KABAWIL: Reducing Intersectional Stigmas

August 21, 2026 updated by: Roberto Orellana, University of Washington

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: E. Roberto Orellana, PhD
  • Phone Number: 206-685-4771
  • Email: popolvuh@uw.edu

Study Contact Backup

  • Name: Devon Bushnell
  • Phone Number: 2065435524
  • Email: devonb@uw.edu

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • University of Washington
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Immediate Intervention
Participants will receive the intervention immediately.
Behavioral: Stigma Reduction Intervention
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.
Active Comparator: Wait-list
Participants will act as comparators and will receive the intervention three months later.
Behavioral: Stigma Reduction Intervention
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Study Feasibility
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fogarty International Center of the National Institute of Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Roberto Orellana, PhD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00020854
  • 5R01TW012904 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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