Durability of Adherence in Self-Management of HIV

People infected with HIV must take the regimen of highly active antiretroviral therapy
(HAART) medications as prescribed to them, without missing doses, or they risk developing a
resistant strain of the virus. Resistant strains of the virus do not respond to certain HAART
regimens and are more dangerous for patients. Poor HAART adherence can lead to further HIV
progression, more hospitalizations and opportunistic infections, and required use of
second-line therapies. Interventions to increase adherence have had mixed success, with
little data to support long-term effects and no one strategy emerging that provides
consistent positive effects. The client adherence profiling and intervention tailoring
(CAP-IT) program was first developed to increase adherence among people already on HAART with
in-home nursing. This study modified CAP-IT to treat people newly on HAART and then tested
whether this modified CAP-IT improved long-term HAART adherence.

This study included two stages. The first stage consisted of two focus groups, one made up of
HIV care providers and professionals and the other made up of people infected with HIV who
had started HAART within the last year. Each focus group met once, for approximately 2 hours,
to determine what modifications would best adapt the CAP-IT program to HIV-infected people
first starting HAART.

The second stage consisted of a randomized trial comparing the modified CAP-IT program to
standard of care. Participation in this stage lasted for 72 weeks. Participants were randomly
assigned to receive either standard care or the modified CAP-IT program in addition to
standard care. The CAP-IT program involved two steps. The first was an assessment of factors
relating to adherence, and the second was development of an individualized plan to address
the deficits found.

Study visits were completed at entry, at Weeks 4 and 12, and then every 12 weeks for
approximately 72 weeks. Assessments for the study included a questionnaire about health
attitudes, a physical exam, counting of pills, and answering questions about taking
medications.

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