ID & Testing in Male Partners

University of North Carolina (UNC)

Status: Completed

Conditions: HIV

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01033812

ATN 084

Details and patient eligibility

About

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.

Enrollment: 177 patients

Sex: All

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

177 participants in 2 patient groups

Index Recruiter

Description:

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

Description:

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.