Vaccination Uptake
Conditions
Keywords
vaccine hesitancy
Brief summary
The purpose of this study is to understand why parents do or do not vaccinate their children and explore what information parents need to vaccinate their children. The study will test whether information about vaccinations provided during pregnancy by a health provider (VISTA intervention) may improve the possibility that a child is vaccinated on time.
Detailed description
The study will be implemented in 10 health facility catchment areas in Mtwara region, Tanzania. The study sites will be non-randomly assigned to receive VISTA or usual care. Only core messages were developed and evaluated in this study. Tailored messages will be developed and evaluated in a follow-up study.
Interventions
BEHAVIORALVISTA
VISTA will be an educational intervention.
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Study outcomes will be measured for health providers implementing the intervention and pregnant women receiving the intervention. Up to 10 health workers (including community health workers (CHW) from each of the intervention sites will participate in the study. To participate in the study, Health workers must be: * 18 years of age or older * Work in one of the study intervention sites Women must be: * In the third trimester of pregnancy * Residing in a study site (intervention or control) * At least 15 years of age * Planning to reside in the study site for the duration of their participation in the study (until approximately 6 months after delivery to enable follow up). * Have at least 1 concern about childhood vaccines
Exclusion criteria
There are no
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Women With Reduced Number of Concerns Immediately Post-counseling in the Intervention Arm | Post-counseling (Baseline visit) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | Follow-up (up to 6 months post-birth; up to 9 months post-baseline) | Includes early doses up to 1 week prior to due date. In the event of twins, information for only 1 child per mother was included in the determination of outcomes. |
| Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | Follow-up (up to 6 months post-birth; up to 9 months post-baseline) | — |
| Percentage of Checklist Items Completed During Counseling in VISTA Intervention Arm | Baseline | — |
| Mean Number of Minutes Spent Delivering Counseling Per Woman in VISTA Intervention Arm | Baseline | — |
| Number of Women in the VISTA Intervention Arm Who Say That the Information Provided by the Community Health Worker (CHW) is Helpful | Baseline | — |
| Number of Women in the VISTA Intervention Arm Who Say That the Information Provided by the Community Health Worker (CHW) Reduced Their Concerns About Vaccinations | Baseline | — |
| Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Helped Them Understand Why Children Needed Vaccines | Baseline | — |
| Percentage of Women With Reduced Number of Concerns in Intervention Versus Control Arms at Follow up. | Follow-up (up to 6 months post-birth; up to 9 months post-baseline) | — |
| Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Was Respectful | Baseline | — |
| Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Explained Things in Terms They Could Understand | Baseline | — |
| Number of Women in the VISTA Intervention Arm Who Were Satisfied With Their Conversation With the Community Health Worker (CHW) | Baseline | — |
| Number of Women in the VISTA Intervention Arm Who Say They Are Comfortable Vaccinating Their Child | Baseline | — |
| Number of Women in the VISTA Intervention Arm Who Say They Will Speak With the CHW Again | Baseline | — |
| Number of Women in the VISTA Intervention Arm Who Say They Would Refer the CHW to Their Friends and Family | Baseline | — |
| Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Answered Most of Their Questions | Baseline | — |
Countries
Tanzania
Participant flow
Recruitment details
Participants recruited from medical clinics and surrounding communities in rural areas.
Participants by arm
| Arm | Count |
|---|---|
| Pregnant Women Receiving VISTA Counseling Up to 30 pregnant women are screened and counseled for vaccine concerns using VISTA (Vaccinator-Initiated Screening and TAilored Counseling for Reducing Vaccine Hesitancy)
VISTA: VISTA will be an educational intervention. | 29 |
| Pregnant Women Receiving Usual Care Up to 30 pregnant women receiving usual care | 30 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Infant death (no follow up data or vaccination outcomes) | 2 | 3 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Withdrawn by PI | 1 | 0 |
Baseline characteristics
| Characteristic | Pregnant Women Receiving VISTA Counseling | Total | Pregnant Women Receiving Usual Care |
|---|---|---|---|
| Age, Continuous | 31.28 years STANDARD_DEVIATION 7.04 | 29.66 years STANDARD_DEVIATION 7.85 | 28.10 years STANDARD_DEVIATION 8.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 59 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 59 Participants | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Tanzania | 29 Participants | 59 Participants | 30 Participants |
| Sex: Female, Male Female | 29 Participants | 59 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 1 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Percentage of Women With Reduced Number of Concerns Immediately Post-counseling in the Intervention Arm
Time frame: Post-counseling (Baseline visit)
Population: Outcome measure only applies to the VISTA arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregnant Women Receiving VISTA Counseling | Percentage of Women With Reduced Number of Concerns Immediately Post-counseling in the Intervention Arm | 51.72 percentage of women |
Secondary
Mean Number of Minutes Spent Delivering Counseling Per Woman in VISTA Intervention Arm
Time frame: Baseline
Population: Outcome measure only applies to the VISTA arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pregnant Women Receiving VISTA Counseling | Mean Number of Minutes Spent Delivering Counseling Per Woman in VISTA Intervention Arm | 15.86 minutes |
Secondary
Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm
Time frame: Follow-up (up to 6 months post-birth; up to 9 months post-baseline)
Population: Data not collected on 13 participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pregnant Women Receiving VISTA Counseling | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | BCG | 6.5 days |
| Pregnant Women Receiving VISTA Counseling | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | Polio 0 | 6 days |
| Pregnant Women Receiving VISTA Counseling | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | Polio 1 | 5 days |
| Pregnant Women Receiving VISTA Counseling | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | Polio 2 | 8 days |
| Pregnant Women Receiving VISTA Counseling | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | Polio 3 | 19 days |
| Pregnant Women Receiving VISTA Counseling | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | Polio IPV | 15 days |
| Pregnant Women Receiving VISTA Counseling | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | DTP 1 | 3 days |
| Pregnant Women Receiving VISTA Counseling | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | DTP 2 | 9.5 days |
| Pregnant Women Receiving VISTA Counseling | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | DTP 3 | 14.5 days |
| Pregnant Women Receiving VISTA Counseling | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | PCV 1 | 3 days |
| Pregnant Women Receiving VISTA Counseling | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | PCV 2 | 9.5 days |
| Pregnant Women Receiving VISTA Counseling | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | PCV 3 | 14.5 days |
| Pregnant Women Receiving VISTA Counseling | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | RTR 1 | 5 days |
| Pregnant Women Receiving VISTA Counseling | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | RTR 2 | 20.5 days |
| Pregnant Women Receiving Usual Care | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | PCV 2 | 13 days |
| Pregnant Women Receiving Usual Care | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | BCG | 12 days |
| Pregnant Women Receiving Usual Care | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | DTP 2 | 12 days |
| Pregnant Women Receiving Usual Care | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | Polio 0 | 8.5 days |
| Pregnant Women Receiving Usual Care | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | RTR 1 | 5 days |
| Pregnant Women Receiving Usual Care | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | Polio 1 | 3 days |
| Pregnant Women Receiving Usual Care | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | DTP 3 | 17 days |
| Pregnant Women Receiving Usual Care | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | Polio 2 | 13 days |
| Pregnant Women Receiving Usual Care | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | PCV 3 | 17 days |
| Pregnant Women Receiving Usual Care | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | Polio 3 | 14 days |
| Pregnant Women Receiving Usual Care | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | PCV 1 | 4 days |
| Pregnant Women Receiving Usual Care | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | Polio IPV | 19.5 days |
| Pregnant Women Receiving Usual Care | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | RTR 2 | 12 days |
| Pregnant Women Receiving Usual Care | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | DTP 1 | 3 days |
Secondary
Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Answered Most of Their Questions
Time frame: Baseline
Population: Data not collected.
Secondary
Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Explained Things in Terms They Could Understand
Time frame: Baseline
Population: Outcome measure only applies to the VISTA arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Women Receiving VISTA Counseling | Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Explained Things in Terms They Could Understand | 27 Participants |
Secondary
Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Helped Them Understand Why Children Needed Vaccines
Time frame: Baseline
Population: Outcome measure only applies to the VISTA arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Women Receiving VISTA Counseling | Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Helped Them Understand Why Children Needed Vaccines | 26 Participants |
Secondary
Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Was Respectful
Time frame: Baseline
Population: Outcome measure only applies to the VISTA arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Women Receiving VISTA Counseling | Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Was Respectful | 28 Participants |
Secondary
Number of Women in the VISTA Intervention Arm Who Say That the Information Provided by the Community Health Worker (CHW) is Helpful
Time frame: Baseline
Population: Outcome measure only applies to the VISTA arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Women Receiving VISTA Counseling | Number of Women in the VISTA Intervention Arm Who Say That the Information Provided by the Community Health Worker (CHW) is Helpful | 28 Participants |
Secondary
Number of Women in the VISTA Intervention Arm Who Say That the Information Provided by the Community Health Worker (CHW) Reduced Their Concerns About Vaccinations
Time frame: Baseline
Population: Outcome measure only applies to the VISTA arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Women Receiving VISTA Counseling | Number of Women in the VISTA Intervention Arm Who Say That the Information Provided by the Community Health Worker (CHW) Reduced Their Concerns About Vaccinations | 24 Participants |
Secondary
Number of Women in the VISTA Intervention Arm Who Say They Are Comfortable Vaccinating Their Child
Time frame: Baseline
Population: Outcome measure only applies to the VISTA arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Women Receiving VISTA Counseling | Number of Women in the VISTA Intervention Arm Who Say They Are Comfortable Vaccinating Their Child | 29 Participants |
Secondary
Number of Women in the VISTA Intervention Arm Who Say They Will Speak With the CHW Again
