Terminé

VHRWHIV Risk Reduction for Women Reporting Intimate Partner Violence

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Ce qui est testé

community support group

+ supporting positive and healthy relationships

Comportemental
Qui peut participer

De 18 à 49 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude de prévention

Interventionnel
Date de début : septembre 2012
Voir le détail du protocole

Résumé

Sponsor principalUniversity of Rochester
Dernière mise à jour : 19 février 2014
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 septembre 2012

Date à laquelle le premier participant a commencé l'étude.

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: 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. Enrollment, attendance, and attrition data will be used to determine the feasibility of the intervention. 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: Women in the experimental and control groups will be assessed at baseline, post-intervention, and at a 3-month follow-up. 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.

NCT01695694
Sponsor principalUniversity of Rochester
Dernière mise à jour : 19 février 2014
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

120 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Prévention

Cette étude cherche à prévenir l'apparition d'une maladie ou d'un trouble chez des personnes qui ne l'ont pas encore développé. Elles concernent souvent des personnes à risque et testent des vaccins, des changements de mode de vie ou des traitements préventifs.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Critères

Femme

Le sexe biologique des participants éligibles à s'inscrire.

De 18 à 49 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Critères

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 l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Comparateur actif

Groupe II

Expérimental

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

University of Rochester

Rochester, United StatesOuvrir University of Rochester dans Google Maps
Terminé1 Centres d'Étude