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:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT00929604
Eligibility Criteria:
Inclusion Criteria:
* Documented HIV-1 infection (according to local standard rapid testing algorithms)
* Age 18 years or greater
* Able and willing to provide informed consent to participate
* Eligible for antiretroviral therapy per Zambian national guidelines, which are any of the following:
* CD4+ cell count less than 200 cells/mm3;
* WHO Stage IV disease; or
* WHO Stage III disease and CD4+ cell count less than 350 cells/mm3
* Residence in the geographical catchment area of the VLS clinic and intent to remain there for the duration of the study
* Willingness to adhere to the study visit schedule and to be followed-up at home in the event of a missed study visit
* Initiating ART on the day of VLS enrollment, informed consent, and baseline blood collection
Exclusion Criteria:
* Receipt of more than 7 days (cumulative) of prior antiretroviral therapy at any time prior to study entry, with the exception of zidovudine and/or single dose nevirapine for prevention of mother-to-child transmission;
* Any exposure to antiretroviral therapy in the past one month
* A condition that, in the opinion of the investigators, would interfere with adherence to study requirements (e.g., mental illness or active drug or alcohol use or dependence)
* Serious illness requiring referral to hospital at the time of ART initiation
* For patients seeking care at sites randomized to the standard of care arm: participation in another research protocol that offers routine viral load testing
* Unwillingness to consent to all aspects of study protocol including blood specimen storage
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00929604
Study Brief:
Protocol Section:
NCT00929604