Trial record 8 of 107 for:    (hispanic OR latina) AND (woman OR women OR female)

ID and Testing Via Friendship Networks

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:
NCT00841360
First received: February 9, 2009
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Asymptomatic HIV
HIV Infections
Other: Index Recruiter
Other: Friendship Network Member

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: A Pilot Study to Identify Undiagnosed Asymptomatic HIV Infections in Adolescent and Young Adult Women

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:
  • 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. [ Time Frame: 2 ] [ Designated as safety issue: No ]
  • Proportion of index recruiters who recruit two or more of their female, friendship network members to undergo HIV screening. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • A description of factors that facilitate and hinder index recruiters in recruiting female friendship network members. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • A description of factors that facilitate and hinder HIV screening among female friendship network members. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 535
Study Start Date: January 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HIV Positive

Participant self-discloses as HIV positive.

Sexually experienced females between the ages of 13 and 24 years old and of African American race, Hispanic/Latina ethnicity, or mixed-race/ethnicity, which must include African American race and/or Hispanic/Latina ethnicity.

Other: Index Recruiter
Participants agree to recruit at least two female friends from their friendship network to undergo HIV screening.
HIV Negative

Participant self-discloses as HIV negative (based on receiving a negative HIV test within 12 months prior to study consent).

Sexually experienced females between the ages of 13 and 24 years old and of African American race, Hispanic/Latina ethnicity, or mixed-race/ethnicity, which must include African American race and/or Hispanic/Latina ethnicity.

Other: Index Recruiter
Participants agree to recruit at least two female friends from their friendship network to undergo HIV screening.
HIV Status Unknown

Participant self-discloses as HIV negative (no history of prior HIV testing, or HIV screening more than 12 months prior to date of study consent).

Sexually experienced females between the ages of 13 and 24 years old and of African American race, Hispanic/Latina ethnicity, or mixed-race/ethnicity, which must include African American race and/or Hispanic/Latina ethnicity.

Other: Index Recruiter
Participants agree to recruit at least two female friends from their friendship network to undergo HIV screening.
Friendship Network Members
Friendship network members will also consist of sexually experienced females, aged 13 years and older. Although most members are expected to be of African American race and/or Hispanic/Latina ethnicity, all races and ethnicities will be included.
Other: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   13 Years to 24 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Index recruiters will consist of sexually experienced females between the ages of 13 and 24 years old and of African American race, Hispanic/Latina ethnicity, or mixed-race/ethnicity, which must include African American race and/or Hispanic/Latina ethnicity.

Friendship network members will also consist of sexually experienced females, aged 13 years and older. Although most members are expected to be of African American race and/or Hispanic/Latina ethnicity, all races and ethnicities will be included.

Criteria

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.
  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: NCT00841360

Locations
United States, Florida
University of Miami School of Medicine
Miami, Florida, United States, 33101
United States, Illinois
Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Investigators
Study Chair: Cherrie B Boyer, PhD University of California, San Francisco; ATN
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00841360     History of Changes
Other Study ID Numbers: ATN 067
Study First Received: February 9, 2009
Last Updated: May 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Social network
Asymptomatic HIV

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 16, 2014