Development of a Novel HIV Risk Reduction Intervention for Abused Women

Study Overview
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Brief Summary
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The purpose of this study is to develop and evaluate an HIV risk reduction intervention for women with a history of abuse.

Detailed Description
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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.

Official Title
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Development of a Novel HIV Risk Reduction Intervention for Abused Women

Conditions
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Sexual Behavior

Intervention / Treatment
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* Behavioral: Abuse-focused intervention
* Behavioral: Sexual behavior-focused intervention


Participation Criteria
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Eligibility Criteria
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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+

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abuse-focused intervention<br>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. | Behavioral: Abuse-focused intervention<br> <br> |
| Active Comparator: Sexual behavior-focused intervention<br>Participants attend 5 weekly, 2-hour intervention sessions focused on current sexual risk behavior. | Behavioral: Sexual behavior-focused intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in number of sexual partners in the past 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in scores on the HIV Knowledge Questionnaire | assessed by computerized survey | baseline and 3 months | 
| change in scores on Condom Attitudes measure | 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 | participant is observed and scored while placing a condom on a model | baseline and 3 months | 
| change in scores on Traumatic Sexualization Survey | assessed by computerized survey | baseline and 3 months | 
| change in scores on Dyadic Trust Scale | assessed by computerized survey | baseline and 3 months | 
| change in scores on Abuse-Related Beliefs Questionnaire | assessed by computerized survey | baseline and 3 months | 
| change in scores on Sexual Relationship Power Scale | assessed by computerized survey | baseline and 3 months | 
| change in scoress on the PTSD Checklist-Civilian Version | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abuse, sexual behavior, sexual risk reduction, behavioral intervention