Preventing & Treating HIV Comorbidities in India: Multi-tiered Strategy for Women (MAHILA)
13 août 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
120
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Karnataka
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Belgaum, Karnataka, Inde
- Belgaum ART Center
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Comparateur actif: Treatment as Usual
Routine HIV clinic-based counseling
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Routine HIV clinic-based counseling
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Viral load
Délai: 6 months post-randomization
|
HIV-1 RNA copies per millilitre of blood plasma
|
6 months post-randomization
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Medication adherence
Délai: 6 weeks post-randomization
|
Self-reported adherence to HIV medications
|
6 weeks post-randomization
|
|
Mental health (Survey)
Délai: 6 weeks post-randomization
|
Survey measures of symptoms of depression, anxiety and cognitive representation of illness
|
6 weeks post-randomization
|
|
Medication adherence (Self-reported)
Délai: 14 weeks post-randomization
|
Self-reported adherence to HIV medications
|
14 weeks post-randomization
|
|
Medication adherence (Self-reported)
Délai: 24 weeks post-randomization
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Self-reported adherence to HIV medications
|
24 weeks post-randomization
|
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Medication adherence (Self-reported)
Délai: 36 weeks post-randomization
|
Self-reported adherence to HIV medications
|
36 weeks post-randomization
|
|
Mental health (survey)
Délai: 14 weeks post-randomization
|
Survey measures of symptoms of depression, anxiety and cognitive representation of illness
|
14 weeks post-randomization
|
|
Mental health
Délai: 24 weeks post-randomization
|
Survey measures of symptoms of depression, anxiety and cognitive representation of illness
|
24 weeks post-randomization
|
|
Mental health
Délai: 36 weeks post-randomization
|
Survey measures of symptoms of depression, anxiety and cognitive representation of illness
|
36 weeks post-randomization
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Feasibility and acceptability (Protocol specific tools)
Délai: 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
|
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Feasibility and acceptability (Protocol specific tools)
Délai: 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)
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Nancy R Reynolds, PhD, Yale University
- Chercheur principal: Prabha Chandra, MD, National Institute of Mental Health and Neuro Sciences (NIMHANS)
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
25 septembre 2013
Achèvement primaire (Réel)
31 juillet 2017
Achèvement de l'étude (Réel)
31 juillet 2017
Dates d'inscription aux études
Première soumission
30 juillet 2014
Première soumission répondant aux critères de contrôle qualité
17 décembre 2014
Première publication (Estimation)
18 décembre 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 août 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 août 2020
Dernière vérification
1 août 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1301011297
- R21MH100939 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
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