Trial Outcomes & Findings for P3 (Prepared, Protected, emPowered) (NCT NCT03320512)
NCT ID: NCT03320512
Last Updated: 2022-10-25
Results Overview
PrEP adherence is measured by blood sample levels of tenofovir diphosphate (TFV-DP) with blood concentration consistent with \> 4 doses/week at 3- and 6- month follow-ups. The estimation of the average treatment effect compared P3 and P3+ combined to Control.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
246 participants
Primary outcome timeframe
Month 3, Month 6
Results posted on
2022-10-25
Participant Flow
Participant milestones
| Measure |
P3 Application
Participants will use P3
P3: P3 is an interactive smartphone app that utilizes social networking and game-based mechanics to improve PrEP adherence and persistence in Pre-Exposure Prophylaxis (PrEP) care. The participant will install P3 on their phone, receive a guided tour of the app and a reminder card with the research coordinator's phone number and email address and instructed to contact the research coordinator immediately to report difficulties with any app components or to report any problems with their phone or phone service. A help link is embedded within the app that directly links to study staff if assistance is needed. P3 arm participants will have 24-hour access to all features of P3.
|
P3+ Application
Participants will use P3+
P3+: In P3+, participants receive all of P3 and the ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve PrEP adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. Participants will install P3+ on their phone. The adherence counselor feature will be unlocked for those in the P3+ arm. P3+ participants will have 24-hour access to all features of P3+.
|
Control
Participants will receive the standard of care
Control: Control participants will receive the standard of care for receiving a prescription for PrEP.
|
|---|---|---|---|
|
Overall Study
STARTED
|
82
|
81
|
83
|
|
Overall Study
Month 3 Survey Started
|
69
|
72
|
71
|
|
Overall Study
Month 3 Survey Completed
|
69
|
72
|
68
|
|
Overall Study
Month 3 Lab Sample Collected
|
51
|
54
|
51
|
|
Overall Study
Month 6 Survey Started
|
67
|
72
|
69
|
|
Overall Study
Month 6 Survey Completed
|
65
|
71
|
68
|
|
Overall Study
Month 6 Lab Sample Collected
|
53
|
59
|
51
|
|
Overall Study
COMPLETED
|
82
|
81
|
83
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
P3 (Prepared, Protected, emPowered)
Baseline characteristics by cohort
| Measure |
P3 Application
n=82 Participants
Participants will use P3
P3: P3 is an interactive smartphone app that utilizes social networking and game-based mechanics to improve PrEP adherence and persistence in PrEP care. The participant will install P3 on their phone, receive a guided tour of the app and a reminder card with the research coordinator's phone number and email address and instructed to contact the research coordinator immediately to report difficulties with any app components or to report any problems with their phone or phone service. A help link is embedded within the app that directly links to study staff if assistance is needed. P3 arm participants will have 24-hour access to all features of P3.
|
P3+ Application
n=81 Participants
Participants will use P3+
P3+: In P3+, participants receive all of P3 and the ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve PrEP adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. Participants will install P3+ on their phone. The adherence counselor feature will be unlocked for those in the P3+ arm. P3+ participants will have 24-hour access to all features of P3+.
|
Control
n=83 Participants
Participants will receive the standard of care
Control: Control participants will receive the standard of care for receiving a prescription for PrEP.
|
Total
n=246 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
22 years
n=93 Participants
|
22 years
n=4 Participants
|
22 years
n=27 Participants
|
22 years
n=483 Participants
|
|
Sex/Gender, Customized
Male
|
71 Participants
n=93 Participants
|
71 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
216 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Trans female, trans woman, or transfeminine
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Genderqueer, gender non-conforming, or non-binary
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Multiple genders reported
|
8 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Declined to answer
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=93 Participants
|
81 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
246 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
71 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=93 Participants
|
63 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
175 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
51 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
137 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
82 Participants
n=93 Participants
|
81 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
246 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Month 3, Month 6Population: Data were included if 3- and/or 6-month samples were available. A participant's data was available if at least one sample was returned and that sample was readable (i.e., sample was not degraded and participant was not using Descovy).
PrEP adherence is measured by blood sample levels of tenofovir diphosphate (TFV-DP) with blood concentration consistent with \> 4 doses/week at 3- and 6- month follow-ups. The estimation of the average treatment effect compared P3 and P3+ combined to Control.
