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Preventing & Treating HIV Comorbidities in India: Multi-tiered Strategy for Women (MAHILA)

13. august 2020 opdateret af: Yale University
The overall objective of this project is to demonstrate that a low cost, cell phone-delivered intervention is a promising, feasible and acceptable way to improve the prevention and treatment outcomes of women in India who are affected by HIV and inter-related mental health and psychosocial risk factors.

Studieoversigt

Detaljeret beskrivelse

The overall objective of this project is to demonstrate that a low cost, cell phone-delivered intervention is a promising, feasible and acceptable way to improve the prevention and treatment outcomes of women in India who are affected by HIV and inter-related mental health and psychosocial risk factors. Over the past decade there have been dramatic improvements in HIV prevention and access to life-saving antiretroviral therapy (ART). Yet, deficits in adherence to the spectrum of HIV care pose significant barriers to success. Women are at a particular disadvantage. Gender inequality, physical and situational factors place many women at increased risk for HIV acquisition and poor mental health and interrelated psychosocial co-factors (depression, gender-discrimination, violence, lack of social support, etc.) that are well established correlates of poor adherence and retention in HIV care. Recent studies have shown alarmingly high rates of loss to follow-up for these women, particularly in the transition after delivery, between PMTCT and lifelong HIV care services. Preliminary work indicates that a theory-guided adherence phone intervention that can be easily integrated and sustained as a component of routine ART Centre services is well suited for the target population, but it needs to be adapted to the sociocultural context. Following initial formative work to refine the intervention for delivery in India, clinic nurses will be trained to deliver the intervention, and the feasibility, fidelity and preliminary efficacy of the novel application of the intervention will be evaluated in a randomized trial. After baseline assessment, women (n=120) will be randomly assigned to treatment as usual (TAU) or TAU plus the phone intervention (delivered over 16 weeks) and outcomes will be evaluated at 6, 14, 24, 36 weeks post-randomization. If the promising mobile phone intervention developed and pilot tested in this project shows promise in this Phase 1 study as we expect, the efficacy and cost of the intervention will then be evaluated in a large scale, multi-site study. If successful, an extremely practical approach will be available to improve the prevention and treatment outcomes of women with HIV and co-morbid mental health problems in India.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Karnataka
      • Belgaum, Karnataka, Indien
        • Belgaum ART Center

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • HIV+ women starting ART
  • Willing to be contacted by mobile phone
  • Speaks English or Hindi or Kannada
  • Screens positive for depressive symptoms or psychosocial risk factors
  • Able to provide informed consent

Exclusion Criteria:

  • Unable to participate in study visits
  • Any condition that, in the opinion of the site investigator, would compromise the candidate's ability to participate

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Phone counseling intervention
Treatment as usual (TAU) plus a nurse-delivered mobile phone counseling intervention delivered at weeks 1 to 12, 14, and 16 post-randomization.
Multi-dimensional, patient-centered counseling approach used to build patient-provider rapport, establish sources of support, and enable and empower problem solving to address inter-related, multi-tiered barriers to care.
Routine HIV clinic-based counseling
Aktiv komparator: Treatment as Usual
Routine HIV clinic-based counseling
Routine HIV clinic-based counseling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Viral load
Tidsramme: 6 months post-randomization
HIV-1 RNA copies per millilitre of blood plasma
6 months post-randomization

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Medication adherence
Tidsramme: 6 weeks post-randomization
Self-reported adherence to HIV medications
6 weeks post-randomization
Mental health (Survey)
Tidsramme: 6 weeks post-randomization
Survey measures of symptoms of depression, anxiety and cognitive representation of illness
6 weeks post-randomization
Medication adherence (Self-reported)
Tidsramme: 14 weeks post-randomization
Self-reported adherence to HIV medications
14 weeks post-randomization
Medication adherence (Self-reported)
Tidsramme: 24 weeks post-randomization
Self-reported adherence to HIV medications
24 weeks post-randomization
Medication adherence (Self-reported)
Tidsramme: 36 weeks post-randomization
Self-reported adherence to HIV medications
36 weeks post-randomization
Mental health (survey)
Tidsramme: 14 weeks post-randomization
Survey measures of symptoms of depression, anxiety and cognitive representation of illness
14 weeks post-randomization
Mental health
Tidsramme: 24 weeks post-randomization
Survey measures of symptoms of depression, anxiety and cognitive representation of illness
24 weeks post-randomization
Mental health
Tidsramme: 36 weeks post-randomization
Survey measures of symptoms of depression, anxiety and cognitive representation of illness
36 weeks post-randomization

