NCT05644886

Brief Summary

This study aims to generate evidence on the feasibility and effectiveness of engaging for-profit private sector family physicians and pharmacies to include family planning (FP) as a routine service in rural areas of Pakistan. The study will enlist family physicians and pharmacies in rural areas of Islamabad, Pakistan. Physicians will be randomly assigned to intervention and control groups. Those in intervention arm will received training on family planning and technical support for six months during the duration of the study, to evaluate the impact of training and support in expanding family planning coverage and impact.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 1, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

7 months

First QC Date

December 1, 2022

Last Update Submit

December 10, 2022

Conditions

Keywords

Family PlanningPakistanFamily PhysiciansContraceptivePharmaciesMale

Outcome Measures

Primary Outcomes (1)

  • Proportion of family physicians successfully providing family planning services to their clients

    the proportion of family physicians in the intervention arm compared to the control arm providing FP services to at least 10 per cent of their total clients during the intervention period.

    6-months

Secondary Outcomes (2)

  • change in contraceptive uptake

    6-months

  • change in number of FP clients

    6-months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Male Family Physicians allocated to intervention arm will receive following: Training and technical support and integrates them with the nearest pharmacies or drug shops for vertical referrals. Technical support will include: * Supportive supervision * Peer-to-peer support * Strengthening referrals for long-acting reversible contraceptives (LARC) and permanent methods * Provision of information, education, and communication (IEC) material and LCD for display of visual material. * Branding of clinics with name boards * Provision of family planning prescription booklets

Behavioral: FP Training and Technical Support

Control Arm

NO INTERVENTION

the providers in the control group will continue to provide their services as usual with no exposure to intervention activities. After the end of the intervention period, providers that fall into control areas will be provided the same training.

Interventions

Same as in Intervention arm description

Intervention Arm

Eligibility Criteria

Age22 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThe study intends to engage male family physicians in family planning service provision in Pakistan. The gender identity is based on self-representation.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Private clinics with a male family physician
  • Male family physician working on a regular basis (3 or more days a week)
  • Clinics located in Islamabad rural areas.

You may not qualify if:

  • Clinics or facilities with specialized care (skin care, laser clinics, surgical clinics, among others)
  • Clinics located in ICT urban areas
  • Male family physicians working in a private clinic where a female medical doctor attends to patients during the same working hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Population Council

Islamabad, Islamabad, 44050, Pakistan

RECRUITING

Related Publications (6)

  • Federal and Provincial Task Force s, 2019, Action Plan (2019-24) for Implementation of Recommendations Approved by CCI Regarding Alarming Population Growth in Pakistan.

    BACKGROUND
  • The Population Council. 2016. Landscape Analysis of Family Planning Situation in Pakistan: Brief Summary of Findings. Islamabad: The Population Council

    BACKGROUND
  • Rehman Ashfaq and Malkani Anam. 2020. Best Bets for Accelerating Family Planning in Pakistan: The Case for Engaging Family Physicians and the for-Profit Private Sector. Islamabad: Population Research Center and the Population Council.

    BACKGROUND
  • Khan, K., & Sathar, Z. (2020). Best Bets for Accelerating Family Planning in Pakistan: Inducting men, sharing responsibility

    BACKGROUND
  • The Population Council. 2019. Improving Access to Family Planning Services through the Private Sector in Pakistan: A Stakeholder Analysis. Islamabad: The Population Council.

    BACKGROUND
  • Bradley, S.E & Shiras, T. Pharmacies and Drug Shops. Expanding contraceptive Choice and access in the private sector. Family Planning High Impact Practices2021

    BACKGROUND

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Officials

  • Ayaz Ahmed Baloch

    Population Council

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the intervention masking is not feasible
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study uses a two arm parallel facility based randomized controlled trial with on-going intervention of training and technical support for six-month.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Manager Research

Study Record Dates

First Submitted

December 1, 2022

First Posted

December 9, 2022

Study Start

November 21, 2022

Primary Completion

June 30, 2023

Study Completion

August 30, 2023

Last Updated

December 13, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations