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

This study has been completed.
Sponsor:
Collaborators:
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
First received: December 23, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Trial of Group vs. Individual Family Planning Counseling in Ghana

Resource links provided by NLM:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Hilary Schwandt, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00814411     History of Changes
Other Study ID Numbers: GCFP
Study First Received: December 23, 2008
Last Updated: December 23, 2008
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 October 19, 2014