ContraceptionNCT02796586
Group Versus Individual Contraceptive Counseling for Resettled African Refugee Women
A study testing Counseling in people with Contraception, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Counseling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Male
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Hospital
Salt Lake City, Utah, 84132
About this study
Official title: Salt Lake Refugee Women's Health Project-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.
Read the 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.
- Conditions
- Contraception
- Being tested
- Counseling
- Keywords
- Refugee Health, Resettled Refugee, Family Planning, Contraception, Group Counseling, Group contraceptive counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingOther
Participants will be randomly assigned to group versus individual contraceptive counseling
| Study group | Role | What they receive |
|---|---|---|
| Individual Contraceptive Counseling | Placebo comparator | Performed by a medical provider and planned to simulate a typical clinic visit addressing contraception. Receives: 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. Receives: Other: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day of intervention (Study Day 1)
Contraceptive uptake
Evaluate contraceptive uptake via query of method choice after counseling
Measured: Day of intervention (Study day 1)
Service Satisfaction via questionnaire
Evaluate satisfaction with service and type of counseling received using questionnaire
Measured: Day of intervention (Study day 1)
Service satisfaction via Likert Scale
Evaluate satisfaction with service and type of counseling received using questionnaire
Measured: Day of intervention (Study day 1)
Secondary outcomes (2)
Method Continuation
Evaluate method continuation via telephone survey
Measured: 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.
Measured: 3, 6, 9 and 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startJul 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Par Royer, University of Utah
- Investigators
- Par Royer, MD MSCI, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796586
- Sponsor's protocol ID
- 00080655
- Status last verified
- May 2017
- First submitted
- 13 May 2016
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salt Lake Refugee Women's Health Project-Group Versus Individual Contraceptive Counseling for Resettled African Refugee Women
- ClinicalTrials.gov ID
- NCT02796586
- Acronym / sponsor ID
- 00080655
- Conditions
- Contraception
- Keywords
- Refugee Health, Resettled Refugee, Family Planning, Contraception, Group Counseling, Group contraceptive counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual Contraceptive Counseling | Placebo comparator | Other: CounselingPerformed by a medical provider and planned to simulate a typical clinic visit addressing contraception. |
| Group Contraceptive Counseling | Experimental | Other: CounselingPerformed by a bicultural study staff member who speaks the primary languages of participants and had been formally trained in contraception counseling. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Male
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CounselingParticipants will be randomly assigned to group versus individual contraceptive counseling | Other | Group Contraceptive Counseling, Individual Contraceptive Counseling |
Primary outcome
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
Contraceptive uptake
Time frame: Day of intervention (Study day 1)
Evaluate contraceptive uptake via query of method choice after counseling
Service Satisfaction via questionnaire
Time frame: Day of intervention (Study day 1)
Evaluate satisfaction with service and type of counseling received using questionnaire
Service satisfaction via Likert Scale
Time frame: Day of intervention (Study day 1)
Evaluate satisfaction with service and type of counseling received using questionnaire
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Individual participant dataSharing planned: No
Related trials for Contraception
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Par Royer, MD MSCI principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling in people with Contraception, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge Acquisition assessed via number of correct questions on modified FogZone questionnaire (time frame: Day of intervention (Study Day 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.