport-building session, while the husbands and mothers-in-law received four group sessions each over four months. The TARANG intervention was delivered via gender-matched moderators from Vikalp Sansthan and uses three overarching themes: sexual and reproductive health, gender norms, and empowerment.

Treatment:

Behavioral: TARANG