Group Versus Individual Contraceptive Counseling for Resettled African Refugee Women

NCT ID: NCT02796586

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-05-31

Brief 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.

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.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Individual Contraceptive Counseling

Performed by a medical provider and planned to simulate a typical clinic visit addressing contraception.

Group Type: PLACEBO_COMPARATOR

Counseling

Intervention Type: OTHER

Participants will be randomly assigned to group versus individual contraceptive counseling

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.

Group Type: EXPERIMENTAL

Counseling

Intervention Type: OTHER

Participants will be randomly assigned to group versus individual contraceptive counseling

Interventions

Counseling

Participants will be randomly assigned to group versus individual contraceptive counseling

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Par Royer

Adjunct Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Par Royer, MD MSCI

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah Hospital

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

00080655

Identifier Type: -

Identifier Source: org_study_id