Trial Outcomes & Findings for Postpartum Integration of Vaccines and Contraception Trial (NCT NCT05732142)
NCT ID: NCT05732142
Last Updated: 2026-06-05
Results Overview
Contraceptive use will be measured through a self-reported survey collected at 6 months postpartum.
COMPLETED
NA
293 participants
6 months after delivery
2026-06-05
Participant Flow
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).
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.
Unit of analysis: Anganwadi community centers
Participant milestones
| Measure |
PIVoT
Gender-transformative family planning counseling and contraception provision at the time of infant vaccination
|
Standard of Care
Standard infant vaccination and family planning referrals
|
|---|---|---|
|
Overall Study
STARTED
|
143 20
|
150 20
|
|
Overall Study
COMPLETED
|
137 20
|
142 20
|
|
Overall Study
NOT COMPLETED
|
6 0
|
8 0
|
Reasons for withdrawal
| Measure |
PIVoT
Gender-transformative family planning counseling and contraception provision at the time of infant vaccination
|
Standard of Care
Standard infant vaccination and family planning referrals
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
8
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PIVoT
n=143 Participants
Gender-transformative family planning counseling and contraception provision at the time of infant vaccination
|
Standard of Care
n=150 Participants
Standard infant vaccination and family planning referrals
|
Total
n=293 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.54 years
STANDARD_DEVIATION 4.6 • n=143 Participants
|
24.73 years
STANDARD_DEVIATION 3.55 • n=150 Participants
|
25.13 years
STANDARD_DEVIATION 3.38 • n=293 Participants
|
|
Sex: Female, Male
Female
|
143 Participants
n=143 Participants
|
150 Participants
n=150 Participants
|
293 Participants
n=293 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=143 Participants
|
0 Participants
n=150 Participants
|
0 Participants
n=293 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 6 months after deliveryContraceptive use will be measured through a self-reported survey collected at 6 months postpartum.
Outcome measures
| Measure |
PIVoT
n=137 Participants
Gender-transformative family planning counseling and contraception provision at the time of infant vaccination
|
Standard of Care
n=142 Participants
Standard infant vaccination and family planning referrals
|
|---|---|---|
|
Proportion of Women Using Modern Contraception at 6 Months Postpartum
|
55 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: 6 months after deliveryPopulation: 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).
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.
Outcome measures
| Measure |
PIVoT
n=137 Participants
Gender-transformative family planning counseling and contraception provision at the time of infant vaccination
|
Standard of Care
Standard infant vaccination and family planning referrals
|
|---|---|---|
|
Feasibility, Acceptability and Appropriateness of the PiVOT Intervention
Selected "agree" or "strongly agree" for all acceptability items
|
137 Participants
|
0 Participants
|
|
Feasibility, Acceptability and Appropriateness of the PiVOT Intervention
Selected "agree" or "strongly agree" for all appropriateness items
|
135 Participants
|
0 Participants
|
|
Feasibility, Acceptability and Appropriateness of the PiVOT Intervention
Selected "agree" or "strongly agree" for all feasibility items
|
132 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 months after deliveryContraceptive use will be measured through a self-reported survey collected at 12 months postpartum
Outcome measures
| Measure |
PIVoT
n=137 Participants
Gender-transformative family planning counseling and contraception provision at the time of infant vaccination
|
Standard of Care
n=142 Participants
Standard infant vaccination and family planning referrals
|
|---|---|---|
|
Proportion of Women Using Modern Contraception at 12 Months Postpartum
|
55 Participants
|
46 Participants
|
Adverse Events
PIVoT
Standard of Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place