The Women's HIV SeroIncidence Study (ISIS)
- Conditions
- HIV Infections
- Registration Number
- NCT00995176
- Lead Sponsor
- HIV Prevention Trials Network
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2099
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method Description of social, structural, and contextual factors in a subgroup of female participants to inform future intervention studies Throughout study Evaluation of laboratory assays for HIV-1 incidence determination Throughout study Estimation of recruitment and retention rates Throughout study Exploration of facilitators and barriers to HIV testing among men residing in high risk areas to inform future studies Throughout study Estimation of HIV-1 prevalence rate among women who have not reported previously testing HIV positive Throughout study Assessment of women's preferred recruitment and retention strategies for future studies Throughout study
Trial Locations
- Locations (9)
New Jersey Medical School- Adult Clinical Research Ctr. CRS
🇺🇸Newark, New Jersey, United States
Harlem Prevention Ctr. CRS
🇺🇸New York, New York, United States
The Ponce de Leon Center
🇺🇸Atlanta, Georgia, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
Bronx- Lebanon Hospital Center Clinical Research Site
🇺🇸Bronx, New York, United States
Hope Clinic of the Emory Vaccine Center
🇺🇸Decatur, Georgia, United States
Johns Hopkins Adult AIDS CRS
🇺🇸Baltimore, Maryland, United States
Unc Aids Crs
🇺🇸Chapel Hill, North Carolina, United States
Wake County Health and Human Services
🇺🇸Raleigh, North Carolina, United States