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Completed

NCT Number: NCT02796586

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.

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Key information

Conditions

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling

Other

Participants will be randomly assigned to group versus individual contraceptive counseling

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 10, 2016
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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