- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06509113
A Pilot Study of an Online HIV Stigma Training for Nursing Students in Iran
July 17, 2024 updated by: University of California, San Francisco
Reducing Stigmatizing Attitudes and Behaviors of Nursing Students in Simulated Clinical Visits of Patients Living With HIV in Iran
In this study, the investigators will assess the feasibility, acceptability, and preliminary efficacy of online HIV stigma training in reducing stigmatizing attitudes and behaviors of nursing students in simulated clinical visits of patients living with HIV compared to an online HIV epidemiology training with no specific content on stigma.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Iran has the highest burden of HIV in the Middle East.
However, only 42% of Iranians living with HIV are diagnosed and 28% on antiretroviral therapy.
The largest gap in the continuum of HIV care is diagnosis.
Due to sociocultural and religious beliefs, HIV- associated stigma and drug use stigma are exceedingly high, and sex outside of marriage, or sex of man with another man are considered to be "sinful" behaviors.
These intersectional stigmas (stigma towards drug use, sexism, and homophobia) in addition to HIV stigma are major barriers for many people at risk for or living with HIV to engage in HIV testing or treatment.
Our prior studies found that health providers have limited clinical encounters with people living with HIV (PLWH) and have no HIV stigma training.
This lack of training can lead to stigmatizing attitudes and behaviors towards people at risk for HIV or PLWH.
The highest HIV stigmatizing behaviors was reported in nurses and physician assistants.
These data, coupled with the extreme marginalization of key populations at high risk for HIV in Iran, call for the development of new ways to train nurses to reduce HIV-related stigma in clinical settings.
The investigators propose to develop, and field test an HIV stigma online training including simulated patients living with HIV for nursing school students.
In a randomized controlled trial, the investigators will assess the feasibility, acceptability, and preliminary efficacy of the online HIV stigma training in reducing stigmatizing attitudes and behaviors of nursing students in simulated clinical visits of patients living with HIV compared to an online HIV epidemiology training with no specific content on stigma.
Successful development of the HIV stigma training and simulated patients at risk for or living with HIV will set the stage for developing a larger trial of nurses and other health providers which can lead to an effective and scalable training program to reduce HIV-related stigma in clinical settings and improve engagement in HIV testing and care services.
The investigators from the University of California San Francisco (UCSF), will lead and co-investigate the project, respectively.
They will collaborate with teams from Kerman University of Medical Sciences (KMU), Iran, and Ponce Health Sciences University (PHSU) in the USA.
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hamid Sharifi, PhD
- Phone Number: 0098-9133485812
- Email: sharifihami@gmail.com
Study Contact Backup
- Name: Mahlagha Dehghan, PhD
- Phone Number: 0098-3431325192
- Email: m_dehghan86@yahoo.com
Study Locations
-
-
-
Kerman, Iran, Islamic Republic of, 76198-13159
- Recruiting
- Skill labs at the nursing school of Kerman Medical University
-
Contact:
- Hamid Sharifi, PhD
- Email: sharifihami@gmail.com
-
Contact:
- Mahlagha Dehghan, PhD
- Email: m_dehghan86@yahoo.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Currently nursing students in their year 3 or 4 of training
- Kerman Medical University (KMU) nursing schools
Exclusion Criteria:
- Nursing student in their year 1 and 2
- Students of other fields and other universities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Intervention
Nursing students will be assigned to the intervention group and will receive online HIV-related stigma training.
|
The intervention is an online HIV-related stigma training that takes 6 hours in 4 weeks to be completed.
|
|
Other: Control
Nursing students will be assigned to the online HIV epidemiology training with no specific content on stigma.
|
Nursing students will be trained in an online HIV epidemiology training with no specific content on stigma.
It will take 6 hours in 4 weeks to complete the training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stigma score
Time Frame: Up to 4 weeks before and after intervention
|
All nursing students will complete a validated stigma scale before and after the training interventions.
|
Up to 4 weeks before and after intervention
|
|
Behavioral manifestations of HIV stigma
Time Frame: Up to 4 weeks before and after intervention
|
Before and after the training interventions, all nursing students will meet with a randomly selected simulated patient for an HIV visit.
These visits will be video recorded and will be coded and scored for stigmatizing behaviors.
|
Up to 4 weeks before and after intervention
|
|
Empathy score
Time Frame: Up to 4 weeks before and after intervention
|
All nursing students will complete a validated empathy scale before and after the training interventions.
|
Up to 4 weeks before and after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The attitudes and behaviors of nursing students after the online HIV stigma training
Time Frame: Three months after the intervention
|
We will qualitatively examine study participants' real-world behaviors with HIV and at-risk patients to (1) explore if behaviors learned during the intervention carry on in real-world settings, (2) better understand how behaviors are manifested in natural settings, and (3) explore best methods to assess behaviors in real-world scenarios
|
Three months after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ali Mirzazadeh, PhD, University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gokengin D, Doroudi F, Tohme J, Collins B, Madani N. HIV/AIDS: trends in the Middle East and North Africa region. Int J Infect Dis. 2016 Mar;44:66-73. doi: 10.1016/j.ijid.2015.11.008.
- UNAIDS. Country factsheets Iran 2020. Retrived from https://www.unaids.org/en/regionscountries/countries/islamicrepublicofiran. 2020.
- Farhoudi B, Ghalekhani N, Afsar Kazerooni P, Namdari Tabar H, Tayeri K, Gouya MM, SeyedAlinaghi S, Haghdoost AA, Mirzazadeh A, Sharifi H. Cascade of care in people living with HIV in Iran in 2019; how far to reach UNAIDS/WHO targets. AIDS Care. 2022 May;34(5):590-596. doi: 10.1080/09540121.2021.1944603. Epub 2021 Jun 28.
- Karamouzian M, Akbari M, Haghdoost AA, Setayesh H, Zolala F. "I am dead to them": HIV-related stigma experienced by people living with HIV in Kerman, Iran. J Assoc Nurses AIDS Care. 2015 Jan-Feb;26(1):46-56. doi: 10.1016/j.jana.2014.04.005. Epub 2014 May 2.
- Rahmati-Najarkolaei F, Niknami S, Aminshokravi F, Bazargan M, Ahmadi F, Hadjizadeh E, Tavafian SS. Experiences of stigma in healthcare settings among adults living with HIV in the Islamic Republic of Iran. J Int AIDS Soc. 2010 Jul 22;13:27. doi: 10.1186/1758-2652-13-27.
- Malekmohammadi N, Mirzazadeh A, Iranpour A, Shafiei Bafti M, Zolala F, McFarland W, et al. HIV Stigma among People Living with HIV in Southeast Iran. Journal of Kerman University of Medical Sciences 2021; 28(5):427-436.
- Etesam F, Assarian F, Hosseini H, Ghoreishi FS. Stigma and its determinants among male drug dependents receiving methadone maintenance treatment. Arch Iran Med. 2014 Feb;17(2):108-14.
- Tavakoli F, Karamouzian M, Rafiei-Rad AA, Iranpour A, Farrokhnia M, Noroozi M, Sharifi A, Marshall BDL, Shokoohi M, Sharifi H. HIV-Related Stigma Among Healthcare Providers in Different Healthcare Settings: A Cross-Sectional Study in Kerman, Iran. Int J Health Policy Manag. 2020 Apr 1;9(4):163-169. doi: 10.15171/ijhpm.2019.92.
- Asadi-Aliabadi M, Abolghasemi J, Rimaz S, Majdzadeh R, Rostami-Maskopaee F, Merghati-Khoei E. Barriers to Health Service Utilization Among Iranian Female Sex Workers: A Qualitative Study. J Prev Med Public Health. 2018 Mar;51(2):64-70. doi: 10.3961/jpmph.17.174.
- Walker D, Cohen S, Fritz J, Olvera M, Lamadrid-Figueroa H, Cowan JG, Hernandez DG, Dettinger JC, Fahey JO. Team training in obstetric and neonatal emergencies using highly realistic simulation in Mexico: impact on process indicators. BMC Pregnancy Childbirth. 2014 Nov 20;14:367. doi: 10.1186/s12884-014-0367-1.
- Walker DM, Cohen SR, Fritz J, Olvera-Garcia M, Zelek ST, Fahey JO, Romero-Martinez M, Montoya-Rodriguez A, Lamadrid-Figueroa H. Impact Evaluation of PRONTO Mexico: A Simulation-Based Program in Obstetric and Neonatal Emergencies and Team Training. Simul Healthc. 2016 Feb;11(1):1-9. doi: 10.1097/SIH.0000000000000106. Erratum In: Simul Healthc. 2017 Feb;12(1):65. doi: 10.1097/SIH.0000000000000219.
- Walton A, Kestler E, Dettinger JC, Zelek S, Holme F, Walker D. Impact of a low-technology simulation-based obstetric and newborn care training scheme on non-emergency delivery practices in Guatemala. Int J Gynaecol Obstet. 2016 Mar;132(3):359-64. doi: 10.1016/j.ijgo.2015.08.009. Epub 2015 Dec 11.
- Mugo C, Wilson K, Wagner AD, Inwani IW, Means K, Bukusi D, Slyker J, John-Stewart G, Richardson BA, Nduati M, Moraa H, Wamalwa D, Kohler P. Pilot evaluation of a standardized patient actor training intervention to improve HIV care for adolescents and young adults in Kenya. AIDS Care. 2019 Oct;31(10):1250-1254. doi: 10.1080/09540121.2019.1587361. Epub 2019 Feb 27.
- Varas-Diaz N, Neilands TB, Cintron-Bou F, Marzan-Rodriguez M, Santos-Figueroa A, Santiago-Negron S, Marques D, Rodriguez-Madera S. Testing the efficacy of an HIV stigma reduction intervention with medical students in Puerto Rico: the SPACES project. J Int AIDS Soc. 2013 Nov 13;16(3 Suppl 2):18670. doi: 10.7448/IAS.16.3.18670. Erratum In: J Int AIDS Soc. 2013 Dec 23;16(1):18973. doi: 10.7448/IAS.16.1.18973.
- Varas-Diaz N, Rivera M, Rivera-Segarra E, Neilands TB, Ortiz N, Pedrogo Y, Mendoza S, Rivera Amador A, Martinez Garcia S, Rivera Suazo S, Albizu-Garcia CE. Beyond negative attitudes: Examining HIV/AIDS stigma behaviors in clinical encounters. AIDS Care. 2017 Nov;29(11):1437-1441. doi: 10.1080/09540121.2017.1322679. Epub 2017 May 3.
- UNAIDS. Fast-Track: ending the AIDS epidemic by 2030, 2014. Retrieved from https://www.unaids.org/en/resources/documents/2014/JC2686_WAD2014report. 18. UNAIDS. Regional factsheets Middle East and North Africa, 2019. Retrived from https://www.unaids.org/en/regionscountries/middleeastandnorthafrica
- Feyissa GT, Lockwood C, Woldie M, Munn Z. Reducing HIV-related stigma and discrimination in healthcare settings: A systematic review of quantitative evidence. PLoS One. 2019 Jan 25;14(1):e0211298. doi: 10.1371/journal.pone.0211298. eCollection 2019.
- Fahimfar N, Sedaghat A, Hatami H, Kamali K, Gooya M. Counseling and Harm Reduction Centers for Vulnerable Women to HIV/AIDS in Iran. Iran J Public Health. 2013 Jan 1;42(Supple1):98-104. Print 2013.
- National AIDS Committee Secretariat, Ministry of Health and Medical Education. Islamic Republic of Iran AIDS progress report on monitoring of the United Nations general assembly special session on HIV and AIDS In; 2017.
- Sharifi H, Mirzazadeh A, Shokoohi M, Karamouzian M, Khajehkazemi R, Navadeh S, Fahimfar N, Danesh A, Osooli M, McFarland W, Gouya MM, Haghdoost AA. Estimation of HIV incidence and its trend in three key populations in Iran. PLoS One. 2018 Nov 29;13(11):e0207681. doi: 10.1371/journal.pone.0207681. eCollection 2018.
- Shahesmaeili A, Karamouzian M, Shokoohi M, Kamali K, Fahimfar N, Nadji SA, Sharifi H, Haghdoost AA, Mirzazadeh A. Symptom-Based Versus Laboratory-Based Diagnosis of Five Sexually Transmitted Infections in Female Sex Workers in Iran. AIDS Behav. 2018 Jul;22(Suppl 1):19-25. doi: 10.1007/s10461-018-2130-5.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 15, 2024
Primary Completion (Estimated)
September 15, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
July 2, 2024
First Submitted That Met QC Criteria
July 17, 2024
First Posted (Actual)
July 19, 2024
Study Record Updates
Last Update Posted (Actual)
July 19, 2024
Last Update Submitted That Met QC Criteria
July 17, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
Other Study ID Numbers
- 23-38482
- R01TW012408 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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