Development of a Novel HIV Risk Reduction Intervention for Abused Women
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
New York
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Rochester, New York, Forenede Stater, 14611
- University of Rochester
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-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
|
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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
|
|
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
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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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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- R34MH095362 (U.S. NIH-bevilling/kontrakt)
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