Outcome measures
| Measure |
P3 Application
n=38 Participants
Participants will use P3
P3: P3 is an interactive smartphone app that utilizes social networking and game-based mechanics to improve PrEP adherence and persistence in PrEP care. The participant will install P3 on their phone, receive a guided tour of the app and a reminder card with the research coordinator's phone number and email address and instructed to contact the research coordinator immediately to report difficulties with any app components or to report any problems with their phone or phone service. A help link is embedded within the app that directly links to study staff if assistance is needed. P3 arm participants will have 24-hour access to all features of P3.
|
P3+ Application
n=52 Participants
Participants will use P3+
P3+: In P3+, participants receive all of P3 and the ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve PrEP adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. Participants will install P3+ on their phone. The adherence counselor feature will be unlocked for those in the P3+ arm. P3+ participants will have 24-hour access to all features of P3+.
|
Control
n=45 Participants
Participants will receive the standard of care
Control: Control participants will receive the standard of care for receiving a prescription for PrEP.
|
|---|---|---|---|
|
PrEP Adherence Defined by Tenofovir Diphosphate (P3 and P3+ vs Control)
Month 3
|
24 Participants
|
33 Participants
|
23 Participants
|
|
PrEP Adherence Defined by Tenofovir Diphosphate (P3 and P3+ vs Control)
Month 6
|
18 Participants
|
25 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Month 3, Month 6Population: Data were included if 3- and/or 6-month samples were available. A participant's data was available if at least one sample was returned and that sample was readable (i.e., sample was not degraded).
PrEP adherence is measured by blood sample levels of emtricitabine triphosphate (FTC-TP) with blood concentration consistent with \> 4 doses/week at 3- and 6- month follow-ups. The estimation of the average treatment effect compared P3 and P3+ combined to Control.
Outcome measures
| Measure |
P3 Application
n=62 Participants
Participants will use P3
P3: P3 is an interactive smartphone app that utilizes social networking and game-based mechanics to improve PrEP adherence and persistence in PrEP care. The participant will install P3 on their phone, receive a guided tour of the app and a reminder card with the research coordinator's phone number and email address and instructed to contact the research coordinator immediately to report difficulties with any app components or to report any problems with their phone or phone service. A help link is embedded within the app that directly links to study staff if assistance is needed. P3 arm participants will have 24-hour access to all features of P3.
|
P3+ Application
n=69 Participants
Participants will use P3+
P3+: In P3+, participants receive all of P3 and the ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve PrEP adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. Participants will install P3+ on their phone. The adherence counselor feature will be unlocked for those in the P3+ arm. P3+ participants will have 24-hour access to all features of P3+.
|
Control
n=64 Participants
Participants will receive the standard of care
Control: Control participants will receive the standard of care for receiving a prescription for PrEP.
|
|---|---|---|---|
|
PrEP Adherence Defined by Emtricitabine Triphosphate (P3 and P3+ vs Control)
Month 3
|
36 Participants
|
38 Participants
|
29 Participants
|
|
PrEP Adherence Defined by Emtricitabine Triphosphate (P3 and P3+ vs Control)
Month 6
|
31 Participants
|
31 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Month 3, Month 6Population: Data were included if 3- and/or 6-month samples were available. A participant's data was available if they sufficiently responded to the clinical care survey questions and the survey was submitted within appropriate time window.
The investigators define "retention in care" as at least 1 PrEP clinical visit occurring in the last 3 months.
Outcome measures
| Measure |
P3 Application
n=73 Participants
Participants will use P3
P3: P3 is an interactive smartphone app that utilizes social networking and game-based mechanics to improve PrEP adherence and persistence in PrEP care. The participant will install P3 on their phone, receive a guided tour of the app and a reminder card with the research coordinator's phone number and email address and instructed to contact the research coordinator immediately to report difficulties with any app components or to report any problems with their phone or phone service. A help link is embedded within the app that directly links to study staff if assistance is needed. P3 arm participants will have 24-hour access to all features of P3.
