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Clinical Trials/NCT02118948
NCT02118948
Completed
N/A

Development of a Novel HIV Risk Reduction Intervention for Abused Women

The Miriam Hospital1 site in 1 country86 target enrollmentApril 2014
ConditionsSexual Behavior

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sexual Behavior
Sponsor
The Miriam Hospital
Enrollment
86
Locations
1
Primary Endpoint
change in number of sexual partners in the past 3 months
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
July 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Theresa E. Senn

Senior Research Scientist and Associate Professor (Research)

The Miriam Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

change in number of sexual partners in the past 3 months

Time Frame: 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

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

Time Frame: 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

Secondary Outcomes

  • change in scores on Abuse-Related Beliefs Questionnaire(baseline and 3 months)
  • change in performance on condom application exercise(baseline and 3 months)
  • change in scores on Dyadic Trust Scale(baseline and 3 months)
  • change in scores on Condom Attitudes measure(baseline and 3 months)
  • change in scores on the HIV Knowledge Questionnaire(baseline and 3 months)
  • change in scores on Traumatic Sexualization Survey(baseline and 3 months)
  • change in scores on Sexual Relationship Power Scale(baseline and 3 months)
  • change in scoress on the PTSD Checklist-Civilian Version(baseline and after each intervention session)

Study Sites (1)

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