SihatMand Khandaan Healthy Families for Pakistan

Not Applicable

Active, not recruiting

• Conditions: Contraception; Contraception Behavior; Maternal Behavior; Reproductive Behavior
• Interventions: Behavioral: Uptake of quality Reproductive health and Family planning products, information and Services; Behavioral: Capacity building of facility based and community based healthcare providers (public and private sector) on FP /SRH; Behavioral: Adolescent Engagement; Behavioral: Renovation and Refurbishment of selected healthcare facilities; Behavioral: Use of Data for Effective Decision-making; Behavioral: Procurement of FP/SRH medical supplies and equipment

• Registration Number: NCT06125470
• Lead Sponsor: Aga Khan University

Brief Summary

The SMK project's primary goal is to improve the status of SRH of women and adolescents within those targeted areas which feature inadequate progress on existing SRH indicators. The focus remains on empowering increasingly marginalized and vulnerable populations to exercise their reproductive rights, free of coercion, discrimination and violence. This will be achieved through the implementation of evidence-based and socio-culturally sensitive FP/ SRH interventions within ten districts of Pakistan. The aim of this project is therefore to evaluate the impact of a package of community and facility-based interventions on improving the SRH/ FP of the targeted population.

In order to achieves this, a quasi-experimental pre \& post evaluation intervention study with a formative phase, baseline assessment, intervention phase and finally an end-line assessment, consisting of both qualitative \& quantitative monitoring \& evaluation tools will be applied at the household, community, healthcare facility and district levels in all project areas.

Furthermore, descriptive statistics will be tabulated on key indicators and stratified on selected variables. Means for continuous variables and proportion for categorical variables will be calculated at a 95% confidence interval within this study

Detailed Description

A Quasi experimental pre \& post evaluation intervention study with a formative research design will be adopted. This study will have three phases; (i) pre-assessment (baseline assessment, quantitative assessment \& qualitative assessment - FGDs \& In-depth Interviews), (ii) intervention and (iii) post assessment. The pre and post assessment will employ a mixed methodology approach.

The primary purpose of the pre-evaluation is to identify the FP / SRH related needs of the targeted population and existing gaps in health service delivery. These will effectively inform the interventions to be implemented. The post-evaluation will encompass mechanisms for quality assurance and monitoring of project impact and sustainability. Both pre and post- evaluations will be conducted using the same tools.

The overarching objective is therefore to evaluate the impact of a package of community and facility-based interventions on the SRH of the targeted population as delivered through the specific objectives outlined below:

1. To roll out effective, gender-responsive and COVID-19 appropriate interventions related to maternal, reproductive and newborn health in the public and private sector for the selected districts in the three provinces of Pakistan.

2. To generate data on knowledge, attitude, practices, access and use of health services for the selected districts.

3. To identify areas for capacity building and training for healthcare providers to improve quality and delivery of FP /SRH (as affected by the ongoing COVID-19 pandemic) for the selected districts.

4. To understand and explore the gender and social barriers to utilization and uptake of FP /SRH services by members of the community within the selected districts.

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-08-31
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-09
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 236000

Inclusion Criteria

• Married women of reproductive age living in the project areas

Exclusion Criteria

• Not residing in the area for more than six months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention areas	Adolescent Engagement	Health facilities and other service delivery points including outreach health workers receiving FP supplies, trainings and renovations to create enabling environment at health and Family planning facilities Community engagement and creating creating adolescents friendly spaces roll out of Gender responsive strategies
Intervention areas	Uptake of quality Reproductive health and Family planning products, information and Services	Health facilities and other service delivery points including outreach health workers receiving FP supplies, trainings and renovations to create enabling environment at health and Family planning facilities Community engagement and creating creating adolescents friendly spaces roll out of Gender responsive strategies
Intervention areas	Capacity building of facility based and community based healthcare providers (public and private sector) on FP /SRH	Health facilities and other service delivery points including outreach health workers receiving FP supplies, trainings and renovations to create enabling environment at health and Family planning facilities Community engagement and creating creating adolescents friendly spaces roll out of Gender responsive strategies
Intervention areas	Procurement of FP/SRH medical supplies and equipment	Health facilities and other service delivery points including outreach health workers receiving FP supplies, trainings and renovations to create enabling environment at health and Family planning facilities Community engagement and creating creating adolescents friendly spaces roll out of Gender responsive strategies
Intervention areas	Renovation and Refurbishment of selected healthcare facilities	Health facilities and other service delivery points including outreach health workers receiving FP supplies, trainings and renovations to create enabling environment at health and Family planning facilities Community engagement and creating creating adolescents friendly spaces roll out of Gender responsive strategies
Intervention areas	Use of Data for Effective Decision-making	Health facilities and other service delivery points including outreach health workers receiving FP supplies, trainings and renovations to create enabling environment at health and Family planning facilities Community engagement and creating creating adolescents friendly spaces roll out of Gender responsive strategies

Primary Outcome Measures

Name	Time	Method
Contraceptive Prevalence Rate	over the period of 3 years	Contraceptive prevalence is the percentage of women who are currently using, or whose sexual partner is currently using, at least one method of contraception, regardless of the method used. It is usually reported for married or in-union women aged 15 to 49.

Secondary Outcome Measures

Name	Time	Method
Unmeet need for Family planning	over the period of 3 years	Women with unmet need are those who are fecund and sexually active but are not using any method of contraception, and report not wanting any more children or wanting to delay the next child. The concept of unmet need points to the gap between women's reproductive intentions and their contraceptive behaviour.
Antenatal coverage	over the period of 3 years	at least one visit to skilled birth attendant during pregnancy
Skilled birth rate	over the period of 3 years	A birth attendant, also known as skilled birth attendant, is a health professional who provides basic and emergency care to women and their newborns during pregnancy, childbirth and the postpartum period.

Trial Locations

Locations (1)

Aga Khan University; 🇵🇰 Karachi, Sindh, Pakistan