A Trial of Group Versus Individual Family Planning Counseling in Ghana - Full Text View

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

This study has been completed.

Sponsors and Collaborators:	Johns Hopkins Bloomberg School of Public Health Bill and Melinda Gates Foundation School of Medical Sciences, Kwame Nkrumah University of Science and Technology
Information provided by:	Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:	NCT00814411

Purpose

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	Intervention	Phase
Contraception	Behavioral: group family planning counseling Behavioral: Individual family planning counseling	Phase III

MedlinePlus related topics: Birth Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Trial of Group vs. Individual Family Planning Counseling in Ghana

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:

Contraceptive Intention [ Time Frame: Follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Modern contraceptive method knowledge [ Time Frame: baseline and follow-up ] [ Designated as safety issue: No ]

Enrollment:	648
Study Start Date:	June 2008
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group Counseling: Experimental Group family planning counseling	Behavioral: group family planning counseling group family planning counseling for gynecological patients with unmet need
Individual Counseling: Active Comparator 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814411

Locations

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

Sponsors and Collaborators

Johns Hopkins Bloomberg School of Public Health

Bill and Melinda Gates Foundation

School of Medical Sciences, Kwame Nkrumah University of Science and Technology

More Information

Responsible Party:	Johns Hopkins Bloomberg School of Public Health ( Hilary Schwandt )
Study ID Numbers:	GCFP
Study First Received:	December 23, 2008
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00814411
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on January 16, 2009