The Women's HIV SeroIncidence Study (ISIS)

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