A Trial of Group Versus Individual Family Planning Counseling in Ghana

Contraception Clinical Trial

— GCFP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00814411
• Other study ID #: GCFP
• Status: Completed
• Phase: Phase 3
• First received: December 23, 2008
• Last updated: December 23, 2008
• Start date: June 2008
• Est. completion date: July 2008

Study information

• Verified date: December 2008
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 648
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age and older

• fertile

• desires to delay pregnancy for at least 12 months

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Behavioral:
• group family planning counseling
group family planning counseling for gynecological patients with unmet need
• Individual family planning counseling
Individual family planning counseling with gynecological patients - the current standard of care

Locations

Country	Name	City	State
Ghana	Korle Bu Teaching Hospital	Accra	Greater Accra
Ghana	Komfo Anokye Teaching Hospital	Kumasi	Ashanti
United States	Johns Hopkins Bloomberg School of Public Health	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Bill and Melinda Gates Foundation, Kwame Nkrumah University of Science and Technology

Countries where clinical trial is conducted

United States,  Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contraceptive Intention		Follow-up	No
Secondary	Modern contraceptive method knowledge		baseline and follow-up	No