AttitudesNCT01965743
Pilot of Social Network Intrauterine Contraceptive (IUC) Intervention
A study testing Contraception Information Packet in people with Attitudes, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study has two goals: 1) to test an approach to helping women who use intrauterine contraception (IUC) spread the word about this type of long-lasting, highly effective birth control method among their friends and family and; 2) to test ways of getting in touch with these women's friends and family so that we can… Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Attitudes
- What is being tested?
- Contraception Information Packet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Aug 2014
- 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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Dissemination agents:
- Have an IUD placed for contraception at clinic visit or 2-6 weeks prior
- speak English
- be at least 15 years old
- willing to disclose IUD use to friends and family
- willing to have research staff contact their friends and family to participate in study related to family planning.
Show all 14Show fewer
- Social contacts:
- Age 15-45
- speak English
- able to get pregnant
- ever sexually active with men
- acquainted with dissemination agent.
- Clinic staff:
- Able to provide family planning care at clinic where intervention is being implemented.
Who cannot join
- Dissemination agents:
- Using IUD for reason other than contraception
- unwilling to disclose IUD use to any social contacts
- unwilling to allow research staff to enroll friends and family in study as social contacts
- do not speak or understand English.
- Social contacts:
Show all 10Show fewer
- Unable to get pregnant
- do not speak or understand English.
- Clinic staff:
- Not working at clinic at time of intervention.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94108
About this study
Official title: The Woman-to-Woman Dissemination Project: Harnessing the Power of Social Networks to Increase IUC Use
This study has two goals: 1) to test an approach to helping women who use intrauterine contraception (IUC) spread the word about this type of long-lasting, highly effective birth control method among their friends and family and; 2) to test ways of getting in touch with these women's friends and family so that we can track whether this approach is effective at spreading birth control information through social groups.
Read the detailed description
Pilot of peer IUC intervention We will assess its feasibility and acceptability as a low-cost intervention designed to be implemented at clinics providing family planning care. The intervention is being designed based off of phase 1 of this study, currently in the analysis phase, which included semi-structured interviews, focus groups, and surveys with a diverse sample of young women with varying degrees of experience with IUC. The intervention will consist of brief education about IUC and development of interpersonal skills, including how to initiate conversations about reproductive health issues in social settings and how to utilize social media. New IUC users will be recruited as "dissemination agents" to provide information about the option of IUC to their peers. Sixteen to twenty IUC users will be recruited from a local family planning clinic to receive the intervention, and we will conduct 3-month qualitative and quantitative follow-up of these individuals and their social contacts to assess the feasibility and impact of the intervention on IUC knowledge, attitudes and practices. We will also conduct a focus group with clinic staff about the feasibility of implementing the intervention in the clinical setting.
Test of snowball sampling for social network analysis The social contacts will be recruited via one of two snowball sampling methods: active or passive recruitment. Eight to ten dissemination agents will be randomized into each recruitment arm. In the passive recruitment arm, the dissemination agents (IUC users receiving the intervention) will give referral cards to their social contacts, encouraging them to contact the research team. Dissemination agents will receive a small "finder's fee" for each friend who contacts the researchers.
In the active recruitment approach, dissemination agents will ask their social contacts for permission to share their contact information with study staff, who will then actively reach out to the social contacts to ask if they would like to enroll in the study. Dissemination agents will also receive a finder's fee for each social contact who enrolls.
In both recruitment arms, social contacts will complete a baseline survey and will be contacted for follow-up at 3 months to assess the effects of the intervention. We will also assess which recruitment method is most effective at enrolling members of the dissemination agents' social network. A randomly selected sub-set of participants will be selected to complete a more detailed qualitative interview at the end of the intervention. To minimize any potential Hawthorne effect, social contacts will initially be blinded as to the specific aims being assessed, and will be debriefed at the end of the study.
This pilot study will provide the data necessary to prepare for a randomized controlled trial of this intervention.
- Conditions
- Attitudes
- Being tested
- Contraception Information Packet
- Keywords
- intrauterine contraception (IUC), social networks, social influence, diffusion of innovation, intrauterine device (IUD), LARC
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contraception Information PacketBehavioural
The intervention will consist of brief education about IUC and development of interpersonal skills, including how to initiate conversations about reproductive health issues in social settings and debunking common IUC myths
| Study group | Role | What they receive |
|---|---|---|
| Contraception Information Packet | Other | Everyone in the study will receive the intervention, which is an information packet designed to facilitate conversations among peers about intrauterine contraception. Receives: Behavioral: Contraception Information Packet |
What is being measured
The primary outcome is the main question the study is designed to answer.
intrauterine contraception social network survey
Survey of social network members about intrauterine contraception. At baseline and at 3 month follow-up, we will assess whether intervention recipients discussed intrauterine contraception with their social networks
Measured: 3 months
Secondary outcomes (1)
Perception of intrauterine contraception
Survey of intrauterine contraception. At baseline and 3 month follow-up, we will assess social network members' attitudes towards IUC
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startApr 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AttitudesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- William and Flora Hewlett Foundation
- Responsible party
- Sponsor
- Investigators
- Christine Dehlendorf, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965743
- Sponsor's protocol ID
- 2012-8070
- Status last verified
- Sep 2014
- First submitted
- 15 Oct 2013
- Last updated
- 10 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Woman-to-Woman Dissemination Project: Harnessing the Power of Social Networks to Increase IUC Use
- ClinicalTrials.gov ID
- NCT01965743
- Acronym / sponsor ID
- 2012-8070
- Conditions
- Attitudes
- Keywords
- intrauterine contraception (IUC), social networks, social influence, diffusion of innovation, intrauterine device (IUD), LARC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- William and Flora Hewlett Foundation
- Study start
- Apr 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 18 Oct 2013 (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.
