NCT06509113

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

July 2, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

July 2, 2024

Last Update Submit

July 17, 2024

Conditions

Keywords

StigmaHIVTrainingIranStudentNursing

Outcome Measures

Primary Outcomes (3)

  • Stigma score

    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

    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

    All nursing students will complete a validated empathy scale before and after the training interventions.

    Up to 4 weeks before and after intervention

Secondary Outcomes (1)

  • The attitudes and behaviors of nursing students after the online HIV stigma training

    Three months after the intervention

Study Arms (2)

Intervention

OTHER

Nursing students will be assigned to the intervention group and will receive online HIV-related stigma training.

Behavioral: The online HIV-related stigma training

Control

OTHER

Nursing students will be assigned to the online HIV epidemiology training with no specific content on stigma.

Behavioral: The online HIV epidemiology training with no specific content on stigma

Interventions

The intervention is an online HIV-related stigma training that takes 6 hours in 4 weeks to be completed.

Intervention

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.

Control

Eligibility Criteria

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

You may qualify if:

  • Currently nursing students in their year 3 or 4 of training
  • Kerman Medical University (KMU) nursing schools

You may not qualify if:

  • Nursing student in their year 1 and 2
  • Students of other fields and other universities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skill labs at the nursing school of Kerman Medical University

Kerman, 76198-13159, Iran

RECRUITING

Related Publications (21)

  • 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.

    PMID: 26948920BACKGROUND
  • UNAIDS. Country factsheets Iran 2020. Retrived from https://www.unaids.org/en/regionscountries/countries/islamicrepublicofiran. 2020.

    BACKGROUND
  • 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.

    PMID: 34180724BACKGROUND
  • 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.

    PMID: 24856436BACKGROUND
  • 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.

    PMID: 20649967BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 24527971BACKGROUND
  • 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.

    PMID: 32331496BACKGROUND
  • 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.

    PMID: 29631351BACKGROUND
  • 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.

    PMID: 25409895BACKGROUND
  • 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.

    PMID: 26312613BACKGROUND
  • 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.

    PMID: 26797198BACKGROUND
  • 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.

    PMID: 30810351BACKGROUND
  • 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.

    PMID: 24242260BACKGROUND
  • 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.

    PMID: 28464694BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 30682131BACKGROUND
  • 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.

    PMID: 23865025BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 30496204BACKGROUND
  • 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.

    PMID: 29744768BACKGROUND

MeSH Terms

Conditions

Social StigmaHIV Infections

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Ali Mirzazadeh, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamid Sharifi, PhD

CONTACT

Mahlagha Dehghan, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
To avoid potential bias based on the timing of enrollment, The investigators will use "block randomization" with randomly permuted block sizes to avoid identification of the allocation of the last participant in a block. Once a nursing student completes their baseline stigma and empathy survey, participants will be assigned the next masked envelope from the randomization list by a research staff, which in turn assign the person to one of the two study arms. The research staff and participants are masked to study arm assignment prior to opening the envelopes. The person analyzing the data will be masked to study arm assignment.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The investigators will develop a 4-module online HIV stigma reduction training with simulated patients for nursing students in the intervention arm. This training includes three case scenarios: a male who injects drugs, a male who has sex with men, and a female sex worker, all with HIV. Interviews with people living with HIV (PLWH) and focus groups with nursing students and faculty will refine the content. The control group will receive a course on HIV epidemiology without stigma-specific content. To assess efficacy, 70 nursing students will initially have a clinical encounter with a simulated patient on a non-HIV topic. A week later, they will have an HIV visit and complete stigma and empathy scales. Participants will then be randomized into two groups: one receiving stigma training and the other, HIV epidemiology training. Afterward, they will have another HIV-related clinical encounter and complete the scales again.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2024

First Posted

July 19, 2024

Study Start

September 15, 2024

Primary Completion

September 15, 2025

Study Completion

December 1, 2025

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations