The Women's HIV SeroIncidence Study (ISIS)

HIV Infections Clinical Trial

Official title:

The Women's HIV SeroIncidence Study (ISIS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995176
• Other study ID #: HPTN 064
• Secondary ID: 1U01AI068619
• Status: Completed
• Start date: April 2009
• Est. completion date: March 2011

Study information

• Verified date: August 2022
• Source: HIV Prevention Trials Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2099
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
United States	The Ponce de Leon Center	Atlanta	Georgia
United States	Johns Hopkins Adult AIDS CRS	Baltimore	Maryland
United States	Bronx- Lebanon Hospital Center Clinical Research Site	Bronx	New York
United States	Unc Aids Crs	Chapel Hill	North Carolina
United States	Hope Clinic of the Emory Vaccine Center	Decatur	Georgia
United States	Harlem Prevention Ctr. CRS	New York	New York
United States	New Jersey Medical School- Adult Clinical Research Ctr. CRS	Newark	New Jersey
United States	Wake County Health and Human Services	Raleigh	North Carolina
United States	George Washington University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
HIV Prevention Trials Network	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (8)

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 H — View Citation

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 Preventio — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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:S69-73. doi: 10.1097/QAI.0b013e3181fbbdf9. — View Citation

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 acqu — View Citation

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 r — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of laboratory assays for HIV-1 incidence determination		Throughout study
Secondary	Estimation of recruitment and retention rates		Throughout study
Secondary	Assessment of women's preferred recruitment and retention strategies for future studies		Throughout study
Secondary	Description of social, structural, and contextual factors in a subgroup of female participants to inform future intervention studies		Throughout study
Secondary	Estimation of HIV-1 prevalence rate among women who have not reported previously testing HIV positive		Throughout study
Secondary	Exploration of facilitators and barriers to HIV testing among men residing in high risk areas to inform future studies		Throughout study