Clinical trial NCT02101697: Reducing AIDS Stigma Among Health Professionals in India
Official title: Reducing AIDS Stigma Among Health Professionals in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stigmatization
Keywords: reduce
Indian health providers
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-04-02
Enrollment: 3733
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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 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

Primary outcomes:
measure: behavioral manifestations of HIV-related stigma
timeFrame: one year
measure: instrumental and symbolic stigma
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: St. John's Research Institute/St John's Medical College & Hospital
state: Karnataka
Study officials:
affiliation: University of California, San Francisco
name: Maria L Ekstrand, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah SM, Heylen E, Srinivasan K, Perumpil S, Ekstrand ML. Reducing HIV stigma among nursing students: a brief intervention. West J Nurs Res. 2014 Nov;36(10):1323-37. doi: 10.1177/0193945914523685. Epub 2014 Feb 25.
citation: Ekstrand ML, Ramakrishna J, Bharat S, Heylen E. Prevalence and drivers of HIV stigma among health providers in urban India: implications for interventions. J Int AIDS Soc. 2013 Nov 13;16(3 Suppl 2):18717. doi: 10.7448/IAS.16.3.18717.
citation: Steward WT, Bharat S, Ramakrishna J, Heylen E, Ekstrand ML. Stigma is associated with delays in seeking care among HIV-infected people in India. J Int Assoc Provid AIDS Care. 2013 Mar-Apr;12(2):103-9. doi: 10.1177/1545109711432315. Epub 2012 Jan 26.
citation: Steward WT, Chandy S, Singh G, Panicker ST, Osmand TA, Heylen E, Ekstrand ML. Depression is not an inevitable outcome of disclosure avoidance: HIV stigma and mental health in a cohort of HIV-infected individuals from Southern India. Psychol Health Med. 2011 Jan;16(1):74-85. doi: 10.1080/13548506.2010.521568.
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