Development of a Novel HIV Risk Reduction Intervention for Abused Women

NCT02118948 | Completed

• 1 other identifier: R34MH095362
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sexual Behavior

Keywords

abuse; sexual behavior; sexual risk reduction; behavioral intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• change in scores on the HIV Knowledge Questionnaire

  baseline and 3 months

• change in scores on Condom Attitudes measure

  baseline and 3 months

• change in performance on condom application exercise

  baseline and 3 months

• change in scores on Traumatic Sexualization Survey

  baseline and 3 months

• change in scores on Dyadic Trust Scale

  baseline and 3 months

Study Arms (2)

Abuse-focused intervention

EXPERIMENTAL

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

Sexual behavior-focused intervention

ACTIVE COMPARATOR

Participants attend 5 weekly, 2-hour intervention sessions focused on current sexual risk behavior.

Behavioral: Sexual behavior-focused intervention

Interventions

Abuse-focused intervention BEHAVIORAL

Abuse-focused intervention

Sexual behavior-focused intervention BEHAVIORAL

Sexual behavior-focused intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• history of abuse
• current sexual risk behavior

You may not qualify if:

• less than age 18
• impaired mentally
• do not speak English
• severely depressed or suicidal
• HIV+

Sponsors & Collaborators

• The Miriam Hospital: lead
• University of Rochester: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14611, United States

Location

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist and Associate Professor (Research)

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 21, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 29, 2016

Record last verified: 2016-08

Locations

US (1)