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

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ClinicalTrials.gov Identifier: NCT00814411
Recruitment Status : Completed
First Posted : December 24, 2008
Last Update Posted : December 24, 2008
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Kwame Nkrumah University of Science and Technology
Information provided by:
Johns Hopkins Bloomberg School of Public Health

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.

Condition or disease Intervention/treatment Phase
Contraception Behavioral: group family planning counseling Behavioral: Individual family planning counseling Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 648 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Trial of Group vs. Individual Family Planning Counseling in Ghana
Study Start Date : June 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Contraceptive Intention [ Time Frame: Follow-up ]

Secondary Outcome Measures :
  1. Modern contraceptive method knowledge [ Time Frame: baseline and follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814411


Locations
United States, Maryland
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21218
Ghana
Komfo Anokye Teaching Hospital
Kumasi, Ashanti, Ghana
Korle Bu Teaching Hospital
Accra, Greater Accra, Ghana
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Bill and Melinda Gates Foundation
Kwame Nkrumah University of Science and Technology

Responsible Party: Hilary Schwandt, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00814411     History of Changes
Other Study ID Numbers: GCFP
First Posted: December 24, 2008    Key Record Dates
Last Update Posted: December 24, 2008
Last Verified: December 2008

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
contraception
noninferiority
intention
family planning counseling
post abortion care
Family planning intention among women with unmet need