ID and Testing Via Friendship Networks

HIV Infections Clinical Trial

Official title:

A Pilot Study to Identify Undiagnosed Asymptomatic HIV Infections in Adolescent and Young Adult Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841360
• Other study ID #: ATN 067
• Status: Completed
• Phase: N/A
• First received: February 9, 2009
• Last updated: February 27, 2017
• Start date: January 2009
• Est. completion date: June 2010

Study information

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

Clinical Trial Summary

This is a pilot study with a cross-sectional research design to recruit Hispanic/Latina and African American adolescent and young adult women, aged 13-24 years to serve as index recruiters, who will in turn recruit members of her female friendship network, aged 13 years and older to undergo HIV screening. This approach seeks to identify new HIV infections in the target population.

Description:

The proposed pilot study will utilize a cross-sectional research design to recruit Hispanic/Latina and African American young women to undergo HIV screening. The research design will consist of a friendship-based, female network recruitment approach that incorporates a dual method of incentives for index recruiters and network members as a strategy for identifying new HIV infections in the target population. Among sexually experienced young women (many of whom who reside in communities with a high prevalence of STIs and HIV), 50 who self-identify as HIV positive, 50 who self-identify as HIV negative (based on receiving a negative HIV test within 12 months prior to study consent), and 50 whose HIV status is self-reported as unknown (who have no history of prior HIV testing or who had HIV screening more than 12 months prior to date of study consent) will be recruited. These women will serve as index recruiters to recruit two or more (on average four) female friendship network members to undergo HIV screening. The index recruiters will be recruited through three participating ATN sites utilizing the existing infrastructure within the AMTUs and their community and clinical partnerships. Index participants that agree to take part in this research will be asked to self-disclose their HIV status, to complete a risk assessment and indicate their willingness to recruit their close female friends to undergo HIV screening. In addition, index recruiters who self-identify as HIV negative and those who do not know their HIV status will be invited to undergo HIV screening.

Index recruiters will be given up to four months to recruit members of their friendship network. At the end of this recruitment period or after successful recruitment of two or more friendship network members, whichever comes first, all index recruiters will be asked to complete a brief questionnaire that describes factors that both facilitated and hindered their ability to recruit the friendship network members. Sexually experienced friendship network members who agree to participate in the study will also complete a risk assessment regardless of whether or not they agree to undergo HIV screening. Participation in this study will be strictly on a voluntary basis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 535
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 24 Years

Eligibility

Inclusion Criteria for INDEX RECRUITERS:

• Born female;

• Aged 13-24 years at the time of consent;

• African American or Hispanic/Latina ethnicity or mixed-race/ethnicity, which must include African American race and/or Hispanic/Latina ethnicity;

• A history of sexual intercourse with at least one male sexual partner;

• Any HIV status as follows: (1) HIV positive; (2) HIV negative defined as receiving a negative HIV test result < 12 months prior to the date of study consent); or (3) HIV status unknown defined as either no history of HIV testing or receipt of negative HIV test results more than 12 months prior to the date of study consent);

• History of vaginal and/or anal sexual intercourse with a male;

• Willing to complete a HIV risk assessment; and

• Willing to recruit two or more friendship network members to discuss and eventually undergo HIV screening;

• Ability to understand written and spoken English; and

• Willing to provide written informed consent/assent.

Inclusion Criteria for FRIENDSHIP NETWORK MEMBERS:

• Born female;

• Aged > 13 years at the time of consent;

• A history of sexual intercourse with at least one male sexual partner;

• Willing to complete an HIV risk assessment;

• Willing to discuss and consider HIV screening;

• Self-report that the most recent HIV test result was negative, or has no prior history of HIV testing;

• Ability to understand written and spoken English; and

• Willing to provide written informed consent/assent.

Exclusion Criteria for INDEX RECRUITERS:

• Psychiatric disorder (untreated) associated with thought disorder, hallucinations, 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; 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 to adhere to the study requirements; and

• Acutely ill at the time of enrollment.

Exclusion Criteria for FRIENDSHIP NETWORK MEMBERS:

• Self-report an HIV positive test result;

• Psychiatric disorder (untreated) associated with thought disorder, hallucinations, 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; 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 to adhere to the study requirements;

• Acutely ill at the time of enrollment.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Asymptomatic HIV
• HIV Infections
• Infection

Intervention

Other:
• Index Recruiter
Participants agree to recruit at least two female friends from their friendship network to undergo HIV screening.
• Friendship Network Member
Participants are recruited by Index Recruiters to enroll in study and receive HIV screening and complete a questionnaire either on Facilitators of HIV Screening or Barriers to HIV Screening.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	Stroger Hospital of Cook County	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	Number of young women (HIV status positive, negative, or unknown) who are identified and recruited to serve as index recruiters divided by the number of young women screened.		2
Primary	Proportion of index recruiters who recruit two or more of their female, friendship network members to undergo HIV screening.		2 years
Primary	A description of factors that facilitate and hinder index recruiters in recruiting female friendship network members.		2 years
Primary	A description of factors that facilitate and hinder HIV screening among female friendship network members.		2 years
Primary	A preliminary estimate of HIV infection prevalence among the friendship networks of all index recruiters and separately in the friendship networks of each group of index recruiters.		2 years

External Links

•   ATN Website