- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02118948
Development of a Novel HIV Risk Reduction Intervention for Abused Women
26 augusti 2016 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
86
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
New York
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Rochester, New York, Förenta staterna, 14611
- University of Rochester
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
change in number of sexual partners in the past 3 months
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
change in scores on the HIV Knowledge Questionnaire
Tidsram: baseline and 3 months
|
assessed by computerized survey
|
baseline and 3 months
|
|
change in scores on Condom Attitudes measure
Tidsram: 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
Tidsram: 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
Tidsram: baseline and 3 months
|
assessed by computerized survey
|
baseline and 3 months
|
|
change in scores on Dyadic Trust Scale
Tidsram: baseline and 3 months
|
assessed by computerized survey
|
baseline and 3 months
|
|
change in scores on Abuse-Related Beliefs Questionnaire
Tidsram: baseline and 3 months
|
assessed by computerized survey
|
baseline and 3 months
|
|
change in scores on Sexual Relationship Power Scale
Tidsram: baseline and 3 months
|
assessed by computerized survey
|
baseline and 3 months
|
|
change in scoress on the PTSD Checklist-Civilian Version
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2014
Primärt slutförande (Faktisk)
1 juli 2016
Avslutad studie (Faktisk)
1 juli 2016
Studieregistreringsdatum
Först inskickad
14 april 2014
Först inskickad som uppfyllde QC-kriterierna
17 april 2014
Första postat (Uppskatta)
21 april 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
29 augusti 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 augusti 2016
Senast verifierad
1 augusti 2016
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- R34MH095362 (U.S.S. NIH-anslag/kontrakt)
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