SihatMand Khandaan Healthy Families for Pakistan

Contraception Clinical Trial

— SMK  

Official title:

Healthy Families for Pakistan Through Accelerating Gender-responsive Sexual Reproductive Health (SRH) and Family Planning (FP) Services

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06125470
• Other study ID #: 2020-3606-11051
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: November 2023
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 236000
• Est. completion date: July 31, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

Inclusion Criteria:

• Married women of reproductive age living in the project areas

Exclusion Criteria:

• Not residing in the area for more than six months

Related Conditions & MeSH terms

• Contraception
• Contraception Behavior
• Maternal Behavior
• Reproductive Behavior

Intervention

Behavioral:
• Uptake of quality Reproductive health and Family planning products, information and Services
Strengthening capacity of health facilities and outreach to deliver quality reproductive and family planning services and address demand side barriers to the uptake of the services
• Capacity building of facility based and community based healthcare providers (public and private sector) on FP /SRH
Training sessions on FP / SRH including FP Methods - LARC, PPIUD - Task Sharing & Shifting for facility based healthcare providers at provincial level for Master Trainers with trickle down sessions at district level. Training on Sayana Press, ECP, Balance Counselling Strategy and Life Skills Based Education for community-based healthcare providers including LHWs at district level.
• Adolescent Engagement
Identification of adolescent-friendly spaces through community based platforms including LHW health houses for girls and village health committees for boys with context-appropriate arrangements for LSBE and SRH counselling.
• Renovation and Refurbishment of selected healthcare facilities
Identification and improvement/ renovation of public and private healthcare facilities to strengthen the quality, provision and delivery of FP/SRH services, especially counselling, to catchment population
• Use of Data for Effective Decision-making
Improvement in data recording at the source level with reporting at existing platforms i.e. DHIS and LHW-MIS and use of this data for local decision making
• Procurement of FP/SRH medical supplies and equipment
Provision of commodities / supplies for shortest-time possible in facilities having stock-outs

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	Sindh
Pakistan	Aga Khan University	Karachi	Sindh

Sponsors (3)

Lead Sponsor	Collaborator
Aga Khan University	Global Affairs Canada, United Nations

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contraceptive Prevalence Rate	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.	over the period of 3 years
Secondary	Unmeet need for Family planning	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.	over the period of 3 years
Secondary	Skilled birth rate	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.	over the period of 3 years
Secondary	Antenatal coverage	at least one visit to skilled birth attendant during pregnancy	over the period of 3 years