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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT00991302
Eligibility Criteria:
Inclusion Criteria:
* Stage 1
* HIV infected Individuals on Highly Active Antiretroviral Therapy (HAART):
* HIV-1 infection
* Initiated HAART within 1 year prior to study entry and remained on HAART for at least 30 consecutive days
* Men and women who hade reached the legal age of majority in the country where they are being enrolled
* Ability and willingness to provide informed consent
* Willingness to discuss personal topics during an audio-taped group interview
* Willingness to protect the confidentiality of other focus group participants
* Health Care Providers and Professionals:
* Healthcare providers or professionals (e.g., medical doctors \[MDs\], nurse practitioner \[NPs\], physician assistants \[PAs\], adherence counselors) recruited from outside of the local clinical research site (CRS) whose patient population included a majority of HIV-1 seropositive patients and who had recent experience managing ART-naive individuals starting HAART
* Men and women who had reached the legal age of majority in the country where they are being enrolled
* Willingness to discuss personal topics during an audio-taped group interview
* Willingness to protect the confidentiality of other focus group participants and of the proceedings
* Stage 2:
* HIV-1 infection
* Antiretroviral (ARV) treatment naive, but planning to initiate HAART within 7 days of study entry either in the context of an approved parent AIDS Clinical Trial Group (ACTG) clinical trial or in the context of primary HIV care at a University of California, San Diego (UCSD), USA or Asociacion Civil Impacta Salud Y Educaci (IMPACTA), Peru, CRS-affiliated site
* HIV-1 RNA greater than 1,000 copies/mL obtained within 90 days prior to study entry by any laboratory that has a clinical laboratory improvement amendments (CLIA) certification or its equivalent
* CD4+/CD8+ count obtained within 90 days prior to study entry by any laboratory that has a CLIA certification or its equivalent
* Men and women who had reached the legal age of majority in the country where they are being enrolled
* Ability to follow instructions and complete surveys and questionnaires with minimal assistance
Exclusion Criteria:
* Stage 1
* HIV-1 Infected Individuals on HAART:
* Failure to remain on HAART for at least 30 consecutive days
* Diminished cognitive capacity that, in the opinion of the screening CRS clinician, would interfere with study participation
* Participation in any prior focus group for study A5250
* Health Care Providers and Professionals:
* Health care providers and professionals who would be involved in administering standard of care (SOC) treatment and adherence counseling to Stage 2 participants randomized to the SOC arm or CRS investigators or health care providers and professionals directly involved in measuring adherence outcomes in Stage 2
* Participation in any prior focus group for study A5250
* Stage 2:
* Potential participants who were, in the judgment of the research team, unable to complete the protocol
* Potential participants who were starting a NNRTI-based regimen within 12 months after receiving single-dose NVP during pregnancy to prevent MTCT of HIV
* Potential participants who were partners or close contacts of participants enrolled in Stage 2
* Potential participants who were currently enrolled in an ACTG protocol utilizing or testing an adherence intervention
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00991302
Study Brief:
Protocol Section:
NCT00991302