StigmatizationDRISTINCT02101697
Reducing AIDS Stigma Among Health Professionals in India
A study testing HIV Stigma Reduction Intervention in people with Stigmatization, run by University of California, San Francisco at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stigmatization
- What is being tested?
- HIV Stigma Reduction Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,733 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2014to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unwilling or unable to participate
Trial locations and contacts
1 site in 1 country.
India1 site
St. John's Research Institute/St John's Medical College & Hospital
Bangalore, Karnataka, 560 034
About this study
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.
Read the 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:
- 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.
- Evaluate the efficacy of the intervention in 24 hospitals in North and South India on:
- behavioral manifestations of HIV stigma, including endorsement of coercive policies, behavioral intentions to discriminate, and non/stigmatizing provider-patient interactions.
- 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).
- Conditions
- Stigmatization
- Being tested
- HIV Stigma Reduction Intervention
- Keywords
- reduce, Indian health providers
- Medical subject headings
- Stereotyping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV Stigma Reduction InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: HIV Stigma Reduction Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for StigmatizationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,733 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Maria L Ekstrand, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101697
- Sponsor's protocol ID
- R01MH093257
- Other IDs
- R01MH093257
- Acronym
- DRISTI
- Status last verified
- Sep 2019
- First submitted
- 27 Mar 2014
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24569699Ekstrand 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.
PubMed 24242265Steward 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.
PubMed 22282878Steward 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.
PubMed 21218366Nyblade 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.
PubMed 24242266Nyblade 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.
PubMed 19660113Varas-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.
PubMed 18071968Varas-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.
PubMed 20024702Ekstrand 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.
PubMed 21290175Li 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.
PubMed 20090857Li 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.
PubMed 17364408Li 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.
PubMed 17949274Li 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.
PubMed 17175545Bharat S. Facing the HIV / AIDS challenge: a study on household and community responses. Health Millions. 1998 Jan-Feb;24(1):15-6, 19.
PubMed 12348525Mahendra 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.
PubMed 18071613
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing AIDS Stigma Among Health Professionals in India
- ClinicalTrials.gov ID
- NCT02101697
- Acronym / sponsor ID
- DRISTI / R01MH093257
- Conditions
- Stigmatization
- Keywords
- reduce, Indian health providers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,733 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2014 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Evaluate the efficacy of the intervention in 24 hospitals in North and South India on:
- behavioral manifestations of HIV stigma, including endorsement of coercive policies, behavioral intentions to discriminate, and non/stigmatizing provider-patient interactions.
- 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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV Stigma Reduction Intervention | Experimental | Behavioral: HIV Stigma Reduction InterventionThe 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. |
| Time Matched Control Group | Placebo comparator | Behavioral: HIV Stigma Reduction InterventionThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- having worked as ward attendant at one of the study hospitals for at least a year
- being 18 years or older,
Key exclusion criteria (1 listed)
- Unwilling or unable to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV Stigma Reduction InterventionThe 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. | Behavioural | HIV Stigma Reduction Intervention, Time Matched Control Group |
Primary outcome
behavioral manifestations of HIV-related stigma
Time frame: one year
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Background: PubMed 24569699Shah 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.
- Background: PubMed 24242265Ekstrand 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.
- Background: PubMed 22282878Steward 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.
- Background: PubMed 21218366Steward 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.
- Background: PubMed 24242266Nyblade 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.
- Background: PubMed 19660113Nyblade 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.
- Background: PubMed 18071968Varas-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.
- Background: PubMed 20024702Varas-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.
- Background: PubMed 21290175Ekstrand 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.
- Background: PubMed 20090857Li 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.
- Background: PubMed 17364408Li 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.
- Background: PubMed 17949274Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria L Ekstrand, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV Stigma Reduction Intervention in people with Stigmatization, run by University of California, San Francisco at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
behavioral manifestations of HIV-related stigma (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02101697, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.