Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

CCTG 595: Text Messaging Intervention to Improve Adherence to PrEP in High-risk MSM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01761643
Recruitment Status : Completed
First Posted : January 7, 2013
Results First Posted : June 2, 2020
Last Update Posted : June 30, 2020
Sponsor:
Collaborators:
University of California, Los Angeles
University of Southern California
City of Long Beach Department of Health and Human Services
California HIV/AIDS Research Program
Gilead Sciences
Information provided by (Responsible Party):
Sheldon Morris, University of California, San Diego

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Patient Adherence
HIV Seronegativity
Intervention Device: SoC + iTab
Enrollment 398
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard of Care (SoC) SoC + iTab
Hide Arm/Group Description Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC) Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC) and daily individualized text-messaging for adherence building (iTAB)
Period Title: Overall Study
Started 198 200
Completed 166 158
Not Completed 32 42
Arm/Group Title Standard of Care (SoC) SoC + iTab Total
Hide Arm/Group Description Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC) Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC) and daily individualized text-messaging for adherence building (iTAB) Total of all reporting groups
Overall Number of Baseline Participants 198 200 398
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 198 participants 200 participants 398 participants
35.4  (8.7) 35.1  (9.8) 35.2  (9.2)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 200 participants 398 participants
Male
198
 100.0%
197
  98.5%
395
  99.2%
Transgender woman
0
   0.0%
3
   1.5%
3
   0.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 200 participants 398 participants
Asian
5
   2.5%
7
   3.5%
12
   3.0%
Black
26
  13.1%
26
  13.0%
52
  13.1%
White
148
  74.7%
147
  73.5%
295
  74.1%
More than one race
10
   5.1%
14
   7.0%
24
   6.0%
Other
4
   2.0%
3
   1.5%
7
   1.8%
Hispanic ethnicity
58
  29.3%
61
  30.5%
119
  29.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 198 participants 200 participants 398 participants
198
 100.0%
200
 100.0%
398
 100.0%
PREP use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 200 participants 398 participants
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Adherence to PrEP
Hide Description Proportion of participants adherent to PrEP as measured by TFV-DP dried blood spot (DBS) concentrations > 719 fmol/punch at Week 12 and the last on-drug visit.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants with a DBS sample collected at study visits were included in this analysis.
Arm/Group Title Standard of Care (SoC) SoC + iTab
Hide Arm/Group Description:
Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC)
Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC) and daily individualized text-messaging for adherence building (iTAB)
Overall Number of Participants Analyzed 181 180
Measure Type: Number
Unit of Measure: % participants with > 719 fmol/punch
Wk 12 85.6 91.7
Wk 48 81.6 83.4
2.Secondary Outcome
Title Perfect Adherence to PrEP
Hide Description Proportion of participants with perfect adherence to PrEP as measured by TFV-DP dried blood spot (DBS) concentrations > 1246 fmol/punch at Week 12 and the last on-drug visit.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants with a DBS sample collected at study visits were included in this analysis.
Arm/Group Title Standard of Care (SoC) SoC + iTab
Hide Arm/Group Description:
Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC)
Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC) and daily individualized text-messaging for adherence building (iTAB)
Overall Number of Participants Analyzed 181 180
Measure Type: Number
Unit of Measure: % participants with > 1246 fmol/punch
Wk 12 43.9 50.8
Wk 48 37.4 51
3.Secondary Outcome
Title Rate of HIV Seroconversion
Hide Description Determine the rate of HIV seroconversion in PrEP users and compare the iTAB to SOC arms for number of new infections as a proportion at 48 weeks and end of study.
Time Frame Up to 2.5 years after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard of Care (SoC) SoC + iTab
Hide Arm/Group Description:
Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC)
Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC) and daily individualized text-messaging for adherence building (iTAB)
Overall Number of Participants Analyzed 198 200
Measure Type: Count of Participants
Unit of Measure: Participants
Wk 48
0
   0.0%
2
   1.0%
End of Study
0
   0.0%
2
   1.0%
Time Frame Up to end of follow up for participants 0-120 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard of Care (SoC) SoC + iTab
Hide Arm/Group Description Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC) Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC) and daily individualized text-messaging for adherence building (iTAB)
All-Cause Mortality
Standard of Care (SoC) SoC + iTab
Affected / at Risk (%) Affected / at Risk (%)
Total   0/198 (0.00%)      0/200 (0.00%)    
Hide Serious Adverse Events
Standard of Care (SoC) SoC + iTab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/198 (0.51%)      2/200 (1.00%)    
Infections and infestations     
HIV Seroconversion   0/198 (0.00%)  0 2/200 (1.00%)  2
Renal and urinary disorders     
Fanconi syndrome  [1]  1/198 (0.51%)  1 0/200 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Related to study drug
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard of Care (SoC) SoC + iTab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/198 (7.58%)      21/200 (10.50%)    
Gastrointestinal disorders     
GI symptoms  [1]  7/198 (3.54%)  8 12/200 (6.00%)  13
Infections and infestations     
infection   1/198 (0.51%)  1 4/200 (2.00%)  4
Metabolism and nutrition disorders     
hypophosphatemia   0/198 (0.00%)  0 1/200 (0.50%)  1
Musculoskeletal and connective tissue disorders     
muscle pain   2/198 (1.01%)  3 3/200 (1.50%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
tonsil lesion   1/198 (0.51%)  1 0/200 (0.00%)  0
Nervous system disorders     
paresthesia   1/198 (0.51%)  1 0/200 (0.00%)  0
Psychiatric disorders     
depression with or without sucidality   2/198 (1.01%)  2 0/200 (0.00%)  0
Renal and urinary disorders     
GU symptoms and disorders   1/198 (0.51%)  1 1/200 (0.50%)  1
Skin and subcutaneous tissue disorders     
rash   1/198 (0.51%)  1 2/200 (1.00%)  2
Indicates events were collected by systematic assessment
[1]
nausea, diarrhea, abdomen pain
Discontinuation of PrEP may be for valid reasons for not needing prevention of HIV due to not being sexually active
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mike Duszynski
Organization: UC San Diego
Phone: 6195438080
EMail: mduszynski@health.ucsd.edu
Layout table for additonal information
Responsible Party: Sheldon Morris, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01761643    
Other Study ID Numbers: CCTG 595
First Submitted: January 2, 2013
First Posted: January 7, 2013
Results First Submitted: May 13, 2020
Results First Posted: June 2, 2020
Last Update Posted: June 30, 2020