Clinical trial NCT06125470: SihatMand Khandaan Healthy Families for Pakistan
Official title: Healthy Families for Pakistan Through Accelerating Gender-responsive Sexual Reproductive Health (SRH) and Family Planning (FP) Services
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Contraception
Contraception Behavior
Reproductive Behavior
Maternal Behavior
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: Global Affairs Canada
name: United Nations
First posted: 2023-11-09
Enrollment: 236000
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Strengthened technical capacity of healthcare workforce to provide quality gender-responsive SRH /FP services to women of reproductive age, youth and adolescents. .

Increased availability of quality gender-responsive materials, equipment and appropriate infrastructure for FP/SRH Enhanced ability of district and provincial health authorities to maintain adequate and sustainable supplies of FP commodities Improved knowledge and attitudes regarding FP/SRH amongst male and female community members Enhanced ability of local community structures, institutions and leaders to identify and respond to gender and social barriers to utilization of FP/SRH services.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* Married women of reproductive age living in the project areas

Exclusion Criteria:

* Not residing in the area for more than six months

Primary outcomes:
measure: Contraceptive Prevalence Rate
timeFrame: over the period of 3 years
Secondary outcomes:
measure: Unmeet need for Family planning
timeFrame: over the period of 3 years
measure: Skilled birth rate
timeFrame: over the period of 3 years
measure: Antenatal coverage
timeFrame: over the period of 3 years
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
Study officials:
References: