Durability of Adherence in Self-Management of HIV

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