- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01965743
Pilot of Social Network Intrauterine Contraceptive (IUC) Intervention
The Woman-to-Woman Dissemination Project: Harnessing the Power of Social Networks to Increase IUC Use
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
California
-
San Francisco, California, Stati Uniti, 94108
- University of California, San Francisco
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Altro: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
intrauterine contraception social network survey
Lasso di tempo: 3 months
|
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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Perception of intrauterine contraception
Lasso di tempo: 3 months
|
Survey of intrauterine contraception.
At baseline and 3 month follow-up, we will assess social network members' attitudes towards IUC
|
3 months
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Christine Dehlendorf, MD, MAS, University of California, San Francisco
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 2012-8070
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Contraception Information Packet
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