- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02319330
Preventing & Treating HIV Comorbidities in India: Multi-tiered Strategy for Women (MAHILA)
13. august 2020 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
120
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Karnataka
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Belgaum, Karnataka, India
- Belgaum ART Center
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
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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
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Aktiv komparator: Treatment as Usual
Routine HIV clinic-based counseling
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Routine HIV clinic-based counseling
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Viral load
Tidsramme: 6 months post-randomization
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HIV-1 RNA copies per millilitre of blood plasma
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6 months post-randomization
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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6 weeks post-randomization
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Medication adherence (Self-reported)
Tidsramme: 14 weeks post-randomization
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Self-reported adherence to HIV medications
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14 weeks post-randomization
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Medication adherence (Self-reported)
Tidsramme: 24 weeks post-randomization
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Self-reported adherence to HIV medications
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24 weeks post-randomization
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Medication adherence (Self-reported)
Tidsramme: 36 weeks post-randomization
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Self-reported adherence to HIV medications
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36 weeks post-randomization
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Mental health (survey)
Tidsramme: 14 weeks post-randomization
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Survey measures of symptoms of depression, anxiety and cognitive representation of illness
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14 weeks post-randomization
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Mental health
Tidsramme: 24 weeks post-randomization
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Survey measures of symptoms of depression, anxiety and cognitive representation of illness
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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 |
Tiltaksbeskrivelse |
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.
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6 weeks post-randomization
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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.
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36 weeks post-randomization
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Nancy R Reynolds, PhD, Yale University
- Hovedetterforsker: Prabha Chandra, MD, National Institute of Mental Health and Neuro Sciences (NIMHANS)
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
25. september 2013
Primær fullføring (Faktiske)
31. juli 2017
Studiet fullført (Faktiske)
31. juli 2017
Datoer for studieregistrering
Først innsendt
30. juli 2014
Først innsendt som oppfylte QC-kriteriene
17. desember 2014
Først lagt ut (Anslag)
18. desember 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. august 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. august 2020
Sist bekreftet
1. august 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1301011297
- R21MH100939 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .