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Violence and HIV Risk Among Women (VHRW)

17 de febrero de 2014 actualizado por: University of Rochester

HIV Risk Reduction for Women Reporting Intimate Partner Violence

The purpose of the study is to test the feasibility, acceptability, and efficacy of an adapted intervention that is theoretically and empirically guided by the Information-Motivation-Behavioral skills model (IMB) and aims at reducing sexual risk behavior among women who have experienced Intimate Partner Violence (IPV), as well as such an intervention.

Descripción general del estudio

Descripción detallada

The two foremost health problems impacting young adult women are STDs/HIV infection and intimate partner violence (IPV). STDs pose a significant public health issue in the US, particularly among women. The consequences of some STDs are more severe for women, and include infertility, pelvic inflammatory disease, and brain, cardiovascular, and organ damage. Women with STDs are at increased risk for HIV. The proportion of AIDS cases among US adult and adolescent women has more than tripled since 1985. Approximately 12,000 US women are infected with HIV annually, primarily through heterosexual contact. Also, in the US HIV is particularly affecting women of color and those in low-income urban areas.

IPV also affects many women. While the causal links between IPV and HIV risk or infection have not yet been established, emerging empirical evidence has drawn connections between IPV with HIV risk. Several researchers have highlighted the importance of developing sexual risk reduction interventions that address the growing concern of gender-based violence against women. Also, scholars are calling for HIV prevention programs aimed at women to be more comprehensive; for example, by combining them with STD screening or with programs designed to reduce violence against women. Despite this call, there are very few empirically tested interventions for prevention and treatment targeting women who are at risk for STDs/HIV and experience IPV in their intimate relationships. To address high risk sexual behaviors among women who experience gender-based violence in their intimate relationships, I have adapted an existing information-motivation-behavioral skills (IMB) STD/HIV prevention intervention for reducing high sexual risk-taking behaviors. The STD/HIV and IPV comprehensive intervention will address both sexual risk reduction and IPV risk; the intention is to help women to acquire knowledge, skills, and strategies that will reduce their risk for both STDs/HIV and IPV.

Aim 1: To assess the feasibility and acceptability of the adapted IMB STD/HIV prevention intervention by implementing the intervention with a sample of women who are at risk for HIV/STDs and experience IPV. To achieve this aim:

  1. 120 women who are at risk for HIV/STDs and have experienced IPV will be randomized either to receive the experimental prevention intervention or to attend a structurally similar drop-in enhanced support group at a domestic violence agency.
  2. Enrollment, attendance, and attrition data will be used to determine the feasibility of the intervention.
  3. The acceptability of the intervention will be appraised by analyzing pre- and post-intervention acceptability ratings completed by subjects and interventionists.

Aim 2: To gather preliminary evidence of the efficacy of the theoretically guided intervention using a controlled design. To achieve this aim:

  1. Women in the experimental and control groups will be assessed at baseline, post-intervention, and at a 3-month follow-up.
  2. Outcome analyses to calculate effect sizes for use in future power analyses for a larger RCT of the proposed intervention will include measures on primary variables of hypothesized risk antecedents, standard measures of protected and unprotected sex, and secondary variables such as mental health, self esteem, and IPV experiences.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

120

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • New York
      • Rochester, New York, Estados Unidos, 14642
        • University of Rochester

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 49 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

Women will be eligible to participate in the research study if they meet the following criteria:

  • between ages 18 and 49;
  • heterosexually active;
  • have experienced intimate partner violence in the last three months;
  • have engaged in risky sexual behavior in the past three months;
  • not currently pregnant or trying to become pregnant; and
  • physically and psychologically capable of providing informed consent. All subjects will be required to provide written informed consent prior to enrolling in the study.

Exclusion Criteria:

Persons who meet one or more of the following criteria will be excluded from the study:

  • men;
  • women who have active psychosis or impaired mental status (confirmed with a Mini-Mental Status Exam);
  • are unable to understand spoken English;
  • are less than 18 years old or greater than 49 years old;
  • are currently pregnant or trying to become pregnant
  • women who are exclusively in same-sex relationships.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: community support group
Experimental: supporting positive and healthy relationships

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from Baseline in sexual risk behavior at 3 months
Periodo de tiempo: at the completion of 3 months after the intervention
Sexual risk behavior is assessed by self-reported number sexual partners in the last three months and number of episodes of unprotected sex with each partner
at the completion of 3 months after the intervention

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from Baseline in experience of violence at 3 months
Periodo de tiempo: At the end 3-months after the end of the intervention
Participant's experiences of violence as well as the frequency and intensity of thse experiences will be assessed using established measures of intimate partner violence
At the end 3-months after the end of the intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Mona Mittal, PhD, University of Rochester

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2012

Finalización primaria (Actual)

1 de octubre de 2013

Finalización del estudio (Actual)

1 de octubre de 2013

Fechas de registro del estudio

Enviado por primera vez

20 de julio de 2012

Primero enviado que cumplió con los criterios de control de calidad

26 de septiembre de 2012

Publicado por primera vez (Estimar)

28 de septiembre de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

19 de febrero de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

17 de febrero de 2014

Última verificación

1 de febrero de 2014

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • RSRB00040309
  • 7K01MH080660 (Subvención/contrato del NIH de EE. UU.)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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