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A Psychosocial Tele-health Stigma Intervention for Youth Living With HIV in Vietnam

24. maj 2022 opdateret af: Mary DeSilva, University of New England

"Sống Vui, Live Happily": A Psychosocial Tele-health Intervention to Address Multi-level Stigma Among Youth Living With HIV in Vietnam

The overall goals of the study are to deepen understanding of the spectrum of stigma experienced by YLHIV in Vietnam, to develop a multi-level stigma intervention for YLHIV delivered by telephone, and to evaluate the feasibility, acceptability, and preliminary efficacy of the intervention on intra- and inter-personal stigma, psychological wellbeing, and treatment adherence.

The project has the following Specific Aims:

  1. Adapt a psychosocial stigma-reduction intervention for YLHIV in Vietnam based on cognitive-behavioral therapy principles and delivered by telephone, using input from youth during intervention development.
  2. Assess the feasibility, acceptability and preliminary efficacy of this innovative approach to reduce stigma, and improve psychosocial wellbeing and ART adherence among YLHIV through a small pre-post study.
  3. Explore the multiple facets of stigma experienced by YLHIV in Vietnam and their relationships with ART adherence and psychosocial wellbeing via quantitative surveys and electronic adherence monitoring.

The study will assess the feasibility and acceptability of this approach among YLVIV in Vietnam, and generate preliminary evidence for the potential effect of the intervention on important endpoints including stigma, psychosocial wellbeing, adherence, CD4 count, and viral load (VL).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

For the pilot, the investigators will recruit YLHIV on ART who self-report intrapersonal stigma and implement a 12-week pre-post intervention study in which participants will receive the phone-based intervention developed in the first phase. YLHIV will use an electronic adherence monitoring device for their ART medications.

In the pre-post intervention study, each of 40 patients will be followed for a total of 16 weeks. All patient subjects will be given an eCAP wireless pill container (WPC) that will be used to measure their adherence throughout the 16-week period. Study participation will involve two phases, with the following activities:

I. Adherence monitoring, pre-intervention period (Weeks 1-2). Once enrolled, the investigators will provide each subject with a WPC and instruction on correct use. The investigators will select one medication for each WPC. While subjects continue to receive care as usual, the investigators will collect their adherence data using the WPC.

II. Intervention period (Weeks 3-12). The intervention will be implemented for about 10 weeks; adherence data will be collected via WPCs through Week 16. They will remain blinded to the adherence information generated by the devices, as will their care providers.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

38

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Vietnam
      • Hanoi, Vietnam
        • Institute for Social Development Studies

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 24 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • are between 18 and 24 years old
  • are a patient at the OPC
  • are expected to remain in care at the OPC for 3 months minimum(?)
  • are currently on ART
  • have primary responsibility for taking their own medications,
  • self-report intrapersonal stigma via a brief screening questionnaire,
  • are able to complete a short phone call from the location where they intend to be when participating in coaching sessions,
  • agree to follow all study procedures, AND
  • provide informed consent.

Exclusion Criteria:

  • are below the age of 18 years or above the age of 24,
  • are not currently on ART,
  • live outside the clinic catchment area,
  • are identified as having severe mental health issues as identified through screening, OR
  • are not willing to provide informed consent.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Supportive life skills coaching
CBT-based supportive like skills delivered by phone by lay coaches
Adfærdsmæssigt: CBT-based supportive skills delivered by phone by lay coaches
8-10 weekly coaching sessions delivered by telephone

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intrapersonal (self) Stigma
Tidsramme: change between Week 1-Week 12
modified 21-item self stigma subscale of Vietnam Stigma Index Studies instrument (People living with HIV: Stigma Index 2014; higher score=worse outcome)
change between Week 1-Week 12
Interpersonal Stigma
Tidsramme: change between Week 1 and Week 12
modified 21-item enacted stigma subscale of Vietnam Stigma Index Studies instrument (People living with HIV: Stigma Index 2014; higher score=worse outcome)
change between Week 1 and Week 12
Depression
Tidsramme: change between Week 1 and Week 12
7-item depression subscale of the Depression, Anxiety and Stress Scale (DASS-21; higher score=worse outcome)
change between Week 1 and Week 12
Anxiety
Tidsramme: change between Week 1 and Week 12
7-item depression subscale of the Depression, Anxiety and Stress Scale (DASS-21; higher score=worse outcome)
change between Week 1 and Week 12
Adherence
Tidsramme: Week 12 (endline)
%≥95% on-time adherence
Week 12 (endline)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of New England

Samarbejdspartnere

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Fogarty International Center of the National Institute of Health
Institute for Social Development Studies (ISDS)

Efterforskere

  • Ledende efterforsker: Mary DeSilva, ScD, MS, University of New England

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. april 2021

Primær færdiggørelse (Faktiske)

15. maj 2022

Studieafslutning (Faktiske)

15. maj 2022

Datoer for studieregistrering

Først indsendt

7. maj 2021

Først indsendt, der opfyldte QC-kriterier

7. maj 2021

Først opslået (Faktiske)

13. maj 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. maj 2022

Sidst verificeret

1. maj 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • R21TW011085-01 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

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