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CTRI Number  CTRI/2021/11/037746 [Registered on: 02/11/2021] Trial Registered Prospectively
Last Modified On: 01/11/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Family Planning Intervention]  
Study Design  Cluster Randomized Trial 
Public Title of Study   Awareness and availability of modern contraceptives at Anganwadi Centers 
Scientific Title of Study   Increasing access to postpartum contraception by linking family planning and infant vaccination services 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shahina Begum 
Designation  Scientist E 
Affiliation  ICMR- National Institute for Research in Reproductive Health 
Address  Department of Biostatistics, ICMR-NIRRH, J.M. Street, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9503956734  
Fax    
Email  begums@nirrh.res.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Shahina Begum 
Designation  Scientist E 
Affiliation  ICMR- National Institute for Research in Reproductive Health 
Address  Department of Biostatistics, ICMR-NIRRH, J.M. Street, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9503956734  
Fax    
Email  begums@nirrh.res.in  
 
Details of Contact Person
Public Query  
Name  Dr Shahina Begum 
Designation  Scientist E 
Affiliation  ICMR- National Institute for Research in Reproductive Health 
Address  Department of Biostatistics, ICMR-NIRRH, J.M. Street, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9503956734  
Fax    
Email  begums@nirrh.res.in  
 
Source of Monetary or Material Support  
The study will be implemented by ICMR-National Institute for Research in Reproductive Health. The proposal is submitted to NIH, USA (applied for) for financial support  
 
Primary Sponsor  
Name  NIH USAapplied for 
Address  9000 Rockville Pike, Bethesda, MD 20892, United States 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shahina Begum  Anganwadi Centres at Junnar Block  ICDS Department, Junnar block, Pune District, Maharashtra
Pune
MAHARASHTRA 		 9503956734

begums@nirrh.res.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIRRH Ethics Committee for Clinical Studies, Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Lactating women who has childbirth recently (6-8 weeks) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Family Planning Counselling in interventions  Participants presenting to AWCs randomized to the intervention will receive FP counselling (one time). All methods of reversible modern contraception that are appropriate for PP use will be offered to women to initiate on that day if they choose. Male and female sterilization will also be discussed and couples will be referred to PHCs if they desire sterilization. 
Comparator Agent  Usual procedures  For control arms, Women presenting to AWCs to the control arm will be offered FP brochures and condoms and they will be referred to the affiliated PHC for further FP 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  Women aged 18 and older residing in rural Maharashtra, who speak Marathi, delivered a baby within the past 8 weeks but did not undergo sterilization, hysterectomy or immediate PPIUCD placement and do not have a new pregnancy will be invited to participate. 
 
ExclusionCriteria 
Details  If a woman is interested, meets inclusion criteria and consents, she will be enrolled and asked to complete a baseline questionnaire. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
the feasibility, acceptability, and appropriateness of linking provision of postpartum family planning and infant vaccination care in rural India using a mixed-methods approach  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
The preliminary effectiveness of linking provision of postpartum family planning and infant vaccination care on contraceptive method use in rural India  2 years 
 
Target Sample Size   Total Sample Size="320"
Sample Size from India="320" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   04/04/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Family planning (FP), including provision of contraception, is care that supports individuals to achieve their desired number and spacing of children. Expanding access to postpartum FP can prevent maternal and infant morbidity and mortality by decreasing unintended pregnancy and short inter-pregnancy intervals. India is the country with the largest number of women with an unmet need for contraception, and rural postpartum women are among those with the highest unmet need. Uptake of postpartum contraception among women in rural India is low, and short inter-pregnancy intervals are common. Key barriers to accessing postpartum FP in India include restrictive gender-based norms – i.e., social expectations of people’s behavior based on their gender – such as limited mobility of young women to reach public health centers and women’s lack of autonomy over contraceptive decision-making. Community-based infant vaccination programs in rural India are well attended and provide an opportunity to offer FP care to postpartum women. The hypothesis is that integrating community-based FP care with the existing infant vaccination program will reach more rural postpartum women and improve uptake of postpartum contraception. Through our prior work, we have shown that programs that address contextual gender-based norms are associated with increased contraceptive use. The objective of this study is to assess the effect of utilizing gender-transformative strategies - i.e., those targeting restrictive gender-based norms – to deliver FP in the context of a public health infant vaccination program. This proposal aims to assess the feasibility, acceptability, appropriateness, and preliminary effectiveness of linking this program with infant vaccination care. The intervention will utilize gender-transformative strategies demonstrating effectiveness in prior FP research, which have not been studied among postpartum women. We will adapt the intervention with input from multi-level stakeholders to help ensure its appropriateness for the infant vaccination program setting. This study involves a pilot cluster randomized controlled trial evaluating the implementation and potential impact of this gender-transformative FP intervention linked to infant vaccination care in rural India (N=320). Subcenters will be randomized to the intervention and control area. The intervention including on-site FP care (FP counselling and provision of contraception) during the infant vaccination visit or the standard of care (referral to public health centers for FP counselling and provision of contraception). Outcomes related to contraceptive use will be assessed via surveys at baseline, a 6-month follow-up visit, and in-depth interviews conducted with women and other key stakeholders (including husbands, mothers-in-law, frontline healthcare providers and community leaders). Implementation science frameworks will be used to guide both the adaptation and implementation processes. This intervention has the potential to increase access to postpartum contraception for women with unmet need across rural India. 
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