Trial Outcomes & Findings for CCTG 595: Text Messaging Intervention to Improve Adherence to PrEP in High-risk MSM (NCT NCT01761643)

NCT ID: NCT01761643

Last Updated: 2020-06-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 398 participants
• Primary outcome timeframe: Baseline to Week 48
• Results posted on: 2020-06-30

Participant Flow

Participant milestones

Measure	Standard of Care (SoC) Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC)	SoC + iTab 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 Study STARTED	198	200
Overall Study COMPLETED	166	158
Overall Study NOT COMPLETED	32	42

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Standard of Care (SoC) n=198 Participants Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC)	SoC + iTab n=200 Participants 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 n=398 Participants Total of all reporting groups
Age, Continuous	35.4 years STANDARD_DEVIATION 8.7 • n=5 Participants	35.1 years STANDARD_DEVIATION 9.8 • n=7 Participants	35.2 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex/Gender, Customized Male	198 Participants n=5 Participants	197 Participants n=7 Participants	395 Participants n=5 Participants
Sex/Gender, Customized Transgender woman	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Black	26 Participants n=5 Participants	26 Participants n=7 Participants	52 Participants n=5 Participants
Race/Ethnicity, Customized White	148 Participants n=5 Participants	147 Participants n=7 Participants	295 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic ethnicity	58 Participants n=5 Participants	61 Participants n=7 Participants	119 Participants n=5 Participants
Region of Enrollment United States	198 Participants n=5 Participants	200 Participants n=7 Participants	398 Participants n=5 Participants
PREP use	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 48

Population: Only participants with a DBS sample collected at study visits were included in this analysis.

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.

Outcome measures

Measure	Standard of Care (SoC) n=181 Participants Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC)	SoC + iTab n=180 Participants 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)
Adherence to PrEP Wk 12	85.6 % participants with > 719 fmol/punch	91.7 % participants with > 719 fmol/punch
Adherence to PrEP Wk 48	81.6 % participants with > 719 fmol/punch	83.4 % participants with > 719 fmol/punch

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: Only participants with a DBS sample collected at study visits were included in this analysis.

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.

Outcome measures

Measure	Standard of Care (SoC) n=181 Participants Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC)	SoC + iTab n=180 Participants 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)
Perfect Adherence to PrEP Wk 12	43.9 % participants with > 1246 fmol/punch	50.8 % participants with > 1246 fmol/punch
Perfect Adherence to PrEP Wk 48	37.4 % participants with > 1246 fmol/punch	51 % participants with > 1246 fmol/punch

SECONDARY outcome

Timeframe: Up to 2.5 years after baseline

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.

Outcome measures

Measure	Standard of Care (SoC) n=198 Participants Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC)	SoC + iTab n=200 Participants 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)
Rate of HIV Seroconversion End of Study	0 Participants	2 Participants
Rate of HIV Seroconversion Wk 48	0 Participants	2 Participants

Adverse Events

Standard of Care (SoC)

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

SoC + iTab

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard of Care (SoC) n=198 participants at risk Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC)	SoC + iTab n=200 participants at risk 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)
Renal and urinary disorders Fanconi syndrome	0.51% 1/198 • Number of events 1 • Up to end of follow up for participants 0-120 weeks	0.00% 0/200 • Up to end of follow up for participants 0-120 weeks
Infections and infestations HIV Seroconversion	0.00% 0/198 • Up to end of follow up for participants 0-120 weeks	1.0% 2/200 • Number of events 2 • Up to end of follow up for participants 0-120 weeks

Other adverse events

Measure	Standard of Care (SoC) n=198 participants at risk Fixed-dose daily oral 300mg tenofovir (TDF) and 200mg emtricitabine (FTC) with Standard of Care (SOC)	SoC + iTab n=200 participants at risk 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)
Gastrointestinal disorders GI symptoms	3.5% 7/198 • Number of events 8 • Up to end of follow up for participants 0-120 weeks	6.0% 12/200 • Number of events 13 • Up to end of follow up for participants 0-120 weeks
Musculoskeletal and connective tissue disorders muscle pain	1.0% 2/198 • Number of events 3 • Up to end of follow up for participants 0-120 weeks	1.5% 3/200 • Number of events 3 • Up to end of follow up for participants 0-120 weeks
Infections and infestations infection	0.51% 1/198 • Number of events 1 • Up to end of follow up for participants 0-120 weeks	2.0% 4/200 • Number of events 4 • Up to end of follow up for participants 0-120 weeks
Nervous system disorders paresthesia	0.51% 1/198 • Number of events 1 • Up to end of follow up for participants 0-120 weeks	0.00% 0/200 • Up to end of follow up for participants 0-120 weeks
Psychiatric disorders depression with or without sucidality	1.0% 2/198 • Number of events 2 • Up to end of follow up for participants 0-120 weeks	0.00% 0/200 • Up to end of follow up for participants 0-120 weeks
Renal and urinary disorders GU symptoms and disorders	0.51% 1/198 • Number of events 1 • Up to end of follow up for participants 0-120 weeks	0.50% 1/200 • Number of events 1 • Up to end of follow up for participants 0-120 weeks
Skin and subcutaneous tissue disorders rash	0.51% 1/198 • Number of events 1 • Up to end of follow up for participants 0-120 weeks	1.0% 2/200 • Number of events 2 • Up to end of follow up for participants 0-120 weeks
Metabolism and nutrition disorders hypophosphatemia	0.00% 0/198 • Up to end of follow up for participants 0-120 weeks	0.50% 1/200 • Number of events 1 • Up to end of follow up for participants 0-120 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) tonsil lesion	0.51% 1/198 • Number of events 1 • Up to end of follow up for participants 0-120 weeks	0.00% 0/200 • Up to end of follow up for participants 0-120 weeks

Additional Information

Mike Duszynski

UC San Diego

Phone: 6195438080

Email: mduszynski@health.ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place