The Women's HIV SeroIncidence Study (ISIS)

HIV Prevention Trials Network

Status: Completed

Conditions: HIV Infections

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00995176

1U01AI068619 (U.S. NIH Grant/Contract)

HPTN 064

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,099 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

2,099 participants in 2 patient groups

1

Description:

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

2

Description:

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