Recruiting
Phase 1

KABAWIL

Sponsor:

University of Washington

Code:

NCT07786441

Conditions

Stigma, Social

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Stigma Reduction Intervention

Study Details

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).

Conditions

Stigma, Social

Study ID

NCT07786441

Start date

Sep 1, 2026

Status verified date

Aug, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Immediate Intervention

Participants will receive the intervention immediately.

active comparator: Wait-list

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

Interventions

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.

Primary outcome measure

  • Study Feasibility [ Time Frame: 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. ]
  • HIV Stigma Scale (Enacted Stigma, Disclosure Concerns, Negative Self-Image, & Concern w/ Public Attitudes) [ Time Frame: From enrollment to the three-month follow-up. ]
  • Study Acceptability [ Time Frame: One-week and three-months after the intervention ]

Central Contacts and Locations

Central contacts

E. Roberto Orellana, PhD

206-685-4771popolvuh@uw.edu

Devon Bushnell

2065435524devonb@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98105

Contacts

E. Roberto Orellana

206-685-4771popolvuh@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2026-08-26.