HIVNCT01033812

ID & Testing in Male Partners

An observational study of HIV, run by University of North Carolina, Chapel Hill at 3 sites 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

Who is it for?: Ages 18 to 24 yearsHealthy volunteers can take part
Conditions the study is for: HIV
Type of treatment: Pill or oral medicine
How many people: 177 participants
Where: 3 sitesUnited States
Study dates: May 2010to Jul 2011
Phase: Observational
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 to 24 years
All sexes
Healthy volunteers accepted
Adult

Study population: This study will include index recruiters and their male sexual partners. The index recruiters will be comprised of young women who served as index recruiters in ATN 067 and members of their female friendship network members who tested HIV positive based on HIV screening and a confirmatory test result that was conducted in ATN 067. All study participants will be 18 years of age or older.

Who may be able to join

1) Completed participation or is currently enrolled as an index recruiter in ATN 067 or 2) Is a female friendship network member enrolled in ATN 067 who is diagnosed as being HIV infected during her participation in the ATN 067 study;
Aged 18 years or older at the time of consent;
Willing to recruit at least one, but no more than six past or current male sexual partners who are willing to discuss and consider HIV screening. A male sexual partner includes individuals with whom the index recruiter has engaged in at least one episode of oral, vaginal or anal sex in the course of their lifetime;
Able to understand written and spoken English; and
Willing to provide written informed consent/assent.
Is born male;

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Aged 18 years or older at the time of consent;
Identified as a male sexual partner of an index recruiter enrolled in ATN 067 (having had vaginal and/or anal sexual intercourse in the past);
Willing to complete a sociodemographic and behavioral risk assessment survey;
Willing to discuss and consider HIV screening;
Able to understand written and spoken English; and
Willing to provide written informed consent/assent.

Who cannot join

Self-report of pregnancy at enrollment (pregnancy testing is not required);
Untreated psychiatric disorder associated with a thought disorder, hallucinations or acute substance use withdrawal. Stabilized patients receiving appropriate psychiatric care will not be excluded if informed consent can be reasonably assumed;
Visibly distraught and/or visibly emotionally unstable (e.g., depressive mood or exhibiting manic, suicidal, or violent behavior);
Active drug or alcohol use or dependence that, in the opinion of the site personnel, would interfere with ability to give true informed consent and adhere to the study requirements or;
Acute illness that, in the opinion of the treating clinician, would interfere with the participant's ability to adhere to the protocol requirements and/or interfere with the protocol objectives.
Untreated psychiatric disorder associated with a thought disorder, hallucinations, and/or acute substance use withdrawal. Stabilized patients receiving appropriate psychiatric care will not be excluded if informed consent can be reasonably assumed;

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Visibly distraught and/or visibly emotionally unstable (e.g., depressive mood or exhibiting manic, suicidal, or violent behavior);
Active drug or alcohol use or dependence that, in the opinion of the site personnel, would interfere with ability to give true informed consent and adhere to the study requirements or;
Acute illness that, in the opinion of the treating clinician, would interfere with the participant's ability to adhere to the protocol requirements and/or interfere with the protocol objectives.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
Chicago, Illinois, 60612
University of Miami School of Medicine
Miami, Florida, 33101
Montefiore Medical Center
The Bronx, New York, 10467

Other trials in United States

About this study

Official title: A Pilot Study to Identify and Describe the Male Sexual Partners of Adolescent and Young Adult Women Enrolled in ATN 067

This pilot study is a sub-study of ATN 067. ATN 067 utilizes a cross-sectional research design to recruit Latina and African American young women to undergo HIV screening. The primary goal of this proposed pilot study, ATN 084, is to explore the feasibility and acceptability of index female recruiters identifying and recruiting their past and present male sexual partners to undergo HIV screening and complete a one-time ACASI interview. In addition, the study will also include female friendship network members who were enrolled in ATN 067 and were diagnosed with HIV. These young women will also be asked to recruit their past and present male sex partners to undergo HIV screening.

Conditions: HIV
Keywords: Networks, Index recruiter

What participants receive

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

Study groups in NCT01033812
Study group	Role	What they receive
Index Recruiter		Young African American or Latina women who served as index recruiters in ATN 067 and members of their female friendship network members who tested HIV positive based on HIV screening and a confirmatory test result that was conducted in ATN 067.
Male Sexual Partners		Any male partner who engaged in at least one episode of oral, vaginal or anal sex during the course of their lifetime with an 084 index recruiter.

