Pilot of Social Network Intrauterine Contraceptive (IUC) Intervention

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
William and Flora Hewlett Foundation
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01965743
First received: October 15, 2013
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Attitudes
Behavioral: Contraception Information Packet

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The Woman-to-Woman Dissemination Project: Harnessing the Power of Social Networks to Increase IUC Use

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • intrauterine contraception social network survey [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Perception of intrauterine contraception [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Survey of intrauterine contraception. At baseline and 3 month follow-up, we will assess social network members' attitudes towards IUC


Estimated Enrollment: 71
Study Start Date: April 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Contraception Information Packet
Everyone in the study will receive the intervention, which is an information packet designed to facilitate conversations among peers about intrauterine contraception.
Behavioral: Contraception Information Packet
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

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.

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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:
  • Unable to get pregnant
  • do not speak or understand English.
  • Clinic staff:
  • Not working at clinic at time of intervention.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01965743

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94108
Sponsors and Collaborators
University of California, San Francisco
William and Flora Hewlett Foundation
Investigators
Principal Investigator: Christine Dehlendorf, MD, MAS University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01965743     History of Changes
Other Study ID Numbers: 2012-8070
Study First Received: October 15, 2013
Last Updated: June 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
intrauterine contraception (IUC)
social networks
social influence
diffusion of innovation
intrauterine device (IUD)
LARC

ClinicalTrials.gov processed this record on July 29, 2014