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The Women's HIV SeroIncidence Study (ISIS)

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ClinicalTrials.gov Identifier: NCT00995176
Recruitment Status : Completed
First Posted : October 15, 2009
Last Update Posted : January 21, 2016
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
HIV Prevention Trials Network

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Approximately 30 percent of new HIV infections in the Unites States occur in women, with a disproportionate number occurring in women of color. This observational study has been designed to help determine the HIV incidence among women in the study communities as well as to identify steps that women can take to lower their HIV-infection risk.

Condition or disease
HIV Infections

Detailed Description:

In 1985 women accounted for only 8 percent of new AIDS diagnoses in the United States. Today women are estimated to account for nearly 30 percent of the people who are diagnosed with new HIV infections (incidence). A disproportionate amount of those infections (80 percent) occur among Black and Hispanic girls and women. This observational study has been designed to help determine the HIV incidence among women in the study communities as well as to identify steps that women can take to lower their HIV-infection risk.

Research teams will conduct eligibility screening interviews with women whom they have encountered in various locations within the study communities. Eligibility screenings, as well as subsequent study visits, will take place in a variety of mutually agreeable locations that are capable of providing both privacy and confidentiality. Examples include clinics, mobile vans, community organizations or other appropriate public places. The eligibility interview contains topics related to sexual behavior, drug and alcohol use, incarceration history and previous STI diagnosis and treatment. Information about where the potential participant resides and her current sexual partners will also be gathered.

The women who are found to be eligible will be asked to provide a blood sample for HIV and other investigational testing. They will also be asked to participate in a longer interview. All participants will receive HIV risk-reduction counseling, free condoms and appropriate referrals. Monthly contact will be maintained with participants through information that was provided upon enrollment. A phone number that participants can use to contact the research team will also be provided. Monthly calls will each last about 5 to 15 minutes.

About six months after enrolling each participant will be scheduled to have another in-person visit with study staff to complete an interview similar to the eligibility interview. Women who have tested HIV negative will be asked to provide another blood sample for HIV testing during that same period of time, while women who are living with HIV will be asked to provide blood samples to evaluate their HIV-related health. Women who enroll during the earliest portion of the study may be asked to complete a second visit in another six months. Those women will continue to receive monthly contacts between the dates of their first and second visits.

In addition to the primary participant group, a small group of women from four of the study communities will also be recruited to participate in interviews and focus groups that will cover issues similar to the topics included in the eligibly screening. A small group of men from those same four study communities will also be recruited to participate in similar focus groups.


Study Design
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Study Type : Observational
Actual Enrollment : 2099 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Women's HIV SeroIncidence Study (ISIS)
Study Start Date : April 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
1
Women residing in areas from defined geographic areas with high HIV prevalence and poverty
2
Men residing in areas from defined geographic areas with high HIV prevalence and poverty


Outcome Measures
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Primary Outcome Measures :
  1. Estimation of the overall HIV-1 incidence rate among 2,000 women in the US from defined geographic areas with high HIV prevalence and poverty [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. Evaluation of laboratory assays for HIV-1 incidence determination [ Time Frame: Throughout study ]
  2. Estimation of recruitment and retention rates [ Time Frame: Throughout study ]
  3. Assessment of women's preferred recruitment and retention strategies for future studies [ Time Frame: Throughout study ]
  4. Description of social, structural, and contextual factors in a subgroup of female participants to inform future intervention studies [ Time Frame: Throughout study ]
  5. Estimation of HIV-1 prevalence rate among women who have not reported previously testing HIV positive [ Time Frame: Throughout study ]
  6. Exploration of facilitators and barriers to HIV testing among men residing in high risk areas to inform future studies [ Time Frame: Throughout study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Men and women residing in areas from defined geographic areas with high HIV prevalence and poverty
Criteria

HPTN 064, potential participants will be approached at randomly selected locations within study communities. As a result, potential participants are not able to self-refer directly through phone, email or in-person.

Inclusion Criteria for Women:

  • Self identify as a woman
  • 18 to 44 years of age, inclusive on the date of screening
  • Willing to receive HIV test results
  • Resides in a designated study community
  • Has engaged in unprotected (e.g. without a condom) vaginal and/or anal sex with a man during the prior 6 months

  • At least one of the following criteria:

    • Illicit injected and/or noninjected drug use (e.g. heroin, cocaine, crack cocaine, methamphetamine, and/or prescription drugs used outside the oversight of a medical professional) within 6 months. Participants whose only illicit drug use is marijuana do not meet the illicit drug use eligibility criteria.
    • Alcohol dependence (within 6 months)
    • Binge drinking defined as four or more drinks at one time (e.g. during the morning, afternoon or evening) within 6 months
    • Incarceration within 5 years (jail and/or prison)
    • STI (gonorrhea, Chlamydia, trichomonas, or syphilis) within 6 months
    • Exchange of sex for commodities (e.g. drugs, money, shelter) within 6 months
    • Male sexual partner within 6 months with any history of self-reported use of illicit injected or noninjected drugs within 6 months, incarceration (within 5 years), STIs (within 6 months), HIV-infected diagnosis, or history of binge drinking defined as 5 or more drinks at one time (within 6 months) and/or alcohol dependence (within 6 months)

Inclusion Criteria for Men:

  • Self identify as a man
  • 18 years of age or older
  • Resides in a designated community
  • Unprotected vaginal and/or anal sex with a woman during the prior 6 months

  • At least one of the following criteria:

    • Illicit injected and/or noninjected drug use within 6 months
    • Alcohol dependence (within 6 months)
    • Binge drinking defined as five or more drinks at one time (e.g. during the morning, afternoon or evening) within 6 months
    • Incarceration (within 5 years, including jail and/or prison)
    • STI within 6 months
    • Exchange of sex for commodities
    • HIV-infected

Exclusion Criteria for Women:

  • History of prior HIV-infected diagnosis
  • Planning on moving out of state within the study follow-up period or traveling out of state for more than 2 consecutive months during the study follow-up period
  • Current enrollment in an HIV prevention trial
  • Current or past participation in an HIV vaccine trial
  • Any condition that, in the opinion of the study staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Exclusion Criteria for Men:

  • Any condition that, in the opinion of the study staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995176


Locations
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
United States, Georgia
The Ponce de Leon Center
Atlanta, Georgia, United States, 30308
Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, United States, 30030
United States, Maryland
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287
United States, New Jersey
New Jersey Medical School- Adult Clinical Research Ctr. CRS
Newark, New Jersey, United States, 07103
United States, New York
Bronx- Lebanon Hospital Center Clinical Research Site
Bronx, New York, United States, 10452
Harlem Prevention Ctr. CRS
New York, New York, United States, 10027
United States, North Carolina
Unc Aids Crs
Chapel Hill, North Carolina, United States, 27514
Wake County Health and Human Services
Raleigh, North Carolina, United States, 27630
Sponsors and Collaborators
HIV Prevention Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Sally Hodder, MD UMDNJ - New Jersey Medical School
Study Chair: Jessica Justman Columbia University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: HIV Prevention Trials Network
ClinicalTrials.gov Identifier: NCT00995176     History of Changes
Other Study ID Numbers: HPTN 064
1U01AI068619 ( U.S. NIH Grant/Contract )
First Posted: October 15, 2009    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: September 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data was collated into manuscripts by the statistical and data management center for the HPTN.

Keywords provided by HIV Prevention Trials Network:
Prevention
HIV
HIV seronegativity

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases