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Stigma and Online Counseling to Increase HIV/STI Testing

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ClinicalTrials.gov Identifier: NCT03107910
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Lisa Eaton, University of Connecticut

Brief Summary:
The alarmingly high rates of HIV/STI (sexually transmitted infections) observed among Black men who have sex with men (BMSM) necessitate a new model for engaging BMSM. New approaches include addressing stigma related concerns and structural barriers in order to increase HIV/STI testing uptake. This research includes a 2 x 2 factorial design to test an intervention that is aimed at increasing HIV/STI testing uptake among BMSM; this design includes testing HIV/STI stigma focused counseling, and online HIV/STI test counseling with at-home, self-administered HIV and STI test kits.

Condition or disease Intervention/treatment Phase
HIV/STI Testing Behavioral: Stigma and Structural Interventions Behavioral: Health Information Seeking Not Applicable

Detailed Description:
This research is aimed at conducting structural and stigma-focused interventions to increase HIV and STI testing uptake among Black men who have sex with men (BMSM). The research is focused on this population due to the alarmingly high rates of HIV/STI (sexually transmitted infections) among BMSM- this group has experienced elevated rates of HIV incidence and prevalence since the beginning of the US epidemic, and current estimates demonstrate that although BMSM make up only 0.2% of the population they make up 22% of new HIV infections. The investigator have documented a 5.1% annual HIV incidence and a 35% HIV prevalence among BMSM. Health care models are failing to engage BMSM at all points of the HIV care continuum including the seek and test components. The CDC recommends that individuals at substantial risk for HIV be tested for HIV/STI every three to six months; however, this goal is not being achieved and, therefore, a new approach to engaging BMSM is needed. To address these shortcomings and based on preliminary studies, the investigators are conducting a 2 x 2 factorial design study to evaluate a model that is aimed at increasing HIV/STI testing uptake among BMSM. The investigators will test a stigma-focused intervention as stigma is a known deterrent to HIV/STI testing, yet little has been done to address this factor; and, the investigators will evaluate HIV/STI test counseling delivered online (in conjunction with at-home HIV/STI test kits) as this delivery of testing may remove key barriers to reaching BMSM in need of HIV/STI related care services. Specific Aim 1: Assess HIV/STI testing uptake at scheduled HIV/STI test counseling appointments during the 12 month follow-up period. 500 BMSM will be randomly assigned to one of four conditions: (a) receive CDC-based risk reduction counseling and scheduled for in-office HIV/STI test counseling appointments, (b) receive HIV stigma-enhanced intervention and scheduled for in-office HIV/STI test counseling appointments, (c) receive CDC-based risk reduction counseling and scheduled for online, via video calling, HIV/STI test counseling appointments, or (d) receive HIV stigma-enhanced intervention and scheduled for online, via video calling, HIV/STI test counseling appointments. Specific Aim 2: Evaluate mediating (key theoretical stigma variables) factors collected via assessments at 3, 6, and 12 month follow-ups. Specific Aim 3: Conduct an economic evaluation to determine the costs of the office-based and online-based HIV/STI test delivery formats from both a community-based payer perspective and a comprehensive societal perspective that includes all costs. This project has the potential to exert a sustained and powerful impact not only on approaches to engaging BMSM, but to improving HIV/STI testing uptake which will likely improve multiple health outcomes among BMSM. If effective, this approach to improving HIV/STI testing uptake would be available for dissemination immediately and would fit within resource limited settings such as community based organizations and health departments.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This project is 2 x 2 factorial approach designed to test an intervention that is aimed at increasing HIV/STI testing uptake among BMSM; this approach includes testing HIV/STI stigma focused counseling, and online HIV/STI test counseling with at-home, self-administered HIV and STI test kits.
Masking: Double (Participant, Investigator)
Masking Description: Participants and investigator are masked to study intervention assignment. Participants are informed that they are randomly assigned to conditions.
Primary Purpose: Screening
Official Title: Novel Stigma/Structural Interventions for HIV/STI Testing
Actual Study Start Date : December 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental Stigma Counseling
Single session, stigma focused, anticipated HIV stigma counseling will be provided. Intervention will include a focus on barriers to testing.
Behavioral: Stigma and Structural Interventions
Stigma focused counseling to address HIV anticipated stigma and online video chatting for HIV/STI testing will be assessed. Stigma and Structural Interventions

Behavioral: Health Information Seeking
Seeking and evaluating online health information will be assessed.

Control Health Information
Single session, online health information seeking and evaluation. HIV/STI testing appointments are provided online. Stigma and Structural Interventions
Behavioral: Stigma and Structural Interventions
Stigma focused counseling to address HIV anticipated stigma and online video chatting for HIV/STI testing will be assessed. Stigma and Structural Interventions

Behavioral: Health Information Seeking
Seeking and evaluating online health information will be assessed.




Primary Outcome Measures :
  1. HIV/STI testing uptake [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Biological males, transgender women
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men who have sex with men
  • Transgender women who have sex with men
  • 18 years of age and older
  • Reside in Atlanta metro area.
  • Other criteria may apply

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107910


Contacts
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Contact: Moira Kalichman, MSW 860-486-8702 moira.kalichman@uconn.edu
Contact: Lisa Eaton, PhD 860-486-6024 lisa.eaton@uconn.edu

Locations
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United States, Georgia
SHARE Project Recruiting
Atlanta, Georgia, United States, 30308
Contact: Moira Kalichman    860-486-8702    moira.kalichman@uconn.edu   
Sponsors and Collaborators
University of Connecticut
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Lisa Eaton, PhD SHARE Project

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Responsible Party: Lisa Eaton, Associate Professor, University of Connecticut
ClinicalTrials.gov Identifier: NCT03107910     History of Changes
Other Study ID Numbers: H16-087
R01MH109409 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No