Human Immunodeficiency Virus (HIV)NCT02454725
Regular HIV Testing Among At-Risk Latino Men
A study testing Social Network and Comparison in people with Human Immunodeficiency Virus (HIV), run by Medical College of Wisconsin.
Trial summary
Early HIV diagnosis followed by linkage to treatment soon after HIV infection can reduce mortality and prevent new HIV infections. To obtain the full benefit of early HIV diagnosis, the US Centers for Disease Control and Prevention suggest that high risk groups get tested for HIV regularly, every three to six months. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Human Immunodeficiency Virus (HIV)
- What is being tested?
- Social Network and Comparison
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to 1 Jun 2018
- 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
- self-report as a Latino man who has sex with men (LMSM);
- living in the Milwaukee area;
- willing and able to provide consent for participation;
- Additional Inclusion Criteria for Social Network Seeds:
- more than 70% of social network members are LMSM
- more than 50% of LMSM social network members are at risk for HIV
Who cannot join
- Female
- 17 years of age or younger
- Unable to provide consent
About this study
Early HIV diagnosis followed by linkage to treatment soon after HIV infection can reduce mortality and prevent new HIV infections. To obtain the full benefit of early HIV diagnosis, the US Centers for Disease Control and Prevention suggest that high risk groups get tested for HIV regularly, every three to six months. This study will examine the feasibility of a strategy to promote regular HIV testing and HIV risk reduction among Latino men at risk for HIV which, if successful, will help to identify Latino men unaware of their HIV status, benefitting them and the society.
Read the detailed description
In the US, the HIV epidemic largely affects clusters of interconnected persons with high HIV prevalence and undiagnosed HIV infections that must be reached to reduce incidence. Latino men who have sex with men (LMSM) are overrepresented in these clusters. Following African Americans, LMSM have the highest HIV incidence rate and are the next most likely to be unaware of their HIV infection. Between 2005 and 2008, nearly one-quarter of the HIV positive LMSM were unaware of the infection.
High HIV prevalence in LMSM networks and lack of strategies to promote regular HIV testing may explain why many LMSM are not benefiting from early diagnosis. Many LMSM face social and legal challenges that hinder their access to healthcare services and outreach. They often have little understanding of HIV treatments, experience discrimination, and hold mistaken assumptions about HIV risk, including beliefs that motivate them to seek sexual partners within their high prevalence in-group as a form of preventing infection.
A social network approach can address the demands of engaging LMSM in regular HIV screening and reduce their collective risk. LMSM often rely on other LMSM who are sources of advice and referrals and who partially shield them from the double jeopardy of being a sexual and ethnic minority. Network interventions can capitalize on these relationships to promote access to resources and foster norms that reward regular testing and encourage collective safety. This project uses social networks to promote regular HIV testing and risk reduction among LMSM. Rather than delivering risk reduction messages and opportunities for HIV testing, the intervention will penetrate networks of LMSM through well positioned members. Unlike strategies that target personal networks or social groups within venues, the intervention will recruit three-ring networks of interconnected LMSM and isolate their ties. Three recruitment rings will help to find less visible LMSM; and isolating their ties will identify who can reach them. In addition to informing and motivating their peers to reduce risk, key network members will be trained to be links to prevention resources, deliver tailored prompts to HIV testing, and support peers' testing behaviors to encourage repetition.
- Conditions
- Human Immunodeficiency Virus (HIV)
- Being tested
- Social Network, Comparison
- Keywords
- HIV Testing, Latino
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social NetworkBehavioural
Leaders of social networks will undergo small group training to develop skills to convey information effectively and deliver messages endorsing regular HIV testing to members of their social networks.
ComparisonBehavioural
Also called HIV Counseling and Testing
All participants will receive HIV counseling and rapid testing following the Wisconsin Department of Health guidelines. Sexually active men who receive a negative test result will be told that they should be HIV-tested every three to six months, unless they have a monogamous HIV negative partner
| Study group | Role | What they receive |
|---|---|---|
| Social Network | Experimental | Leaders of social networks will communicate messages endorsing regular HIV testing to network members. Receives: Behavioral: Social Network; Behavioral: Comparison |
| Comparison | Active comparator | HIV counseling and testing Receives: Behavioral: Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of HIV testing
Maximum number of months between two HIV tests
Measured: Twelve months post intervention
Secondary outcomes (3)
Frequency of HIV testing
Whether the participant received an HIV test every < six months during the 12-month period following study intake
Measured: Twelve months post intervention
HIV risk behaviors: Number of unprotected anal intercourse occasions with a non-monogamous partner
Number of unprotected anal intercourse occasions with a non-monogamous partner
Measured: Twelve months post intervention
HIV risk behaviors: Number of sexual partners
Number of sexual partners
Measured: Twelve months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startJun 2015
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Laura R. Glasman, Ph.D., Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454725
- Sponsor's protocol ID
- PRO00020837
- Other IDs
- R34MH100947
- Status last verified
- Jan 2019
- First submitted
- 20 Apr 2015
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regular HIV Testing Among At-Risk Latino Men
- ClinicalTrials.gov ID
- NCT02454725
- Acronym / sponsor ID
- PRO00020837
- Conditions
- Human Immunodeficiency Virus (HIV)
- Keywords
- HIV Testing, Latino
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2015
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 27 May 2015 (estimated)
- 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.
Early HIV diagnosis followed by linkage to treatment soon after HIV infection can reduce mortality and prevent new HIV infections. To obtain the full benefit of early HIV diagnosis, the US Centers for Disease Control and Prevention suggest that high risk groups get tested for HIV regularly, every three to six months. This study will examine the feasibility of a strategy to promote regular HIV testing and HIV risk reduction among Latino men at risk for HIV which, if successful, will help to identify Latino men unaware of their HIV status, benefitting them and the society.
Detailed description
In the US, the HIV epidemic largely affects clusters of interconnected persons with high HIV prevalence and undiagnosed HIV infections that must be reached to reduce incidence. Latino men who have sex with men (LMSM) are overrepresented in these clusters. Following African Americans, LMSM have the highest HIV incidence rate and are the next most likely to be unaware of their HIV infection. Between 2005 and 2008, nearly one-quarter of the HIV positive LMSM were unaware of the infection.
High HIV prevalence in LMSM networks and lack of strategies to promote regular HIV testing may explain why many LMSM are not benefiting from early diagnosis. Many LMSM face social and legal challenges that hinder their access to healthcare services and outreach. They often have little understanding of HIV treatments, experience discrimination, and hold mistaken assumptions about HIV risk, including beliefs that motivate them to seek sexual partners within their high prevalence in-group as a form of preventing infection.
A social network approach can address the demands of engaging LMSM in regular HIV screening and reduce their collective risk. LMSM often rely on other LMSM who are sources of advice and referrals and who partially shield them from the double jeopardy of being a sexual and ethnic minority. Network interventions can capitalize on these relationships to promote access to resources and foster norms that reward regular testing and encourage collective safety. This project uses social networks to promote regular HIV testing and risk reduction among LMSM. Rather than delivering risk reduction messages and opportunities for HIV testing, the intervention will penetrate networks of LMSM through well positioned members. Unlike strategies that target personal networks or social groups within venues, the intervention will recruit three-ring networks of interconnected LMSM and isolate their ties. Three recruitment rings will help to find less visible LMSM; and isolating their ties will identify who can reach them. In addition to informing and motivating their peers to reduce risk, key network members will be trained to be links to prevention resources, deliver tailored prompts to HIV testing, and support peers' testing behaviors to encourage repetition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Network | Experimental | Behavioral: Social Network, Behavioral: ComparisonLeaders of social networks will communicate messages endorsing regular HIV testing to network members. |
| Comparison | Active comparator | Behavioral: ComparisonHIV counseling and testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- self-report as a Latino man who has sex with men (LMSM);
- living in the Milwaukee area;
- willing and able to provide consent for participation;
- more than 70% of social network members are LMSM
- more than 50% of LMSM social network members are at risk for HIV
Key exclusion criteria (3 listed)
- Female
- 17 years of age or younger
- Unable to 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 |
|---|---|---|
| Social NetworkLeaders of social networks will undergo small group training to develop skills to convey information effectively and deliver messages endorsing regular HIV testing to members of their social networks. | Behavioural | Social Network |
| ComparisonAlso: HIV Counseling and TestingAll participants will receive HIV counseling and rapid testing following the Wisconsin Department of Health guidelines. Sexually active men who receive a negative test result will be told that they should be HIV-tested every three to six months, unless they have a monogamous HIV negative partner | Behavioural | Comparison, Social Network |
Primary outcome
Frequency of HIV testing
Time frame: Twelve months post intervention
Maximum number of months between two HIV tests
3 secondary outcomes
Frequency of HIV testing
Time frame: Twelve months post intervention
HIV risk behaviors: Number of unprotected anal intercourse occasions with a non-monogamous partner
Time frame: Twelve months post intervention
HIV risk behaviors: Number of sexual partners
Time frame: Twelve months post intervention
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 4 Feb 2019.
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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.
Laura R. Glasman, Ph.D. principal investigator
Medical College of Wisconsin
Questions about this trial
What is this clinical trial studying?
A study testing Social Network and Comparison in people with Human Immunodeficiency Virus (HIV), run by Medical College of Wisconsin.
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 6 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: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Frequency of HIV testing (time frame: Twelve months post intervention). 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 4 Feb 2019; AzTrials last refreshed its copy on 31 Oct 2026.