NCT06125470

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
236,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2021

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

3.8 years

First QC Date

August 31, 2021

Last Update Submit

July 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Unmeet need for Family planning

    over the period of 3 years

  • Skilled birth rate

    over the period of 3 years

  • Antenatal coverage

    over the period of 3 years

Study Arms (1)

Intervention areas

EXPERIMENTAL

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

Behavioral: Uptake of quality Reproductive health and Family planning products, information and ServicesBehavioral: Capacity building of facility based and community based healthcare providers (public and private sector) on FP /SRHBehavioral: Adolescent EngagementBehavioral: Renovation and Refurbishment of selected healthcare facilitiesBehavioral: Use of Data for Effective Decision-makingBehavioral: Procurement of FP/SRH medical supplies and equipment

Interventions

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

Intervention areas

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.

Intervention areas

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.

Intervention areas

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

Intervention areas

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

Intervention areas

Provision of commodities / supplies for shortest-time possible in facilities having stock-outs

Intervention areas

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Married women of reproductive age living in the project areas

You may not qualify if:

  • Not residing in the area for more than six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Aga Khan University

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Contraception BehaviorReproductive Behavior

Interventions

Private SectorEquipment and Supplies

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

OwnershipOrganization and AdministrationHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished University Professor

Study Record Dates

First Submitted

August 31, 2021

First Posted

November 9, 2023

Study Start

April 1, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations