Clinical trial NCT05732142: Postpartum Integration of Vaccines and Contraception Trial
Official title: Postpartum Integration of Vaccines and Contraception Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Gender Equity
Keywords: Family Planning
Infant Vaccination
Linked Care
India
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Indian Council of Medical Research
First posted: 2023-02-16
Enrollment: 293
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to examine how to implement a gender-transformative post-partum family planning program integrated into community-based infant vaccination services, and to evaluate preliminary effectiveness of this approach on postpartum contraceptive use in a low resource, rural setting.

Detailed description: Using effective postpartum contraception allows postpartum people to prevent short inter-pregnancy intervals which are associated with an increased risk of maternal and infant morbidity and mortality. India is the country with the highest number of women with an unmet need for contraception, and postpartum and rural women are those with the greatest need. Uptake of postpartum contraception among women in rural India is low; less than half of postpartum women use contraception within the first year after delivery, and many births do not follow the recommended interval.

A promising intervention to address barriers to family planning care is to build on an existing successful health program, the infant vaccination program, by linking family planning services with infant vaccination. India's Ministry of Health has promoted community-based delivery of infant vaccinations, and monthly childhood vaccination services are offered at Village Health and Nutrition Days typically held at Anganwadi Community Centers. Six-week vaccination rates are high, indicating that these services are routinely used by families of young infants, which provides an opportunity to reach postpartum women simultaneously. This programming addresses gender-inequitable social norms and has shown to facilitate more successful family planning intervention but has not been studied among postpartum women. This study will adapt a gender-transformative family planning intervention to support community-based delivery of family planning with infant vaccination; this intervention has the potential to increase family planning use among postpartum women with unmet need in low-resources and rural settings.

This is a two-arm, cluster randomized-trial where postpartum women will be assigned to participation in the linked care model (PIVoT) or the standard of care (referring women to public health centers for family planning counseling and contraceptive provision). The study team will enroll 286 women in the study, 143 in each the intervention and control arms. Randomization will occur at the subcenter level. Participants will be recruited among postpartum women presenting for infant vaccination services at VHND.

Follow-up will occur with women at 6 months and 12 months postpartum and outcomes will be assessed via tablet-based surveys. In addition, a total of 40 in-depth interviews will take place with a group of PIVoT intervention participants, their husbands, and health care providers who delivered the program after completion of the study for further evaluation.

Eligibility criteria: Inclusion Criteria:

* Postpartum women who delivered a baby within the past 12 weeks
* Speak Marathi
* Reside in rural Maharashtra
* Did not undergo sterilization, hysterectomy or immediate postpartum intrauterine device (IUD) placement

Exclusion Criteria:

* Currently pregnant

Primary outcomes:
measure: Proportion of women using modern contraception at 6 months postpartum
timeFrame: 6 months after delivery
Secondary outcomes:
measure: Feasibility, acceptability and appropriateness of the PiVOT intervention (quantitative)
timeFrame: 6 months after delivery
measure: Proportion of women using modern contraception at 12 months postpartum
timeFrame: 12 months after delivery
measure: Feasibility, acceptability and appropriateness of the PiVOT intervention (qualitative) among participants
timeFrame: 6 months postpartum
measure: Feasibility, acceptability and appropriateness of the PiVOT intervention (qualitative) among providers of the program
timeFrame: 6 months postpartum
measure: Feasibility, acceptability and appropriateness of the PiVOT intervention (qualitative) among husbands of participants
timeFrame: 6 months postpartum
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Pune
country: India
facility: Junnar Taluka
state: Maharashtra
Study officials:
affiliation: University of California, San Diego
name: Sarah Averbach, MD, MAS
role: PRINCIPAL_INVESTIGATOR
affiliation: Indian Council of Medical Research-National Institute for Research in Reproductive and Child Health
name: Shahina Begum, PhD
role: PRINCIPAL_INVESTIGATOR
References: