Contraceptive UsageFPFPNCT05644886
Pilot Study on Engaging Family Physicians in Family Planning in Pakistan
A study testing FP Training and Technical Support in people with Contraceptive Usage and Contraception, run by Population Council at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Usage, Contraception
- What is being tested?
- FP Training and Technical Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Nov 2022to 30 Aug 2023
- 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 22 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Population Council
Islamabad, Islamabad, 44050
Program Manager Research, 92519205566 ext. 136, abaloch@popcouncil.org
About this study
Official title: Assessing the Feasibility, Effectiveness and Outcomes of Engaging Family Physicians and Pharmacies to Expand Family Planning Services in Rural Areas of Islamabad
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.
Read the detailed description
Pakistan has an overall national goal under the National Plan of Action on Population Growth and the national commitment for the international FP2030 goals to expand family planning services by raising Contraceptive Prevalence Rate (CPR) to 60 percent by 2030 in Pakistan . Based on the Population Council's earlier Landscape study of Family planning services, the total market approach has not been fully adopted in Pakistan (The Population Council, 2016). It called for the inclusion of the private sector and pharmacies to expand access to family planning services and commodities. Another study by the Council also explored the potential of including the private sector and proposed the case for engaging family physicians in family planning . The National Plan of Action on Population Growth's recommendation no. 2 calls for engaging the for-profit private sector, especially family physicians in efforts to expand family planning services . However, a review of evidence in 2020 noted that no determined effort was found to engage private physicians to provide family planning in a sustainable and for-profit model. Internationally, the involvement of the private sector in family planning has been proposed as a High Impact Practice (HIP). The ultimate goal of this study is to provide a model for a successful engagement of male family physicians and pharmacies in family planning and, thereby, expanding family planning services in rural areas to achieve universal access to FP. The engagement of for-profit (male) family physicians in the provision of FP services in linkage with pharmacies will combine three high-impact practices (HIPs) in family planning: (i) private sector engagement (ii) male participation in family planning (Khan, K \& Sathar, Z, 2020) and (iii) integrating pharmacies in the health system.
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. It aims to fill the knowledge gap about the effectiveness of engaging private sector family physicians, and also the optimal approach of integrating family physicians' and pharmacies in Pakistan. Given that the lack of family planning services is particularly dire in rural areas, we situate the study in the rural areas of Islamabad. The study outcomes would provide evidence for advocacy for a sustainable model that can be scaled up to both rural and urban areas.
The study involves an intervention to test the feasibility of engaging male family physicians and pharmacies in expanding the provision of family planning services in the rural areas, on the basis of a review of previous studies, and discussions with a number of private providers, pharmacists, government officials and researchers, The impact of the intervention is to be tested through a randomized control study. The study will enlist family physicians and pharmacies in rural Islamabad Capital Territory (ICT) , who will give their written and informed consent to participate in the study. Physicians will be randomly assigned to intervention and control groups with equal chances of falling into each group.
- The intervention will provide male family physicians with 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 signboards
- Provision of family planning prescription booklets The providers in the intervention group will receive the intervention package, 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. We hypothesize that the proposed intervention will enable male family physicians to provide information, counselling, family planning prescriptions, and referrals, as requested by clients and will result in increased uptake of contraceptive methods.
To evaluate intervention outcomes, baseline assessments in both intervention and control arms will obtain quantitative data from family physicians and pharmacies. We will assess our primary and secondary outcomes using the Management Information System (MIS) tool for obtaining routine service statistics data from clinics and contraceptive sales data from pharmacies. After 6 months of completing the intervention, end-line assessments will be conducted with family physicians in both intervention and control arms to measure changes in providers' KAP towards FP due to intervention. We will also interview family physicians in the intervention arm to get their feedback on the intervention's effectiveness and feasibility through in-depth interviews.
In addition, data on contraceptive availability and sales trends, monitoring stock positions, will be obtained from pharmacies, those nearest to; and linked with participating clinics, at the start, at 3 months, and at 6 months of intervention. The regular availability of contraceptives at the participating pharmacies will be ensured, and mechanisms to address declining stocks or stock outs would be addressed by linking with manufacturers and distributors and with health or population welfare department facilities if needed.
- Conditions
- Contraceptive Usage, Contraception
- Being tested
- FP Training and Technical Support
- Keywords
- Family Planning, Pakistan, Family Physicians, Contraceptive, Pharmacies, Male
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FP Training and Technical SupportBehavioural
Same as in Intervention arm description
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-months
Secondary outcomes (2)
change in contraceptive uptake
- Percentage point difference in contraceptive sales in pharmacies linked to clinics in the intervention arm as compared to the control arm.
Measured: 6-months
change in number of FP clients
Estimate the average (mean) number of clients receiving FP services in the intervention group compared to the control group by the end of intervention period.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start21 Nov 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Contraceptive UsageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study uses a two arm parallel facility based randomized controlled trial with on-going intervention of training and technical support for six-month.
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Council
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Ayaz Ahmed Baloch, Population Council
- Investigators
- Ayaz Ahmed Baloch, Principal investigator, Population Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644886
- Sponsor's protocol ID
- 1014
- Acronym
- FPFP
- Status last verified
- Dec 2022
- First submitted
- 1 Dec 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Federal and Provincial Task Force s, 2019, Action Plan (2019-24) for Implementation of Recommendations Approved by CCI Regarding Alarming Population Growth in Pakistan.
The Population Council. 2016. Landscape Analysis of Family Planning Situation in Pakistan: Brief Summary of Findings. Islamabad: The Population Council
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.
Khan, K., & Sathar, Z. (2020). Best Bets for Accelerating Family Planning in Pakistan: Inducting men, sharing responsibility
The Population Council. 2019. Improving Access to Family Planning Services through the Private Sector in Pakistan: A Stakeholder Analysis. Islamabad: The Population Council.
Bradley, S.E & Shiras, T. Pharmacies and Drug Shops. Expanding contraceptive Choice and access in the private sector. Family Planning High Impact Practices2021
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility, Effectiveness and Outcomes of Engaging Family Physicians and Pharmacies to Expand Family Planning Services in Rural Areas of Islamabad
- ClinicalTrials.gov ID
- NCT05644886
- Acronym / sponsor ID
- FPFP / 1014
- Conditions
- Contraceptive Usage, Contraception
- Keywords
- Family Planning, Pakistan, Family Physicians, Contraceptive, Pharmacies, Male
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Population CouncilUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pakistan has an overall national goal under the National Plan of Action on Population Growth and the national commitment for the international FP2030 goals to expand family planning services by raising Contraceptive Prevalence Rate (CPR) to 60 percent by 2030 in Pakistan . Based on the Population Council's earlier Landscape study of Family planning services, the total market approach has not been fully adopted in Pakistan (The Population Council, 2016). It called for the inclusion of the private sector and pharmacies to expand access to family planning services and commodities. Another study by the Council also explored the potential of including the private sector and proposed the case for engaging family physicians in family planning . The National Plan of Action on Population Growth's recommendation no. 2 calls for engaging the for-profit private sector, especially family physicians in efforts to expand family planning services . However, a review of evidence in 2020 noted that no determined effort was found to engage private physicians to provide family planning in a sustainable and for-profit model. Internationally, the involvement of the private sector in family planning has been proposed as a High Impact Practice (HIP). The ultimate goal of this study is to provide a model for a successful engagement of male family physicians and pharmacies in family planning and, thereby, expanding family planning services in rural areas to achieve universal access to FP. The engagement of for-profit (male) family physicians in the provision of FP services in linkage with pharmacies will combine three high-impact practices (HIPs) in family planning: (i) private sector engagement (ii) male participation in family planning (Khan, K \& Sathar, Z, 2020) and (iii) integrating pharmacies in the health system.