|
P3+ Application
n=75 Participants
Participants will use P3+
P3+: In P3+, participants receive all of P3 and the ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve PrEP adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. Participants will install P3+ on their phone. The adherence counselor feature will be unlocked for those in the P3+ arm. P3+ participants will have 24-hour access to all features of P3+.
|
Control
n=74 Participants
Participants will receive the standard of care
Control: Control participants will receive the standard of care for receiving a prescription for PrEP.
|
|---|---|---|---|
|
Number of Participants With Self-reported Retention in PrEP Clinical Care
Month 3
|
38 Participants
|
43 Participants
|
38 Participants
|
|
Number of Participants With Self-reported Retention in PrEP Clinical Care
Month 6
|
32 Participants
|
34 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Month 3, Month 6Population: Data were included if 3- and/or 6-month responses were available. A participant's data was available if they sufficiently responded to the PrEP persistence survey questions and the survey was submitted within appropriate time window.
PrEP persistence will be measured by self-report at follow up of current PrEP use.
Outcome measures
| Measure |
P3 Application
n=74 Participants
Participants will use P3
P3: P3 is an interactive smartphone app that utilizes social networking and game-based mechanics to improve PrEP adherence and persistence in PrEP care. The participant will install P3 on their phone, receive a guided tour of the app and a reminder card with the research coordinator's phone number and email address and instructed to contact the research coordinator immediately to report difficulties with any app components or to report any problems with their phone or phone service. A help link is embedded within the app that directly links to study staff if assistance is needed. P3 arm participants will have 24-hour access to all features of P3.
|
P3+ Application
n=77 Participants
Participants will use P3+
P3+: In P3+, participants receive all of P3 and the ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve PrEP adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. Participants will install P3+ on their phone. The adherence counselor feature will be unlocked for those in the P3+ arm. P3+ participants will have 24-hour access to all features of P3+.
|
Control
n=74 Participants
Participants will receive the standard of care
Control: Control participants will receive the standard of care for receiving a prescription for PrEP.
|
|---|---|---|---|
|
PrEP Persistence
Month 3
|
66 Participants
|
64 Participants
|
59 Participants
|
|
PrEP Persistence
Month 6
|
52 Participants
|
49 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: Month 3, Month 6Population: Data were included if 3- and/or 6-month responses were available. A participant's data was available if they sufficiently responded to the sexual activity survey questions and the survey was submitted within appropriate time window.
Sexual Practices were assessed by self-reported number of insertive condomless anal sex occurrences during the past 3 months. This question is asked at the 3- and 6-month follow-up surveys.
Outcome measures
| Measure |
P3 Application
n=73 Participants
Participants will use P3
P3: P3 is an interactive smartphone app that utilizes social networking and game-based mechanics to improve PrEP adherence and persistence in PrEP care. The participant will install P3 on their phone, receive a guided tour of the app and a reminder card with the research coordinator's phone number and email address and instructed to contact the research coordinator immediately to report difficulties with any app components or to report any problems with their phone or phone service. A help link is embedded within the app that directly links to study staff if assistance is needed. P3 arm participants will have 24-hour access to all features of P3.
|
P3+ Application
n=77 Participants
Participants will use P3+
P3+: In P3+, participants receive all of P3 and the ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve PrEP adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. Participants will install P3+ on their phone. The adherence counselor feature will be unlocked for those in the P3+ arm. P3+ participants will have 24-hour access to all features of P3+.
|
Control
n=73 Participants
Participants will receive the standard of care
Control: Control participants will receive the standard of care for receiving a prescription for PrEP.
|
|---|---|---|---|
|
Insertive Condomless Anal Sex
Month 3
|
1 sex acts
Interval 0.0 to 2.0
|
0 sex acts
Interval 0.0 to 2.0
|
0 sex acts
Interval 0.0 to 2.0
|
|
Insertive Condomless Anal Sex
Month 6
|
0 sex acts
Interval 0.0 to 2.0
|
0 sex acts
Interval 0.0 to 1.0
|
0 sex acts
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Month 3, Month 6Population: Data were included if 3- and/or 6-month responses were available. A participant's data was available if they sufficiently responded to the sexual activity survey questions and the survey was submitted within appropriate time window.
Sexual Practices were assessed by self-reported number of receptive condomless anal sex occurrences during the past 3 months. This question is asked at the 3- and 6-month follow-up surveys.
Outcome measures
| Measure |
P3 Application
n=73 Participants
Participants will use P3
P3: P3 is an interactive smartphone app that utilizes social networking and game-based mechanics to improve PrEP adherence and persistence in PrEP care. The participant will install P3 on their phone, receive a guided tour of the app and a reminder card with the research coordinator's phone number and email address and instructed to contact the research coordinator immediately to report difficulties with any app components or to report any problems with their phone or phone service. A help link is embedded within the app that directly links to study staff if assistance is needed. P3 arm participants will have 24-hour access to all features of P3.
|
P3+ Application
n=77 Participants
Participants will use P3+
P3+: In P3+, participants receive all of P3 and the ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve PrEP adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. Participants will install P3+ on their phone. The adherence counselor feature will be unlocked for those in the P3+ arm. P3+ participants will have 24-hour access to all features of P3+.
|
Control
n=73 Participants
Participants will receive the standard of care
Control: Control participants will receive the standard of care for receiving a prescription for PrEP.
|
|---|---|---|---|
|
Receptive Condomless Anal Sex
Month 3
|
1 sex acts
Interval 0.0 to 3.0
|
0 sex acts
Interval 0.0 to 2.0
|
1 sex acts
Interval 0.0 to 3.0
|
|
Receptive Condomless Anal Sex
Month 6
|
1 sex acts
Interval 0.0 to 3.0
|
0 sex acts
Interval 0.0 to 1.0
|
0 sex acts
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Month 3, Month 6Population: Data were included if 3- and/or 6-month responses were available. A participant's data was available if they sufficiently responded to the STI survey questions and the survey was submitted within appropriate time window.
Self-reported STIs (combined rectal and urethral gonorrhea and chlamydia, syphilis) in last 3 months. This question is asked at the 3- and 6-month follow-up surveys.
Outcome measures
| Measure |
P3 Application
n=54 Participants
Participants will use P3
P3: P3 is an interactive smartphone app that utilizes social networking and game-based mechanics to improve PrEP adherence and persistence in PrEP care. The participant will install P3 on their phone, receive a guided tour of the app and a reminder card with the research coordinator's phone number and email address and instructed to contact the research coordinator immediately to report difficulties with any app components or to report any problems with their phone or phone service. A help link is embedded within the app that directly links to study staff if assistance is needed. P3 arm participants will have 24-hour access to all features of P3.
|
P3+ Application
n=60 Participants
Participants will use P3+
P3+: In P3+, participants receive all of P3 and the ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve PrEP adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. Participants will install P3+ on their phone. The adherence counselor feature will be unlocked for those in the P3+ arm. P3+ participants will have 24-hour access to all features of P3+.
|
Control
n=55 Participants
Participants will receive the standard of care
Control: Control participants will receive the standard of care for receiving a prescription for PrEP.
|
|---|---|---|---|
|
Sexually Transmitted Infections (STI) Incidence
Month 3 Syphilis
|
9 Participants
|
8 Participants
|
12 Participants
|
|
Sexually Transmitted Infections (STI) Incidence
Month 3 Gonorrhea
|
12 Participants
|
14 Participants
|
14 Participants
|
|
Sexually Transmitted Infections (STI) Incidence
Month 6 Gonorrhea
|
11 Participants
|
6 Participants
|
10 Participants
|
|
Sexually Transmitted Infections (STI) Incidence
Month 3 Chlamydia
|
11 Participants
|
14 Participants
|
17 Participants
|
|
Sexually Transmitted Infections (STI) Incidence
Month 6 Chlamydia
|
11 Participants
|
8 Participants
|
12 Participants
|
|
Sexually Transmitted Infections (STI) Incidence
Month 6 Syphilis
|
11 Participants
|
3 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Month 3, Month 6Population: Data were included if 3- and/or 6-month samples were available. A participant's data was available if at least one sample was returned and that sample was readable (i.e., sample was not degraded and participant was not using Descovy).
PrEP adherence is measured by blood sample levels of tenofovir diphosphate (TFV-DP) with blood concentration consistent with \> 4 doses/week at 3- and 6- month follow-ups. The estimation of the average treatment effect compared P3 to Control and also P3+ to Control.
