NCT00991302

Durability of Adherence in Self-Management of HIV

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BEHAVIORAL	CAP-IT	Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)

Timeline

• Start date: 2010-01-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2009-10-08
• Last updated: 2018-03-20
• Results posted: 2015-08-26

Locations

2 sites across 2 countries: United States, Peru