The Women's HIV SeroIncidence Study (ISIS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Women's HIV SeroIncidence Study (ISIS)

Conditions
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HIV Infections

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Women residing in areas from defined geographic areas with high HIV prevalence and poverty | |
| 2<br>Men residing in areas from defined geographic areas with high HIV prevalence and poverty | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Exploration of facilitators and barriers to HIV testing among men residing in high risk areas to inform future studies |  | Throughout study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, HIV, HIV seronegativity