This study has two goals: 1) to test an approach to helping women who use intrauterine contraception (IUC) spread the word about this type of long-lasting, highly effective birth control method among their friends and family and; 2) to test ways of getting in touch with these women's friends and family so that we can track whether this approach is effective at spreading birth control information through social groups.
Detailed description
Pilot of peer IUC intervention We will assess its feasibility and acceptability as a low-cost intervention designed to be implemented at clinics providing family planning care. The intervention is being designed based off of phase 1 of this study, currently in the analysis phase, which included semi-structured interviews, focus groups, and surveys with a diverse sample of young women with varying degrees of experience with IUC. The intervention will consist of brief education about IUC and development of interpersonal skills, including how to initiate conversations about reproductive health issues in social settings and how to utilize social media. New IUC users will be recruited as "dissemination agents" to provide information about the option of IUC to their peers. Sixteen to twenty IUC users will be recruited from a local family planning clinic to receive the intervention, and we will conduct 3-month qualitative and quantitative follow-up of these individuals and their social contacts to assess the feasibility and impact of the intervention on IUC knowledge, attitudes and practices. We will also conduct a focus group with clinic staff about the feasibility of implementing the intervention in the clinical setting.
Test of snowball sampling for social network analysis The social contacts will be recruited via one of two snowball sampling methods: active or passive recruitment. Eight to ten dissemination agents will be randomized into each recruitment arm. In the passive recruitment arm, the dissemination agents (IUC users receiving the intervention) will give referral cards to their social contacts, encouraging them to contact the research team. Dissemination agents will receive a small "finder's fee" for each friend who contacts the researchers.
In the active recruitment approach, dissemination agents will ask their social contacts for permission to share their contact information with study staff, who will then actively reach out to the social contacts to ask if they would like to enroll in the study. Dissemination agents will also receive a finder's fee for each social contact who enrolls.
In both recruitment arms, social contacts will complete a baseline survey and will be contacted for follow-up at 3 months to assess the effects of the intervention. We will also assess which recruitment method is most effective at enrolling members of the dissemination agents' social network. A randomly selected sub-set of participants will be selected to complete a more detailed qualitative interview at the end of the intervention. To minimize any potential Hawthorne effect, social contacts will initially be blinded as to the specific aims being assessed, and will be debriefed at the end of the study.
This pilot study will provide the data necessary to prepare for a randomized controlled trial of this intervention.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contraception Information Packet | Other | Behavioral: Contraception Information PacketEveryone in the study will receive the intervention, which is an information packet designed to facilitate conversations among peers about intrauterine contraception. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Dissemination agents:
- Have an IUD placed for contraception at clinic visit or 2-6 weeks prior
- speak English
- be at least 15 years old
- willing to disclose IUD use to friends and family
Key exclusion criteria (10 listed)
- Dissemination agents:
- Using IUD for reason other than contraception
- unwilling to disclose IUD use to any social contacts
- unwilling to allow research staff to enroll friends and family in study as social contacts
- do not speak or understand English.
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 |
|---|---|---|
| Contraception Information PacketThe intervention will consist of brief education about IUC and development of interpersonal skills, including how to initiate conversations about reproductive health issues in social settings and debunking common IUC myths | Behavioural | Contraception Information Packet |
Primary outcome
intrauterine contraception social network survey
Time frame: 3 months
Survey of social network members about intrauterine contraception. At baseline and at 3 month follow-up, we will assess whether intervention recipients discussed intrauterine contraception with their social networks
1 secondary outcome
Perception of intrauterine contraception
Time frame: 3 months
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 10 Sep 2014.
Related trials for Attitudes
RecruitingObservational study
The Decision To Enroll In Therapeutic Clinical Trials In A Pediatric Cancer Clinical Network
Knowledge, Attitudes, Practice
Not yet recruiting
The Effectiveness of Comic-based Learning Materials on Nursing Students' Knowledge, Attitudes, and Confidence in Dementia Care
Dementia Care Education, Students, Nursing
Not yet recruitingObservational study
An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia
Hypercholesterolaemia, Familial Hypercholesterolaemia
RecruitingObservational study
Breast Cancer Rehabilitation Needs and Service Uptake
Breast Cancer, Cancer Survivorship
Recruiting
Climate-Responsive Nutrition, WASH, and Heat Counselling for Maternal and Child Health in Sindh, Pakistan
Maternal Nutrition, Child Nutrition
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.
Christine Dehlendorf, MD, MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contraception Information Packet in people with Attitudes, run by University of California, San Francisco 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 14 inclusion and 10 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 10 Sep 2014. 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. 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?
intrauterine contraception social network survey (time frame: 3 months). 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 10 Sep 2014.