NCT05446064

Brief Summary

Thailand remains one of the countries with the largest population of people living with HIV (PLWH). It is estimated that 30 Thai provinces account for 75% of the HIV infections in that country, with ChiangMai as the most prevalent province in northern Thailand. Also, HIV/AIDS remains among the top 10 most common causes of death in Thailand. This high mortality rate may be partially explained by the notable HIV treatment cascade in Thailand: Among all the Thai PLWH, only 74% were retained in care, while 68% received ART, and roughly 50% reached viral suppression. An important reason for this is that HIV-related stigma still poses significant barriers for Thai PLWH to access healthcare and carry out health-protective behaviors, including adherence to medication schedules, to manage their HIV. In Thailand, substance use, including use of tobacco, alcohol, and other emerging recreational drugs, is a pressing health concern. In the HIV+ population in Thailand, it was found that 15% use tobacco, 70% use alcohol, and 2% use recreational drugs. In addition, among Thai HIV+ alcohol drinkers, about 13%-22% were heavy drinkers and 40% had sex under the influence of alcohol. Although the literature evaluating prevalence of substance use among Thai HIV+ individuals is emerging, the knowledge remains very limited regarding their risk and protective factors for substance use. Self-management interventions, typically include training modules for symptom management skills and coping strategies. In Buddhist-Thai culture, the goal of self-management may become assisting PLWH to find the peace and harmony within themselves by gradually "letting go" of those strong desires for certain materials or status that contribute to the uncertainty in lives. Therefore, this project aims to further the investigator's knowledge about self-management behaviors in HIV+ substance users in the context of Buddhist-Thai culture. The investigator aims to: 1. Explore how PLWH experience and interpret substance use, mental health, and self-management and identify key social-cultural factors that influence these factors. 2. Test the associations among mental health, substance use, self-management, health outcomes and selected key social-cultural factors among PLWH using a partial correlation network model. The results will be used for development of a culturally tailored, evidence-based self-management intervention to promote better health outcomes among Thai PLWH.

Trial Health

57
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Trial Health Score

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

Enrollment
110

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
terminated

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

June 24, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

October 15, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

2.4 years

First QC Date

June 24, 2022

Last Update Submit

May 30, 2025

Conditions

Keywords

People living with HIVStigmaBuddhismIntervention testing

Outcome Measures

Primary Outcomes (1)

  • Stigma change

    Personalized Stigma and Negative Image subscales of the HIV Stigma Scale Outcome will be used to assess stigma levels. The instrument contains 40-item in totally to measure the stigma perceived by people with HIV to address the respondent's actual experiences or feelings related to having HIV, as well as how other's responses to their HIV status. Subcategories of the scale include personalized stigma subscale, disclosure subscale, negative self-image subscale, and public attitudes subscale. Each stigma item uses a 4-point Likert-type scale (strongly disagree, disagree, agree and strongly agree), with higher values indicating greater agreement with the item.

    weeks 1,4,7,10

Secondary Outcomes (3)

  • Care Engagement change

    weeks 1,4,7,10

  • Buddhism change

    weeks 1,4,7,10

  • Mindfulness change

    weeks 1,4,7,10

Study Arms (2)

Enhanced Treatment

EXPERIMENTAL

Participants will receive the stigma-reduction intervention as well as typical services including care co-ordination and linkage to public health nurses in local communities.

Behavioral: Stigma-reduction intervention

Treatment-as-Usual

NO INTERVENTION

Participants will receive typical services including care co-ordination and linkage to public health nurses in local communities.

Interventions

The intervention is modularized into four weekly 1-hour group sessions, led by a trained facilitator who provides psychoeducation to promote awareness and understanding of HIV stigma and teach CBT-based coping skills. Each group session will last 45-60 minutes. Participants are introduced to the general CBT model of HIV stigma and encouraged to track thoughts, feelings, and behavioral responses when encountering external stigma or adverse events. The participants further learn to differentiate effective and ineffective coping strategies and practice applying new coping skills to reduce internalized HIV stigma. The interventionist will follow the intervention manual to deliver the intervention and assign homework for group members to practice on their own. In the following sessions, the interventionist will review progress with participants, guide participants through exercises, and identify additional problems to be addressed in subsequent sessions.

Enhanced Treatment

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years of age
  • self-identify as a Person Living with HIV
  • physically well enough to attend counseling sessions and follow-up visits

You may not qualify if:

  • have a significant condition, such as neurological or cardiovascular diseases, that prevents them from fully participating the study
  • unable to communicate
  • unable to provide informed consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanpatong Hospital

Chiang Mai, 50120, Thailand

Location

MeSH Terms

Conditions

HIV InfectionsSocial Stigma

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 24, 2022

First Posted

July 6, 2022

Study Start

October 15, 2022

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

June 4, 2025

Record last verified: 2025-05

Locations