- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02319330
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
Status
Afsluttet
Betingelser
Intervention / Behandling
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
|
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Medication adherence (Self-reported)
Tidsramme: 36 weeks post-randomization
|
Self-reported adherence to HIV medications
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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
Samarbejdspartnere
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.
Generelle publikationer
- Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
- Reynolds NR, Satyanarayana V, Duggal M, Varghese M, Liberti L, Singh P, Ranganathan M, Jeon S, Chandra PS. MAHILA: a protocol for evaluating a nurse-delivered mHealth intervention for women with HIV and psychosocial risk factors in India. BMC Health Serv Res. 2016 Aug 4;16(a):352. doi: 10.1186/s12913-016-1605-1.
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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