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

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

• 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 ]
  

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.