What is being measured

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

To examine the feasibility of identifying/recruiting the male sex partners of African American and Latina sexually experienced females aged 18 or older who were either index recruiters in ATN 067 or their HIV-infected female friendship network members.
Measured: 2 months
To conduct HIV screening among the male sexual partners of the ATN 084 female index recruiters and examine factors that facilitate and hinder these individuals in undergoing HIV screening.
Measured: 2 months

Secondary outcomes (2)

To compare sociodemographic characteristics, risk behaviors, psychosocial variables and self-reported sex partners of the male sexual partners of the ATN 084 female index recruiters.
Measured: 2 months
To describe sexual mixing patterns (assortative/dissortative), bridging and concurrency among the ATN 084 index recruiters and their male sexual partners by age race/ethnicity and HIV status.
Measured: 2 months

Timeline

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

May 2010Jul 2011

First posted17 Dec 2009 (estimated)
Study startMay 2010
Primary completionJul 2011
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIVStudies 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: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 177 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01033812
Sponsor's protocol ID: ATN 084
Status last verified: Mar 2016
First submitted: 16 Dec 2009
Last updated: 12 Apr 2023
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Body Fluids in People Living With and Without HIV
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Active, not recruitingPhase 2
Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity
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Analysis of HIV-1 Replication During Antiretroviral Therapy
HIV
RecruitingObservational study
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
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Active, not recruitingPhase 2
Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia
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All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study to Identify and Describe the Male Sexual Partners of Adolescent and Young Adult Women Enrolled in ATN 067
ClinicalTrials.gov ID: NCT01033812
Acronym / sponsor ID: ATN 084
Conditions: HIV
Keywords: Networks, Index recruiter
Study type: Observational
Recruitment status: Completed
Enrolment: 177 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
Study start: May 2010
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 17 Dec 2009 (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.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Index Recruiter	–	–Young African American or Latina women who served as index recruiters in ATN 067 and members of their female friendship network members who tested HIV positive based on HIV screening and a confirmatory test result that was conducted in ATN 067.
Male Sexual Partners	–	–Any male partner who engaged in at least one episode of oral, vaginal or anal sex during the course of their lifetime with an 084 index recruiter.

Who may qualify

Ages: 18 to 24 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
Study population: This study will include index recruiters and their male sexual partners. The index recruiters will be comprised of young women who served as index recruiters in ATN 067 and members of their female friendship network members who tested HIV positive based on HIV screening and a confirmatory test result that was conducted in ATN 067. All study participants will be 18 years of age or older.

Key inclusion criteria (12 listed)

1) Completed participation or is currently enrolled as an index recruiter in ATN 067 or 2) Is a female friendship network member enrolled in ATN 067 who is diagnosed as being HIV infected during her participation in the ATN 067 study;
Aged 18 years or older at the time of consent;
Willing to recruit at least one, but no more than six past or current male sexual partners who are willing to discuss and consider HIV screening. A male sexual partner includes individuals with whom the index recruiter has engaged in at least one episode of oral, vaginal or anal sex in the course of their lifetime;
Able to understand written and spoken English; and
Willing to provide written informed consent/assent.

Key exclusion criteria (9 listed)

Self-report of pregnancy at enrollment (pregnancy testing is not required);
Untreated psychiatric disorder associated with a thought disorder, hallucinations or acute substance use withdrawal. Stabilized patients receiving appropriate psychiatric care will not be excluded if informed consent can be reasonably assumed;
Visibly distraught and/or visibly emotionally unstable (e.g., depressive mood or exhibiting manic, suicidal, or violent behavior);
Active drug or alcohol use or dependence that, in the opinion of the site personnel, would interfere with ability to give true informed consent and adhere to the study requirements or;
Acute illness that, in the opinion of the treating clinician, would interfere with the participant's ability to adhere to the protocol requirements and/or interfere with the protocol objectives.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

To examine the feasibility of identifying/recruiting the male sex partners of African American and Latina sexually experienced females aged 18 or older who were either index recruiters in ATN 067 or their HIV-infected female friendship network members.
Time frame: 2 months
To conduct HIV screening among the male sexual partners of the ATN 084 female index recruiters and examine factors that facilitate and hinder these individuals in undergoing HIV screening.
Time frame: 2 months

2 secondary outcomes

To compare sociodemographic characteristics, risk behaviors, psychosocial variables and self-reported sex partners of the male sexual partners of the ATN 084 female index recruiters.
Time frame: 2 months
To describe sexual mixing patterns (assortative/dissortative), bridging and concurrency among the ATN 084 index recruiters and their male sexual partners by age race/ethnicity and HIV status.
Time frame: 2 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 12 Apr 2023.
ATN WebsiteLink provided by the sponsor.

Related trials for HIV

RecruitingObservational study
Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Body Fluids in People Living With and Without HIV
HIV, Immunodeficiencies
Active, not recruitingPhase 2
Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity
Lymphoproliferative Disorder, HHV-8
Enrolling by invitationObservational study
Analysis of HIV-1 Replication During Antiretroviral Therapy
HIV
RecruitingObservational study
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
HIV
Active, not recruitingPhase 2
Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia
Idiopathic CD4 T Cell Lymphocytopenia

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 Hightow-Weidman, M.D., MPH study chair

Adolescent Trials Network

Cherrie Boyer, Ph.D. study chair

Adolescent Trials Network

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV, run by University of North Carolina, Chapel Hill 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 12 inclusion and 9 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 12 Apr 2023. 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?

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?

To examine the feasibility of identifying/recruiting the male sex partners of African American and Latina sexually experienced females aged 18 or older who were either index recruiters in ATN 067 or their HIV-infected female friendship network members. (time frame: 2 months). The study lists 2 primary outcomes in all. 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 NCT01033812.

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 12 Apr 2023; AzTrials last refreshed its copy on 30 Oct 2026.