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Development of a Novel HIV Risk Reduction Intervention for Abused Women

Not Applicable
Completed
Conditions
Sexual Behavior
Interventions
Behavioral: Abuse-focused intervention
Behavioral: Sexual behavior-focused intervention
Registration Number
NCT02118948
Lead Sponsor
The Miriam Hospital
Brief Summary

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

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
86
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+

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Abuse-focused interventionAbuse-focused interventionParticipants attend 5 weekly, 2-hour intervention sessions focused on the psychological consequences of abuse, current sexual risk behavior, and the link between the two.
Sexual behavior-focused interventionSexual behavior-focused interventionParticipants attend 5 weekly, 2-hour intervention sessions focused on current sexual risk behavior.
Primary Outcome Measures
NameTimeMethod
change in number of sexual partners in the past 3 monthsbaseline 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

change in number of episodes of unprotected sex in the past 3 monthsbaseline 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

Secondary Outcome Measures
NameTimeMethod
change in scores on Abuse-Related Beliefs Questionnairebaseline and 3 months

assessed by computerized survey

change in performance on condom application exercisebaseline and 3 months

participant is observed and scored while placing a condom on a model

change in scores on Dyadic Trust Scalebaseline and 3 months

assessed by computerized survey

change in scores on Condom Attitudes measurebaseline 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

change in scores on the HIV Knowledge Questionnairebaseline and 3 months

assessed by computerized survey

change in scores on Traumatic Sexualization Surveybaseline and 3 months

assessed by computerized survey

change in scores on Sexual Relationship Power Scalebaseline and 3 months

assessed by computerized survey

change in scoress on the PTSD Checklist-Civilian Versionbaseline and after each intervention session

assessed via computerized survey at baseline and via paper and pencil survey at the end of each intervention session

Trial Locations

Locations (1)

University of Rochester

🇺🇸

Rochester, New York, United States

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