Group Versus Individual Contraceptive Counseling for Resettled African Refugee Women

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Contraception

Intervention / Treatment
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* Other: Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refugee Health, Resettled Refugee, Family Planning, Contraception, Group Counseling, Group contraceptive counseling