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Pilot #2 of Social Network Intrauterine Contraceptive (IUC) Intervention

15 de setembro de 2015 atualizado por: University of California, San Francisco

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.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

40

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • California
      • North Highlands, California, Estados Unidos, 95660
        • Planned Parenthood North Highlands

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

15 anos a 45 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

Inclusion Criteria:

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.

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: 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.
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Acceptability of WhyIUD intervention to intervention participants
Prazo: 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.
3 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Feasability of snowball sampling procedure to obtain social network sample
Prazo: 3 months
Study staff will measure the percentage of identified social contacts who participate in the study and their retention during the study period.
3 months
Change in IUD-related knowledge among intervention participants
Prazo: 3 months
Baseline and 3-month surveys with participants will include measures related to IUD knowledge.
3 months
Change in IUD-related attitudes among patient participants
Prazo: 3 months
Baseline and 3-month surveys with participants will include measures related to IUD attitudes.
3 months
Change in IUD-related social communication among patient participants
Prazo: 3 months
Baseline and 3-month surveys with participants will include measures related to social communication with friends and family about the IUD.
3 months
Acceptability of WhyIUD intervention to clinic staff
Prazo: 1 month
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.
1 month

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Christine Dehlendorf, MD, MAS, University of California, San Francisco

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de fevereiro de 2015

Conclusão Primária (Real)

1 de julho de 2015

Conclusão do estudo (Real)

1 de julho de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

15 de setembro de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de setembro de 2014

Primeira postagem (Estimativa)

17 de setembro de 2014

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

17 de setembro de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de setembro de 2015

Última verificação

1 de setembro de 2015

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 2012-8070-2

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