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Development of a Novel HIV Risk Reduction Intervention for Abused Women

26. august 2016 oppdatert av: Theresa E. Senn, The Miriam Hospital
The purpose of this study is to develop and evaluate an HIV risk reduction intervention for women with a history of abuse.

Studieoversikt

Detaljert beskrivelse

The purpose of the proposed research is to pilot test an innovative, theoretically-guided sexual risk reduction intervention for women with a history of abuse. T intervention builds on previous findings suggesting that it is important to address the psychological consequences of abuse, as well as the typical antecedents of sexual risk behavior. To inform intervention development, women who reported a history of abuse were recruited to participate in key informant interviews. Based on interview findings and guided by theory and empirical precedent, a novel sexual risk reduction intervention was developed and refined. The intervention will be pilot tested with 80 women recruited from a publicly-funded clinic who report a history of abuse and current sexual risk behavior. These women will complete a computerized survey to assess abuse, adult sexual risk behavior, HIV-related information, safer sex motivation, behavioral skills, interpersonal trust, guilt, and powerlessness. Behavioral skills will also be assessed through role-plays and simulation scenarios. Women will be randomly assigned to the novel intervention or to a structurally equivalent intervention focused only on the psychological antecedents of sexual risk behavior. Three months after intervention completion, women will return to complete computerized interviews and behavioral skills assessments. The long-term goal of this research is to develop a feasible and effective sexual risk reduction intervention for women who have a history of abuse.

Studietype

Intervensjonell

Registrering (Faktiske)

86

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • New York
      • Rochester, New York, Forente stater, 14611
        • University of Rochester

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • history of abuse
  • current sexual risk behavior

Exclusion Criteria:

  • less than age 18
  • impaired mentally
  • do not speak English
  • severely depressed or suicidal
  • HIV+

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Abuse-focused intervention
Participants attend 5 weekly, 2-hour intervention sessions focused on the psychological consequences of abuse, current sexual risk behavior, and the link between the two.
Aktiv komparator: Sexual behavior-focused intervention
Participants attend 5 weekly, 2-hour intervention sessions focused on current sexual risk behavior.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
change in number of sexual partners in the past 3 months
Tidsramme: baseline and 3 months
at baseline and at 3 months post intervention, participants will respond to the question, "How many sexual partners have you had in the past 3 months?", assessed by computerized survey
baseline and 3 months
change in number of episodes of unprotected sex in the past 3 months
Tidsramme: baseline and 3 months
at baseline and at 3 months post intervention, participants will report (a) the number of times they had sex with a primary partner in the past 3 months (b) out of the number of sex episodes with a primary partner in the past 3 months, how many times a condom was used; (c) the number of times they had sex with non-primary partners in the past 3 months; and (d) out of the number of sex episodes with a non-primary partner in the past 3 months, how many times a condom was used; responses to these 4 items will be used to determine the change in the total number of unprotected sex episodes (past 3 months) from baseline to 3 months post-intervention, assessed by computerized survey
baseline and 3 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
change in scores on the HIV Knowledge Questionnaire
Tidsramme: baseline and 3 months
assessed by computerized survey
baseline and 3 months
change in scores on Condom Attitudes measure
Tidsramme: baseline and 3 months
condom attitudes measure assessing (a) attitudes towards condom use in primary relationships; (b) attitudes towards condom use in non-primary relationship; (c) pleasure-related condom attitudes; and (d) respect-related condom attitudes, assessed by computerized survey
baseline and 3 months
change in performance on condom application exercise
Tidsramme: baseline and 3 months
participant is observed and scored while placing a condom on a model
baseline and 3 months
change in scores on Traumatic Sexualization Survey
Tidsramme: baseline and 3 months
assessed by computerized survey
baseline and 3 months
change in scores on Dyadic Trust Scale
Tidsramme: baseline and 3 months
assessed by computerized survey
baseline and 3 months
change in scores on Abuse-Related Beliefs Questionnaire
Tidsramme: baseline and 3 months
assessed by computerized survey
baseline and 3 months
change in scores on Sexual Relationship Power Scale
Tidsramme: baseline and 3 months
assessed by computerized survey
baseline and 3 months
change in scoress on the PTSD Checklist-Civilian Version
Tidsramme: baseline and after each intervention session
assessed via computerized survey at baseline and via paper and pencil survey at the end of each intervention session
baseline and after each intervention session

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2014

Primær fullføring (Faktiske)

1. juli 2016

Studiet fullført (Faktiske)

1. juli 2016

Datoer for studieregistrering

Først innsendt

14. april 2014

Først innsendt som oppfylte QC-kriteriene

17. april 2014

Først lagt ut (Anslag)

21. april 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

29. august 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. august 2016

Sist bekreftet

1. august 2016

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • R34MH095362 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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