Trial Outcomes & Findings for A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services (NCT NCT01781806)
NCT ID: NCT01781806
Last Updated: 2018-04-06
Results Overview
Number and frequency rate of clinical and laboratory AEs (Gr 2 and above), including SAEs by Cohort.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
328 participants
Primary outcome timeframe
Baseline to 48 weeks
Results posted on
2018-04-06
Participant Flow
Of the 328 participants who enrolled in the study, 27 screen failed for various reasons and were not assigned to a cohort.
Participant milestones
| Measure |
Cohort H (PrEP)
Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).
High Risk Cohort Criteria (one or more of the following has to be met):
1. No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.
2. STI diagnosis during the last 12 months.
3. Previous PEP use during the last 12 months (\* see exclusion criteria)
4. Has at least one HIV infected sexual partner for ≥4 weeks.
emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \<30 mL/min, Truvada will be discontinued.
|
Cohort LM (PEP)
Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.
emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \<30 mL/min, Truvada will be discontinued.
|
|---|---|---|
|
Overall Study
STARTED
|
297
|
4
|
|
Overall Study
Week 0
|
297
|
4
|
|
Overall Study
Week 4
|
284
|
4
|
|
Overall Study
Week 8
|
278
|
4
|
|
Overall Study
Week 12
|
272
|
2
|
|
Overall Study
Week 24
|
260
|
1
|
|
Overall Study
Week 36
|
247
|
1
|
|
Overall Study
Week 48
|
222
|
1
|
|
Overall Study
COMPLETED
|
218
|
1
|
|
Overall Study
NOT COMPLETED
|
79
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services
Baseline characteristics by cohort
| Measure |
Cohort H (PrEP)
n=297 Participants
Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).
High Risk Cohort Criteria (one or more of the following has to be met):
1. No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.
2. STI diagnosis during the last 12 months.
3. Previous PEP use during the last 12 months (\* see exclusion criteria)
4. Has at least one HIV infected sexual partner for ≥4 weeks.
emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \<30 mL/min, Truvada will be discontinued.
|
Cohort LM (PEP)
n=4 Participants
Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.
emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \<30 mL/min, Truvada will be discontinued.
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33 years
n=5 Participants
|
35 years
n=7 Participants
|
34 years
n=5 Participants
|
|
Sex/Gender, Customized
Male · Male
|
296 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male · Transfemale
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
150 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
30 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
82 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
14 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander/Alaskan Native
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race/Other
|
16 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
297 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
301 Participants
n=5 Participants
|
|
Education
High school or less
|
33 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Education
Some college
|
105 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Education
College graduate
|
104 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Education
Any postgraduate
|
55 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Insurance
Uninsured
|
91 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Insurance
Insured
|
200 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Insurance
Unknown
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Marital Status
Married/civil union/legal partnership
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Marital Status
Living with primary or main partner
|
42 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Marital Status
Have primary or main partner, not living together
|
39 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Marital Status
Single/divorced/widowed
|
194 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Marital Status
Other
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Marital Status
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Family Income
$20,000 or less
|
92 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Family Income
$20,001 - $50,000
|
111 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Family Income
$50,001 or more
|
94 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 48 weeksNumber and frequency rate of clinical and laboratory AEs (Gr 2 and above), including SAEs by Cohort.
Outcome measures
| Measure |
Cohort H (PrEP)
n=297 Participants
Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).
High Risk Cohort Criteria (one or more of the following has to be met):
1. No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.
2. STI diagnosis during the last 12 months.
3. Previous PEP use during the last 12 months (\* see exclusion criteria)
4. Has at least one HIV infected sexual partner for ≥4 weeks.
emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \<30 mL/min, Truvada will be discontinued.
|
Cohort LM (PEP)
n=4 Participants
Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.
emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \<30 mL/min, Truvada will be discontinued.
|
|---|---|---|
|
Number of Participants With a Grade 2 or Higher Adverse Event by Cohort
|
230 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to 48 weeksOptimal adherence to daily oral emtricitabine/tenofovir disoproxil fumarate by study visit as measured by tenofovir diphosphate (TFV-DP) in dried blood spots (DBS). Optimal adherence is defined as TFV-DP levels great than or equal to 700 femtomoles per punch in DBS samples (approximately 4 or more doses a week over the past 60 days).
Outcome measures
| Measure |
Cohort H (PrEP)
n=296 Participants
Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).
