ID & Testing in Male Partners

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01033812
• Other study ID #: ATN 084
• Status: Completed
• Start date: May 2010
• Est. completion date: July 2011

Study information

• Verified date: March 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital	Chicago	Illinois
United States	University of Miami School of Medicine	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 months
Primary	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.		2 months
Secondary	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.		2 months
Secondary	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.		2 months

External Links

•   ATN Website