Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT00342160
Eligibility Criteria:
* INCLUSION CRITERIA:
Group 1 (HIV concordant partners, n = 20 couples):
* Documentation of HIV infection in both partners, a current history of continued sexual activity within the partnership, and demonstration that they have been in a partnership for at least two years.
* CD4+ T cell count greater than 250/microliters blood in both partners and not currently on HAART.
* Plasma viremia greater than 5,000 copies of HIV RNA/ml plasma in both partners.
* Able and willing to provide informed consent.
* Must agree to continued couple counseling regarding HIV results
Group 2 (HIV-discordant partners, n = 20 couples):
* Documentation of HIV infection in one partner and seronegative status in the other partner, a current history of continued sexual activity within the partnership, and demonstration that they have been in a partnership for at least two years.
* CD4+ T cell count greater than 250/microliters blood in both partners and not currently on HAART.
* Plasma viremia greater than 5,000 copies of HIV RNA/ml plasma in each infected partner.
* Able and willing to provide informed consent.
* Must agree to continued couple counseling regarding HIV results
Group 3 (HIV-uninfected partners, n = 10 couples):
* Documentation of HIV-seronegative status in both partners, a current history of continued sexual activity within the partnership, and demonstration that they have been in a partnership for at least two years.
* CD4+ T cell count greater than 250/microliters blood in both partners.
* Able and willing to provide informed consent.
* Must agree to continued couple counseling regarding HIV results
EXCLUSION CRITERIA:
Inability or unwillingness to provide individual informed consent, on the part of either or both members of the couple.
Refusal of couples counseling on the part of one or both partners.
Severe illness in one or the other, and /or a hemoglobin value less than 8 g/dL.
Age less than 18. Children are not included in this study since it specifically focuses on sexual transmission of HIV in long term married couples.
Having had a blood transfusion within the last 60 days. Though individuals can be scheduled after this time period has passed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00342160
Study Brief:
Protocol Section:
NCT00342160