Group Versus Individual Contraceptive Counseling for Resettled African Refugee Women

NCT02796586 | Completed

• 1 other identifier: 00080655
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Keywords

Refugee Health; Resettled Refugee; Family Planning; Contraception; Group Counseling; Group contraceptive counseling

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Method Continuation

  3, 6, 9 and 12 months post-intervention

• Knowledge Retention assessed via modified FogZone questionnaire

  3, 6, 9 and 12 months post-intervention

Study Arms (2)

Individual Contraceptive Counseling

PLACEBO COMPARATOR

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

Other: Counseling

Group Contraceptive Counseling

EXPERIMENTAL

Performed by a bicultural study staff member who speaks the primary languages of participants and had been formally trained in contraception counseling.

Other: Counseling

Interventions

Counseling OTHER

Participants will be randomly assigned to group versus individual contraceptive counseling

Group Contraceptive Counseling; Individual Contraceptive Counseling

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Male

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Par Royer, MD MSCI

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Faculty

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: June 10, 2016
• Study Start: July 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 17, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)