AzTrials
AzTrials

ContraceptionSMKNCT06125470

SihatMand Khandaan Healthy Families for Pakistan

A study testing Uptake of quality Reproductive health and Family planning products, information and Services, Capacity building of facility based and community based healthcare providers (public and private sector) on FP /SRH and Adolescent Engagement in people with Contraception and Contraception Behavior, run by Aga Khan University at 2 sites in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 15 to 49 years, women onlyHealthy volunteers can take part
What is being tested?
Uptake of quality Reproductive health and Family planning products, information and Services, Capacity building of facility based and community based healthcare providers (public and private sector) on FP /SRH and Adolescent Engagement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
236,000 participants
Where
2 sitesPakistan
Study dates
1 Apr 2021to 31 Dec 2024
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

  • Married women of reproductive age living in the project areas

Who cannot join

  • Not residing in the area for more than six months

Trial locations and contacts

2 sites in 1 country.

Pakistan2 sites

  • Aga Khan University

    Karachi, Sindh, 74800

  • Aga Khan University

    Karachi, Sindh

Other trials in Pakistan

About this study

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

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

Read the 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.
Being tested
Uptake of quality Reproductive health and Family planning products, information and Services, Capacity building of facility based and community based healthcare providers (public and private sector) on FP /SRH, Adolescent Engagement, Renovation and Refurbishment of selected healthcare facilities, Use of Data for Effective Decision-making
Medical subject headings
Contraception Behavior, Reproductive Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Uptake of quality Reproductive health and Family planning products, information and ServicesBehavioural

    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 /SRHBehavioural

    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 EngagementBehavioural

    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 facilitiesBehavioural

    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-makingBehavioural

    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 equipmentBehavioural

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

Study groups in NCT06125470
Study groupRoleWhat they receive
Intervention areasExperimentalHealth 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
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: over the period of 3 years

Secondary outcomes (3)

  1. 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.

    Measured: over the period of 3 years

  2. 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.

    Measured: over the period of 3 years

  3. Antenatal coverage

    at least one visit to skilled birth attendant during pregnancy

    Measured: over the period of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2023
  2. Study start1 Apr 2021
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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
Health services research
Allocation
Not applicable
Intervention model
Sequential
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.
Masking
None (open label)
Enrolment
236,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06125470
Sponsor's protocol ID
2020-3606-11051
Acronym
SMK
Status last verified
Jul 2024
First submitted
31 Aug 2021
Last updated
31 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Uptake of quality Reproductive health and Family planning products, information and Services, Capacity building of facility based and community based healthcare providers (public and private sector) on FP /SRH and Adolescent Engagement in people with Contraception and Contraception Behavior, run by Aga Khan University at 2 sites 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 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Contraceptive Prevalence Rate (time frame: over the period of 3 years). 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 NCT06125470.

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 31 Jul 2024.

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