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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CAP-IT
Sponsored by
AIDS Clinical Trials Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Adherence, Behavioral Intervention, Antiretroviral Therapy, ART, Highly Active Antiretroviral Therapy, HAART, Treatment experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ucsd, Avrc Crs
  • Barranco CRS (11301)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CAP-IT

Standard care

Arm Description

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)

Participants received standard care.

Outcomes

Primary Outcome Measures

Mean Self-reported Adherence Score (%) Over a One-month Recall
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.

Secondary Outcome Measures

Mean Self-reported Adherence Score Over a One-month Recall
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
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
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
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)
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.

Full Information

First Posted
October 7, 2009
Last Updated
February 21, 2018
Sponsor
AIDS Clinical Trials Group
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00991302
Brief Title
Durability of Adherence in Self-Management of HIV
Acronym
DASH
Official Title
Durability of Adherence in Self-Management of HIV
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AIDS Clinical Trials Group
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Adherence, Behavioral Intervention, Antiretroviral Therapy, ART, Highly Active Antiretroviral Therapy, HAART, Treatment experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAP-IT
Arm Type
Experimental
Arm Description
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)
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Participants received standard care.
Intervention Type
Behavioral
Intervention Name(s)
CAP-IT
Other Intervention Name(s)
Client adherence profiling and intervention tailoring
Intervention Description
Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)
Primary Outcome Measure Information:
Title
Mean Self-reported Adherence Score (%) Over a One-month Recall
Description
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.
Time Frame
At weeks 4, 12, 24, 36, and 48
Secondary Outcome Measure Information:
Title
Mean Self-reported Adherence Score Over a One-month Recall
Description
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.
Time Frame
Weeks 4, 12, 24, 36, 48, 60, and 72
Title
Kaplan-Meier Estimate of the Cumulative Probability of Time to Change of Initial Antiretroviral (ARV) Treatment Regimen for Any Reason by Week 48
Description
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.
Time Frame
From study entry to week 48
Title
Virologic Suppression
Description
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.
Time Frame
At week 24, 48, 72
Title
Self-management Skills, as Measured by Self-reported General Self-efficacy Scale (GSES) Score
Description
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.
Time Frame
At weeks 0 (entry), 4, 12, 24, 36, 48, 60, and 72
Title
Cumulative Probability of First Grade 3 or 4 Adverse Events (AEs)
Description
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.
Time Frame
From study entry to week 72

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constance Benson, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tari Gilbert, MSN
Organizational Affiliation
University of California, San Diego
Official's Role
Study Chair
Facility Information:
Facility Name
Ucsd, Avrc Crs
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Barranco CRS (11301)
City
Lima
ZIP/Postal Code
18 PE
Country
Peru

12. IPD Sharing Statement

Citations:
PubMed Identifier
17577653
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.
Results Reference
background
PubMed Identifier
16816559
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.
Results Reference
background

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Durability of Adherence in Self-Management of HIV

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