- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05045599
Effectiveness of Integrating Family Planning - Maternal, Newborn and Child Health (MNCH) Services on Uptake of Voluntary Modern Contraceptive Methods (RMNCH FP)
Effectiveness of Integrating Family Planning - Maternal, Newborn and Child Health (MNCH) Services on Uptake of Voluntary Modern Contraceptive Methods in Rural District of Sindh Province: A Quasi-experimental Study
Aim To evaluate the impact of an integrated Family Planning-Maternal,Newborn and Child Health service delivery model to increase coverage of MCM in a rural Pakistan.
Objectives
- To gain an understanding of the cultural and health service delivery contexts to inform a socio-culturally appropriate and acceptable intervention package scalable in rural Pakistan.
- To implement the intervention package at health facilities and outreach communities through existing public and private sector resources
- To measure the impact and level of effectiveness of interventions on the uptake MCM
- To identify and quantify the drivers of improved uptake of voluntary methods of FP especially MCM
Study Overview
Status
Detailed Description
Interventions focusing on community outreach programs and interpersonal communications increase social acceptance of FP methods. However, home based counseling alone is not sufficient for the uptake and continuation of FP methods and developing linkages with health facilities and maintaining privacy at a health facility and being more culturally and religiously acceptable is also important. With this in mind, efforts have been made involving facility and community level health care providers for provision of MNCH services as the primary mandate of National Maternal Newborn and Child Health program. However, there are still deficiencies at inter and intra facility level, for example; a lack of coordination among departments such as Paediatrics and Gynecology & Obstetrics, lack of management level coordination with front line providers, lack of equipment and logistics management manifested as imbalance demand and supply and lack of overall governing bodies . Thus, overarching interventions covering service delivery platforms at facility and community levels necessitates the integration and scaling up of FP and MNCH services.
The theoretical underpinning of behavior change will be based on the Theoretical Domain Framework (TDF) v2.0. The TDF will be applied to provide an in-depth exploration and understanding of factors on the demand and supply side and their interaction with and influences on FP uptake. This project aims to implement a complex intervention (see figure 2) within health facilities and their catchment communities. This complex intervention includes a series of strategies involving community engagement by extensive community mobilization, availability of trained staff and sustainable supply of commodities with the required recording and reporting system. Continuous process monitoring and quality assurance will help to replicate the success and address possible barriers during implementation of the intervention. The mechanism of action built on the TDF adopts domains and constructs including, knowledge, skills, beliefs and intentions. Furthermore, the TDF provides a detailed understanding of complex behaviour thus will be used to evaluate the impact of complex interventions/ strategies.
Research Question What is the impact of integrating FP- MNCH services on uptake of voluntary modern contraceptive methods in a rural district of Sindh province, Pakistan?
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zahid A Memon, MPH
- Phone Number: +9213085550859
- Email: zahid.memon@aku.edu
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 74800
- Recruiting
- Aga Khan University
-
Contact:
- Zahid. A Memon
- Phone Number: 13085550859
- Email: zahid.memon@aku.edu
-
Principal Investigator:
- Zahid Memon, MPH
-
Principal Investigator:
- Hora Soltani, PhD
-
Sub-Investigator:
- Rachel Spencer, PhD
-
Sub-Investigator:
- Sophie Reale, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy women of reproductive age living in the study areas
Exclusion Criteria:
- non resident living foe short term less than three months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard of care
|
Community engagement to improve awareness, and use of family planning products and services
Other Names:
|
Experimental: Integration of Family planning in Maternal, Newborn and Child Health
Strengthening of capacity of LHWs and Health care provider in providing integrated services Ensure Sustained supplies are available Community Mobilization Infrastructure support to ensure privacy and confidentiality Improvement of data recording, reporting and use
|
Community engagement to improve awareness, and use of family planning products and services
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mCPR
Time Frame: 18 -24 Months
|
Number of women age 15-49 years currently married who are using (or whose partner is using) a modern contraceptive method.
(Modern methods include: male and female sterilization, injectable, intrauterine devices (IUDs), contraceptive pills, implants, male condoms, the standard days method, locational amenorrhea method, and emergency contraception)
|
18 -24 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unmet need
Time Frame: 18- 24 months
|
Proportion of women who
|
18- 24 months
|
Demand satisfied
Time Frame: 18- 24 months
|
Proportion of demand satisfied by modern methods: Current contraceptive use (any modern method) divided by Unmet need + current contraceptive use (any method) |
18- 24 months
|
Women attitude towards family planning
Time Frame: 18- 24 months
|
Proportion of women showing positive attitude towards FP
|
18- 24 months
|
Unwanted pregnancy/births
Time Frame: 18- 24 months
|
Planning status of births/pregnancies Women reported whether their births/pregnancies were wanted at the time (planned birth), at a later time (mistimed birth), or not at all (unwanted birth). Sample: Current pregnancies and births in the 5 years before the survey to women age 15-49 |
18- 24 months
|
Inter-pregnancy Interval
Time Frame: 18- 24 months
|
The number of months between a live birth and the conception of the next live birth.
This was calculated by subtracting the "Date of last live birth" item from the date of birth to obtain a live-birth interval, then subtracting gestational age (months) of the birth from the live-birth interval.
|
18- 24 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2021-3606-18261-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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