HIV InfectionsNCT04563715
HIV Prevention Among At-risk Latinos in the Heartland
A study testing HIV counseling and testing and Network intervention in people with HIV Infections, run by Medical College of Wisconsin at 3 sites in United States.
Trial summary
This study is a randomized controlled trial that evaluates the efficacy of a network intervention to promote regular HIV testing and prevention (risk reduction and PrEP awareness and referrals) among friendship networks of Latino men who have sex with men and transwomen (LMSMT) in three mid sized Midwestern cities. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- HIV counseling and testing and Network intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Nov 2020to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Latinx men who have sex with men or transgender women 18 or more years of age.
- Lives in the Milwaukee, Cleveland or Indianapolis area.
- Can provide informed consent.
- Additional inclusion criteria for networks: 80% or more of the network is of Latinx descent.
Who cannot join
- Cis-gender female.
- Did not have sex with men or identify as homosexual or bisexual.
- Cannot provide consent.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
AIDS Taskforce of Greater Cleveland
Cleveland, Ohio, 44115
Shalom Health Care Center
Indianapolis, Indiana, 46222
Sixteenth Street Community Health Centers
Milwaukee, Wisconsin, 54204
About this study
Official title: Regular HIV Testing and HIV Prevention Among At-Risk Latino Men in the Heartland
This study is a randomized controlled trial that evaluates the efficacy of a network intervention to promote regular HIV testing and prevention (risk reduction and PrEP awareness and referrals) among friendship networks of Latino men who have sex with men and transwomen (LMSMT) in three mid sized Midwestern cities.
Read the detailed description
To benefit from early HIV diagnosis, the CDC suggests that groups at higher HIV risk get tested regularly. The study will evaluate the efficacy of an intervention to promote regular HIV testing and prevention (risk reduction and PrEP awareness and referrals) among friendship networks of Latino men who have sex with men and transwomen (LMSMT) in three midsized Midwestern cities. The intervention uses the relationships that permeate networks of LMSMT by training well-positioned members to encourage a collective response to the epidemic and to disseminate HIV testing and prevention messages and resources within the network. Thus, we will (a) recruit 36 friendship networks of LMSMT in Milwaukee, Cleveland, and Indianapolis (N ≈ 432); (b) test them for HIV and recommend that they test regularly; (c) invite key members of 18 randomly selected networks to a 4-session training to promote regular HIV testing and prevention in their networks; (d) conduct chart reviews to verify regular testing and PrEP visits and assess regular testing, PrEP visits, and risk behavior and mediators at 6, 12 and 18-month follow up.
- Conditions
- HIV Infections
- Being tested
- HIV counseling and testing, Network intervention
- Keywords
- HIV, Latinos, Networks, Men who have sex with men, Transgender, USA Midwest
- Medical subject headings
- HIV Infections, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV counseling and testingDiagnostic test
Receive HIV testing risk assessment and advice about risk reduction and future testing.
Network interventionBehavioural
Key individuals are trained to provide advice about regular testing and risk reduction.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | HIV counseling and testing Receives: Diagnostic Test: HIV counseling and testing |
| Standard of Care plus Network Intervention | Experimental | Network intervention Receives: Diagnostic Test: HIV counseling and testing; Behavioral: Network intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percentage of participants who report having tested for HIV twice in the past 12 months.
Participants will complete surveys assessing HIV testing behavior.
Measured: Past 12 months
Mean percentage of PrEP-eligible participants who report having consulted with a provider about PrEP.
Participants will complete surveys in which they will report whether they consulted with a provider about PrEP.
Measured: Past 6 months
Mean percentage of participants who report having had unprotected sex with a casual partner.
Participants will complete surveys in which they will report whether they had unprotected sex with a casual partner.
Measured: Past 6 months
Mean percentage of participants who report having tested for HIV in the past 6 months.
Participants will complete surveys assessing HIV testing behavior.
