Development of a Novel HIV Risk Reduction Intervention for Abused Women

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

Study Overview

• Status: Completed
• Conditions: Sexual Behavior
• Intervention / Treatment: Behavioral: Abuse-focused intervention; Behavioral: Sexual behavior-focused intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14611
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: University of Rochester

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: April 14, 2014
• First Submitted That Met QC Criteria: April 17, 2014
• First Posted (Estimate): April 21, 2014

Study Record Updates

• Last Update Posted (Estimate): August 29, 2016
• Last Update Submitted That Met QC Criteria: August 26, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: behavioral intervention; abuse; sexual behavior; sexual risk reduction
• Other Study ID Numbers: R34MH095362 (U.S. NIH Grant/Contract)