This trial is active, not recruiting.

Condition contraception
Treatment counseling
Sponsor University of Utah
Start date July 2015
End date December 2016
Trial size 17 participants
Trial identifier NCT02796586, 00080655


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
(Placebo Comparator)
Performed by a medical provider and planned to simulate a typical clinic visit addressing contraception.
Participants will be randomly assigned to group versus individual contraceptive counseling
Performed by a bicultural study staff member who speaks the primary languages of participants and had been formally trained in contraception counseling.
Participants will be randomly assigned to group versus individual contraceptive counseling

Primary Outcomes

Knowledge Acquisition assessed via number of correct questions on modified FogZone questionnaire
time frame: Day of intervention (Study Day 1)
Contraceptive uptake
time frame: Day of intervention (Study day 1)
Service Satisfaction via questionnaire
time frame: Day of intervention (Study day 1)
Service satisfaction via Likert Scale
time frame: Day of intervention (Study day 1)

Secondary Outcomes

Method Continuation
time frame: 3, 6, 9 and 12 months post-intervention
Knowledge Retention assessed via modified FogZone questionnaire
time frame: 3, 6, 9 and 12 months post-intervention

Eligibility Criteria

Female participants from 18 years up to 49 years old.

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

Additional Information

Official title Salt Lake Refugee Women's Health Project-Group Versus Individual Contraceptive Counseling for Resettled African Refugee Women
Principal investigator Par Royer, MD MSCI
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Utah.