RMNCH FP: Effectiveness of Integrating Family Planning - Maternal, Newborn and Child Health (MNCH) Services on Uptake of Voluntary Modern Contraceptive Methods

Sponsor
Aga Khan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05045599
Collaborator
United Nations (Other), Global Affairs Canada (Other)
125,000
1
2
39
3208

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Capacity Building of Health care workers and providers to deliver integrated Family Planning and Maternal, Newborn and Child Health
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
125000 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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

Behavioral: Capacity Building of Health care workers and providers to deliver integrated Family Planning and Maternal, Newborn and Child Health
Community engagement to improve awareness, and use of family planning products and services
Other Names:
  • Community Mobilization
  • Active Comparator: Standard of care

    Behavioral: Capacity Building of Health care workers and providers to deliver integrated Family Planning and Maternal, Newborn and Child Health
    Community engagement to improve awareness, and use of family planning products and services
    Other Names:
  • Community Mobilization
  • Outcome Measures

    Primary Outcome Measures

    1. mCPR [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)

    Secondary Outcome Measures

    1. Unmet need [18- 24 months]

      Proportion of women who are not pregnant and not postpartum amenorrhea and are considered fecund and want to postpone their next birth for 2 or more years or stop childbearing altogether but are not using a contraceptive method, or have a mistimed or unwanted current pregnancy, or are postpartum amenorrhea and their last birth in the last 2 years was mistimed or unwanted.

    2. Demand satisfied [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)

    3. Women attitude towards family planning [18- 24 months]

      Proportion of women showing positive attitude towards FP

    4. Unwanted pregnancy/births [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

    5. Inter-pregnancy Interval [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 49 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Healthy women of reproductive age living in the study areas
    Exclusion Criteria:
    • non resident living foe short term less than three months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aga Khan University Karachi Sindh Pakistan 74800

    Sponsors and Collaborators

    • Aga Khan University
    • United Nations
    • Global Affairs Canada

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Zulfiqar Ahmed Bhutta, Distinguished University Professor, Aga Khan University
    ClinicalTrials.gov Identifier:
    NCT05045599
    Other Study ID Numbers:
    • 2021-3606-18261-1
    First Posted:
    Sep 16, 2021
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr Zulfiqar Ahmed Bhutta, Distinguished University Professor, Aga Khan University

    Study Results

    No Results Posted as of Sep 16, 2021