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility and acceptability (Protocol specific tools)
Tidsramme: 6 weeks post-randomization
Protocol specific tools will be used to measure feasibility and user acceptability The assessment will include: 1) The ratio of eligible study participants to those enrolled; 2) Number of scheduled study visits completed at 6, 14, 24, and 36 weeks; 3) Attrition between baseline and follow-up; 4) Reason for premature drop-out; 5) Number of phone calls that were made on schedule; 6) Level of participation in intervention sessions including the total number sessions, number of sessions completed without break offs, number of break offs, length (minutes) of sessions; 7) Congruence of topic/content discussed on calls with protocol; 8) Patient and study nurse satisfaction with intervention content, mode of delivery, and protocol.
6 weeks post-randomization
Feasibility and acceptability (Protocol specific tools)
Tidsramme: 14 weeks post-randomization
Protocol specific tools will be used to measure feasibility and user acceptability The assessment will include: 1) The ratio of eligible study participants to those enrolled; 2) Number of scheduled study visits completed at 6, 14, 24, and 36 weeks; 3) Attrition between baseline and follow-up; 4) Reason for premature drop-out; 5) Number of phone calls that were made on schedule; 6) Level of participation in intervention sessions including the total number sessions, number of sessions completed without break offs, number of break offs, length (minutes) of sessions; 7) Congruence of topic/content discussed on calls with protocol; 8) Patient and study nurse satisfaction with intervention content, mode of delivery, and protocol.
14 weeks post-randomization
Feasibility and acceptability (Protocol specific tools)
Tidsramme: 24 weeks post-randomization
Protocol specific tools will be used to measure feasibility and user acceptability The assessment will include: 1) The ratio of eligible study participants to those enrolled; 2) Number of scheduled study visits completed at 6, 14, 24, and 36 weeks; 3) Attrition between baseline and follow-up; 4) Reason for premature drop-out; 5) Number of phone calls that were made on schedule; 6) Level of participation in intervention sessions including the total number sessions, number of sessions completed without break offs, number of break offs, length (minutes) of sessions; 7) Congruence of topic/content discussed on calls with protocol; 8) Patient and study nurse satisfaction with intervention content, mode of delivery, and protocol.
24 weeks post-randomization
Feasibility and acceptability (Protocol specific tools)
Tidsramme: 36 weeks post-randomization
Protocol specific tools will be used to measure feasibility and user acceptability The assessment will include: 1) The ratio of eligible study participants to those enrolled; 2) Number of scheduled study visits completed at 6, 14, 24, and 36 weeks; 3) Attrition between baseline and follow-up; 4) Reason for premature drop-out; 5) Number of phone calls that were made on schedule; 6) Level of participation in intervention sessions including the total number sessions, number of sessions completed without break offs, number of break offs, length (minutes) of sessions; 7) Congruence of topic/content discussed on calls with protocol; 8) Patient and study nurse satisfaction with intervention content, mode of delivery, and protocol.
36 weeks post-randomization

Samarbejdspartnere og efterforskere

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

Sponsor

Efterforskere

  • Ledende efterforsker: Nancy R Reynolds, PhD, Yale University
  • Ledende efterforsker: Prabha Chandra, MD, National Institute of Mental Health and Neuro Sciences (NIMHANS)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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)

25. september 2013

Primær færdiggørelse (Faktiske)

31. juli 2017

Studieafslutning (Faktiske)

31. juli 2017

Datoer for studieregistrering

Først indsendt

30. juli 2014

Først indsendt, der opfyldte QC-kriterier

17. december 2014

Først opslået (Skøn)

18. december 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. august 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. august 2020

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1301011297
  • R21MH100939 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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