Stigma and Online Counseling to Increase HIV/STI Testing

NCT ID: NCT03107910

Last Updated: 2021-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2021-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV/STI Testing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators
Participants and investigator are masked to study intervention assignment. Participants are informed that they are randomly assigned to conditions.

Study Groups

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Experimental Stigma Counseling

Single session, stigma focused, anticipated HIV stigma counseling will be provided. Intervention will include a focus on barriers to testing.

Group Type OTHER

Stigma and Structural Interventions

Intervention Type BEHAVIORAL

Stigma focused counseling to address HIV anticipated stigma and online video chatting for HIV/STI testing will be assessed. Stigma and Structural Interventions

Health Information Seeking

Intervention Type BEHAVIORAL

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

Group Type OTHER

Stigma and Structural Interventions

Intervention Type BEHAVIORAL

Stigma focused counseling to address HIV anticipated stigma and online video chatting for HIV/STI testing will be assessed. Stigma and Structural Interventions

Health Information Seeking

Intervention Type BEHAVIORAL

Seeking and evaluating online health information will be assessed.

Interventions

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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

Intervention Type BEHAVIORAL

Health Information Seeking

Seeking and evaluating online health information will be assessed.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Connecticut

OTHER

Sponsor Role lead

Responsible Party

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Lisa Eaton

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa Eaton, PhD

Role: PRINCIPAL_INVESTIGATOR

SHARE Project

Locations

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SHARE Project

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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Eaton LA, Huedo-Medina T, Earnshaw VA, Kalichman M, Watson RJ, Driver R, Chandler CJ, Kalinowski J, Kalichman SC. Randomized Clinical Trial of Stigma Counseling and HIV Testing Access Interventions to Increase HIV Testing Among Black Sexual Minority Men and Transwomen. Prev Sci. 2024 May;25(4):650-660. doi: 10.1007/s11121-023-01603-4. Epub 2023 Oct 29.

Reference Type DERIVED
PMID: 37898978 (View on PubMed)

Other Identifiers

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R01MH109409

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H16-087

Identifier Type: -

Identifier Source: org_study_id

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