Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05692531
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-01-20
First Post:
2022-12-22
Brief Title:
Evaluation of A Story Within A Story The Novel CHHARGE Intervention Component
Sponsor:
City University of New York
Organization:
City University of New York
Study Overview
Official Title:
Optimizing Study Design to Test a Community-level Intervention to Reduce Intersectional Stigma and Increase HIV Testing and Prevention Among African-AmericanBlack MSM
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHHARGE
Brief Summary:
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
Detailed Description:
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-AmericanBlack MSM who are disproportionately affected by HIVAIDS 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 HIVAIDS 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 eg PrEPPEP stigma and HIV testing have emerged and influence intentions to use PrEPPEP 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-AmericanBlack MSM who test less often and are more likely to live with undiagnosed HIVAIDS compared with white MSM African-AmericanBlack 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 andor 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 HIVAIDS 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 PEPPrEP 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 PrEPPEP 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 PrEPPEP and testing stigma The investigators will conduct group model building GMB a systems science technique with community residents and African-AmericanBlack MSM N80 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 N30 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 eg 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 PrEPPEP 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 PrEPPEP uptake
Thus far the research has completed phases 1 and 2 in partnership with Mobilizing Our Brother Initiative MOBI creating an innovative module that facilitates consistent HIV testing and access to uptake of and adherence to new biomedical HIV prevention modalities with the goal of lowering community-level viral load and ultimately a diminution of the HIV epidemic among urban Black MSM in the US
Interventions to decrease HIV stigma have aimed primarily at the individual level and on internalized stigma andor 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 HIVAIDS 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 PEPPrEP 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 PrEPPEP 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 PrEPPEP and testing stigma The investigators will conduct group model building GMB a systems science technique with community residents and African-AmericanBlack MSM N80 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 N30 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 eg 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 PrEPPEP 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 PrEPPEP uptake
Thus far the research has completed phases 1 and 2 in partnership with Mobilizing Our Brother Initiative MOBI creating an innovative module that facilitates consistent HIV testing and access to uptake of and adherence to new biomedical HIV prevention modalities with the goal of lowering community-level viral load and ultimately a diminution of the HIV epidemic among urban Black MSM in the US
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None