The Women's HIV SeroIncidence Study (ISIS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00995176 |
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Recruitment Status :
Completed
First Posted : October 15, 2009
Last Update Posted : January 21, 2016
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| Condition or disease |
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| HIV Infections |
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.
| Study Type : | Observational |
| Actual Enrollment : | 2099 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | The Women's HIV SeroIncidence Study (ISIS) |
| Study Start Date : | April 2009 |
| Actual Primary Completion Date : | March 2011 |
| Actual Study Completion Date : | March 2011 |
| Group/Cohort |
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1
Women residing in areas from defined geographic areas with high HIV prevalence and poverty
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2
Men residing in areas from defined geographic areas with high HIV prevalence and poverty
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- 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 [ Time Frame: Throughout study ]
- Evaluation of laboratory assays for HIV-1 incidence determination [ Time Frame: Throughout study ]
- Estimation of recruitment and retention rates [ Time Frame: Throughout study ]
- Assessment of women's preferred recruitment and retention strategies for future studies [ Time Frame: Throughout study ]
- Description of social, structural, and contextual factors in a subgroup of female participants to inform future intervention studies [ Time Frame: Throughout study ]
- Estimation of HIV-1 prevalence rate among women who have not reported previously testing HIV positive [ Time Frame: Throughout study ]
- Exploration of facilitators and barriers to HIV testing among men residing in high risk areas to inform future studies [ Time Frame: Throughout study ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995176
| United States, District of Columbia | |
| George Washington University | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Georgia | |
| The Ponce de Leon Center | |
| Atlanta, Georgia, United States, 30308 | |
| Hope Clinic of the Emory Vaccine Center | |
| Decatur, Georgia, United States, 30030 | |
| United States, Maryland | |
| Johns Hopkins Adult AIDS CRS | |
| Baltimore, Maryland, United States, 21287 | |
| United States, New Jersey | |
| New Jersey Medical School- Adult Clinical Research Ctr. CRS | |
| Newark, New Jersey, United States, 07103 | |
| United States, New York | |
| Bronx- Lebanon Hospital Center Clinical Research Site | |
| Bronx, New York, United States, 10452 | |
| Harlem Prevention Ctr. CRS | |
| New York, New York, United States, 10027 | |
| United States, North Carolina | |
| Unc Aids Crs | |
| Chapel Hill, North Carolina, United States, 27514 | |
| Wake County Health and Human Services | |
| Raleigh, North Carolina, United States, 27630 | |
| Study Chair: | Sally Hodder, MD | UMDNJ - New Jersey Medical School | |
| Study Chair: | Jessica Justman | Columbia University |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | HIV Prevention Trials Network |
| ClinicalTrials.gov Identifier: | NCT00995176 History of Changes |
| Other Study ID Numbers: |
HPTN 064 1U01AI068619 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 15, 2009 Key Record Dates |
| Last Update Posted: | January 21, 2016 |
| Last Verified: | September 2014 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Data was collated into manuscripts by the statistical and data management center for the HPTN. |
Keywords provided by HIV Prevention Trials Network:
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Prevention HIV HIV seronegativity |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |