NCT02101697

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,733

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

5.1 years

First QC Date

March 27, 2014

Last Update Submit

September 18, 2019

Conditions

Keywords

reduceIndian health providers

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

HIV Stigma Reduction Intervention

EXPERIMENTAL

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

Time Matched Control Group

PLACEBO COMPARATOR

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).

Behavioral: HIV Stigma Reduction Intervention

Interventions

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.

HIV Stigma Reduction InterventionTime Matched Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For Nursing Students:
  • being enrolled as a 2nd year nursing student in one of the study colleges,
  • being 18 years or older,
  • being able and willing to participate in the intervention and all assessments.
  • For ward attendants:
  • having worked as ward attendant at one of the study hospitals for at least a year
  • being 18 years or older,
  • being able and willing to participate in the intervention and all assessments.

You may not qualify if:

  • a) Unwilling or unable to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. John's Research Institute/St John's Medical College & Hospital

Bangalore, Karnataka, 560 034, India

Location

Related Publications (17)

  • 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.

    PMID: 24569699BACKGROUND
  • 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.

    PMID: 24242265BACKGROUND
  • 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.

    PMID: 22282878BACKGROUND
  • 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.

    PMID: 21218366BACKGROUND
  • Nyblade L, Jain A, Benkirane M, Li L, Lohiniva AL, McLean R, Turan JM, Varas-Diaz N, Cintron-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.

    PMID: 24242266BACKGROUND
  • 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.

    PMID: 19660113BACKGROUND
  • Varas-Diaz N, Marzan-Rodriguez M. The emotional aspect of AIDS stigma among health professionals in Puerto Rico. AIDS Care. 2007 Nov;19(10):1247-57. doi: 10.1080/09540120701405403.

    PMID: 18071968BACKGROUND
  • Varas-Diaz 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.

    PMID: 20024702BACKGROUND
  • 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.

    PMID: 21290175BACKGROUND
  • 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.

    PMID: 20090857BACKGROUND
  • 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. doi: 10.1080/09540120600828473.

    PMID: 17364408BACKGROUND
  • 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. doi: 10.1089/apc.2006.0219.

    PMID: 17949274BACKGROUND
  • 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. doi: 10.1093/ije/dyl256. Epub 2006 Dec 14.

    PMID: 17175545BACKGROUND
  • Bharat S. Facing the HIV / AIDS challenge: a study on household and community responses. Health Millions. 1998 Jan-Feb;24(1):15-6, 19.

    PMID: 12348525BACKGROUND
  • 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. doi: 10.1080/17290376.2007.9724883.

    PMID: 18071613BACKGROUND
  • 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.

    PMID: 19050392BACKGROUND
  • 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.

    PMID: 19996978BACKGROUND

MeSH Terms

Conditions

Stereotyping

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Maria L Ekstrand, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2014

First Posted

April 2, 2014

Study Start

July 1, 2014

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

September 20, 2019

Record last verified: 2019-09

Locations