- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07706634
Care Disengagement Prevention in PLWH in Indonesia
15. Juli 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
110
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Wei-Ti Chen, RN, CNM, Ph.D., FAAN
- Telefonnummer: 310-206-8539
- E-Mail: wchen@sonnet.ucla.edu
Studienorte
-
-
West Java
-
Depok, West Java, Indonesien, 16424
- Rekrutierung
- University of Indonesia Hospital
-
Kontakt:
- Wei-Ti Chen, RN, CNM, PhD, FAAN
- Telefonnummer: 310-206-8539
- E-Mail: wchen@sonnet.ucla.edu
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Stigma reduction
Participants receive a stigma-reduction intervention that has been adapted for use in the target population.
|
The study intervention was adapted for stigma reduction and care engagement in a Muslim-dominant population.
|
|
Kein Eingriff: Treatment as Usual
Participants receive typical services including care co-ordination and linkage to public health nurses in local communities.
|
|
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Kein Eingriff: 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.
|
|
|
Kein Eingriff: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Perceived Stigma Score From Baseline to End of Intervention
Zeitfenster: Baseline to 26 weeks
|
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.
|
Baseline to 26 weeks
|
|
Change in Adherence From Baseline to End of Intervention
Zeitfenster: Baseline to 26 weeks
|
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.
|
Baseline to 26 weeks
|
|
Level of Healthcare Engagement From Baseline to End of Intervention as Measured by Missed or Delayed Clinic Visits
Zeitfenster: Baseline to 26 weeks
|
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.
|
Baseline to 26 weeks
|
|
Changes in Patient Activation from Baseline to End of Intervention
Zeitfenster: Baseline to 26 weeks
|
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.
|
Baseline to 26 weeks
|
|
Change in Internal Stigma Score From Baseline to End of Intervention
Zeitfenster: Baseline to 26 weeks
|
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.
|
Baseline to 26 weeks
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
11. Februar 2026
Primärer Abschluss (Geschätzt)
31. Januar 2028
Studienabschluss (Geschätzt)
31. Januar 2028
Studienanmeldedaten
Zuerst eingereicht
11. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
11. Juli 2026
Zuerst gepostet (Tatsächlich)
16. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
17. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
15. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRB-25-1193
- 1R01TW013110 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
Data available upon reasonable request.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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