Outcome measures
| Measure |
P3 Application
n=38 Participants
Participants will use P3
P3: P3 is an interactive smartphone app that utilizes social networking and game-based mechanics to improve PrEP adherence and persistence in PrEP care. The participant will install P3 on their phone, receive a guided tour of the app and a reminder card with the research coordinator's phone number and email address and instructed to contact the research coordinator immediately to report difficulties with any app components or to report any problems with their phone or phone service. A help link is embedded within the app that directly links to study staff if assistance is needed. P3 arm participants will have 24-hour access to all features of P3.
|
P3+ Application
n=52 Participants
Participants will use P3+
P3+: In P3+, participants receive all of P3 and the ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve PrEP adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. Participants will install P3+ on their phone. The adherence counselor feature will be unlocked for those in the P3+ arm. P3+ participants will have 24-hour access to all features of P3+.
|
Control
n=45 Participants
Participants will receive the standard of care
Control: Control participants will receive the standard of care for receiving a prescription for PrEP.
|
|---|---|---|---|
|
PrEP Adherence Defined by Tenofovir Diphosphate (P3 vs Control and P3+ vs Control)
Month 3
|
24 Participants
|
33 Participants
|
23 Participants
|
|
PrEP Adherence Defined by Tenofovir Diphosphate (P3 vs Control and P3+ vs Control)
Month 6
|
18 Participants
|
25 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Month 3, Month 6Population: Data were included if 3- and/or 6-month samples were available. A participant's data was available if at least one sample was returned and that sample was readable (i.e., sample was not degraded).
PrEP adherence is measured by blood sample levels of emtricitabine triphosphate (FTC-TP) with blood concentration consistent with \> 4 doses/week at 3- and 6- month follow-ups. The estimation of the average treatment effect compared P3 to Control and also P3+ to Control.
Outcome measures
| Measure |
P3 Application
n=62 Participants
Participants will use P3
P3: P3 is an interactive smartphone app that utilizes social networking and game-based mechanics to improve PrEP adherence and persistence in PrEP care. The participant will install P3 on their phone, receive a guided tour of the app and a reminder card with the research coordinator's phone number and email address and instructed to contact the research coordinator immediately to report difficulties with any app components or to report any problems with their phone or phone service. A help link is embedded within the app that directly links to study staff if assistance is needed. P3 arm participants will have 24-hour access to all features of P3.
|
P3+ Application
n=69 Participants
Participants will use P3+
P3+: In P3+, participants receive all of P3 and the ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve PrEP adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. Participants will install P3+ on their phone. The adherence counselor feature will be unlocked for those in the P3+ arm. P3+ participants will have 24-hour access to all features of P3+.
|
Control
n=64 Participants
Participants will receive the standard of care
Control: Control participants will receive the standard of care for receiving a prescription for PrEP.
|
|---|---|---|---|
|
PrEP Adherence Defined by Emtricitabine Triphosphate (P3 vs Control and P3+ vs Control)
Month 3
|
36 Participants
|
38 Participants
|
29 Participants
|
|
PrEP Adherence Defined by Emtricitabine Triphosphate (P3 vs Control and P3+ vs Control)
Month 6
|
31 Participants
|
31 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Month 3, Month 6Population: Data were included if 3- and/or 6-month responses were available. A participant's data was available if they sufficiently responded to the PrEP use survey questions and the survey was submitted within appropriate time window.
Number of participants reported taking their PrEP medication \>/= 4 days in the past week.
Outcome measures
| Measure |
P3 Application
n=73 Participants
Participants will use P3
P3: P3 is an interactive smartphone app that utilizes social networking and game-based mechanics to improve PrEP adherence and persistence in PrEP care. The participant will install P3 on their phone, receive a guided tour of the app and a reminder card with the research coordinator's phone number and email address and instructed to contact the research coordinator immediately to report difficulties with any app components or to report any problems with their phone or phone service. A help link is embedded within the app that directly links to study staff if assistance is needed. P3 arm participants will have 24-hour access to all features of P3.
|
P3+ Application
n=77 Participants
Participants will use P3+
P3+: In P3+, participants receive all of P3 and the ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve PrEP adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. Participants will install P3+ on their phone. The adherence counselor feature will be unlocked for those in the P3+ arm. P3+ participants will have 24-hour access to all features of P3+.
|
Control
n=74 Participants
Participants will receive the standard of care
Control: Control participants will receive the standard of care for receiving a prescription for PrEP.
|
|---|---|---|---|
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Self-Reported Weekly PrEP Use
Month 3
|
58 Participants
|
59 Participants
|
51 Participants
|
|
Self-Reported Weekly PrEP Use
Month 6
|
49 Participants
|
48 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Month 3, Month 6Population: Data were included if 3- and/or 6-month responses were available. A participant's data was available if they sufficiently responded to the PrEP use survey questions and the survey was submitted within appropriate time window.
