Acceptability, Family Planning, Feasibility, Unintended Pregnancy
Conditions
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.
Interventions
BEHAVIORALTARANG
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.
Sponsors
Network for Engineering and Economics Research and Management
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Vikalp Sansthan
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Intervention | Post-intervention at 5 month endline survey | Proportion of participants who complete 50% of the intervention sessions |
| Acceptability | Post-intervention at 5 month endline survey | Proportion of participants who were completely or somewhat satisfied with the intervention |
| Usefulness | Post-intervention at 5 month endline survey | Proportion of participants who found the TARANG intervention sessions very useful or somewhat useful |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TARANG Arm A single-arm trial in which intervention groups receive an introductory rapport-building session, followed by 16 group sessions facilitated by the moderators over six months. The intervention used practical skill-building activities to empower participants by enhancing their understanding of fundamental topics such as menstruation, conception, and contraception. | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | TARANG Arm |
|---|---|
| Age, Continuous | 20.3 Years STANDARD_DEVIATION 1.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 42 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 42 |
| other Total, other adverse events | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
Primary
Acceptability
Proportion of participants who were completely or somewhat satisfied with the intervention
Time frame: Post-intervention at 5 month endline survey
Population: Only participants who attended at least one session were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TARANG Arm | Acceptability | 34 Participants |
Primary
Feasibility of the Intervention
Proportion of participants who complete 50% of the intervention sessions
Time frame: Post-intervention at 5 month endline survey
Population: The outcome was only analyzed for those participants who attended at least one session.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TARANG Arm | Feasibility of the Intervention | 28 Participants |
Primary
Usefulness
Proportion of participants who found the TARANG intervention sessions very useful or somewhat useful
Time frame: Post-intervention at 5 month endline survey
Population: Only those who attended at least one session were asked about usefulness of sessions.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TARANG Arm | Usefulness | 35 Participants |