Time frame: Baseline
Population: Outcome measure only applies to the VISTA arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Women Receiving VISTA Counseling | Number of Women in the VISTA Intervention Arm Who Say They Will Speak With the CHW Again | 28 Participants |
Secondary
Number of Women in the VISTA Intervention Arm Who Say They Would Refer the CHW to Their Friends and Family
Time frame: Baseline
Population: Outcome measure only applies to the VISTA arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Women Receiving VISTA Counseling | Number of Women in the VISTA Intervention Arm Who Say They Would Refer the CHW to Their Friends and Family | 28 Participants |
Secondary
Number of Women in the VISTA Intervention Arm Who Were Satisfied With Their Conversation With the Community Health Worker (CHW)
Time frame: Baseline
Population: Outcome measure only applies to the VISTA arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Women Receiving VISTA Counseling | Number of Women in the VISTA Intervention Arm Who Were Satisfied With Their Conversation With the Community Health Worker (CHW) | 28 Participants |
Secondary
Percentage of Checklist Items Completed During Counseling in VISTA Intervention Arm
Time frame: Baseline
Population: Outcome measure only applies to the VISTA arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pregnant Women Receiving VISTA Counseling | Percentage of Checklist Items Completed During Counseling in VISTA Intervention Arm | 90.17 percentage of items |
Secondary
Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm
Includes early doses up to 1 week prior to due date. In the event of twins, information for only 1 child per mother was included in the determination of outcomes.
Time frame: Follow-up (up to 6 months post-birth; up to 9 months post-baseline)
Population: Data not collected on 13 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregnant Women Receiving VISTA Counseling | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | Polio 1 | 64.00 percentage of children |
| Pregnant Women Receiving VISTA Counseling | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | DTP 3 | 84.00 percentage of children |
| Pregnant Women Receiving VISTA Counseling | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | Polio 3 (OPV3/IPV) | 68.00 percentage of children |
| Pregnant Women Receiving VISTA Counseling | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | PCV 1 | 92.00 percentage of children |
| Pregnant Women Receiving VISTA Counseling | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | Polio 0 | 88.00 percentage of children |
| Pregnant Women Receiving VISTA Counseling | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | PCV 2 | 88.00 percentage of children |
| Pregnant Women Receiving VISTA Counseling | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | DTP 1 | 100.00 percentage of children |
| Pregnant Women Receiving VISTA Counseling | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | PCV 3 | 84.00 percentage of children |
| Pregnant Women Receiving VISTA Counseling | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | Polio 2 | 48.00 percentage of children |
| Pregnant Women Receiving VISTA Counseling | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | RTR 1 | 76.00 percentage of children |
| Pregnant Women Receiving VISTA Counseling | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | DTP 2 | 96.00 percentage of children |
| Pregnant Women Receiving VISTA Counseling | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | RTR 2 | 72.00 percentage of children |
| Pregnant Women Receiving VISTA Counseling | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | BCG | 96.00 percentage of children |
| Pregnant Women Receiving Usual Care | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | RTR 2 | 69.57 percentage of children |
| Pregnant Women Receiving Usual Care | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | BCG | 86.96 percentage of children |
| Pregnant Women Receiving Usual Care | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | Polio 0 | 82.61 percentage of children |
| Pregnant Women Receiving Usual Care | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | Polio 1 | 73.91 percentage of children |
| Pregnant Women Receiving Usual Care | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | Polio 2 | 56.52 percentage of children |
| Pregnant Women Receiving Usual Care | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | Polio 3 (OPV3/IPV) | 60.87 percentage of children |
| Pregnant Women Receiving Usual Care | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | DTP 1 | 95.65 percentage of children |
| Pregnant Women Receiving Usual Care | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | DTP 2 | 86.96 percentage of children |
| Pregnant Women Receiving Usual Care | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | DTP 3 | 69.57 percentage of children |
| Pregnant Women Receiving Usual Care | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | PCV 1 | 86.96 percentage of children |
| Pregnant Women Receiving Usual Care | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | PCV 2 | 78.26 percentage of children |
| Pregnant Women Receiving Usual Care | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | PCV 3 | 60.87 percentage of children |
| Pregnant Women Receiving Usual Care | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | RTR 1 | 78.00 percentage of children |
Secondary
Percentage of Women With Reduced Number of Concerns in Intervention Versus Control Arms at Follow up.
Time frame: Follow-up (up to 6 months post-birth; up to 9 months post-baseline)
Population: Data not collected on 6 participants in each group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregnant Women Receiving VISTA Counseling | Percentage of Women With Reduced Number of Concerns in Intervention Versus Control Arms at Follow up. | 48.0 percentage of women |
| Pregnant Women Receiving Usual Care | Percentage of Women With Reduced Number of Concerns in Intervention Versus Control Arms at Follow up. | 62.5 percentage of women |