Contraception, Gender Equity
Conditions
Keywords
Family Planning, Infant Vaccination, Linked Care, India
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.
Interventions
OTHERPostpartum Integration of Vaccines and Contraception Through Gender-Transformative Programming(PIVoT)
The PIVoT intervention is a 30-minute focused information exchange that supports shared contraceptive decision making. The program includes a gender-equity and family planning curriculum covering basic family planning information as well as gender norms and son preference and interactive family planning method index cards (detailing method characteristics, use, duration of action, efficacy, side effects, and contraindications for each method). The program is designed to support person-centered contraceptive choice and encourages women to consider joint family planning decision-making with male partners. If a contraceptive method is desired, it will be provided by nurses who are trained to provide comprehensive family planning care.
Sponsors
University of California, San Diego
Indian Council of Medical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Women Using Modern Contraception at 6 Months Postpartum | 6 months after delivery | Contraceptive use will be measured through a self-reported survey collected at 6 months postpartum. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility, Acceptability and Appropriateness of the PiVOT Intervention | 6 months after delivery | Self-reported survey questions using validated items regarding feasibility, acceptability and appropriateness of linked care will be collected at 6 months postpartum. Participants will rate the 3 constructs using 12 items comprising 3 4-item scales with a 5-point Likert scale: completely agree=1, agree=2, neither agree nor disagree=3, disagree=4, completely disagree=5. Higher scores on these items reflect more supportive attitudes toward the linked care model. |
| Proportion of Women Using Modern Contraception at 12 Months Postpartum | 12 months after delivery | Contraceptive use will be measured through a self-reported survey collected at 12 months postpartum |
Countries
India, United States
Contacts
PRINCIPAL_INVESTIGATORSarah Averbach, MD, MAS
University of California, San Diego
PRINCIPAL_INVESTIGATORShahina Begum, PhD
Indian Council of Medical Research-National Institute for Research in Reproductive and Child Health
Participant flow
Recruitment details
From September 2023 to June 2024, we recruited and enrolled 293 postpartum women who were presenting with their infant for an infant vaccination visit (143 in the intervention group and 150 in the control/standard of care group).
Pre-assignment details
279 women were surveyed at 6 month follow up-137 in the intervention group and 142 in the control / standard of care group; 14 were lost to follow up.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 25.13 years STANDARD_DEVIATION 3.38 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 143 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 143 | 0 / 150 |
| other Total, other adverse events | 0 / 143 | 0 / 150 |
| serious Total, serious adverse events | 0 / 143 | 0 / 150 |
Outcome results
None listed