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

Depression Clinical Trial

— MAHILA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02319330
• Other study ID #: 1301011297
• Secondary ID: R21MH100939
• Status: Completed
• Phase: N/A
• Start date: September 25, 2013
• Est. completion date: July 31, 2017

Study information

• Verified date: August 2019
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• HIV

Intervention

Behavioral:
• Nurse-delivered mobile phone counseling intervention
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.
• Treatment as Usual
Routine HIV clinic-based counseling

Locations

Country	Name	City	State
India	Belgaum ART Center	Belgaum	Karnataka

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Institute of Mental Health (NIMH), National Institute of Mental Health and Neuro Sciences, India

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility and acceptability (Protocol specific tools)	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
Other	Feasibility and acceptability (Protocol specific tools)	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
Other	Feasibility and acceptability (Protocol specific tools)	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
Other	Feasibility and acceptability (Protocol specific tools)	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
Primary	Viral load	HIV-1 RNA copies per millilitre of blood plasma	6 months post-randomization
Secondary	Medication adherence	Self-reported adherence to HIV medications	6 weeks post-randomization
Secondary	Mental health (Survey)	Survey measures of symptoms of depression, anxiety and cognitive representation of illness	6 weeks post-randomization
Secondary	Medication adherence (Self-reported)	Self-reported adherence to HIV medications	14 weeks post-randomization
Secondary	Medication adherence (Self-reported)	Self-reported adherence to HIV medications	24 weeks post-randomization
Secondary	Medication adherence (Self-reported)	Self-reported adherence to HIV medications	36 weeks post-randomization
Secondary	Mental health (survey)	Survey measures of symptoms of depression, anxiety and cognitive representation of illness	14 weeks post-randomization
Secondary	Mental health	Survey measures of symptoms of depression, anxiety and cognitive representation of illness	24 weeks post-randomization
Secondary	Mental health	Survey measures of symptoms of depression, anxiety and cognitive representation of illness	36 weeks post-randomization