- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02118948
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
Status
Fullført
Forhold
Intervensjon / Behandling
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
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New York
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Rochester, New York, Forente stater, 14611
- University of Rochester
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-
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 |
|---|---|
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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.
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Aktiv komparator: Sexual behavior-focused intervention
Participants attend 5 weekly, 2-hour intervention sessions focused on current sexual risk behavior.
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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
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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
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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
|
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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
|
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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
|
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change in scores on Traumatic Sexualization Survey
Tidsramme: baseline and 3 months
|
assessed by computerized survey
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baseline and 3 months
|
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change in scores on Dyadic Trust Scale
Tidsramme: baseline and 3 months
|
assessed by computerized survey
|
baseline and 3 months
|
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change in scores on Abuse-Related Beliefs Questionnaire
Tidsramme: baseline and 3 months
|
assessed by computerized survey
|
baseline and 3 months
|
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change in scores on Sexual Relationship Power Scale
Tidsramme: baseline and 3 months
|
assessed by computerized survey
|
baseline and 3 months
|
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change in scoress on the PTSD Checklist-Civilian Version
Tidsramme: baseline and after each intervention session
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assessed via computerized survey at baseline and via paper and pencil survey at the end of each intervention session
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baseline and after each intervention session
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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)
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