The Women's HIV SeroIncidence Study (ISIS)

August 25, 2022 updated by: HIV Prevention Trials Network
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

2099

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • The Ponce de Leon Center
      • Decatur, Georgia, United States, 30030
        • Hope Clinic of The Emory Vaccine Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Adult AIDS CRS
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • New Jersey Medical School- Adult Clinical Research Ctr. CRS
    • New York
      • Bronx, New York, United States, 10452
        • Bronx- Lebanon Hospital Center Clinical Research Site
      • New York, New York, United States, 10027
        • Harlem Prevention Ctr. CRS
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Unc Aids Crs
      • Raleigh, North Carolina, United States, 27630
        • Wake County Health and Human Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Men and women residing in areas from defined geographic areas with high HIV prevalence and poverty

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Throughout study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HIV Prevention Trials Network

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

October 14, 2009

First Submitted That Met QC Criteria

October 14, 2009

First Posted (Estimate)

October 15, 2009

Study Record Updates

Last Update Posted (Actual)

August 30, 2022

Last Update Submitted That Met QC Criteria

August 25, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPTN 064
  • 1U01AI068619 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data was collated into manuscripts by the statistical and data management center for the HPTN.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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