A Trial of Group Versus Individual Family Planning Counse... | NCT00814411

Studies
A Trial of Group Versus Individual Family Planning Counseling in Ghana

NCT00814411

Sponsor

Johns Hopkins Bloomberg School of Public Health

Status

Completed

Last Update Posted

Dec 24, 2008Estimated

Enrollment

648Actual

Phase

Phase 3

Conditions

Contraception

Interventions

group family planning counseling
Individual family planning counseling

Countries

United States
Ghana

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Dec 23, 2008

First Submission Date that Met QC Criteria

Dec 23, 2008

First Posted Date

Dec 24, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2008

Last Update Posted Date

Dec 24, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Johns Hopkins Bloomberg School of Public HealthOTHER

Collaborators

Name	Class
Bill and Melinda Gates Foundation	OTHER
Kwame Nkrumah University of Science and Technology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study uses a randomized, noninferiority design to determine whether group family planning counseling is as effective as individual family planning counseling among gynecological patients with unmet need at two teaching hospitals in Ghana.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

648Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group Counseling	Experimental	Group family planning counseling	Behavioral: group family planning counseling
Individual Counseling	Active Comparator	Individual family planning counseling with gynecological patients who have unmet need	Behavioral: Individual family planning counseling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
group family planning counseling	Behavioral	group family planning counseling for gynecological patients with unmet need	Group Counseling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Contraceptive Intention		Follow-up

Secondary Outcomes

Measure	Description	Time Frame
Modern contraceptive method knowledge		baseline and follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age and older
fertile
desires to delay pregnancy for at least 12 months

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins Bloomberg School of Public Health		Baltimore	Maryland	21218	United States
Komfo Anokye Teaching Hospital