Clinical trial NCT02118948: Development of a Novel HIV Risk Reduction Intervention for Abused Women
Official title: Development of a Novel HIV Risk Reduction Intervention for Abused Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Behavior
Keywords: abuse
sexual behavior
sexual risk reduction
behavioral intervention
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: University of Rochester
First posted: 2014-04-21
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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
* HIV+

Primary outcomes:
measure: change in number of sexual partners in the past 3 months
timeFrame: baseline and 3 months
measure: change in number of episodes of unprotected sex in the past 3 months
timeFrame: baseline and 3 months
Secondary outcomes:
measure: change in scores on the HIV Knowledge Questionnaire
timeFrame: baseline and 3 months
measure: change in scores on Condom Attitudes measure
timeFrame: baseline and 3 months
measure: change in performance on condom application exercise
timeFrame: baseline and 3 months
measure: change in scores on Traumatic Sexualization Survey
timeFrame: baseline and 3 months
measure: change in scores on Dyadic Trust Scale
timeFrame: baseline and 3 months
measure: change in scores on Abuse-Related Beliefs Questionnaire
timeFrame: baseline and 3 months
measure: change in scores on Sexual Relationship Power Scale
timeFrame: baseline and 3 months
measure: change in scoress on the PTSD Checklist-Civilian Version
timeFrame: baseline and after each intervention session
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References: