- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07786441
KABAWIL: Reducing Intersectional Stigmas
Kabawil: Adapting an Intervention to Reduce Intersectional Stigmas Among Indigenous Sexual Minority Men and Traditional Healers in Mesoamerica
The goal of this study is to develop and test KABAWIL, a culturally tailored intervention designed to reduce HIV-related and intersectional stigmas experienced by Indigenous communities in Guatemala and improve engagement across the HIV Continuum of Care. The study will also assess the feasibility, acceptability, and implementation of the intervention. The main questions it aims to answer are:
Can a culturally adapted version of the FRESH intervention reduce HIV-related and intersectional stigmas among Indigenous men and Indigenous healers? Does participation in KABAWIL improve outcomes related to HIV prevention, testing, treatment, and care using a status-neutral approach? Is KABAWIL feasible, acceptable, and appropriate for implementation in Indigenous communities in Guatemala?
Researchers will first adapt the existing FRESH intervention through interviews and focus groups with Indigenous men, Indigenous healers, healthcare providers, stigma experts, and Maya knowledge keepers. Researchers will then compare participants who receive KABAWIL immediately with participants assigned to a 3-month wait-list control group.
Participants will:
Participate in interviews or focus groups to help adapt the intervention (Aim 1).
Attend one of three KABAWIL workshops or be assigned to a 3-month wait-list control group (Aim 2).
Complete surveys and assessments measuring HIV-related intersectional stigma and HIV Continuum of Care outcomes before and after the intervention (Aim 2).
Participate in post-intervention interviews to provide feedback on the intervention's feasibility, acceptability, and implementation (Aim 3).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The goal of this study is to develop, culturally adapt, and evaluate KABAWIL, a community-based intervention designed to reduce HIV-related stigma and intersecting forms of stigma experienced by Indigenous communities in Guatemala. By addressing stigma at multiple levels, the intervention seeks to improve engagement across the HIV Continuum of Care, including HIV prevention, testing, linkage to care, treatment initiation, retention in care, and viral suppression. In addition, the study will assess the feasibility, acceptability, appropriateness, and implementation potential of KABAWIL within Indigenous communities and local healthcare settings.
HIV-related stigma remains a significant barrier to HIV prevention and treatment in Guatemala, particularly among Indigenous populations who may also experience discrimination related to ethnicity, language, socioeconomic status, traditional healing practices, gender, and sexual identity. These overlapping forms of marginalization, often referred to as intersectional stigmas, can discourage individuals from seeking HIV testing, accessing healthcare services, disclosing HIV status, and remaining engaged in treatment. KABAWIL is designed to address these interconnected barriers through a culturally grounded approach that incorporates Indigenous worldviews, community knowledge systems, and traditional healing practices.
This study will evaluate whether a culturally adapted version of the FRESH (Finding Respect and Ending Stigma around HIV) intervention can effectively reduce HIV-related and intersectional stigma among Indigenous men and Indigenous healers. The study will also examine whether participation in KABAWIL leads to improvements in HIV prevention behaviors, HIV testing uptake, engagement in HIV care, treatment adherence, and other outcomes across the HIV Continuum of Care using a status-neutral framework, which supports individuals regardless of their HIV status by promoting appropriate prevention or treatment services.
Study Objectives
The study is organized around three primary aims:
Aim 1: Cultural Adaptation of the Intervention
Researchers will work collaboratively with community stakeholders to adapt the existing FRESH intervention to the cultural, linguistic, and social contexts of Indigenous communities in Guatemala. This process will involve individual interviews and focus group discussions with:
Indigenous men from participating communities Indigenous healers and traditional medicine practitioners Healthcare providers and HIV service professionals HIV stigma and public health experts Maya knowledge keepers and community leaders
Information gathered during this phase will be used to refine intervention content, delivery methods, educational materials, and facilitation strategies to ensure cultural relevance and community acceptability.
Aim 2: Pilot Evaluation of KABAWIL
Following adaptation, researchers will conduct a pilot study to assess the intervention's preliminary effectiveness. Participants will be assigned either to:
An immediate intervention group that participates in KABAWIL workshops, or A 3-month wait-list control group that receives the intervention after the comparison period.
The intervention consists of one culturally tailored KABAWIL workshop designed to promote stigma reduction, increase HIV-related knowledge, strengthen supportive attitudes and behaviors, and improve engagement with HIV prevention and treatment services.
Researchers will compare outcomes between groups to determine whether participation in KABAWIL reduces HIV-related and intersectional stigma.