High Risk Cohort Criteria (one or more of the following has to be met):
1. No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.
2. STI diagnosis during the last 12 months.
3. Previous PEP use during the last 12 months (\* see exclusion criteria)
4. Has at least one HIV infected sexual partner for ≥4 weeks.
emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \<30 mL/min, Truvada will be discontinued.
|
Cohort LM (PEP)
Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.
emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \<30 mL/min, Truvada will be discontinued.
|
|---|---|---|
|
Cohort H PrEP Engagement by Study Visit
Week 4
|
246 Participants
|
—
|
|
Cohort H PrEP Engagement by Study Visit
Week 12
|
247 Participants
|
—
|
|
Cohort H PrEP Engagement by Study Visit
Week 24
|
224 Participants
|
—
|
|
Cohort H PrEP Engagement by Study Visit
Week 36
|
212 Participants
|
—
|
|
Cohort H PrEP Engagement by Study Visit
Week 48
|
194 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 48 weeksChanges in sexual risk behavior as assessed via CASI-based self-report questionnaire, measured longitudinally over time.
Outcome measures
| Measure |
Cohort H (PrEP)
n=301 Participants
Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).
High Risk Cohort Criteria (one or more of the following has to be met):
1. No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.
2. STI diagnosis during the last 12 months.
3. Previous PEP use during the last 12 months (\* see exclusion criteria)
4. Has at least one HIV infected sexual partner for ≥4 weeks.
emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \<30 mL/min, Truvada will be discontinued.
|
Cohort LM (PEP)
Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.
emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \<30 mL/min, Truvada will be discontinued.
|
|---|---|---|
|
Escalation in Transmission Risk Behavior Among Participants Reporting Low Risk Behaviors at Baseline
High risk reported at baseline and remained high
|
278 Participants
|
—
|
|
Escalation in Transmission Risk Behavior Among Participants Reporting Low Risk Behaviors at Baseline
Risk increased from low (baseline) to high
|
19 Participants
|
—
|
|
Escalation in Transmission Risk Behavior Among Participants Reporting Low Risk Behaviors at Baseline
Low risk reported at baseline and remained low
|
4 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 48 weeksOutcome measures
| Measure |
Cohort H (PrEP)
n=297 Participants
Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).
High Risk Cohort Criteria (one or more of the following has to be met):
1. No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.
2. STI diagnosis during the last 12 months.
3. Previous PEP use during the last 12 months (\* see exclusion criteria)
4. Has at least one HIV infected sexual partner for ≥4 weeks.
emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \<30 mL/min, Truvada will be discontinued.
|
Cohort LM (PEP)
n=4 Participants
Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.
emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \<30 mL/min, Truvada will be discontinued.
|
|---|---|---|
|
Number of HIV Seroconversions by Cohort.
|
1 Participants
|
0 Participants
|
Adverse Events
Cohort H (PrEP)
Serious events: 2 serious events
Other events: 195 other events
Deaths: 0 deaths
Cohort LM (PEP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort H (PrEP)
n=297 participants at risk
Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).
High Risk Cohort Criteria (one or more of the following has to be met):
1. No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.
2. STI diagnosis during the last 12 months.
3. Previous PEP use during the last 12 months (\* see exclusion criteria)
4. Has at least one HIV infected sexual partner for ≥4 weeks.
emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \<30 mL/min, Truvada will be discontinued.
|
Cohort LM (PEP)
n=4 participants at risk
Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.
emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \<30 mL/min, Truvada will be discontinued.
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
0.34%
1/297 • Number of events 1
|
0.00%
0/4
|
|
Psychiatric disorders
Anger
|
0.34%
1/297 • Number of events 2
|
0.00%
0/4
|
|
Psychiatric disorders
Intentional self-injury
|
0.34%
1/297 • Number of events 1
|
0.00%
0/4
|
Other adverse events
| Measure |
Cohort H (PrEP)
n=297 participants at risk
Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).
High Risk Cohort Criteria (one or more of the following has to be met):
1. No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.
2. STI diagnosis during the last 12 months.
3. Previous PEP use during the last 12 months (\* see exclusion criteria)
4. Has at least one HIV infected sexual partner for ≥4 weeks.
emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \<30 mL/min, Truvada will be discontinued.
|
Cohort LM (PEP)
n=4 participants at risk
Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.
emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \<30 mL/min, Truvada will be discontinued.
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
4.4%
13/297 • Number of events 13
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
20.9%
62/297 • Number of events 80
|
0.00%
0/4
|
|
Infections and infestations
Oropharyngeal gonococcal infection
|
21.9%
65/297 • Number of events 68
|
0.00%
0/4
|
|
Infections and infestations
Proctitis chlamydial
|
28.3%
84/297 • Number of events 109
|
0.00%
0/4
|
|
Infections and infestations
Proctitis gonococcal
|
18.9%
56/297 • Number of events 61
|
0.00%
0/4
|
|
Infections and infestations
Syphilis
|
11.1%
33/297 • Number of events 35
|
0.00%
0/4
|
|
Infections and infestations
Urethritis chlamydial
|
7.7%
23/297 • Number of events 24
|
0.00%
0/4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place