跳至主要内容
临床试验/NCT05692531
NCT05692531尚未招募不适用

Optimizing Study Design to Test a Community-level Intervention to Reduce Intersectional Stigma and Increase HIV Testing and Prevention Among African-American/Black MSM

City University of New York0 个研究点目标入组 100 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
internalized/anticipated PrEP stigma

研究概览

简要总结

Using a quasi-experimental evaluation approach, the purpose of this study is to assess feasibility, acceptability, and preliminary efficacy of a novel community-level intervention component, which is a filmed dramatization or set of "scenarios" to be "screened" in a virtual event. Attendees will be polled and engaged in an evaluation of the scenarios, before during and after the screening. This NCT registration is for the final aim of the study as described in the detailed description (AIMS) below. (Please note Aims 1-2 are complete.)

详细描述

Increasing access to and uptake of consistent HIV testing and biomedical prevention is critical to ending the epidemic in the United States (US) among gay, bisexual and other men who have sex with other men (MSM). This is particularly true for urban, African-American/Black MSM, who are disproportionately affected by HIV/AIDS in the US2-4 and would thus benefit from consistent testing, which is the gateway to treatment and prevention. NYC is the metropolitan area in the US with the largest number of newly diagnosed HIV infections among MSM and 89-94% of all people living with HIV/AIDS (PLWHA) in the US reside in urban areas. HIV stigma is a key barrier to HIV treatment and prevention, reducing access to testing and anti-retroviral treatment (ART). Stigmas specific to biomedical prevention (e.g., PrEP/PEP stigma) and HIV testing have emerged and influence intentions to use PrEP/PEP and testing. In addition, homophobia has been identified as a barrier to prevention access, with structural homophobia negatively associated with PEP awareness and PrEP use. Intersectional HIV-related stigmas and homophobia may be especially significant barriers to HIV testing and prevention among African-American/Black MSM, who test less often and are more likely to live with undiagnosed HIV/AIDS compared with white MSM. African-American/Black MSM live in a racist society, which operates at the personal and institutional levels. This results in experiences of HIV-related stigma and homophobia being racialized, further inhibiting access to and uptake of testing, prevention and treatment.

Interventions to decrease HIV stigma have aimed primarily at the individual level and on internalized stigma and/or personal attitudes, providing education and increased contact with PLWHA to reduce stereotyping and active discrimination. Few have addressed HIV stigma and homophobia simultaneously or at the community level. One exception, designed and evaluated by study team leaders, Frye & Taylor-Akutagawa, is CHHANGE (Challenge HIV/AIDS Stigma & Homophobia and Gain Empowerment; R21 MH102182-01; PI: Frye), a community-level, theory-based, anti-stigma and -homophobia intervention. Designed for African-American urban neighborhoods with high HIV prevalence, and broadly framed within socioecological, empowerment and stigma theories, CHHANGE focused on: enhancing visibility; increasing contact with LGBTQ people and PLWHA; educating on stigmatization processes and effects; enhancing empathy and perspective-taking; challenging stereotyped beliefs; raising critical consciousness; and teaching skills to analyze and interrupt stigma & homophobia in organizations, families and individuals. Results of the quasi-experimental, matched-community study found that HIV testing increased by 350% at the intervention community site, though changes in community-level HIV stigma and homophobia were not statistically significant across communities.

The emergence of PEP/PrEP and testing stigmas highlight a gap in our HIV testing and prevention toolbox for MSM of color and a need for interventions that address intersectional stigmas. To our knowledge, no intervention addresses intersectional HIV, PrEP/PEP, testing stigmas, and homophobia, in the context of racism. To address this gap, the investigators propose an R34 to adapt and enhance CHHANGE to simultaneously address intersectional stigmas and plan a trial to test the community-level intervention.

The Specific Aims are:

  1. Inform design of novel components specific to PrEP/PEP and testing stigma. The investigators will conduct group model building (GMB), a systems science technique, with community residents and African-American/Black MSM (N=80) to understand the intersectional complexity of HIV-related stigmas, homophobia, and racism, in context, and identify novel levers that may influence consistent HIV testing and prevention uptake.
  2. Systematically adapt the CHHANGE intervention to integrate novel anti-stigma, -homophobia, and -racism content and activities (re-named CHHARGE: Challenge HIV Stigma, Homophobia and Racism and Gain Empowerment) and plan a pilot using optimal study design methods. The investigators will ideate, prototype and component test (N=30), using design thinking and traditional adaptation methods, novel modules and components in the community. With input from a Senior Advisory Board (SAB), the investigators will identify optimal study design features (around areal boundaries, "big data" outcome measures, sampling, contamination, lagged effects) for planning a trial of the community-level intervention (e.g., a community cluster randomized trial).
  3. Assess feasibility, acceptability, and preliminary efficacy of novel component. The investigators will conduct a quasi-experimental evaluation to assess feasibility of the novel component. The investigators will assess preliminary efficacy of the component in reducing community-level stigmas (HIV, PrEP/PEP, testing) by increasing likelihood of engaging in stigma interrupting communication and behavior, particularly as related to the theoretical targets identified via Phases 1 and 2, as well as likelihood of consistent HIV testing and PrEP/PEP uptake.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • all attendees of the event

排除标准

  • 未提供

结局指标

主要结局

internalized/anticipated PrEP stigma

时间窗: immediately post-intervention

single-item, self-reported PrEP stigma; we will use an item from a measure of PrEP stigma (Frye et al 2020) (for example "People who who use PrEP are having too much sex or sex with the wrong kinds of people") From: Chittamuru, D., Frye, V., Koblin, B. A., Brawner, B., Tieu, H. V., Davis, A., \& Teitelman, A. M. (2020). PrEP stigma, HIV stigma, and intention to use PrEP among women in New York City and Philadelphia. Stigma and health, 5(2), 240.

internalized homophobia

时间窗: immediately post-intervention

single-item, self-reported internalized HIV stigma; we will use items from a valid and reliable measure of internalized homophobia (Smolenski et al 2010; for example "I would change myself to be heterosexual, if I could") From: Smolenski, D. J., Diamond, P. M., Ross, M. W., \& Rosser, B. S. (2010). Revision, criterion validity, and multigroup assessment of the Reactions to Homosexuality Scale. Journal of Personality Assessment,92, 568-576

internalized/anticipated HIV stigma

时间窗: immediately post-intervention

single-item, adapted, self-reported internalized/anticipated HIV stigma; we will use an item from Sayles et al (2008) valid and reliable measure of internalized/anticipated stigma (for example "I am living with HIV and feel ashamed when I tell people that I have HIV/I am not living with HIV but would feel ashamed if I had to tell people that I have HIV"). This item is adapted from Sayles, J. N., Hays, R. D., Sarkisian, C. A., Mahajan, A. P., Spritzer, K. L., \& Cunningham, W. E. (2008). Development and psychometric assessment of a multidimensional measure of internalized HIV stigma in a sample of HIV-positive adults. AIDS and Behavior, 12(5), 748-758.

HIV testing stigma

时间窗: immediately post-intervention

single-item, self-reported HIV testing stigma; we will use an item adapted from a measure of HIV testing stigma (for example "if people know I get HIV tests frequently, they will think I am promiscuous or am having sex with men") From: Andrinopoulos, K., Hembling, J., Guardado, M. E., de Maria Hernández, F., Nieto, A. I., \& Melendez, G. (2015). Evidence of the negative effect of sexual minority stigma on HIV testing among MSM and transgender women in San Salvador, El Salvador. AIDS and Behavior, 19(1), 60-71.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Victoria Frye

Medical Professor

City University of New York

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