Aim 3: Implementation Evaluation
The final phase of the study will assess how well KABAWIL can be implemented in real-world settings. Researchers will evaluate:
Feasibility (whether the intervention can be delivered successfully) Acceptability (whether participants and stakeholders view it positively) Appropriateness (whether the intervention fits community needs and contexts) Potential barriers and facilitators to future implementation and scale-up Participant Activities
By combining evidence-based stigma reduction strategies with Indigenous knowledge, cultural values, and community engagement, KABAWIL aims to create a sustainable and culturally responsive approach to improving HIV-related health outcomes among Indigenous populations in Guatemala. Findings from this study will provide important evidence regarding the effectiveness and implementation of stigma-reduction interventions and may inform future HIV prevention and care programs in Indigenous communities throughout Guatemala and other settings with similar cultural and health equity challenges.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: E. Roberto Orellana, PhD
- Número de teléfono: 206-685-4771
- Correo electrónico: popolvuh@uw.edu
Copia de seguridad de contactos de estudio
- Nombre: Devon Bushnell
- Número de teléfono: 2065435524
- Correo electrónico: devonb@uw.edu
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98105
- Reclutamiento
- University of Washington
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Contacto:
- E. Roberto Orellana
- Número de teléfono: 206-685-4771
- Correo electrónico: popolvuh@uw.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 18 year of age and older
- Self identifies as a man who has had sex with other men
- Self identifies as traditional healer
Exclusion Criteria:
- Requires working knowledge of Spanish
- Minor (under age 18)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Immediate Intervention
Participants will receive the intervention immediately.
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This a workshop-based intervention that has reduced HIV stigma among healthcare workers and gay, bisexual, and other men who have sex with men (GBM) in multiple countries.
Guatemala's Indigenous population, which comprises nearly half of the country's residents, faces significant health inequities.
Indigenous GBM experience intersecting forms of stigma related to HIV, sexual orientation, and Indigenous identity, increasing their vulnerability to poor HIV outcomes.
The adapted intervention, KABAWIL, will be the first adaptation to include both Indigenous men and traditional healers.
We will pilot test KABAWIL using a randomized wait-list controlled trial with 120 participants.
Sixty participants (30 Indigenous GBM and 30 ITH) will receive the intervention through three workshops, while 60 participants will be assigned to a 3-month wait-list control group.
The study will evaluate KABAWIL's preliminary efficacy, feasibility, acceptability, and implementation potential.
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Comparador activo: Wait-list
Participants will act as comparators and will receive the intervention three months later.
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This a workshop-based intervention that has reduced HIV stigma among healthcare workers and gay, bisexual, and other men who have sex with men (GBM) in multiple countries.
Guatemala's Indigenous population, which comprises nearly half of the country's residents, faces significant health inequities.
Indigenous GBM experience intersecting forms of stigma related to HIV, sexual orientation, and Indigenous identity, increasing their vulnerability to poor HIV outcomes.
The adapted intervention, KABAWIL, will be the first adaptation to include both Indigenous men and traditional healers.
We will pilot test KABAWIL using a randomized wait-list controlled trial with 120 participants.
Sixty participants (30 Indigenous GBM and 30 ITH) will receive the intervention through three workshops, while 60 participants will be assigned to a 3-month wait-list control group.
The study will evaluate KABAWIL's preliminary efficacy, feasibility, acceptability, and implementation potential.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Study Feasibility
Periodo de tiempo: One-week and three-months after the intervention workshop is completed.
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Feasibility will be assessed by: Recruitment Rates: Track the number of eligible participants screened, approached, and successfully enrolled in the study. Retention and Attrition: Measure how many participants drop out or are lost to follow-up over time. Data Completeness: Assess how many outcome assessments or questionnaires have missing or invalid data point |
One-week and three-months after the intervention workshop is completed.
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HIV stigma among healthcare workers Scale
Periodo de tiempo: From enrollment to the end of the three-month follow-up.
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This is a survey instrument designed to measure stigmatizing attitudes, beliefs, and behaviors toward people living with HIV among healthcare professionals.
It is commonly used in research and program evaluation to assess the extent of HIV-related stigma within healthcare settings and to evaluate the effectiveness of stigma-reduction interventions.
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From enrollment to the end of the three-month follow-up.
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HIV Stigma Scale (Enacted Stigma, Disclosure Concerns, Negative Self-Image, & Concern w/ Public Attitudes)
Periodo de tiempo: From enrollment to the three-month follow-up.
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This is a self-report measure that assesses stigma experienced by people living with HIV across four key domains: Enacted Stigma: Experiences of discrimination, rejection, or unfair treatment due to HIV status; Disclosure Concerns: Worries about revealing one's HIV status and potential negative consequences of disclosure; Negative Self-Image: Internalized stigma, including feelings of shame, guilt, or lowered self-worth related to HIV infection; and, Concern with Public Attitudes: Perceptions of societal prejudice, stereotypes, and negative views toward people living with HIV.
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From enrollment to the three-month follow-up.
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Study Acceptability
Periodo de tiempo: One-week and three-months after the intervention
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Will use a use Likert scale (1 to 5) survey to ask participants to rate their satisfaction, ease of use, and willingness to repeat the process.
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One-week and three-months after the intervention
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Roberto Orellana, PhD, University of Washington
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00020854
- 5R01TW012904 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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