Development of a Novel HIV Risk Reduction Intervention for Abused Women

Sexual Behavior Clinical Trial

Official title:

Development of a Novel HIV Risk Reduction Intervention for Abused Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02118948
• Other study ID #: R34MH095362
• Status: Completed
• Phase: N/A
• First received: April 14, 2014
• Last updated: August 26, 2016
• Start date: April 2014
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sexual Behavior

Intervention

Behavioral:
• Abuse-focused intervention

• Sexual behavior-focused intervention

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	change in scores on the HIV Knowledge Questionnaire	assessed by computerized survey	baseline and 3 months	No
Secondary	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	No
Secondary	change in performance on condom application exercise	participant is observed and scored while placing a condom on a model	baseline and 3 months	No
Secondary	change in scores on Traumatic Sexualization Survey	assessed by computerized survey	baseline and 3 months	No
Secondary	change in scores on Dyadic Trust Scale	assessed by computerized survey	baseline and 3 months	No
Secondary	change in scores on Abuse-Related Beliefs Questionnaire	assessed by computerized survey	baseline and 3 months	No
Secondary	change in scores on Sexual Relationship Power Scale	assessed by computerized survey	baseline and 3 months	No
Secondary	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	Yes