Postabortion CareNCT01020552
Integrating Family Planning Into Postabortion Care
An observational study of Postabortion Care, run by FHI 360 at 8 sites in Kenya.
Trial summary
A descriptive post-intervention study designed to provide data to decision-makers at the Kenyan Ministry of Health, the Extending Service Delivery Project (ESD), and Pathfinder International about whether and how to scale-up the ESD Project's postabortion care (PAC) services package. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Postabortion Care
- What is being tested?
- Provision of PAC job aids and provider training on the use of the job aids
- How many people
- 300 participants
- Where
- 8 sitesKenya
- Study dates
- Sep 2009to Apr 2010
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: non healthy participants
Who may be able to join
- For Facilities: APHIA II facilities supported by the ESD project in Central Province and Nairobi, Kenya where: (1) PAC services are provided, (2) at least one provider has received PAC and Youth-friendly PAC training, (3) Community mobilization has been initiated, (4) PAC equipment and supplies have been procured, (5) PAC job aids have been distributed.
- For Clients: Women aged 15 years or older who have received PAC services at a study facility and who have a telephone on which they can be contacted
- For Providers: Any person who offers PAC services at a study facility
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Kenya8 sites
Gatundu District Hospital
Gatundu, Central
Karatina District Hospital
Karatina, Central
Kerugoya District Hospital
Kerugoya, Central
Muranga District Hospital
Muranga, Central
Muthethania Maternity
Nairobi, Nairobi-West
Mbagathi District Hospital
Nairobi, West
Thika District Hospital
Thika, Central
Tigoni District Hospital
Tigoni, Central
About this study
Official title: ESD: Integrated Services for Women Seeking Postabortion Care in Kenya
A descriptive post-intervention study designed to provide data to decision-makers at the Kenyan Ministry of Health, the Extending Service Delivery Project (ESD), and Pathfinder International about whether and how to scale-up the ESD Project's postabortion care (PAC) services package. Approximately three months of data will be collected following the introduction of postabortion care job aids in eight public sector health facilities in Central Province and Nairobi, Kenya. Postabortion clients and providers will be interviewed; facilities providing PAC services will be inventoried using facility checklists.
Read the detailed description
A descriptive post-intervention study designed to provide data to decision-makers at the Kenyan Ministry of Health, the Extending Service Delivery Project (ESD), and Pathfinder International about whether and how to scale-up the ESD Project's postabortion care (PAC) services package. Approximately three months of data will be collected following the introduction of postabortion care job aids in eight public sector health facilities in Central Province and Nairobi, Kenya. Postabortion clients and providers will be interviewed; facilities providing PAC services will be inventoried using facility checklists.
- Conditions
- Postabortion Care
- Being tested
- Provision of PAC job aids and provider training on the use of the job aids
- Keywords
- APHIA II, AIDS, Population, and Health Integrated Assistance project, DCF, data collection forms, FDA, Federal Drug Administration, FP, family planning, IRB, Institutional Review Board, PAC, postabortion care, To document the ESD PAC svc pkg including the provision of services, client satisfaction with those services and provider attitudes towards PAC services, To examine any differences in implementation of the ESD PAC services package for youth and adult clients, To assess the usefulness of five Youth-Friendly PAC Job Aids developed by ESD
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provision of PAC job aids and provider training on the use of the job aidsOther
Facility-level intervention applied to all study facilities
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge, attitudes, and practice regarding PAC job aids (clients and providers)
Measured: Anticipated end of data collection 12/31/09
Secondary outcomes (1)
Client-report of provider counseling, by client age
Measured: Anticipated end of analysis/report writing 4/28/10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postabortion CareStudies 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Pathfinder International
- Investigators
- Emily Evens, MPH, Principal investigator, FHI 360Rose Otieno-Masaba, MD, Principal investigator, Family Health International - Nairobi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020552
- Sponsor's protocol ID
- 10035
- Status last verified
- Apr 2010
- First submitted
- 18 Nov 2009
- Last updated
- 29 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESD: Integrated Services for Women Seeking Postabortion Care in Kenya
- ClinicalTrials.gov ID
- NCT01020552
- Acronym / sponsor ID
- 10035
- Conditions
- Postabortion Care
- Keywords
- APHIA II, AIDS, Population, and Health Integrated Assistance project, DCF, data collection forms, FDA, Federal Drug Administration, FP, family planning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Pathfinder International
- Study start
- Sep 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 25 Nov 2009 (estimated)
- 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.
A descriptive post-intervention study designed to provide data to decision-makers at the Kenyan Ministry of Health, the Extending Service Delivery Project (ESD), and Pathfinder International about whether and how to scale-up the ESD Project's postabortion care (PAC) services package. Approximately three months of data will be collected following the introduction of postabortion care job aids in eight public sector health facilities in Central Province and Nairobi, Kenya. Postabortion clients and providers will be interviewed; facilities providing PAC services will be inventoried using facility checklists.
Detailed description
A descriptive post-intervention study designed to provide data to decision-makers at the Kenyan Ministry of Health, the Extending Service Delivery Project (ESD), and Pathfinder International about whether and how to scale-up the ESD Project's postabortion care (PAC) services package. Approximately three months of data will be collected following the introduction of postabortion care job aids in eight public sector health facilities in Central Province and Nairobi, Kenya. Postabortion clients and providers will be interviewed; facilities providing PAC services will be inventoried using facility checklists.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- non healthy participants
Key inclusion criteria (3 listed)
- For Facilities: APHIA II facilities supported by the ESD project in Central Province and Nairobi, Kenya where: (1) PAC services are provided, (2) at least one provider has received PAC and Youth-friendly PAC training, (3) Community mobilization has been initiated, (4) PAC equipment and supplies have been procured, (5) PAC job aids have been distributed.
- For Clients: Women aged 15 years or older who have received PAC services at a study facility and who have a telephone on which they can be contacted
- For Providers: Any person who offers PAC services at a study facility
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Provision of PAC job aids and provider training on the use of the job aidsFacility-level intervention applied to all study facilities | Other | – |
Primary outcome
Knowledge, attitudes, and practice regarding PAC job aids (clients and providers)
Time frame: Anticipated end of data collection 12/31/09
1 secondary outcome
Client-report of provider counseling, by client age
Time frame: Anticipated end of analysis/report writing 4/28/10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2010.
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.
Emily Evens, MPH principal investigator
FHI 360
Rose Otieno-Masaba, MD principal investigator
Family Health International - Nairobi
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postabortion Care, run by FHI 360 at 8 sites in Kenya.
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 0 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: finished, as of the sponsor's last update on 29 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Kenya. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Knowledge, attitudes, and practice regarding PAC job aids (clients and providers) (time frame: Anticipated end of data collection 12/31/09). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2010.