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Development of a Novel HIV Risk Reduction Intervention for Abused Women

Development of a Novel HIV Risk Reduction Intervention for Abused Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02118948
Enrollment
86
Registered
2014-04-21
Start date
2014-04-30
Completion date
2016-07-31
Last updated
2016-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexual Behavior

Keywords

abuse, sexual behavior, sexual risk reduction, behavioral intervention

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.

Interventions

BEHAVIORALAbuse-focused intervention
BEHAVIORALSexual behavior-focused intervention

Sponsors

University of Rochester
CollaboratorOTHER
The Miriam Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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+

Design outcomes

Primary

MeasureTime frameDescription
change in number of sexual partners in the past 3 monthsbaseline and 3 monthsat 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 monthsbaseline and 3 monthsat 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

MeasureTime frameDescription
change in performance on condom application exercisebaseline and 3 monthsparticipant is observed and scored while placing a condom on a model
change in scores on Traumatic Sexualization Surveybaseline and 3 monthsassessed by computerized survey
change in scores on Dyadic Trust Scalebaseline and 3 monthsassessed by computerized survey
change in scores on the HIV Knowledge Questionnairebaseline and 3 monthsassessed by computerized survey
change in scores on Sexual Relationship Power Scalebaseline and 3 monthsassessed by computerized survey
change in scoress on the PTSD Checklist-Civilian Versionbaseline and after each intervention sessionassessed via computerized survey at baseline and via paper and pencil survey at the end of each intervention session
change in scores on Abuse-Related Beliefs Questionnairebaseline and 3 monthsassessed by computerized survey
change in scores on Condom Attitudes measurebaseline and 3 monthscondom 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026