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

December 16, 2009
May 8, 2014
May 2010
July 2011   (final data collection date for 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 ] [ 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 ]
  • Feasibility and acceptability of identifying and recruiting the male sexual partners of African American and Hispanic/Latina females aged 13 or older (either index recruiters in ATN 067 or their HIV positive female friendship network members) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Conduct HIV screening among 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: 4 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01033812 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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: 12 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: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
ID & Testing in Male Partners
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

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.

HIV
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
177
July 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01033812
ATN 084
Yes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
Study Chair: Lisa Hightow-Weidman, M.D., MPH Adolescent Trials Network
Study Chair: Cherrie Boyer, Ph.D. Adolescent Trials Network
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP