Durability of Adherence in Self-Management of HIV (The DASH Study)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00991302
First received: October 7, 2009
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
HIV Infections
Behavioral: Modified client adherence profiling and intervention tailoring (CAP-IT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Durability of Adherence in Self-Management of HIV

Resource links provided by NLM:


Further study details as provided by AIDS Clinical Trials Group:

Primary Outcome Measures:
  • Mean self-reported adherence score [ Time Frame: Measured during the first 48 weeks of follow-up in Stage 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean self-reported adherence score [ Time Frame: Measured during the 72 weeks of follow-up in Stage 2 ] [ Designated as safety issue: No ]
  • Time to change of initial antiretroviral (ARV) treatment regimen [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Time to virologic failure [ Time Frame: Measured approximately every 12 weeks ] [ Designated as safety issue: Yes ]
  • Self-management skills, as measured by self-report, HIV knowledge, and self-efficacy scores [ Time Frame: Measured at entry and at Weeks 4, 12, 24, 36, 48, 60, and 72 ] [ Designated as safety issue: No ]
  • Time to first Grade 3 or higher adverse events (AEs) that are one grade higher than baseline [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 213
Study Start Date: January 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modified CAP-IT adherence intervention with standard care
Participants will receive the modified CAP-IT adherence intervention in addition to standard care.
Behavioral: Modified client adherence profiling and intervention tailoring (CAP-IT)
Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)
No Intervention: Standard care
Participants will receive standard care.

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 will modify CAP-IT to treat people newly on HAART and then test whether this modified CAP-IT improves long-term HAART adherence.

This study will include two stages. The first stage consists of two focus groups, one made up of HIV care providers and professionals and the other made up of people infected with HIV who have started HAART within the last year. Each focus group will meet 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 consists of a randomized trial comparing the modified CAP-IT program to standard of care. Participation in this stage will last for 72 weeks. Participants will be randomly assigned to receive either standard care or the modified CAP-IT program with standard care. The CAP-IT program involves two steps. The first is an assessment of factors relating to adherence, and the second is development of an individualized plan to address the deficits found.

Study visits will be completed at entry, at Weeks 4 and 12, and then every 12 weeks for approximately 72 weeks. Assessments for the study will include a questionnaire about health attitudes, a physical exam, counting of pills, and answering questions about taking medications. Blood draws will also occur at Weeks 4, 24, and 48.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Stage 1 for HIV infected Individuals on Highly Active Antiretroviral Therapy (HAART):

  • HIV-1 infection
  • Initiated HAART within 1 year prior to study entry
  • Men and women who have 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

Inclusion Criteria for Stage 1 for 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 includes a majority of HIV-1 seropositive patients and who have recent experience managing ART-naive individuals starting HAART
  • Men and women who have 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

Inclusion Criteria for 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) or Y.R. Gaitonde Centre for AIDS Research and Education, Chennai, India (YRG CARE) CRS-affiliated site
  • HIV-1 RNA greater than 2,000 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
  • Men and women who have 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 for Stage 1 for 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

Exclusion Criteria for Stage 1 for Health Care Providers and Professionals:

  • Health care providers and professionals who will 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

Exclusion Criteria for Stage 2:

  • Potential participants who are, in the judgment of the research team, unable to complete the protocol
  • Potential participants who are partners or close contacts of participants enrolled in Stage 2
  • Potential participants who are currently enrolled in an ACTG protocol utilizing or testing an adherence intervention
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991302

Locations
United States, California
Ucsd, Avrc Crs
San Diego, California, United States, 92037
India
Y.R. Gaitonde Centre for AIDS Research and Education (YRG CARE)
Chennai, India
Sponsors and Collaborators
AIDS Clinical Trials Group
Investigators
Study Chair: Constance Benson, MD University of California, San Diego
Study Chair: Tari Gilbert, MSN University of California, San Diego
  More Information

Publications:
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00991302     History of Changes
Other Study ID Numbers: ACTG A5250, 1U01AI068636, 10654
Study First Received: October 7, 2009
Last Updated: December 5, 2013
Health Authority: United States: Federal Government

Keywords provided by AIDS Clinical Trials Group:
Adherence
Behavioral Intervention
Antiretroviral Therapy
ART
Highly Active Antiretroviral Therapy
HAART
Treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 18, 2014