ID & Testing in Male Partners

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01033812
First received: December 16, 2009
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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.


Condition
HIV

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 177
Study Start Date: May 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033812

Locations
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
Sponsors and Collaborators
Investigators
Study Chair: Lisa Hightow-Weidman, M.D., MPH Adolescent Trials Network
Study Chair: Cherrie Boyer, Ph.D. Adolescent Trials Network
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01033812     History of Changes
Other Study ID Numbers: ATN 084
Study First Received: December 16, 2009
Last Updated: May 8, 2014
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Networks
Index recruiter

ClinicalTrials.gov processed this record on July 10, 2014