The Women's HIV SeroIncidence Study (ISIS)

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.

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