Stigma and Online Counseling to Increase HIV/STI Testing

Novel Stigma/Structural Interventions for HIV/STI Testing

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.

Study Overview

• Status: Completed
• Conditions: HIV/STI Testing
• Intervention / Treatment: Behavioral: Stigma and Structural Interventions; Behavioral: Health Information Seeking

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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • SHARE Project

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HIV/STI testing uptake	12 months

Collaborators and Investigators

• Sponsor: University of Connecticut
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Lisa Eaton, PhD, SHARE Project

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: H16-087; R01MH109409 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No