Clinical trial NCT02796586: Group Versus Individual Contraceptive Counseling for Resettled African Refugee Women
Official title: Salt Lake Refugee Women's Health Project-Group Versus Individual Contraceptive Counseling for Resettled African Refugee Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: Refugee Health
Resettled Refugee
Family Planning
Contraception
Group Counseling
Group contraceptive counseling
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Knowledge Acquisition assessed via number of correct questions on modified FogZone questionnaire
timeFrame: Day of intervention (Study Day 1)
measure: Contraceptive uptake
timeFrame: Day of intervention (Study day 1)
measure: Service Satisfaction via questionnaire
timeFrame: Day of intervention (Study day 1)
measure: Service satisfaction via Likert Scale
timeFrame: Day of intervention (Study day 1)
Secondary outcomes:
measure: Method Continuation
timeFrame: 3, 6, 9 and 12 months post-intervention
measure: Knowledge Retention assessed via modified FogZone questionnaire
timeFrame: 3, 6, 9 and 12 months post-intervention
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
Study officials:
affiliation: University of Utah
name: Par Royer, MD MSCI
role: PRINCIPAL_INVESTIGATOR
References: