Rapid HIV Testing and Counseling in High Risk Women in Shelters
調査の概要
詳細な説明
A. Specific Aims More than one million Americans are living with HIV, with over 20% unaware of their HIV status. Early detection of HIV status is crucial to prevent transmission to others and to link those who are HIV positive to medical care and other clinical services. Consistently, the National HIV/AIDS strategy has established a goal of increasing the awareness of HIV status in Americans from 79% to 90% within the next four years. Thus, there is a strong need for increased testing efforts, particularly among high risk, underserved populations. To be effective, these testing efforts need to address many of the barriers to testing and linkage to care faced by these underserved populations. Victims of intimate partner violence (IPV) are one such underserved population who are at high risk for HIV infection and face many barriers to testing and linkage to care.
IPV is a pervasive public health problem with 25% of women reporting IPV in their lifetime. A growing body of literature highlights the association between IPV and HIV risk. IPV victims are more likely to engage in HIV risk behaviors, including unprotected sex, sex with risky partners (e.g., HIV-positive, injection drug users), sex with more than one sex partner, and trading sex, and are more likely to have a sexually transmitted disease (STI). Additionally, posttraumatic stress disorder (PTSD) and substance use disorder (SUD), highly prevalent in IPV victims, are associated with high risk sexual behaviors. Furthermore, women with IPV underutilize medical care and often encounter numerous barriers to health care (e.g., transportation, under or un-insured). Unfortunately, very few HIV prevention interventions have been developed or tested for this vulnerable and underserved population of women.
IPV Victims in domestic shelters are at significant risk for HIV (i.e., 69-87% report unprotected sex and 33% report having an STI). Domestic violence shelters also present an opportune setting for providing health care services for women. There are approximately 2,000 community-based shelter programs throughout the US, providing emergency shelter to approximately 300,000 women and children each year. Considering the number of women who seek help from these facilities and that IPV victims who seek shelter have already instituted a change in their life, a prime time to intervene may be while these women are already seeking help from these community based organizations. Further, domestic shelters provide a safe and supportive environment which is ideal for HIV testing and prevention. Thus incorporating HIV testing and prevention within domestic shelters will provide access to a significant population of women with an overall high risk for HIV infection while significantly reducing many of the barriers to testing and linkage to care faced by IPV victims. Rapid HIV testing allows for provision of HIV testing, counseling, and test results in one visit, eliminating the problem of clients not returning for test results. Thus, rapid testing offers an ideal option for residents of domestic shelters, given their multiple competing demands and barriers to traditional HIV testing and prevention. RESPECT is an evidence-based CDC Diffusion of Effective Behavioral Interventions (DEBI), utilizing a client-focused, interactive HIV risk reduction counseling model delivered in conjunction with HIV testing. RESPECT-2, which has been adapted for use with rapid testing, is brief and easily adaptable to many clinical settings. IPV victims, however, face distinct HIV risk factors, such as difficulty in negotiating condom use and other preventative sexual behaviors, out of fear of retaliation or being raped by their abusive partner. Hence, RESPECT-2 needs to be tailored to meet the specific needs of our target population.
The Specific Aims of this R21 Exploratory/Developmental Research Proposal are to (a) expand RESPECT-2 for our target population (i.e., RESPECT-IPV) and (b) to collect preliminary data on RESPECT-IPV + rapid testing's feasibility, acceptability, and initial efficacy in residents of domestic shelters. To facilitate sustainability and future dissemination of RESPECT-IPV + rapid testing, the intervention will be delivered by trained personnel from community-based CDC supported counseling, testing, and referral (CTC) sites.
The development aim of this R21 proposal is to develop the manual for RESPECT-IPV, incorporating information gathered from four focus groups with IPV victims and two focus groups with shelter staff, the literature on IPV and HIV risk, and a pre-pilot open trial to increase acceptability of RESPECT-IPV and to tailor the intervention to meet the unique needs of our target population. The pilot study aims of this R21 proposal are to: (1) Assess the feasibility and acceptability of RESPECT-IPV + rapid testing in a sample of 100 high-risk shelter women. Predictors of acceptability (e.g., PTSD symptoms, substance use, IPV severity, prior testing history, HIV knowledge, HIV risk behavior, HIV anxiety, stage of change) will also be explored. (2) Conduct an open trial of RESPECT-IPV + rapid testing in a sample of 100 high-risk shelter women and examine preliminary evidence for the hypotheses that RESPECT-IPV will be associated with reduced unprotected vaginal or anal sex occasions (USOs) at 1-week and 3-months after leaving shelter and fewer cases of vaginal trichomoniasis 3-months after leaving shelter. Secondary outcomes include HIV knowledge, risk intentions, and other HIV risk behaviors (e.g. multiple partners, substance use). As a result we will have created a novel testing and counseling intervention for high-risk, underserved, shelter women, providing the groundwork to test RESPECT-IPV's efficacy in future R01 clinical trials and dissemination studies.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Ohio
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Akron、Ohio、アメリカ、44325
- University of Akron
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- intimate partner violence and at least one unprotected sexual occasion 3 months prior to entering shelter
Exclusion Criteria:
- HIV positive
研究計画
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:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:RESPECT-IPV
Rapid HIV testing and risk prevention intervention for victims of intimate partner violence
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rapid HIV testing intervention and behavioral counseling session where identify risks and develop a risk reduction plan
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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 |
---|---|---|
number of unprotected sexual occasions
時間枠:up to 3 months post shelter
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Calendar assessment of number of unprotected sexual occasions
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up to 3 months post shelter
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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- R21NR013628-02 (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。
HIV リスクの臨床試験
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French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS Foundation完了パートナーの HIV 検査 | カップルの HIV カウンセリング | カップルのコミュニケーション | HIV の発生率カメルーン, ドミニカ共和国, グルジア, インド
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University of Minnesota引きこもったHIV感染症 | HIV/エイズ | HIV | AIDS | エイズ・HIV問題 | エイズと感染症アメリカ
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Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University of Southampton と他の協力者募集
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ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement; Centre Pasteur... と他の協力者わからないHIV | HIVに感染していない子供たち | HIVにさらされた子供たちカメルーン
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Erasmus Medical Centerまだ募集していません
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University of Maryland, Baltimore引きこもった
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Hospital Clinic of Barcelona完了
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University of WashingtonNational Institute of Mental Health (NIMH)募集
RESPECT-IPVの臨床試験
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Columbia UniversityNational Institute on Drug Abuse (NIDA); Medical University of South Carolina; University of Pittsburgh と他の協力者完了
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China National Biotec Group Company LimitedPeking University; Hubei Provincial Center for Disease Control and Prevention; Shaanxi Provincial... と他の協力者完了
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Zhejiang Provincial Center for Disease Control...China National Biotec Group Company Limited完了
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Aga Khan UniversityNational Institutes of Health (NIH); Centers for Disease Control and Prevention; World Health...完了
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Fidec CorporationBill and Melinda Gates Foundation; Centers for Disease Control and Prevention完了
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China National Biotec Group Company LimitedPeking University; Beijing Institute of Biological Products Co Ltd.; Sichuan Center for Disease... と他の協力者完了
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Centers for Disease Control and PreventionInternational Centre for Diarrhoeal Disease Research, Bangladesh完了
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Fidec CorporationBill and Melinda Gates Foundation完了
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Fidec CorporationBill and Melinda Gates Foundation引きこもった