Group Versus Individual Contraceptive Counseling for Resettled African Refugee Women

Contraception Clinical Trial

Official title:

Salt Lake Refugee Women's Health Project-Group Versus Individual Contraceptive Counseling for Resettled African Refugee Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796586
• Other study ID #: 00080655
• Status: Completed
• Phase: N/A
• First received: May 13, 2016
• Last updated: May 16, 2017
• Start date: July 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the feasibility and effectiveness of group contraceptive counseling on family planning knowledge acquisition, service satisfaction, method uptake and continuation among a group of resettled African refugee women.

Description:

Thousands of women refugees arrive in the United States each year, yet there is very little known about reproductive health and family planning needs of these women after resettlement.

This randomized controlled pilot study, in a population of resettled African refugee women, will evaluate differences between group and individual contraceptive counseling on the decision to use contraception, satisfaction with counseling method, and modern family planning knowledge.

Participants will arrive to clinic during an assigned "intervention day." An intake and exit survey will be performed before and after their counseling session. Demographics, attitudes towards contraception, and knowledge regarding contraceptive methods will be assessed via questionnaire. Participants will be randomized to either group or individual contraceptive counseling. After each session, participants will have the option to privately choose a reversible method of contraception free of charge.

Telephone survey follow-up with participants will occur every three months for one year. Follow-up surveys will include questions regarding method continuation, method satisfaction and and modern contraceptive knowledge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Resettled refugee

• Ability to speak and comprehend conversational Swahili, French or Lingala

• Interest in contraceptive counseling

• Willing to adhere to study protocols including randomization and follow-up

• Cellular phone access

Exclusion Criteria:

• Male

Related Conditions & MeSH terms

• Contraception

Intervention

Other:
• Counseling
Participants will be randomly assigned to group versus individual contraceptive counseling

Locations

Country	Name	City	State
United States	University of Utah Hospital	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge Acquisition assessed via number of correct questions on modified FogZone questionnaire	Evaluate knowledge acquisition by comparing results on pre and post test of modern contraceptive knowledge. Contraceptive knowledge will be assessed using a modified version of the FogZone questionnaire	Day of intervention (Study Day 1)
Primary	Contraceptive uptake	Evaluate contraceptive uptake via query of method choice after counseling	Day of intervention (Study day 1)
Primary	Service Satisfaction via questionnaire	Evaluate satisfaction with service and type of counseling received using questionnaire	Day of intervention (Study day 1)
Primary	Service satisfaction via Likert Scale	Evaluate satisfaction with service and type of counseling received using questionnaire	Day of intervention (Study day 1)
Secondary	Method Continuation	Evaluate method continuation via telephone survey	3, 6, 9 and 12 months post-intervention
Secondary	Knowledge Retention assessed via modified FogZone questionnaire	Evaluate knowledge retention by repeating knowledge questionnaire and comparing baseline and interval results.	3, 6, 9 and 12 months post-intervention