ID & Testing in Male Partners
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ClinicalTrials.gov Identifier: NCT01033812 |
Recruitment Status
:
Completed
First Posted
: December 17, 2009
Last Update Posted
: February 28, 2017
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Condition or disease |
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HIV |
Study Type : | Observational |
Actual Enrollment : | 177 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | A Pilot Study to Identify and Describe the Male Sexual Partners of Adolescent and Young Adult Women Enrolled in ATN 067 |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | July 2011 |
Actual Study Completion Date : | July 2011 |

Group/Cohort |
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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.
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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.
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- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria for 084 Index Recruiters:
- 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.
Exclusion Criteria for 084 Index Recruiters:
- 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.
Inclusion Criteria for Male Sexual Partners:
- Is born male;
- 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.
Exclusion Criteria for Male Sexual Partners:
- 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;
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033812
United States, Florida | |
University of Miami School of Medicine | |
Miami, Florida, United States, 33101 | |
United States, Illinois | |
Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital | |
Chicago, Illinois, United States, 60612 | |
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10467 |
Study Chair: | Lisa Hightow-Weidman, M.D., MPH | Adolescent Trials Network | |
Study Chair: | Cherrie Boyer, Ph.D. | Adolescent Trials Network |
Additional Information:
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT01033812 History of Changes |
Other Study ID Numbers: |
ATN 084 |
First Posted: | December 17, 2009 Key Record Dates |
Last Update Posted: | February 28, 2017 |
Last Verified: | March 2016 |
Keywords provided by University of North Carolina, Chapel Hill:
Networks Index recruiter |