NCT02242890

Brief 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 investigators can track whether this approach is effective at spreading birth control information through social groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 17, 2015

Status Verified

September 1, 2015

Enrollment Period

5 months

First QC Date

September 15, 2014

Last Update Submit

September 15, 2015

Conditions

Keywords

intrauterine contraception (IUC)social networkssocial influencediffusion of innovationintrauterine device (IUD)LARC

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (5)

  • Feasability of snowball sampling procedure to obtain social network sample

    3 months

  • Change in IUD-related knowledge among intervention participants

    3 months

  • Change in IUD-related attitudes among patient participants

    3 months

  • Change in IUD-related social communication among patient participants

    3 months

  • Acceptability of WhyIUD intervention to clinic staff

    1 month

Study Arms (1)

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.

Behavioral: Contraception Information Packet

Interventions

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.

Contraception Information Packet

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Planned Parenthood North Highlands

North Highlands, California, 95660, United States

Location

MeSH Terms

Conditions

Behavior

Study Officials

  • Christine Dehlendorf, MD, MAS

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 17, 2014

Study Start

February 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 17, 2015

Record last verified: 2015-09

Locations