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HIV/STI TestingNCT03107910

Stigma and Online Counseling to Increase HIV/STI Testing

A study testing Stigma and Structural Interventions and Health Information Seeking in people with HIV/STI Testing, run by University of Connecticut at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
HIV/STI Testing
What is being tested?
Stigma and Structural Interventions and Health Information Seeking
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteUnited States
Study dates
Dec 2016to Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

United States1 site
  • SHARE Project

    Atlanta, Georgia, 30308

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
HIV/STI Testing
Being tested
Stigma and Structural Interventions, Health Information Seeking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stigma and Structural InterventionsBehavioural

    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 SeekingBehavioural

    Seeking and evaluating online health information will be assessed.

Study groups in NCT03107910
Study groupRoleWhat they receive
Experimental Stigma CounselingOtherSingle session, stigma focused, anticipated HIV stigma counseling will be provided. Intervention will include a focus on barriers to testing.
Receives: Behavioral: Stigma and Structural Interventions; Behavioral: Health Information Seeking
Control Health InformationOtherSingle session, online health information seeking and evaluation. HIV/STI testing appointments are provided online. Stigma and Structural Interventions
Receives: Behavioral: Stigma and Structural Interventions; Behavioral: Health Information Seeking

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HIV/STI testing uptake

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2017
  2. Study startDec 2016
  3. Primary completionDec 2020
  4. Study completionMar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Investigator
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03107910
Sponsor's protocol ID
H16-087
Other IDs
R01MH109409
Status last verified
Mar 2021
First submitted
5 Apr 2017
Last updated
30 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared with other researchers.

Publications

  • 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.

    PubMed 37898978

Questions about this trial

What is this clinical trial studying?

A study testing Stigma and Structural Interventions and Health Information Seeking in people with HIV/STI Testing, run by University of Connecticut at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV/STI testing uptake (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03107910, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.

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