NCT07786441

Brief 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. 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
7mo left

Started Sep 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

August 17, 2026

Last Update Submit

August 21, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

    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.

    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.

    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.

    One-week and three-months after the intervention

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

Participants will receive the intervention immediately.

Behavioral: Stigma Reduction Intervention

Wait-list

ACTIVE COMPARATOR

Participants will act as comparators and will receive the intervention three months later.

Behavioral: Stigma Reduction Intervention

Interventions

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.

Immediate InterventionWait-list

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • year of age and older
  • Self identifies as a man who has had sex with other men
  • Self identifies as traditional healer

You may not qualify if:

  • Requires working knowledge of Spanish
  • Minor (under age 18)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

RECRUITING

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Roberto Orellana, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

E. Roberto Orellana, PhD

CONTACT

Devon Bushnell

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants do not know which arm they belong to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Wait-list control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Social Work

Study Record Dates

First Submitted

August 17, 2026

First Posted

August 26, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

August 26, 2026

Record last verified: 2026-08

Locations