The Women's HIV SeroIncidence Study (ISIS)

NCT ID: NCT00995176

Last Updated: 2022-08-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2099 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-03-31

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.

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.

Conditions

HIV Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

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

No interventions assigned to this group

2

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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)

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

HIV Prevention Trials Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sally Hodder, MD

Role: STUDY_CHAIR

UMDNJ - New Jersey Medical School

Jessica Justman

Role: STUDY_CHAIR

Columbia University

Locations

George Washington University

Washington D.C., District of Columbia, United States

The Ponce de Leon Center

Atlanta, Georgia, United States

Hope Clinic of the Emory Vaccine Center

Decatur, Georgia, United States

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, United States

New Jersey Medical School- Adult Clinical Research Ctr. CRS

Newark, New Jersey, United States

Harlem Prevention Ctr. CRS

New York, New York, United States

Bronx- Lebanon Hospital Center Clinical Research Site

The Bronx, New York, United States

Unc Aids Crs

Chapel Hill, North Carolina, United States

Wake County Health and Human Services

Raleigh, North Carolina, United States

Countries

United States

References

Hodder SL, Justman J, Haley DF, Adimora AA, Fogel CI, Golin CE, O'Leary A, Soto-Torres L, Wingood G, El-Sadr WM; HIV Prevention Trials Network Domestic Prevention in Women Working Group. Challenges of a hidden epidemic: HIV prevention among women in the United States. J Acquir Immune Defic Syndr. 2010 Dec;55 Suppl 2(Suppl 2):S69-73. doi: 10.1097/QAI.0b013e3181fbbdf9.

Reference Type: BACKGROUND

PMID: 21406990 (View on PubMed)

Haley DF, Justman JE. The HIV epidemic among women in the United States: a persistent puzzle. J Womens Health (Larchmt). 2013 Sep;22(9):715-7. doi: 10.1089/jwh.2013.4562. No abstract available.

Reference Type: BACKGROUND

PMID: 24007379 (View on PubMed)

Haley DF, Lucas J, Golin CE, Wang J, Hughes JP, Emel L, El-Sadr W, Frew PM, Justman J, Adimora AA, Watson CC, Mannheimer S, Rompalo A, Soto-Torres L, Tims-Cook Z, Carter Y, Hodder SL; HPTN 064 Study Team. Retention strategies and factors associated with missed visits among low income women at increased risk of HIV acquisition in the US (HPTN 064). AIDS Patient Care STDS. 2014 Apr;28(4):206-17. doi: 10.1089/apc.2013.0366.

Reference Type: BACKGROUND

PMID: 24697160 (View on PubMed)

Eshleman SH, Hughes JP, Laeyendecker O, Wang J, Brookmeyer R, Johnson-Lewis L, Mullis CE, Hackett J Jr, Vallari AS, Justman J, Hodder S. Use of a multifaceted approach to analyze HIV incidence in a cohort study of women in the United States: HIV Prevention Trials Network 064 Study. J Infect Dis. 2013 Jan 15;207(2):223-31. doi: 10.1093/infdis/jis658. Epub 2012 Nov 5.

Reference Type: RESULT

PMID: 23129758 (View on PubMed)

Hodder SL, Justman J, Hughes JP, Wang J, Haley DF, Adimora AA, Del Rio C, Golin CE, Kuo I, Rompalo A, Soto-Torres L, Mannheimer SB, Johnson-Lewis L, Eshleman SH, El-Sadr WM; HIV Prevention Trials Network 064; Women's HIV SeroIncidence Study Team. HIV acquisition among women from selected areas of the United States: a cohort study. Ann Intern Med. 2013 Jan 1;158(1):10-8. doi: 10.7326/0003-4819-158-1-201301010-00004.

Reference Type: RESULT

PMID: 23277896 (View on PubMed)

Adimora AA, Hughes JP, Wang J, Haley DF, Golin CE, Magnus M, Rompalo A, Justman J, del Rio C, El-Sadr W, Mannheimer S, Soto-Torres L, Hodder SL; HPTN 064 Protocol Team. Characteristics of multiple and concurrent partnerships among women at high risk for HIV infection. J Acquir Immune Defic Syndr. 2014 Jan 1;65(1):99-106. doi: 10.1097/QAI.0b013e3182a9c22a.

Reference Type: RESULT

PMID: 24056163 (View on PubMed)

Haley DF, Golin C, El-Sadr W, Hughes JP, Wang J, Roman Isler M, Mannheimer S, Kuo I, Lucas J, DiNenno E, Justman J, Frew PM, Emel L, Rompalo A, Polk S, Adimora AA, Rodriquez L, Soto-Torres L, Hodder S. Venue-based recruitment of women at elevated risk for HIV: an HIV Prevention Trials Network study. J Womens Health (Larchmt). 2014 Jun;23(6):541-51. doi: 10.1089/jwh.2013.4654. Epub 2014 Apr 17.

Reference Type: RESULT

PMID: 24742266 (View on PubMed)

Kuo I, Golin CE, Wang J, Haley DF, Hughes J, Mannheimer S, Justman J, Rompalo A, Frew PM, Adimora AA, Soto-Torres L, Hodder S; HPTN 064 Study Team. Substance use patterns and factors associated with changes over time in a cohort of heterosexual women at risk for HIV acquisition in the United States. Drug Alcohol Depend. 2014 Jun 1;139:93-9. doi: 10.1016/j.drugalcdep.2014.03.007. Epub 2014 Mar 19.

Reference Type: RESULT

PMID: 24698079 (View on PubMed)

Abrams JA, Odlum M, Tillett E, Haley D, Justman J, Hodder S, Vo L, O'Leary A, Frew PM; HIV Prevention Trials Network 064 (HTPN) Study Team. Strategies for increasing impact, engagement, and accessibility in HIV prevention programs: suggestions from women in urban high HIV burden counties in the Eastern United States (HPTN 064). BMC Public Health. 2020 Sep 3;20(1):1340. doi: 10.1186/s12889-020-09426-6.

Reference Type: DERIVED

PMID: 32883248 (View on PubMed)

Frew PM, Parker K, Vo L, Haley D, O'Leary A, Diallo DD, Golin CE, Kuo I, Soto-Torres L, Wang J, Adimora AA, Randall LA, Del Rio C, Hodder S; HIV Prevention Trials Network 064 (HTPN) Study Team. Socioecological factors influencing women's HIV risk in the United States: qualitative findings from the women's HIV SeroIncidence study (HPTN 064). BMC Public Health. 2016 Aug 17;16(1):803. doi: 10.1186/s12889-016-3364-7.

Reference Type: DERIVED

PMID: 27530401 (View on PubMed)

Other Identifiers

1U01AI068619

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HPTN 064

Identifier Type: -

Identifier Source: org_study_id