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Development of a Novel HIV Risk Reduction Intervention for Abused Women

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Lifespan

Status

Completed

Conditions

Sexual Behavior

Treatments

Behavioral: Abuse-focused intervention
Behavioral: Sexual behavior-focused intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02118948
R34MH095362

Details and patient eligibility

About

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

Full 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.

Enrollment

86 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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+

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

86 participants in 2 patient groups

Abuse-focused intervention
Experimental group
Description:
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.
Treatment:
Behavioral: Abuse-focused intervention
Sexual behavior-focused intervention
Active Comparator group
Description:
Participants attend 5 weekly, 2-hour intervention sessions focused on current sexual risk behavior.
Treatment:
Behavioral: Sexual behavior-focused intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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