Group Versus Individual Contraceptive Counseling for Resettled African Refugee Women

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

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Other: Counseling

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Individual Contraceptive Counseling; Performed by a medical provider and planned to simulate a typical clinic visit addressing contraception.	Other: Counseling; Participants will be randomly assigned to group versus individual contraceptive counseling
Experimental: Group Contraceptive Counseling; Performed by a bicultural study staff member who speaks the primary languages of participants and had been formally trained in contraception counseling.	Other: Counseling; Participants will be randomly assigned to group versus individual contraceptive counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Contraceptive uptake	Evaluate contraceptive uptake via query of method choice after counseling	Day of intervention (Study day 1)
Service Satisfaction via questionnaire	Evaluate satisfaction with service and type of counseling received using questionnaire	Day of intervention (Study day 1)
Service satisfaction via Likert Scale	Evaluate satisfaction with service and type of counseling received using questionnaire	Day of intervention (Study day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Method Continuation	Evaluate method continuation via telephone survey	3, 6, 9 and 12 months post-intervention
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

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Par Royer, MD MSCI, University of Utah

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: May 13, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (Estimate): June 10, 2016

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Contraception; Family Planning; Group Counseling; Refugee Health; Resettled Refugee; Group contraceptive counseling
• Other Study ID Numbers: 00080655

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO