- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07706634
Care Disengagement Prevention in PLWH in Indonesia
15 luglio 2026 aggiornato da: Weiti Chen, RN, CNM, PhD, FAAN, University of California, Los Angeles
Care Disengagement Prevention in Treatment Naive Indonesians Living With HIV
This study is being done because the investigators want to learn about how stigma and culture in Indonesia affects how much contact people living with HIV have with the healthcare system and also how it might affect their health status.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This project focuses on an innovative evidence-based stigma-reduction intervention that addresses HIV care engagement, which is key for reducing HIV transmission.
This work is directly relevant to the U.S., including the Ending the HIV Epidemic (EHE) initiative, as stigma remains a key barrier to care engagement across variable populations.
U.S. communities, including faith-based populations, need to strengthen retention across the HIV care continuum to reduce HIV transmission and eventually eradicate HIV infection from the U.S.
However, there is a dearth of information related to strategies to reduce HIV stigma among Muslims who are living with HIV in the U.S., who are both widely distributed and in concentrations that make studies impossible to carry out over short time frames.
As the world's largest Muslim-majority country, accounting for 13% of the global Muslim population, Indonesia provides a critical context for developing culturally grounded stigma-reduction interventions to improve HIV treatment engagement.
In Asia, the population size of people living with HIV (PLH) in Indonesia is second only to that in India and China.
According to recent estimates from UNAIDS, while there were an estimated 540,000 PLH in Indonesia in 2022, only 179,659 (33.27%) were reportedly on antiretroviral therapy (ART), 36,821 (6.82%) were regularly tested for viral load, and 33,395 (6.18%) achieved viral suppression.
The majority of Indonesian PLHs are lost across the HIV care continuum, even after the government's Strategic Use of Antiretroviral Therapy program launched in 2013.
The reasons for this failure to retain PLH in care include insufficient knowledge and limited accessibility and affordability of care, but the most prominent barrier is the fear of stigma.
Stigma not only deters PLH from seeking care but also strains patient-provider relationships.
Indeed, stigma is considered the greatest barrier to ending HIV in Indonesia whose cultural meanings surrounding HIV are rooted in the local "religious-familial" complex.
The scientific premise is that HIV stigma remains rampant in Indonesia, where Islamic doctrine is prominent, with severe negative impacts on treatment engagement.
This study addresses the critical need to increase treatment engagement among PLH and retain them in care by addressing the stigma surrounding HIV.
Study aims are to adapt an evidence-based stigma reduction intervention and to test the feasibility, acceptability, and preliminary efficacy of the adapted intervention for stigma reduction and care engagement in a Muslim-dominant population.
This study will provide transferable insights to inform stigma-reduction strategies and improve HIV care engagement in the U.S. context.
The project's key innovations are culturally grounded modules informed by Islamic teachings on justice, compassion, and mindful prayer, while employing a nurse-led, low-intensity, four-session intervention model designed for scalability in resource-poor settings in the U.S. The project findings will advance the understanding of stigma reduction tools used to prevent leakage from the HIV care continuum and ultimately help protect the health of Americans.
Tipo di studio
Interventistico
Iscrizione (Stimato)
110
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Wei-Ti Chen, RN, CNM, Ph.D., FAAN
- Numero di telefono: 310-206-8539
- Email: wchen@sonnet.ucla.edu
Luoghi di studio
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West Java
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Depok, West Java, Indonesia, 16424
- Reclutamento
- University of Indonesia Hospital
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Contatto:
- Wei-Ti Chen, RN, CNM, PhD, FAAN
- Numero di telefono: 310-206-8539
- Email: wchen@sonnet.ucla.edu
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Living with HIV
- Able to give informed consent
- Able to attend study visits
Exclusion Criteria:
- Condition that prevents full participation in the study such as neurological disease, major depression or cardiovascular disease
- Unable to communicate
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Stigma reduction
Participants receive a stigma-reduction intervention that has been adapted for use in the target population.
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The study intervention was adapted for stigma reduction and care engagement in a Muslim-dominant population.
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Nessun intervento: Treatment as Usual
Participants receive typical services including care co-ordination and linkage to public health nurses in local communities.
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Nessun intervento: Interview group
With the goal of culturally adapting an existing intervention for use among people living with HIV from Indonesia, in-depth interviews are conducted with Indonesians living with HIV.
Participants in the interview group are not followed for outcomes or AEs.
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Nessun intervento: Focus Group
Focus groups made up of Indonesians living with HIV are presented the adapted intervention.
Feasibility, acceptability, and appropriateness are assessed that inform the final version of the adapted intervention for use in the target population.
Participants in the focus group are not followed for outcomes or AEs.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Perceived Stigma Score From Baseline to End of Intervention
Lasso di tempo: Baseline to 26 weeks
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The Perceived Stigma Scale (PSS) of the HIV Stigma Scale will be used to measure perceived stigma.
Each item is measured using a 4-point Likert scale and the scale contains four factors: personalized stigma (18 items, subscore total 18-72), disclosure concerns (12 items, subscore total 12-48), negative self-image (9 items, subscore total 9-36), and concern with public attitudes about people with HIV (12 items, subscore total 12-48).
Each factor is scored separately, with total score is computed by summing all 40 items, with a minimum total PSS score of 40 and a maximum possible score of 160.
Raw PSS scores were transformed into Stigma scores 1-4.
Higher scores reflect higher levels of perceived stigma.
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Baseline to 26 weeks
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Change in Adherence From Baseline to End of Intervention
Lasso di tempo: Baseline to 26 weeks
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A one-item visual analog scale assesses 30-day HIV medication adherence, reported separately for each drug, along a continuum of "none of the doses" to "every dose."
The maximum possible score for an individual drug item is 100 (representing 100% adherence, or "every dose").
Each drug is scored separately, with total score computed by summing all items, with a minimum total score of 0 (no medications taken) and a maximum possible score depending on the total number of medications in the participant's specific HIV regimen.
Higher scores reflect higher levels of HIV medication adherence.
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Baseline to 26 weeks
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Level of Healthcare Engagement From Baseline to End of Intervention as Measured by Missed or Delayed Clinic Visits
Lasso di tempo: Baseline to 26 weeks
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Proportions of missed or delayed clinic visits for HIV care will be calculated for each participant.
Minimum scores are 0 (missed or delayed zero scheduled appointments) and maximum score is 1 (missed or delayed every single scheduled appointment).
The score is derived by dividing the number of missed/delayed visits by the total number of scheduled visits for that specific participant.
Higher scores indicate lower levels of HIV healthcare engagement.
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Baseline to 26 weeks
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Changes in Patient Activation from Baseline to End of Intervention
Lasso di tempo: Baseline to 26 weeks
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The Patient Activation Measure-Short Form will be used to measure knowledge, skill, and confidence managing health.
Statements are rated on a 4-point scale from "strongly disagree" to "strongly agree".
Scores range from 0 to 100, which corresponds to one of four activation levels: Level 1 (0-47.0),
Level 2 (47.1-55.1),
Level 3 (55.2-72.4) and Level 4 (72.5-100).
Higher levels means greater patient activation.
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Baseline to 26 weeks
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Change in Internal Stigma Score From Baseline to End of Intervention
Lasso di tempo: Baseline to 26 weeks
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Negative Image subscale of the HIV Stigma Scale will be used to detect internal stigma.
The negative self-image subscale assesses an individual's negative feelings towards oneself due to HIV.
The subscale uses a 4-point Likert scale that consists of items that ask respondents to rate their level of agreement (from strongly disagree to strongly agree) with statements related to self-worth.
Total maximum score of the scale is 52 and minimum score is 13.
Lower scores reflect better self-image.
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Baseline to 26 weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
11 febbraio 2026
Completamento primario (Stimato)
31 gennaio 2028
Completamento dello studio (Stimato)
31 gennaio 2028
Date di iscrizione allo studio
Primo inviato
11 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
11 luglio 2026
Primo Inserito (Effettivo)
16 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
17 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
15 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB-25-1193
- 1R01TW013110 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Descrizione del piano IPD
Data available upon reasonable request.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .