Durability of Adherence in Self-Management of HIV (DASH)
|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|
- Mean Self-reported Adherence Score (%) Over a One-month Recall [ Time Frame: At weeks 4, 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
The adherence self-report questionnaire captured adherence at an Antiretroviral Therapy (ART) regimen over a one-month recall (0-100): 0 means none of anti-HIV medications were taken, 100 means every single dose of anti-HIV medications were taken. The primary endpoint evaluated for each participant was the average self-reported adherence over a one-month recall across each of their study visit week 4, 12, 24, 36, and 48: missing values were ignored.
Note: This was a change to the primary endpoint as described in the study protocol. This was due to an update to ACTG Case Report Form (CRF) that captured self-report adherence. Since the data captured on this form captured adherence over a longer timeframe and allowed for more variability in response, it was anticipated this endpoint would provide greater power to assess treatment differences.
- Mean Self-reported Adherence Score Over a One-month Recall [ Time Frame: Weeks 4, 12, 24, 36, 48, 60, and 72 ] [ Designated as safety issue: No ]The mean of participant's average self-reported adherence score over a one-month recall across visit week 4, 12, 24, 36, 48, 60, and 72; missing values were ignored.
- Kaplan-Meier Estimate of the Cumulative Probability of Time to Change of Initial Antiretroviral (ARV) Treatment Regimen for Any Reason by Week 48 [ Time Frame: From study entry to week 48 ] [ Designated as safety issue: No ]
The Kaplan-Meier estimate of the cumulative probability of initial antiretroviral (ARV) treatment regimen for any reason by week 48.
Time to ARV treatment regimen change was defined as first time to change in the drug class of participant's ART regimen for any reason from study entry. Participants completing the study without a change in the drug class of their ART regimen were censored at their last visit.
- Virologic Suppression [ Time Frame: At week 24, 48, 72 ] [ Designated as safety issue: No ]Virologic suppression was defined as HIV-1 RNA <=200 copies/mL at week 24, 48, and 72. The results obtained within +/- 12 weeks of 24, 48, and 72 weeks were included. If there were multiple HIV-1 RNA measurement within the specified window, the HIV-1 RNA result closest to the center of the window was selected.
- Self-management Skills, as Measured by Self-reported General Self-efficacy Scale (GSES) Score [ Time Frame: At weeks 0 (entry), 4, 12, 24, 36, 48, 60, and 72 ] [ Designated as safety issue: No ]
The GSES is a 10-item scale designed to assess optimistic self-beliefs used to cope with a variety of demands in life. The scale was designed to assess self efficacy, i.e., the belief that one's actions are responsible for successful outcomes. The scaled score for each question ranges from 1 to 4. Higher scores indicate participant's stronger belief in self-efficacy.
The GSES score was sum of all responses. The range was from 0 to 40 scores: any unfinished question got a score of zero.
- Cumulative Probability of First Grade 3 or 4 Adverse Events (AEs) [ Time Frame: From study entry to week 72 ] [ Designated as safety issue: Yes ]
The Kaplan-Meier estimate of the cumulative probability of experiencing a grade 3 or 4 adverse event by week 72.
New Grade 3 or 4 signs, symptoms were identified by MedDRA preferred term. Events were included regardless of participant status on ART. If a participant had multiple reports of the same event, only the event reported at the highest grade were included.
Time was measured from the study entry until the date of the first new grade 3 or 4 adverse event. Participants lost to follow-up prior to reaching an adverse event endpoint or not documented to have reached an adverse event endpoint at the end of the study had their endpoint censored at the date of their last visit.
|Study Start Date:||January 2010|
|Study Completion Date:||January 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Participants received the modified CAP-IT adherence intervention in addition to standard care.
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)
Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)
Other Name: Client adherence profiling and intervention tailoring
No Intervention: Standard care
Participants received standard care.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991302
|United States, California|
|Ucsd, Avrc Crs|
|San Diego, California, United States, 92037|
|Barranco CRS (11301)|
|Lima, Peru, 18 PE|
|Study Chair:||Constance Benson, MD||University of California, San Diego|
|Study Chair:||Tari Gilbert, MSN||University of California, San Diego|