Preventing & Treating HIV Comorbidities in India: Multi-tiered Strategy for Women (MAHILA)
13. srpna 2020 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
120
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Karnataka
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Belgaum, Karnataka, Indie
- Belgaum ART Center
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Ženský
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Aktivní komparátor: Treatment as Usual
Routine HIV clinic-based counseling
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Routine HIV clinic-based counseling
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Viral load
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Medication adherence
Časové okno: 6 weeks post-randomization
|
Self-reported adherence to HIV medications
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6 weeks post-randomization
|
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Mental health (Survey)
Časové okno: 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)
Časové okno: 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)
Časové okno: 24 weeks post-randomization
|
Self-reported adherence to HIV medications
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24 weeks post-randomization
|
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Medication adherence (Self-reported)
Časové okno: 36 weeks post-randomization
|
Self-reported adherence to HIV medications
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36 weeks post-randomization
|
|
Mental health (survey)
Časové okno: 14 weeks post-randomization
|
Survey measures of symptoms of depression, anxiety and cognitive representation of illness
|
14 weeks post-randomization
|
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Mental health
Časové okno: 24 weeks post-randomization
|
Survey measures of symptoms of depression, anxiety and cognitive representation of illness
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24 weeks post-randomization
|
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Mental health
Časové okno: 36 weeks post-randomization
|
Survey measures of symptoms of depression, anxiety and cognitive representation of illness
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36 weeks post-randomization
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Feasibility and acceptability (Protocol specific tools)
Časové okno: 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)
Časové okno: 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
|
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Feasibility and acceptability (Protocol specific tools)
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Nancy R Reynolds, PhD, Yale University
- Vrchní vyšetřovatel: Prabha Chandra, MD, National Institute of Mental Health and Neuro Sciences (NIMHANS)
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
25. září 2013
Primární dokončení (Aktuální)
31. července 2017
Dokončení studie (Aktuální)
31. července 2017
Termíny zápisu do studia
První předloženo
30. července 2014
První předloženo, které splnilo kritéria kontroly kvality
17. prosince 2014
První zveřejněno (Odhad)
18. prosince 2014
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
17. srpna 2020
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
13. srpna 2020
Naposledy ověřeno
1. srpna 2019
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 1301011297
- R21MH100939 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .