A Trial of Group Versus Individual Family Planning Counseling in Ghana (GCFP)

December 23, 2008 updated by: Johns Hopkins Bloomberg School of Public Health

A Randomized Trial of Group vs. Individual Family Planning Counseling in Ghana

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

648

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ghana
    • Ashanti
      • Kumasi, Ashanti, Ghana
        • Komfo Anokye Teaching Hospital
    • Greater Accra
      • Accra, Greater Accra, Ghana
        • Korle Bu Teaching Hospital
  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Johns Hopkins Bloomberg School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group Counseling
Group family planning counseling
Behavioral: group family planning counseling
group family planning counseling for gynecological patients with unmet need
ACTIVE_COMPARATOR: Individual Counseling
Individual family planning counseling with gynecological patients who have unmet need
Behavioral: Individual family planning counseling
Individual family planning counseling with gynecological patients - the current standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Contraceptive Intention
Time Frame: Follow-up
Follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Bill and Melinda Gates Foundation
Kwame Nkrumah University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

July 1, 2008

Study Completion (ACTUAL)

July 1, 2008

Study Registration Dates

First Submitted

December 23, 2008

First Submitted That Met QC Criteria

December 23, 2008

First Posted (ESTIMATE)

December 24, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 24, 2008

Last Update Submitted That Met QC Criteria

December 23, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GCFP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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