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Completed

NCT Number: NCT02118948

Development of a Novel HIV Risk Reduction Intervention for Abused Women

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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+

Treatment and study plan

Abuse-focused intervention

Behavioral

Sexual behavior-focused intervention

Behavioral

Primary outcomes

  1. 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

  2. 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

  1. change in scores on the HIV Knowledge Questionnaire

    Time frame: baseline and 3 months

    assessed by computerized survey

  2. change in scores on Condom Attitudes measure

    Time frame: baseline and 3 months

    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

  3. change in performance on condom application exercise

    Time frame: baseline and 3 months

    participant is observed and scored while placing a condom on a model

  4. change in scores on Traumatic Sexualization Survey

    Time frame: baseline and 3 months

    assessed by computerized survey

  5. change in scores on Dyadic Trust Scale

    Time frame: baseline and 3 months

    assessed by computerized survey

  6. change in scores on Abuse-Related Beliefs Questionnaire

    Time frame: baseline and 3 months

    assessed by computerized survey

  7. change in scores on Sexual Relationship Power Scale

    Time frame: baseline and 3 months

    assessed by computerized survey

  8. change in scoress on the PTSD Checklist-Civilian Version

    Time frame: baseline and after each intervention session

    assessed via computerized survey at baseline and via paper and pencil survey at the end of each intervention session

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • University of Rochester

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 21, 2014
Registry last updated
Aug 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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