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).
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
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 estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Estágio
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
Contato de estudo
- Nome: E. Roberto Orellana, PhD
- Número de telefone: 206-685-4771
- E-mail: popolvuh@uw.edu
Estude backup de contato
- Nome: Devon Bushnell
- Número de telefone: 2065435524
- E-mail: devonb@uw.edu
Locais de estudo
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98105
- Recrutamento
- University of Washington
-
Contato:
- E. Roberto Orellana
- Número de telefone: 206-685-4771
- E-mail: popolvuh@uw.edu
-
-
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
|
Experimental: Immediate Intervention
Participants will receive the intervention immediately.
|
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.
|
|
Comparador Ativo: Wait-list
Participants will act as comparators and will receive the intervention three months later.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Study Feasibility
Prazo: One-week and three-months after the intervention workshop is completed.
|
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.
|
|
HIV stigma among healthcare workers Scale
Prazo: From enrollment to the end of the three-month follow-up.
|
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.
|
From enrollment to the end of the three-month follow-up.
|
|
HIV Stigma Scale (Enacted Stigma, Disclosure Concerns, Negative Self-Image, & Concern w/ Public Attitudes)
Prazo: From enrollment to the three-month follow-up.
|
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.
|
From enrollment to the three-month follow-up.
|
|
Study Acceptability
Prazo: One-week and three-months after the intervention
|
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.
|
One-week and three-months after the intervention
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Roberto Orellana, PhD, University of Washington
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- STUDY00020854
- 5R01TW012904 (Concessão/Contrato do NIH dos EUA)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .