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Group Versus Individual Contraceptive Counseling for Resettled African Refugee Women

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ClinicalTrials.gov Identifier: NCT02796586
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Par Royer, University of Utah

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.

Condition or disease Intervention/treatment Phase
Contraception Other: Counseling Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Salt Lake Refugee Women's Health Project-Group Versus Individual Contraceptive Counseling for Resettled African Refugee Women
Study Start Date : July 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

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




Primary Outcome Measures :
  1. Knowledge Acquisition assessed via number of correct questions on modified FogZone questionnaire [ Time Frame: Day of intervention (Study Day 1) ]
    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

  2. Contraceptive uptake [ Time Frame: Day of intervention (Study day 1) ]
    Evaluate contraceptive uptake via query of method choice after counseling

  3. Service Satisfaction via questionnaire [ Time Frame: Day of intervention (Study day 1) ]
    Evaluate satisfaction with service and type of counseling received using questionnaire

  4. Service satisfaction via Likert Scale [ Time Frame: Day of intervention (Study day 1) ]
    Evaluate satisfaction with service and type of counseling received using questionnaire


Secondary Outcome Measures :
  1. Method Continuation [ Time Frame: 3, 6, 9 and 12 months post-intervention ]
    Evaluate method continuation via telephone survey

  2. Knowledge Retention assessed via modified FogZone questionnaire [ Time Frame: 3, 6, 9 and 12 months post-intervention ]
    Evaluate knowledge retention by repeating knowledge questionnaire and comparing baseline and interval results.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796586


Locations
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United States, Utah
University of Utah Hospital
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Par Royer, MD MSCI University of Utah

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Responsible Party: Par Royer, Adjunct Faculty, University of Utah
ClinicalTrials.gov Identifier: NCT02796586     History of Changes
Other Study ID Numbers: 00080655
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Par Royer, University of Utah:
Refugee Health
Resettled Refugee
Family Planning
Contraception
Group Counseling
Group contraceptive counseling

Additional relevant MeSH terms:
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Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs