Reproductive Behavior, Family Planning ServicesRMNCH FPNCT05045599
Effectiveness of Integrating Family Planning - Maternal, Newborn and Child Health (MNCH) Services on Uptake of Voluntary Modern Contraceptive Methods
A study testing Capacity Building of Health care workers and providers to deliver integrated Family Planning and Maternal, Newborn and Child Health in people with Reproductive Behavior, Family Planning Services, run by Aga Khan University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reproductive Behavior, Family Planning Services
- What is being tested?
- Capacity Building of Health care workers and providers to deliver integrated Family Planning and Maternal, Newborn and Child Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125,000 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy women of reproductive age living in the study areas
Who cannot join
- non resident living foe short term less than three months
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University
Karachi, Sindh, 74800
Zahid. A Memon, 13085550859, zahid.memon@aku.edu
Hora Soltani, PhD
About this study
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
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
Read the 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?
- Being tested
- Capacity Building of Health care workers and providers to deliver integrated Family Planning and Maternal, Newborn and Child Health
- Keywords
- RMNCH, FP
- Medical subject headings
- Reproductive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capacity Building of Health care workers and providers to deliver integrated Family Planning and Maternal, Newborn and Child HealthBehavioural
Also called Community Mobilization
Community engagement to improve awareness, and use of family planning products and services
| Study group | Role | What they receive |
|---|---|---|
| Integration of Family planning in Maternal, Newborn and Child Health | Experimental | 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 Receives: Behavioral: Capacity Building of Health care workers and providers to deliver integrated Family Planning and Maternal, Newborn and Child Health |
| Standard of care | Active comparator | Not described Receives: Behavioral: Capacity Building of Health care workers and providers to deliver integrated Family Planning and Maternal, Newborn and Child Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
mCPR
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)
Measured: 18 -24 Months
Secondary outcomes (5)
Unmet need
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.
Measured: 18- 24 months
Demand satisfied
Proportion of demand satisfied by modern methods:
Current contraceptive use (any modern method) divided by Unmet need + current contraceptive use (any method)
Measured: 18- 24 months
Women attitude towards family planning
Proportion of women showing positive attitude towards FP
Measured: 18- 24 months
Unwanted pregnancy/births
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
Measured: 18- 24 months
Inter-pregnancy Interval
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.
Measured: 18- 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Oct 2020
- Primary completion30 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reproductive Behavior, Family Planning ServicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- United Nations, Global Affairs Canada
- Responsible party
- Principal investigator, Dr Zulfiqar Ahmed Bhutta, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045599
- Sponsor's protocol ID
- 2021-3606-18261-1
- Acronym
- RMNCH FP
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Memon ZA, Reale S, Ahmed W, Spencer R, Lashari TH, Bhutta Z, Soltani H. Effects of Integrating Family Planning With Maternal, Newborn, and Child Health Services on Uptake of Voluntary Modern Contraceptive Methods in Rural Pakistan: Protocol for a Quasi-experimental Study. JMIR Res Protoc. 2022 Mar 8;11(3):e35291. doi: 10.2196/35291.
PubMed 35258461
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05045599
- Acronym / sponsor ID
- RMNCH FP / 2021-3606-18261-1
- Keywords
- RMNCH, FP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125,000 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- United Nations, Global Affairs Canada
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integration of Family planning in Maternal, Newborn and Child Health | Experimental | Behavioral: Capacity Building of Health care workers and providers to deliver integrated Family Planning and Maternal, Newborn and Child HealthStrengthening 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 |
| Standard of care | Active comparator | Behavioral: Capacity Building of Health care workers and providers to deliver integrated Family Planning and Maternal, Newborn and Child Health |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Healthy women of reproductive age living in the study areas
Key exclusion criteria (1 listed)
- non resident living foe short term less than three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capacity Building of Health care workers and providers to deliver integrated Family Planning and Maternal, Newborn and Child HealthAlso: Community MobilizationCommunity engagement to improve awareness, and use of family planning products and services | Behavioural | Integration of Family planning in Maternal, Newborn and Child Health, Standard of care |
Primary outcome
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)
5 secondary outcomes
Unmet need
Time frame: 18- 24 months
Demand satisfied
Time frame: 18- 24 months
Women attitude towards family planning
Time frame: 18- 24 months
Unwanted pregnancy/births
Time frame: 18- 24 months
Inter-pregnancy Interval
Time frame: 18- 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Derived from this study: PubMed 35258461Memon ZA, Reale S, Ahmed W, Spencer R, Lashari TH, Bhutta Z, Soltani H. Effects of Integrating Family Planning With Maternal, Newborn, and Child Health Services on Uptake of Voluntary Modern Contraceptive Methods in Rural Pakistan: Protocol for a Quasi-experimental Study. JMIR Res Protoc. 2022 Mar 8;11(3):e35291. doi: 10.2196/35291.
- Individual participant dataSharing planned: No
Related trials for Reproductive Behavior, Family Planning Services
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Recruiting
Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years
Alcohol-Related Disorders, Substance-Related Disorders
Not yet recruiting
Teen motHers' ReproductIve and behaVioral Health intErvention in Barbados
Pregnancy in Adolescence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capacity Building of Health care workers and providers to deliver integrated Family Planning and Maternal, Newborn and Child Health in people with Reproductive Behavior, Family Planning Services, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zahid A Memon, MPH (+9213085550859, zahid.memon@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mCPR (time frame: 18 -24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05045599, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.