The Women's HIV SeroIncidence Study (ISIS)

NCT00995176 | Completed

• 2 other identifiers: HPTN 0641U01AI068619
• Study Type: observational
• Target: 2,099
• Locations: 1 country
• Sites: 9

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.

Conditions

HIV Infections

Keywords

Prevention; HIV; HIV seronegativity

Outcome Measures

Primary Outcomes (1)

• 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

  Throughout study

Secondary Outcomes (6)

• Evaluation of laboratory assays for HIV-1 incidence determination

  Throughout study

• Estimation of recruitment and retention rates

  Throughout study

• Assessment of women's preferred recruitment and retention strategies for future studies

  Throughout study

• Description of social, structural, and contextual factors in a subgroup of female participants to inform future intervention studies

  Throughout study

• Estimation of HIV-1 prevalence rate among women who have not reported previously testing HIV positive

  Throughout study

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Self identify as a woman
• 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
• years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• HIV Prevention Trials Network: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (9)

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

The Ponce de Leon Center

Atlanta, Georgia, 30308, United States

Location

Hope Clinic of the Emory Vaccine Center

Decatur, Georgia, 30030, United States

Location

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, 21287, United States

Location

New Jersey Medical School- Adult Clinical Research Ctr. CRS

Newark, New Jersey, 07103, United States

Location

Harlem Prevention Ctr. CRS

New York, New York, 10027, United States

Location

Bronx- Lebanon Hospital Center Clinical Research Site

The Bronx, New York, 10452, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 27514, United States

Location

Wake County Health and Human Services

Raleigh, North Carolina, 27630, United States

Location

Related Publications (10)

• 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.

  PMID: 21406990 BACKGROUND

• 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.

  PMID: 24007379 BACKGROUND

• 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.

  PMID: 24697160 BACKGROUND

• 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.

  PMID: 23129758 RESULT

• 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.

  PMID: 23277896 RESULT

• 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.

  PMID: 24056163 RESULT

• 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.

  PMID: 24742266 RESULT

• 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.

  PMID: 24698079 RESULT

• 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.

  PMID: 32883248 DERIVED

• 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.

  PMID: 27530401 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Sally Hodder, MD

  UMDNJ - New Jersey Medical School

  STUDY CHAIR

• Jessica Justman

  Columbia University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: October 15, 2009
• Study Start: April 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: August 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)