Median self-reported percent of time in the past month that participants' took their PrEP as prescribed.
Outcome measures
| Measure |
P3 Application
n=74 Participants
Participants will use P3
P3: P3 is an interactive smartphone app that utilizes social networking and game-based mechanics to improve PrEP adherence and persistence in PrEP care. The participant will install P3 on their phone, receive a guided tour of the app and a reminder card with the research coordinator's phone number and email address and instructed to contact the research coordinator immediately to report difficulties with any app components or to report any problems with their phone or phone service. A help link is embedded within the app that directly links to study staff if assistance is needed. P3 arm participants will have 24-hour access to all features of P3.
|
P3+ Application
n=77 Participants
Participants will use P3+
P3+: In P3+, participants receive all of P3 and the ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve PrEP adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. Participants will install P3+ on their phone. The adherence counselor feature will be unlocked for those in the P3+ arm. P3+ participants will have 24-hour access to all features of P3+.
|
Control
n=74 Participants
Participants will receive the standard of care
Control: Control participants will receive the standard of care for receiving a prescription for PrEP.
|
|---|---|---|---|
|
Self-Reported Monthly PrEP Use
Month 3
|
100 percentage of time compliant
Interval 80.0 to 100.0
|
100 percentage of time compliant
Interval 90.0 to 100.0
|
90 percentage of time compliant
Interval 72.5 to 100.0
|
|
Self-Reported Monthly PrEP Use
Month 6
|
90 percentage of time compliant
Interval 50.0 to 100.0
|
90 percentage of time compliant
Interval 25.0 to 100.0
|
90 percentage of time compliant
Interval 67.5 to 100.0
|
SECONDARY outcome
Timeframe: Throughout the duration of the study, approximately 1.5 yearsPopulation: This outcome pertains to participating sites rather than actual participants. The analysis was applicable only to the intervention arms; the control arm is excluded since there was no intervention or associated cost. Data were not reported for 1 site which was inactive during the data collection periods.
Information was collected on (1) time spent by study staff for training and supervision of adherence counselor(s); (2) time participants spent in the adherence counseling sessions; and (3) costs associated with the delivery of both P3 and P3+. Resources were organized into standard expenditure categories and attributed to the corresponding P3 or P3+ arm and study site as appropriate.
Outcome measures
| Measure |
P3 Application
n=8 Participating Sites
Participants will use P3
P3: P3 is an interactive smartphone app that utilizes social networking and game-based mechanics to improve PrEP adherence and persistence in PrEP care. The participant will install P3 on their phone, receive a guided tour of the app and a reminder card with the research coordinator's phone number and email address and instructed to contact the research coordinator immediately to report difficulties with any app components or to report any problems with their phone or phone service. A help link is embedded within the app that directly links to study staff if assistance is needed. P3 arm participants will have 24-hour access to all features of P3.
|
P3+ Application
n=8 Participating Sites
Participants will use P3+
P3+: In P3+, participants receive all of P3 and the ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve PrEP adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. Participants will install P3+ on their phone. The adherence counselor feature will be unlocked for those in the P3+ arm. P3+ participants will have 24-hour access to all features of P3+.
|
Control
Participants will receive the standard of care
Control: Control participants will receive the standard of care for receiving a prescription for PrEP.
|
|---|---|---|---|
|
Mean Site-Level Intervention Cost
|
551.88 average cost per participant in USD
Standard Deviation 160.43
|
673.52 average cost per participant in USD
Standard Deviation 161.06
|
—
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Adverse Events
P3 Application
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
P3+ Application
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lisa Hightow-Weidman
University of North Carolina at Chapel Hill
Phone: 919-843-0033
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place