AttitudesNCT02242890
Pilot #2 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… 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Jul 2015
- 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 have existing IUD for contraception
- Speak English
- Age 15-45
- 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 15Show fewer
- Social contacts:
- Age 15-45 Speak English
- Able to get pregnant
- Ever sexually active with men
- Acquainted with dissemination agent
- Makes contact with study team within one month of dissemination agent's enrollment (baseline arm) or within one month of dissemination agent's 3 months follow up (follow up arm)
- Lives in the United States of America.
- 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
Planned Parenthood North Highlands
North Highlands, California, 95660
About this study
Official title: Pilot #2: 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 investigators can track whether this approach is effective at spreading birth control information through social groups.
Read the detailed description
Pilot of peer IUC intervention:
Investigators will assess the feasibility and acceptability of a low-cost intervention implemented at a clinic providing family planning care. The intervention was first piloted in the an earlier phase of this study (ClincalTrials.gov ID: NCT01965743) which is currently in the analysis phase. Based off of participant feedback from this first pilot, investigators have revised and optimized the intervention which investigators will be testing again here at a new clinic and with a new population.
New IUC users as well as experienced IUC users will be recruited as "dissemination agents" to provide information about the option of IUC to their peers. Ten to sixteen IUC users will be recruited from a family planning clinic to receive the intervention.The intervention which will be delivered by a clinic staff member to new or existing IUC users includes handing her a packet of pamphlets, encouraging her to sign up for a series of SMS messages, and informing her about the intervention's website. The content on the intervention across all media forms consists of a brief education about IUC and development of interpersonal skills for IUC users, including how to initiate conversations about reproductive health issues and their personal experience with IUC in social settings.
Investigators will conduct baseline and 3 month quantitative surveys as well as 3-month qualitative interviews of dissemination agents to asses the feasibility and impact of the intervention on IUC knowledge, attitudes and social communication practices. As described in more detail below, investigators will also enroll the social contacts of dissemination agents to measure the effect of the intervention on their IUC knowledge and attitudes.
At the completion of dissemination agent enrollment and intervention implementation in clinic, investigators 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 of dissemination agents will be recruited via one of two snowball sampling methods: baseline or follow up recruitment methods. Dissemination agents will be randomized into each recruitment arm. In both recruitment arms, dissemination agents will list at baseline and at 3 month follow up their female social contacts between the ages of 15-45 with whom they feel comfortable talking about birth control with.
In the baseline recruitment arm, the dissemination agents within the first 2 weeks of being enrolled will ask their listed social contacts if they are interested in joining a study about birth control and for permission for the dissemination agent to share their contact info with the study staff. Study staff will then reach out to the social contacts whom have shared their contact information with us to ask if they would like to enroll in the study. Social contacts who choose to enroll will complete a baseline survey as well as another follow up survey 3 months from when their respective dissemination agent enrolled.
In the follow up recruitment arm, dissemination agents at 3 months from their enrollment will recruit in the same manner as the baseline arm their social contacts. They will be asked to recruit all social contacts listed at baseline and any additional ones added at 3 months. Social contacts who enroll will complete 1 survey at the time of their enrollment.
In both arms, dissemination agents will receive a small "finder's fee" for each social contact with whom the study is able to make contact with and confirms that she gave the dissemination agent permission to share her contact info.
Investigators will assess which recruitment method is most effective at enrolling members of the dissemination agents' social network and whether social contacts in the baseline arm had more conversations about IUC with their dissemination agents between baseline and follow up due to the presence of recruitment conversations happening concurrently.
A randomly selected sub-set of social contacts in both arms will be selected to complete a more detailed qualitative interview after quantitative data collection is complete. 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.
Acceptability of WhyIUD intervention to intervention participants
Study staff will administer 3-month post-intervention surveys with participants to quantitatively assess their opinions of and engagement with the WhyIUD intervention. Staff will also conduct structured interviews with a selection of participants at 3 months to gather qualitative feedback on the intervention.
Measured: 3 months
Secondary outcomes (5)
Feasability of snowball sampling procedure to obtain social network sample
Study staff will measure the percentage of identified social contacts who participate in the study and their retention during the study period.
Measured: 3 months
Change in IUD-related knowledge among intervention participants
Baseline and 3-month surveys with participants will include measures related to IUD knowledge.
Measured: 3 months
Change in IUD-related attitudes among patient participants
Baseline and 3-month surveys with participants will include measures related to IUD attitudes.
Measured: 3 months
Change in IUD-related social communication among patient participants
Baseline and 3-month surveys with participants will include measures related to social communication with friends and family about the IUD.
Measured: 3 months
Acceptability of WhyIUD intervention to clinic staff
After the 1-month period during which the intervention is actively delivered in clinic, study staff will conduct a focus group with clinic personnel who were involved in the delivery of WhyIUD to assess acceptability by gathering their opinions and experience of the intervention.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startFeb 2015
- Primary completionJul 2015
- Study completionJul 2015
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
- 40 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
- NCT02242890
- Sponsor's protocol ID
- 2012-8070-2
- Status last verified
- Sep 2015
- First submitted
- 15 Sep 2014
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot #2: The Woman-to-Woman Dissemination Project: Harnessing the Power of Social Networks to Increase IUC Use
- ClinicalTrials.gov ID
- NCT02242890
- Acronym / sponsor ID
- 2012-8070-2
- Conditions
- Attitudes
- Keywords
- intrauterine contraception (IUC), social networks, social influence, diffusion of innovation, intrauterine device (IUD), LARC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- William and Flora Hewlett Foundation
- Study start
- Feb 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 17 Sep 2014 (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 investigators can track whether this approach is effective at spreading birth control information through social groups.
Detailed description
Pilot of peer IUC intervention:
Investigators will assess the feasibility and acceptability of a low-cost intervention implemented at a clinic providing family planning care. The intervention was first piloted in the an earlier phase of this study (ClincalTrials.gov ID: NCT01965743) which is currently in the analysis phase. Based off of participant feedback from this first pilot, investigators have revised and optimized the intervention which investigators will be testing again here at a new clinic and with a new population.
New IUC users as well as experienced IUC users will be recruited as "dissemination agents" to provide information about the option of IUC to their peers. Ten to sixteen IUC users will be recruited from a family planning clinic to receive the intervention.The intervention which will be delivered by a clinic staff member to new or existing IUC users includes handing her a packet of pamphlets, encouraging her to sign up for a series of SMS messages, and informing her about the intervention's website. The content on the intervention across all media forms consists of a brief education about IUC and development of interpersonal skills for IUC users, including how to initiate conversations about reproductive health issues and their personal experience with IUC in social settings.
Investigators will conduct baseline and 3 month quantitative surveys as well as 3-month qualitative interviews of dissemination agents to asses the feasibility and impact of the intervention on IUC knowledge, attitudes and social communication practices. As described in more detail below, investigators will also enroll the social contacts of dissemination agents to measure the effect of the intervention on their IUC knowledge and attitudes.
At the completion of dissemination agent enrollment and intervention implementation in clinic, investigators 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 of dissemination agents will be recruited via one of two snowball sampling methods: baseline or follow up recruitment methods. Dissemination agents will be randomized into each recruitment arm. In both recruitment arms, dissemination agents will list at baseline and at 3 month follow up their female social contacts between the ages of 15-45 with whom they feel comfortable talking about birth control with.
In the baseline recruitment arm, the dissemination agents within the first 2 weeks of being enrolled will ask their listed social contacts if they are interested in joining a study about birth control and for permission for the dissemination agent to share their contact info with the study staff. Study staff will then reach out to the social contacts whom have shared their contact information with us to ask if they would like to enroll in the study. Social contacts who choose to enroll will complete a baseline survey as well as another follow up survey 3 months from when their respective dissemination agent enrolled.
In the follow up recruitment arm, dissemination agents at 3 months from their enrollment will recruit in the same manner as the baseline arm their social contacts. They will be asked to recruit all social contacts listed at baseline and any additional ones added at 3 months. Social contacts who enroll will complete 1 survey at the time of their enrollment.
In both arms, dissemination agents will receive a small "finder's fee" for each social contact with whom the study is able to make contact with and confirms that she gave the dissemination agent permission to share her contact info.
Investigators will assess which recruitment method is most effective at enrolling members of the dissemination agents' social network and whether social contacts in the baseline arm had more conversations about IUC with their dissemination agents between baseline and follow up due to the presence of recruitment conversations happening concurrently.
A randomly selected sub-set of social contacts in both arms will be selected to complete a more detailed qualitative interview after quantitative data collection is complete. 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 (15 listed)
- Have an IUD placed for contraception at clinic visit or have existing IUD for contraception
- Speak English
- Age 15-45
- 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
Key exclusion criteria (10 listed)
- 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
- Unable to get pregnant
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
Acceptability of WhyIUD intervention to intervention participants
Time frame: 3 months
Study staff will administer 3-month post-intervention surveys with participants to quantitatively assess their opinions of and engagement with the WhyIUD intervention. Staff will also conduct structured interviews with a selection of participants at 3 months to gather qualitative feedback on the intervention.
5 secondary outcomes
Feasability of snowball sampling procedure to obtain social network sample
Time frame: 3 months
Change in IUD-related knowledge among intervention participants
Time frame: 3 months
Change in IUD-related attitudes among patient participants
Time frame: 3 months
Change in IUD-related social communication among patient participants
Time frame: 3 months
Acceptability of WhyIUD intervention to clinic staff
Time frame: 1 month
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 Sep 2015.
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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 15 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 17 Sep 2015. 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?
Acceptability of WhyIUD intervention to intervention participants (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 17 Sep 2015.