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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00995176 |
Purpose
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.
| Condition |
|---|
|
HIV Infections |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | The Women's HIV SeroIncidence Study (ISIS) |
| Estimated Enrollment: | 2000 |
| Study Start Date: | April 2009 |
| Groups/Cohorts |
|---|
|
1
Women residing in areas from defined geographic areas with high HIV prevalence and poverty
|
|
2
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Men and women residing in areas from defined geographic areas with high HIV prevalence and poverty
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:
At least one of the following criteria:
Inclusion Criteria for Men:
At least one of the following criteria:
Exclusion Criteria for Women:
Exclusion Criteria for Men:
Contacts and Locations| United States, District of Columbia | |
| George Wasington University | Recruiting |
| Washington, District of Columbia, United States, 20037 | |
| Contact: Shelita Merchant 202-994-4656 sphsgm@gwumc.edu | |
| United States, Georgia | |
| Hope Clinic of the Emory Vaccine Center | Recruiting |
| Decatur, Georgia, United States, 30030 | |
| Contact: Jane Skvarich, RN, MN 404-377-3719 ext 19 jskvari@emory.edu | |
| The Ponce de Leon Center | Recruiting |
| Atlanta, Georgia, United States, 30308 | |
| Contact: Ericka Patrick 404-616-6313 erpatri@emory.edu | |
| United States, Maryland | |
| Johns Hopkins Adult AIDS CRS | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Ilene Wiggins, RN 410-614-2766 imp@jhmi.edu | |
| United States, New Jersey | |
| New Jersey Medical School- Adult Clinical Research Ctr. CRS | Recruiting |
| Newark, New Jersey, United States, 07103 | |
| Contact: Rondalya DeShields, RN, BSN 973-972-3729 deshierd@umdnj.edu | |
| Principal Investigator: Sally Hodder, MD | |
| United States, New York | |
| Bronx- Lebanon Hospital Center Clinical Research Site | Recruiting |
| Bronx, New York, United States, 10452 | |
| Contact: Rita Sondengam, MPH 718-960-1452 rsondeng@bronxleb.org | |
| Harlem Prevention Ctr. CRS | Not yet recruiting |
| New York, New York, United States, 10027 | |
| Contact: Luis A. Fuentes, MPH 212-939-2957 laf2@columbia.edu | |
| United States, North Carolina | |
| Unc Aids Crs | Active, not recruiting |
| Chapel Hill, North Carolina, United States, 27514 | |
| Wake County Health and Human Services | Recruiting |
| Raleigh, North Carolina, United States, 27630 | |
| Contact: Susan Pederson 919-966-6713 spederse@med.unc.edu | |
| Study Chair: | Sally Hodder, MD | UMDNJ - New Jersey Medical School |
| Study Chair: | Jessica Justman | Columbia University |
More Information
| Responsible Party: | DAIDS ( Rona Siskind ) |
| Study ID Numbers: | HPTN 064 |
| Study First Received: | October 14, 2009 |
| Last Updated: | November 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00995176 History of Changes |
| Health Authority: | United States: Federal Government |
|
Prevention HIV HIV seronegativity |
|
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |