Clinical trial NCT00991302: Durability of Adherence in Self-Management of HIV
Official title: Durability of Adherence in Self-Management of HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Adherence
Behavioral Intervention
Antiretroviral Therapy
ART
Highly Active Antiretroviral Therapy
HAART
Treatment experienced
Lead sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2009-10-08
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adherence to highly active antiretroviral therapy (HAART) is critical to successful treatment of HIV. This study tested an intervention that helps people infected with HIV take all their medications when and how they were supposed to.

Detailed description: 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.

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

Primary outcomes:
measure: Mean Self-reported Adherence Score (%) Over a One-month Recall
timeFrame: At weeks 4, 12, 24, 36, and 48
Secondary outcomes:
measure: Mean Self-reported Adherence Score Over a One-month Recall
timeFrame: Weeks 4, 12, 24, 36, 48, 60, and 72
measure: Kaplan-Meier Estimate of the Cumulative Probability of Time to Change of Initial Antiretroviral (ARV) Treatment Regimen for Any Reason by Week 48
timeFrame: From study entry to week 48
measure: Virologic Suppression
timeFrame: At week 24, 48, 72
measure: Self-management Skills, as Measured by Self-reported General Self-efficacy Scale (GSES) Score
timeFrame: At weeks 0 (entry), 4, 12, 24, 36, 48, 60, and 72
measure: Cumulative Probability of First Grade 3 or 4 Adverse Events (AEs)
timeFrame: From study entry to week 72
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Ucsd, Avrc Crs
state: California
city: Lima
country: Peru
facility: Barranco CRS (11301)
Study officials:
affiliation: University of California, San Diego
name: Constance Benson, MD
role: STUDY_CHAIR
affiliation: University of California, San Diego
name: Tari Gilbert, MSN
role: STUDY_CHAIR
References:
citation: Lu M, Safren SA, Skolnik PR, Rogers WH, Coady W, Hardy H, Wilson IB. Optimal recall period and response task for self-reported HIV medication adherence. AIDS Behav. 2008 Jan;12(1):86-94. doi: 10.1007/s10461-007-9261-4. Epub 2007 Jun 19.
citation: Wagner GJ, Kanouse DE, Golinelli D, Miller LG, Daar ES, Witt MD, Diamond C, Tilles JG, Kemper CA, Larsen R, Goicoechea M, Haubrich RH. Cognitive-behavioral intervention to enhance adherence to antiretroviral therapy: a randomized controlled trial (CCTG 578). AIDS. 2006 Jun 12;20(9):1295-302. doi: 10.1097/01.aids.0000232238.28415.d2.