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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02101697
Other study ID # R01MH093257
Secondary ID R01MH093257
Status Completed
Phase N/A
First received
Last updated
Start date July 2014
Est. completion date August 2019

Study information

Verified date September 2019
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 3733
Est. completion date August 2019
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
India St. John's Research Institute/St John's Medical College & Hospital Bangalore Karnataka

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

India, 

References & Publications (17)

Bharat S. Facing the HIV / AIDS challenge: a study on household and community responses. Health Millions. 1998 Jan-Feb;24(1):15-6, 19. — View Citation

Ekstrand ML, Bharat S, Ramakrishna J, Heylen E. Blame, symbolic stigma and HIV misconceptions are associated with support for coercive measures in urban India. AIDS Behav. 2012 Apr;16(3):700-10. doi: 10.1007/s10461-011-9888-z. — View 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. — View Citation

Li L, Liang LJ, Lin C, Wu Z, Wen Y. Individual attitudes and perceived social norms: Reports on HIV/AIDS-related stigma among service providers in China. Int J Psychol. 2009 Dec;44(6):443-50. doi: 10.1080/00207590802644774. — View Citation

Li L, Lin C, Wu Z, Wu S, Rotheram-Borus MJ, Detels R, Jia M. Stigmatization and shame: consequences of caring for HIV/AIDS patients in China. AIDS Care. 2007 Feb;19(2):258-63. — View Citation

Li L, Wu Z, Wu S, Zhaoc Y, Jia M, Yan Z. HIV-related stigma in health care settings: a survey of service providers in China. AIDS Patient Care STDS. 2007 Oct;21(10):753-62. — View Citation

Li L, Wu Z, Zhao Y, Lin C, Detels R, Wu S. Using case vignettes to measure HIV-related stigma among health professionals in China. Int J Epidemiol. 2007 Feb;36(1):178-84. Epub 2006 Dec 14. — View Citation

Lightfoot M, Rotheram-Borus MJ, Comulada WS, Reddy VS, Duan N. Efficacy of brief interventions in clinical care settings for persons living with HIV. J Acquir Immune Defic Syndr. 2010 Mar;53(3):348-56. doi: 10.1097/QAI.0b013e3181c429b3. — View Citation

Mahendra VS, Gilborn L, Bharat S, Mudoi R, Gupta I, George B, Samson L, Daly C, Pulerwitz J. Understanding and measuring AIDS-related stigma in health care settings: a developing country perspective. SAHARA J. 2007 Aug;4(2):616-25. — View Citation

Noar SM, Black HG, Pierce LB. Efficacy of computer technology-based HIV prevention interventions: a meta-analysis. AIDS. 2009 Jan 2;23(1):107-15. doi: 10.1097/QAD.0b013e32831c5500. Review. — View Citation

Nyblade L, Jain A, Benkirane M, Li L, Lohiniva AL, McLean R, Turan JM, Varas-Díaz N, Cintrón-Bou F, Guan J, Kwena Z, Thomas W. A brief, standardized tool for measuring HIV-related stigma among health facility staff: results of field testing in China, Dominica, Egypt, Kenya, Puerto Rico and St. Christopher & Nevis. J Int AIDS Soc. 2013 Nov 13;16(3 Suppl 2):18718. doi: 10.7448/IAS.16.3.18718. — View Citation

Nyblade L, Stangl A, Weiss E, Ashburn K. Combating HIV stigma in health care settings: what works? J Int AIDS Soc. 2009 Aug 6;12:15. doi: 10.1186/1758-2652-12-15. — View 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. — View 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. — View 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. — View Citation

Varas-Díaz N, Marzán-Rodríguez M. The emotional aspect of AIDS stigma among health professionals in Puerto Rico. AIDS Care. 2007 Nov;19(10):1247-57. — View Citation

Varas-Díaz N, Neilands TB. Development and validation of a culturally appropriate HIV/AIDS Stigma Scale for Puerto Rican health professionals in training. AIDS Care. 2009 Oct;21(10):1259-70. doi: 10.1080/09540120902804297. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary behavioral manifestations of HIV-related stigma 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. one year
Primary instrumental and symbolic stigma 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. one year
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