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| Name | Class |
|---|---|
| Indian Council of Medical Research | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PIVoT | Experimental | Gender-transformative family planning counseling and contraception provision at the time of infant vaccination |
|
| Standard of care | No Intervention | Standard infant vaccination and family planning referrals |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postpartum Integration of Vaccines and Contraception Through Gender-Transformative Programming(PIVoT) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Women Using Modern Contraception at 6 Months Postpartum | Contraceptive use will be measured through a self-reported survey collected at 6 months postpartum. | 6 months after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility, Acceptability and Appropriateness of the PiVOT Intervention | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Averbach, MD, MAS | University of California, San Diego | Principal Investigator |
| Shahina Begum, PhD | Indian Council of Medical Research-National Institute for Research in Reproductive and Child Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92093 | United States | ||
| Junnar Taluka |
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.
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).
| ID | Title | Description |
|---|---|---|
| FG000 | PIVoT | Gender-transformative family planning counseling and contraception provision at the time of infant vaccination |
| FG001 | Standard of Care | Standard infant vaccination and family planning referrals |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | PIVoT | Gender-transformative family planning counseling and contraception provision at the time of infant vaccination |
| BG001 | Standard of Care | Standard infant vaccination and family planning referrals |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Women Using Modern Contraception at 6 Months Postpartum | Contraceptive use will be measured through a self-reported survey collected at 6 months postpartum. | Posted | Count of Participants | Participants | 6 months after delivery |
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From enrollment until end of follow-up, at 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PIVoT | Gender-transformative family planning counseling and contraception provision at the time of infant vaccination |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Averbach MD (PI) | UC San Diego | 8586578648 | saverbach@health.ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2022 | Mar 17, 2026 | Prot_SAP_000.pdf |
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|
| 6 months after delivery |
| Proportion of Women Using Modern Contraception at 12 Months Postpartum | Contraceptive use will be measured through a self-reported survey collected at 12 months postpartum | 12 months after delivery |
| Pune |
| Maharashtra |
| India |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Secondary | Feasibility, Acceptability and Appropriateness of the PiVOT Intervention | 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. | Number of postpartum women in the intervention group assessed at 6 month follow up. These questions were only asked of those who participated in the PIVoT program (i.e. the intervention group). | Posted | Count of Participants | Participants | 6 months after delivery |
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| Secondary | Proportion of Women Using Modern Contraception at 12 Months Postpartum | Contraceptive use will be measured through a self-reported survey collected at 12 months postpartum | Posted | Count of Participants | Participants | 12 months after delivery |
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|
| 0 |
| 143 |
| 0 |
| 143 |
| 0 |
| 143 |
| EG001 | Standard of Care | Standard infant vaccination and family planning referrals | 0 | 150 | 0 | 150 | 0 | 150 |
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| Selected "agree" or "strongly agree" for all feasibility items |
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