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Trial record 14 of 56 for:    " September 09, 2009":" October 09, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

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ClinicalTrials.gov Identifier: NCT00991302
Recruitment Status : Completed
First Posted : October 8, 2009
Results First Posted : August 26, 2015
Last Update Posted : March 20, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Intervention Behavioral: CAP-IT
Enrollment 172
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CAP-IT Standard Care
Hide Arm/Group 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.
Period Title: Overall Study
Started 86 86
Completed 72 73
Not Completed 14 13
Reason Not Completed
Death             0             1
Lost to Follow-up             14             12
Arm/Group Title CAP-IT Standard Care Total
Hide Arm/Group 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. Total of all reporting groups
Overall Number of Baseline Participants 86 86 172
Hide Baseline Analysis Population Description
Intention to treat: All eligible participants were included in the baseline characteristics.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants 86 participants 172 participants
31  (8) 32  (10) 31  (9)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 86 participants 172 participants
18-29 years 48 43 91
30-39 years 25 23 48
40-49 years 10 14 24
50+ years 3 6 9
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 86 participants 172 participants
Female
1
   1.2%
5
   5.8%
6
   3.5%
Male
85
  98.8%
81
  94.2%
166
  96.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 86 participants 172 participants
White Non-Hispanic 7 16 23
Black Non-Hispanic 4 1 5
Hispanic (Regardless of Race) 73 62 135
Asian, Pacific Islander 0 3 3
More than Once Race 1 1 2
Missing 1 3 4
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 86 participants 172 participants
United States 26 26 52
Peru 60 60 120
Regimen complexity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 86 participants 172 participants
QD 25 25 50
BID or TID 61 61 122
HIV-1 RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 86 participants 86 participants 172 participants
4.9  (0.8) 5.0  (0.7) 5.0  (0.7)
CD4+ T-cell count  
Mean (Standard Deviation)
Unit of measure:  Cells/mm^3
Number Analyzed 86 participants 86 participants 172 participants
318  (178) 313  (213) 315  (195)
1.Primary Outcome
Title Mean Self-reported Adherence Score (%) Over a One-month Recall
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.
Arm/Group Title CAP-IT Standard Care
Hide Arm/Group 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.
Overall Number of Participants Analyzed 86 86
Median (Inter-Quartile Range)
Unit of Measure: percentage of adherence score
97.5
(93.4 to 100.0)
98.2
(94.0 to 99.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CAP-IT, Standard Care
Comments

Treatment comparison was made using a Wilcoxon rank sum test stratified by dosing complexity.

