The Women's HIV SeroIncidence Study (ISIS)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Women's HIV SeroIncidence Study (ISIS)|
- 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 ] [ Designated as safety issue: No ]
- Evaluation of laboratory assays for HIV-1 incidence determination [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Estimation of recruitment and retention rates [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Assessment of women's preferred recruitment and retention strategies for future studies [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Description of social, structural, and contextual factors in a subgroup of female participants to inform future intervention studies [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Estimation of HIV-1 prevalence rate among women who have not reported previously testing HIV positive [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Exploration of facilitators and barriers to HIV testing among men residing in high risk areas to inform future studies [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Women residing in areas from defined geographic areas with high HIV prevalence and poverty
Men residing in areas from defined geographic areas with high HIV prevalence and poverty
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|