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Violence and HIV Risk Among Women (VHRW)

2014年2月17日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (予想される)

120

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • New York
      • Rochester、New York、アメリカ、14642
        • University of Rochester

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~49年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ:community support group
実験的:supporting positive and healthy relationships

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change from Baseline in sexual risk behavior at 3 months
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change from Baseline in experience of violence at 3 months
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Mona Mittal, PhD、University of Rochester

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2012年9月1日

一次修了 (実際)

2013年10月1日

研究の完了 (実際)

2013年10月1日

試験登録日

最初に提出

2012年7月20日

QC基準を満たした最初の提出物

2012年9月26日

最初の投稿 (見積もり)

2012年9月28日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年2月19日

QC基準を満たした最後の更新が送信されました

2014年2月17日

最終確認日

2014年2月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • RSRB00040309
  • 7K01MH080660 (米国 NIH グラント/契約)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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