The test was not stratified by region of enrollment due to dosing complexity and region of enrollment were almost identical: almost all (exception with two) participants in the US region were on QD and all participants in the Peru region were on BID or TID.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments stratified by dosing complexity
2.Secondary Outcome
Title Mean Self-reported Adherence Score Over a One-month Recall
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.
Arm/Group Title CAP-IT Standard Care
Hide Arm/Group 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.
Overall Number of Participants Analyzed 86 86
Median (Inter-Quartile Range)
Unit of Measure: percentage of adherence score
97.2
(92.9 to 99.4)
97.8
(93.4 to 99.7)
3.Secondary Outcome
Title Kaplan-Meier Estimate of the Cumulative Probability of Time to Change of Initial Antiretroviral (ARV) Treatment Regimen for Any Reason by Week 48
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.
Arm/Group Title CAP-IT Standard Care
Hide Arm/Group 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.
Overall Number of Participants Analyzed 86 86
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: cumulative probability per 100 persons
17
(9 to 25)
19
(11 to 28)
4.Secondary Outcome
Title Virologic Suppression
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.
Arm/Group Title CAP-IT Standard Care
Hide Arm/Group 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.
Overall Number of Participants Analyzed 86 86
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 24 (nCAP-IT=80, nSOC=79)
94
(88 to 99)
86
(78 to 94)
Week 48 (nCAP-IT=77, nSOC=73)
95
(90 to 100)
85
(77 to 93)
Week 72 (nCAP-IT=64, nSOC=66)
88
(79 to 96)
88
(80 to 96)
5.Secondary Outcome
Title Self-management Skills, as Measured by Self-reported General Self-efficacy Scale (GSES) Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.
Arm/Group Title CAP-IT Standard Care
Hide Arm/Group 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.
Overall Number of Participants Analyzed 86 86
Median (Inter-Quartile Range)
Unit of Measure: scores on a scale
Week 0 (nCAP-IT=86, nSOC=86)
36
(31 to 39)
36
(32 to 38)
Week 4 (nCAP-IT=84, nSOC=86)
37
(33 to 38)
36
(31 to 39)
Week 12 (nCAP-IT=81, nSOC=77)
36
(33 to 38)
36
(32 to 39)
Week 24 (nCAP-IT=81, nSOC=82)
36
(32 to 39)
37
(34 to 39)
Week 36 (nCAP-IT=81, nSOC=79)
37
(33 to 39)
37
(33 to 39)
Week 48 (nCAP-IT=75, nSOC=77)
37
(34 to 40)
38
(33 to 40)
Week 60 (nCAP-IT=73, nSOC=73)
37
(34 to 39)
36
(33 to 39)
Week 72 (nCAP-IT=71, nSOC=72)
37
(31 to 40)
38
(33 to 40)
6.Secondary Outcome
Title Cumulative Probability of First Grade 3 or 4 Adverse Events (AEs)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.
Arm/Group Title CAP-IT Standard Care
Hide Arm/Group 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.
Overall Number of Participants Analyzed 86 86
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: cumulative probability per 100 persons
6
(3 to 14)
2
(1 to 9)
Time Frame From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable
Adverse Event Reporting Description There were no drugs administered through the study and SAEs were reported to local IRB/ECs only. The protocol requested recording of new signs and symptoms >=Grade 3, any AEs that led to a change in ART, regardless of grade, and all diagnoses identified according to ACTG criteria. DAIDS AE Grading Table (V1, 2004; Clarification 2009) was used.
 
Arm/Group Title CAP-IT Standard Care
Hide Arm/Group 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.
All-Cause Mortality
CAP-IT Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CAP-IT Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/86 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CAP-IT Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   44/86 (51.16%)   38/86 (44.19%) 
Blood and lymphatic system disorders     
Anaemia  1  9/86 (10.47%)  6/86 (6.98%) 
Gastrointestinal disorders     
Diarrhoea  1  8/86 (9.30%)  4/86 (4.65%) 
Nausea  1  7/86 (8.14%)  4/86 (4.65%) 
Hepatobiliary disorders     
Hypertransaminasaemia  1  4/86 (4.65%)  6/86 (6.98%) 
Immune system disorders     
Drug hypersensitivity  1  30/86 (34.88%)  23/86 (26.74%) 
Infections and infestations     
Latent syphilis  1  5/86 (5.81%)  3/86 (3.49%) 
Nasopharyngitis  1  7/86 (8.14%)  5/86 (5.81%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anogenital warts  1  3/86 (3.49%)  8/86 (9.30%) 
Nervous system disorders     
Dizziness  1  7/86 (8.14%)  4/86 (4.65%) 
Headache  1  7/86 (8.14%)  3/86 (3.49%) 
Psychiatric disorders     
Depression  1  9/86 (10.47%)  2/86 (2.33%) 
Skin and subcutaneous tissue disorders     
Skin lesion  1  1/86 (1.16%)  6/86 (6.98%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00991302     History of Changes
Other Study ID Numbers: ACTG A5250
1U01AI068636 ( U.S. NIH Grant/Contract )
10654
First Submitted: October 7, 2009
First Posted: October 8, 2009
Results First Submitted: July 29, 2015
Results First Posted: August 26, 2015
Last Update Posted: March 20, 2018