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Reducing AIDS Stigma Among Health Professionals in India (DRISTI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02101697
First received: March 27, 2014
Last updated: November 21, 2014
Last verified: November 2014
  Purpose

This Randomized Controlled Trial has been designed to test the efficacy of a behavioral intervention to reduce HIV-related stigma among nursing students and ward attendants in 16 sites in South India and 8 sites in North India.


Condition Intervention
Reducing HIV-related Stigma Among Healthcare Providers
Behavioral: HIV Stigma Reduction Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Reducing AIDS Stigma Among Health Professionals in India

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • behavioral manifestations of HIV-related stigma [ Time Frame: one year ] [ Designated as safety issue: No ]
    Evaluate the efficacy of the intervention in a RCT, among nursing students and ward attendants on behavioral manifestations of AIDS stigma including their endorsement of coercive policies, behavioral intentions to discriminate, and non/stigmatizing provider-patient interactions, using face-to-face interviews, computer-based assessments, and ratings by behavioral observers at pre-, 6- and 12 month follow-up.

  • instrumental and symbolic stigma [ Time Frame: one year ] [ Designated as safety issue: No ]
    Evaluate the efficacy of the intervention in a RCT, among nursing students and ward attendants on the factors underlying stigma proposed by our conceptual model and targeted in the intervention modules, including fears and misconceptions regarding casual transmission (instrumental stigma), and negative attitudes toward marginalized, vulnerable groups (symbolic stigma), which have consistently been found to drive the behavioral manifestations of AIDS stigma and discrimination.


Estimated Enrollment: 3640
Study Start Date: July 2014
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIV Stigma Reduction Intervention
The HIV stigma reduction arm group will participate in a promising intervention designed to reduce HIV stigma among health professionals. The intervention builds on results of our previous research, identifying prevalence and drivers of stigma and discrimination in Indian healthcare settings among PLHIV, health care providers, and uninfected patients.The HIV stigma reduction intervention consists of two computer-administered sessions and one group session.
Behavioral: HIV Stigma Reduction Intervention

The HIV stigma reduction intervention consists of two computer-administered sessions and one group session.

Session 1. (approx. 60 min). Introduction of the concepts of stigma and discrimination, vulnerable populations and symbolic stigma delivered in an interactive tablet format, using games and videos.

Session 2. (approx. 60 min). Interactive activities to address HIV transmission myths and misconceptions and the importance of universal precautions.

Session 3. (approx 90 min). Patient interaction skills. In person interactive group session co-facilitated by PLHIV and staff focusing on skills building through role-plays and feedback.

Our previous research has found that these modules address factors identified as contributing to health professionals' stigma.

Placebo Comparator: Time Matched Control Group
The time-matched control group will also receive three sessions; two administered by computers and one in small group format to control for attention effects. However, rather than AIDS stigma, the content will be focused on diabetes management (a disease not considered to be stigmatized).

Detailed Description:

Across the globe, HIV stigma inflicts hardship and suffering on people with HIV and has been found to reduce the likelihood of seeking HIV counseling and testing and PMTCT. Stigma also deters infected individuals from disclosing their status, seeking timely medical treatment for HIV-related problems, reduces ART adherence, and leads to delays in clinic appointments and prescription refills, which can lead to virologic failure and the development and transmission of drug resistance. Medical professionals unfortunately constitute a significant source of stigma for PLHIV.

This study will evaluate the efficacy of a promising intervention designed to reduce HIV stigma among Indian health professionals. The intervention builds on results of our previous research, identifying prevalence and drivers of stigma and discrimination in Indian healthcare settings among PLHIV, health care providers and uninfected patients.

Specifically, the study will:

  1. Adapt our pilot-tested 3-session stigma reduction intervention for partial tablet-based delivery to increase its long-term sustainability in health care settings. The two tablet-administered sessions of the intervention use interactive touch screen methodology and video vignettes tailored to situations likely to be encountered by Indian nurses and ward attendants. The third session focuses on skills-building in a group format and is co-facilitated by a PLHIV.
  2. Evaluate the efficacy of the intervention in 24 hospitals in North and South India on:

    1. behavioral manifestations of HIV stigma, including endorsement of coercive policies, behavioral intentions to discriminate, and non/stigmatizing provider-patient interactions.
    2. the factors underlying stigma proposed by our conceptual model and targeted in the intervention modules, including fears and misconceptions regarding casual transmission (instrumental stigma), and negative attitudes toward marginalized, vulnerable groups (symbolic stigma).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For Nursing Students:

  1. being enrolled as a 2nd year nursing student in one of the study colleges,
  2. being 18 years or older,
  3. being able and willing to participate in the intervention and all assessments.

For ward attendants:

  1. having worked as ward attendant at one of the study hospitals for at least a year
  2. being 18 years or older,
  3. being able and willing to participate in the intervention and all assessments.

Exclusion Criteria:

a) Unwilling or unable to participate

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02101697

Contacts
Contact: Krishnamachari Srinivasan, MD srinivasanstjohns@gmail.com

Locations
India
St. John's Research Institute/St John's Medical College & Hospital Recruiting
Bangalore, Karnataka, India, 560 034
Contact: Sijuthomas Panicker       sijuthomaspanicker@gmail.com   
Principal Investigator: Krishnamachari Srinivasan, MD         
Sub-Investigator: Tony Raj, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Maria L Ekstrand, PhD University of California, San Francisco
  More Information

Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02101697     History of Changes
Other Study ID Numbers: R01MH093257, R01MH093257
Study First Received: March 27, 2014
Last Updated: November 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
reduce
Indian health providers

ClinicalTrials.gov processed this record on November 25, 2014