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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01965743
Other study ID # 2012-8070
Secondary ID
Status Completed
Phase N/A
First received October 15, 2013
Last updated September 9, 2014
Start date April 2014
Est. completion date August 2014

Study information

Verified date September 2014
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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 track whether this approach is effective at spreading birth control information through social groups.


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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 45 Years
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco William and Flora Hewlett Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 3 months No
Secondary Perception of intrauterine contraception Survey of intrauterine contraception. At baseline and 3 month follow-up, we will assess social network members' attitudes towards IUC 3 months No
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