Stigma, SocialPhase 1NCT07786441
KABAWIL: Reducing Intersectional Stigmas
A Phase 1 study testing Stigma Reduction Intervention in people with Stigma, Social, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stigma, Social
- What is being tested?
- Stigma Reduction Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 year of age and older
- Self identifies as a man who has had sex with other men
- Self identifies as traditional healer
Who cannot join
- Requires working knowledge of Spanish
- Minor (under age 18)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98105
E. Roberto Orellana, 206-685-4771, popolvuh@uw.edu
About this study
Official title: 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?
Read more
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).
Read the 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.
- Conditions
- Stigma, Social
- Being tested
- Stigma Reduction Intervention
- Medical subject headings
- Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stigma Reduction InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Experimental | Participants will receive the intervention immediately. Receives: Behavioral: Stigma Reduction Intervention |
| Wait-list | Active comparator | Participants will act as comparators and will receive the intervention three months later. Receives: Behavioral: Stigma Reduction Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Feasibility
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
Measured: One-week and three-months after the intervention workshop is completed.
HIV stigma among healthcare workers Scale
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.
Measured: 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)
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.
Measured: From enrollment to the three-month follow-up.
Study Acceptability
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.
Measured: One-week and three-months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stigma, SocialStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Wait-list control trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Roberto Orellana, University of Washington
- Investigators
- Roberto Orellana, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786441
- Sponsor's protocol ID
- STUDY00020854
- Other IDs
- 5R01TW012904
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kabawil: Adapting an Intervention to Reduce Intersectional Stigmas Among Indigenous Sexual Minority Men and Traditional Healers in Mesoamerica
- ClinicalTrials.gov ID
- NCT07786441
- Acronym / sponsor ID
- STUDY00020854
- Conditions
- Stigma, Social
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Wait-list control trial
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Behavioral: Stigma Reduction InterventionParticipants will receive the intervention immediately. |
| Wait-list | Active comparator | Behavioral: Stigma Reduction InterventionParticipants will act as comparators and will receive the intervention three months later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 year of age and older
- Self identifies as a man who has had sex with other men
- Self identifies as traditional healer
Key exclusion criteria (2 listed)
- Requires working knowledge of Spanish
- Minor (under age 18)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stigma Reduction InterventionThis 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. | Behavioural | Immediate Intervention, Wait-list |
Primary outcome
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
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roberto Orellana, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stigma Reduction Intervention in people with Stigma, Social, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact E. Roberto Orellana, PhD (206-685-4771, popolvuh@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Feasibility (time frame: One-week and three-months after the intervention workshop is completed.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.