Asymptomatic HIVNCT00841360
ID and Testing Via Friendship Networks
An observational study of Asymptomatic HIV and HIV Infections, run by University of North Carolina, Chapel Hill at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic HIV, HIV Infections
- What is being tested?
- Index Recruiter and Friendship Network Member
- How many people
- 535 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2009to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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;
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- 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.
- 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.
Who cannot join
- 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.
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Stroger Hospital of Cook County
Chicago, Illinois, 60612
University of Miami School of Medicine
Miami, Florida, 33101
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Pilot Study to Identify Undiagnosed Asymptomatic HIV Infections in Adolescent and Young Adult Women
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.
Read the 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.
- Conditions
- Asymptomatic HIV, HIV Infections
- Being tested
- Index Recruiter, Friendship Network Member
- Keywords
- Social network, Asymptomatic HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Index RecruiterOther
Participants agree to recruit at least two female friends from their friendship network to undergo HIV screening.
Friendship Network MemberOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Index Recruiter | |
| 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. Receives: Other: Index Recruiter | |
| 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. Receives: Other: Index Recruiter | |
| 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. Receives: Other: Friendship Network Member |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2
Proportion of index recruiters who recruit two or more of their female, friendship network members to undergo HIV screening.
Measured: 2 years
A description of factors that facilitate and hinder index recruiters in recruiting female friendship network members.
Measured: 2 years
A description of factors that facilitate and hinder HIV screening among female friendship network members.
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Cherrie B Boyer, PhD, Study chair, University of California, San Francisco; ATN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841360
- Sponsor's protocol ID
- ATN 067
- Status last verified
- Feb 2016
- First submitted
- 9 Feb 2009
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Identify Undiagnosed Asymptomatic HIV Infections in Adolescent and Young Adult Women
- ClinicalTrials.gov ID
- NCT00841360
- Acronym / sponsor ID
- ATN 067
- Conditions
- Asymptomatic HIV, HIV Infections
- Keywords
- Social network, Asymptomatic HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- Jan 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 11 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIV Positive | – | Other: Index RecruiterParticipant 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. |
| HIV Negative | – | Other: Index RecruiterParticipant 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. |
| HIV Status Unknown | – | Other: Index RecruiterParticipant 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. |
| Friendship Network Members | – | Other: Friendship Network MemberFriendship 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. |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (18 listed)
- 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);
Key exclusion criteria (9 listed)
- 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.
- Self-report an HIV positive test result;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Index RecruiterParticipants agree to recruit at least two female friends from their friendship network to undergo HIV screening. | Other | HIV Negative, HIV Positive, HIV Status Unknown |
| Friendship Network MemberParticipants 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. | Other | Friendship Network Members |
Primary outcome
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
Proportion of index recruiters who recruit two or more of their female, friendship network members to undergo HIV screening.
Time frame: 2 years
A description of factors that facilitate and hinder index recruiters in recruiting female friendship network members.
Time frame: 2 years
A description of factors that facilitate and hinder HIV screening among female friendship network members.
Time frame: 2 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- ATN WebsiteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cherrie B Boyer, PhD study chair
University of California, San Francisco; ATN
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asymptomatic HIV and HIV Infections, run by University of North Carolina, Chapel Hill at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017; AzTrials last refreshed its copy on 26 Oct 2026.