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. It aims to fill the knowledge gap about the effectiveness of engaging private sector family physicians, and also the optimal approach of integrating family physicians' and pharmacies in Pakistan. Given that the lack of family planning services is particularly dire in rural areas, we situate the study in the rural areas of Islamabad. The study outcomes would provide evidence for advocacy for a sustainable model that can be scaled up to both rural and urban areas.
The study involves an intervention to test the feasibility of engaging male family physicians and pharmacies in expanding the provision of family planning services in the rural areas, on the basis of a review of previous studies, and discussions with a number of private providers, pharmacists, government officials and researchers, The impact of the intervention is to be tested through a randomized control study. The study will enlist family physicians and pharmacies in rural Islamabad Capital Territory (ICT) , who will give their written and informed consent to participate in the study. Physicians will be randomly assigned to intervention and control groups with equal chances of falling into each group.
- The intervention will provide male family physicians with 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 signboards
- Provision of family planning prescription booklets The providers in the intervention group will receive the intervention package, 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. We hypothesize that the proposed intervention will enable male family physicians to provide information, counselling, family planning prescriptions, and referrals, as requested by clients and will result in increased uptake of contraceptive methods.
To evaluate intervention outcomes, baseline assessments in both intervention and control arms will obtain quantitative data from family physicians and pharmacies. We will assess our primary and secondary outcomes using the Management Information System (MIS) tool for obtaining routine service statistics data from clinics and contraceptive sales data from pharmacies. After 6 months of completing the intervention, end-line assessments will be conducted with family physicians in both intervention and control arms to measure changes in providers' KAP towards FP due to intervention. We will also interview family physicians in the intervention arm to get their feedback on the intervention's effectiveness and feasibility through in-depth interviews.
In addition, data on contraceptive availability and sales trends, monitoring stock positions, will be obtained from pharmacies, those nearest to; and linked with participating clinics, at the start, at 3 months, and at 6 months of intervention. The regular availability of contraceptives at the participating pharmacies will be ensured, and mechanisms to address declining stocks or stock outs would be addressed by linking with manufacturers and distributors and with health or population welfare department facilities if needed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study uses a two arm parallel facility based randomized controlled trial with on-going intervention of training and technical support for six-month.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: FP Training and Technical SupportMale 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 |
| 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. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FP Training and Technical SupportSame as in Intervention arm description | Behavioural | Intervention Arm |
Primary outcome
Proportion of family physicians successfully providing family planning services to their clients
Time frame: 6-months
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.
2 secondary outcomes
change in contraceptive uptake
Time frame: 6-months
change in number of FP clients
Time frame: 6-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- BackgroundFederal and Provincial Task Force s, 2019, Action Plan (2019-24) for Implementation of Recommendations Approved by CCI Regarding Alarming Population Growth in Pakistan.
- BackgroundThe Population Council. 2016. Landscape Analysis of Family Planning Situation in Pakistan: Brief Summary of Findings. Islamabad: The Population Council
- BackgroundRehman 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.
- BackgroundKhan, K., & Sathar, Z. (2020). Best Bets for Accelerating Family Planning in Pakistan: Inducting men, sharing responsibility
- BackgroundThe Population Council. 2019. Improving Access to Family Planning Services through the Private Sector in Pakistan: A Stakeholder Analysis. Islamabad: The Population Council.
- BackgroundBradley, S.E & Shiras, T. Pharmacies and Drug Shops. Expanding contraceptive Choice and access in the private sector. Family Planning High Impact Practices2021
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayaz Ahmed Baloch principal investigator
Population Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FP Training and Technical Support in people with Contraceptive Usage and Contraception, run by Population Council at 1 site 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 3 inclusion and 3 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 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Manager Research (+92(051)9205566 ext. 136, abaloch@popcouncil.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of family physicians successfully providing family planning services to their clients (time frame: 6-months). 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 NCT05644886, which also lists 6 linked publications.
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 13 Dec 2022.