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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| Experimental Stigma Counseling | Other | Single 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 Information | Other | Single 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.
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.
- First posted11 Apr 2017
- Study startDec 2016
- Primary completionDec 2020
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/STI TestingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Lisa Eaton, University of Connecticut
- Investigators
- Lisa Eaton, PhD, Principal investigator, SHARE Project
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Stigma/Structural Interventions for HIV/STI Testing
- ClinicalTrials.gov ID
- NCT03107910
- Acronym / sponsor ID
- H16-087
- Conditions
- HIV/STI Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Stigma Counseling | Other | Behavioral: Stigma and Structural Interventions, Behavioral: Health Information SeekingSingle session, stigma focused, anticipated HIV stigma counseling will be provided. Intervention will include a focus on barriers to testing. |
| Control Health Information | Other | Behavioral: Stigma and Structural Interventions, Behavioral: Health Information SeekingSingle session, online health information seeking and evaluation. HIV/STI testing appointments are provided online. Stigma and Structural Interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stigma and Structural InterventionsStigma focused counseling to address HIV anticipated stigma and online video chatting for HIV/STI testing will be assessed. Stigma and Structural Interventions | Behavioural | Control Health Information, Experimental Stigma Counseling |
| Health Information SeekingSeeking and evaluating online health information will be assessed. | Behavioural | Control Health Information, Experimental Stigma Counseling |
Primary outcome
HIV/STI testing uptake
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Derived from this study: PubMed 37898978Eaton 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
Related trials for HIV/STI Testing
Active, not recruiting
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Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study
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Not yet recruiting
Testing a Multi-Level Approach to Reduce Stigma for Women Living With HIV
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Eaton, PhD principal investigator
SHARE Project
1 site in 1 country: see every site and its status.
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.