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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT03292432
Eligibility Criteria:
Inclusion Criteria:
1. Confirmation of HIV-1 Infection as documented in the participant's medical record by at least two of the following criteria:
* Reactive HIV screening test result with an HIV antibody or HIV antibody/antigen-based, Food and Drug Administration (FDA)-licensed assay followed by a positive supplemental assay (e.g., HIV-1 Western Blot, HIV-1 indirect immunofluorescence, HIV-1/HIV-2 discriminatory immunoassay);
* Plasma HIV-1 quantitative ribonucleic acid (RNA) assay \>1,000 copies/mL;
* Positive HIV-1 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay; or
* Positive plasma HIV-1 RNA qualitative assay
2. Participant aware of his or her HIV infection, as determined by site staff
3. Documented plasma HIV-1 RNA plasma ≥200 copies/mL within 45 days of the date of the enrollment visit
4. Prescribed antiretroviral therapy for at least 24 weeks or more prior to documented plasma HIV-1 RNA plasma ≥200 copies/mL.
5. Prescribed a once-daily (one or more pills once a day) ART regimen with at least two active agents (per clinician judgment or genotype evidence) at enrollment
6. Able to communicate in spoken and written English
7. Currently has a cellular phone that is also able to send and receive text messages
8. Willing and able to provide at least one additional contact phone number (preferably two) to contact participant
9. Able and willing to provide written informed assent/consent and able to obtain written parental or guardian permission (if required as specified by the site, by state law, and/or Institutional Review Board policy, and detailed in each site's Protocol Implementation Plans) to be screened for and to enroll in this study
Exclusion Criteria:
1. Gross cognitive limitations, acute emotional instability, or medical or mental health illness that in the opinion of site personnel would impair the individual's ability to provide informed consent and/or interfere with the protocol's objectives
2. Concurrent participation in interventional studies addressing adherence unless approved in advance by study team
3. Positive pregnancy test at the time of enrollment. If participant becomes pregnant while on study, they may continue on study
4. Currently using or planning to use an electronic dose monitoring and reminder device outside of the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
24 Years
Study:
NCT03292432
Study Brief:
Protocol Section:
NCT03292432