Measured: Past 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start16 Nov 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Laura R. Glasman, Medical College of Wisconsin
- Investigators
- Laura R Glasman, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563715
- Sponsor's protocol ID
- 32961
- Other IDs
- R01MH116787
- Status last verified
- Nov 2021
- First submitted
- 21 Sep 2020
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regular HIV Testing and HIV Prevention Among At-Risk Latino Men in the Heartland
- ClinicalTrials.gov ID
- NCT04563715
- Acronym / sponsor ID
- 32961
- Conditions
- HIV Infections
- Keywords
- HIV, Latinos, Networks, Men who have sex with men, Transgender, USA Midwest
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Sep 2020 (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.
This study is a randomized controlled trial that evaluates the efficacy of a network intervention to promote regular HIV testing and prevention (risk reduction and PrEP awareness and referrals) among friendship networks of Latino men who have sex with men and transwomen (LMSMT) in three mid sized Midwestern cities.
Detailed description
To benefit from early HIV diagnosis, the CDC suggests that groups at higher HIV risk get tested regularly. The study will evaluate the efficacy of an intervention to promote regular HIV testing and prevention (risk reduction and PrEP awareness and referrals) among friendship networks of Latino men who have sex with men and transwomen (LMSMT) in three midsized Midwestern cities. The intervention uses the relationships that permeate networks of LMSMT by training well-positioned members to encourage a collective response to the epidemic and to disseminate HIV testing and prevention messages and resources within the network. Thus, we will (a) recruit 36 friendship networks of LMSMT in Milwaukee, Cleveland, and Indianapolis (N ≈ 432); (b) test them for HIV and recommend that they test regularly; (c) invite key members of 18 randomly selected networks to a 4-session training to promote regular HIV testing and prevention in their networks; (d) conduct chart reviews to verify regular testing and PrEP visits and assess regular testing, PrEP visits, and risk behavior and mediators at 6, 12 and 18-month follow up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Diagnostic Test: HIV counseling and testingHIV counseling and testing |
| Standard of Care plus Network Intervention | Experimental | Diagnostic Test: HIV counseling and testing, Behavioral: Network interventionNetwork intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Latinx men who have sex with men or transgender women 18 or more years of age.
- Lives in the Milwaukee, Cleveland or Indianapolis area.
- Can provide informed consent.
- Additional inclusion criteria for networks: 80% or more of the network is of Latinx descent.
Key exclusion criteria (3 listed)
- Cis-gender female.
- Did not have sex with men or identify as homosexual or bisexual.
- Cannot provide consent.
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 |
|---|---|---|
| HIV counseling and testingReceive HIV testing risk assessment and advice about risk reduction and future testing. | Diagnostic test | Standard of Care, Standard of Care plus Network Intervention |
| Network interventionKey individuals are trained to provide advice about regular testing and risk reduction. | Behavioural | Standard of Care plus Network Intervention |
Primary outcome
Mean percentage of participants who report having tested for HIV twice in the past 12 months.
Time frame: Past 12 months
Participants will complete surveys assessing HIV testing behavior.
Mean percentage of PrEP-eligible participants who report having consulted with a provider about PrEP.
Time frame: Past 6 months
Participants will complete surveys in which they will report whether they consulted with a provider about PrEP.
Mean percentage of participants who report having had unprotected sex with a casual partner.
Time frame: Past 6 months
Participants will complete surveys in which they will report whether they had unprotected sex with a casual partner.
Mean percentage of participants who report having tested for HIV in the past 6 months.
Time frame: Past 6 months
Participants will complete surveys assessing HIV testing behavior.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Laura R Glasman principal investigator
Medical College of Wisconsin
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV counseling and testing and Network intervention in people with HIV Infections, run by Medical College of Wisconsin at 3 sites 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 4 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Mean percentage of participants who report having tested for HIV twice in the past 12 months. (time frame: Past 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2021.