Trial Outcomes & Findings for PrEP My Way: A Novel PrEP Delivery System to Meet the Needs of Young African Women (NCT NCT04408729)
NCT ID: NCT04408729
Last Updated: 2024-05-24
Results Overview
PrEP adherence as measured by detectable tenofovir-diphosphate (TFV-DP) in dried blood spots
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
Six months
Results posted on
2024-05-24
Participant Flow
Participant milestones
| Measure |
PrEP My Way Intervention
PrEP My Way is an intervention that involves peer-delivery of a kit containing PrEP and other sexual health services. Participants will be offered PrEP if HIV-negative per a point-of-care test, pregnancy testing, vaginal swabs for gonorrhea and chlamydia testing, condoms, and/or self-injection medroxyprogesterone, as desired.
PrEP My Way: Intervention components may be modified pending the input from Aim 1. As currently planned, the peer delivering the PrEP My Way kit will be trained to provide basic education and support use of the kit components. The peer will also have a smart phone to show an instructional video. Participants will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit delivery at Months 1, 3, and 6 via unmarked vehicles at home or a preferred safe site during reasonable hours. Two-way mobile phone communication will also be used to convey test results and provide on-going support and empowerment. Follow-up with the clinic will occur at Month 6 and as needed (e.g., treatment for positive tests).
This intervention aims to increase adherence/persistence on PrEP. We hypothesize that removing the structural barriers and stigma associated with going to the clinic, women may be more likely to continue on PrEP.
|
Control
These participants will continue to receive PrEP at the clinic.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
71
|
71
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PrEP My Way: A Novel PrEP Delivery System to Meet the Needs of Young African Women
Baseline characteristics by cohort
| Measure |
PrEP My Way Intervention
n=75 Participants
PrEP My Way is an intervention that involves peer-delivery of a kit containing PrEP and other sexual health services. Participants will be offered PrEP if HIV-negative per a point-of-care test, pregnancy testing, vaginal swabs for gonorrhea and chlamydia testing, condoms, and/or self-injection medroxyprogesterone, as desired.
PrEP My Way: Intervention components may be modified pending the input from Aim 1. As currently planned, the peer delivering the PrEP My Way kit will be trained to provide basic education and support use of the kit components. The peer will also have a smart phone to show an instructional video. Participants will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit delivery at Months 1, 3, and 6 via unmarked vehicles at home or a preferred safe site during reasonable hours. Two-way mobile phone communication will also be used to convey test results and provide on-going support and empowerment. Follow-up with the clinic will occur at Month 6 and as needed (e.g., treatment for positive tests).
This intervention aims to increase adherence/persistence on PrEP. We hypothesize that removing the structural barriers and stigma associated with going to the clinic, women may be more likely to continue on PrEP.
|
Control
n=75 Participants
These participants will continue to receive PrEP at the clinic.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.6 years
n=5 Participants
|
22.6 years
n=7 Participants
|
22.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
75 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Kenya
|
75 participants
n=5 Participants
|
75 participants
n=7 Participants
|
150 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Six monthsPopulation: TFV-DP detection at 6 months per dried blood spots
PrEP adherence as measured by detectable tenofovir-diphosphate (TFV-DP) in dried blood spots
Outcome measures
| Measure |
PrEP My Way Intervention
n=75 Participants
PrEP My Way is an intervention that involves peer-delivery of a kit containing PrEP and other sexual health services. Participants will be offered PrEP if HIV-negative per a point-of-care test, pregnancy testing, vaginal swabs for gonorrhea and chlamydia testing, condoms, and/or self-injection medroxyprogesterone, as desired.
PrEP My Way: Intervention components may be modified pending the input from Aim 1. As currently planned, the peer delivering the PrEP My Way kit will be trained to provide basic education and support use of the kit components. The peer will also have a smart phone to show an instructional video. Participants will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit delivery at Months 1, 3, and 6 via unmarked vehicles at home or a preferred safe site during reasonable hours. Two-way mobile phone communication will also be used to convey test results and provide on-going support and empowerment. Follow-up with the clinic will occur at Month 6 and as needed (e.g., treatment for positive tests).
This intervention aims to increase adherence/persistence on PrEP. We hypothesize that removing the structural barriers and stigma associated with going to the clinic, women may be more likely to continue on PrEP.
|
Control
n=75 Participants
These participants will continue to receive PrEP at the clinic.
|
|---|---|---|
|
PrEP Adherence
|
12 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Months 1, 3, 6 (intervention arm)Population: Intervention participants reporting PrEP use at each kit delivery. Up to 75 participants could have taken PrEP at each time point; the number of participants analyzed at each time point is a subset of the 75, because not all participants chose to receive kits.
PrEP adherence as measured by questionnaires at kit delivery.
Outcome measures
| Measure |
PrEP My Way Intervention
n=75 Participants
PrEP My Way is an intervention that involves peer-delivery of a kit containing PrEP and other sexual health services. Participants will be offered PrEP if HIV-negative per a point-of-care test, pregnancy testing, vaginal swabs for gonorrhea and chlamydia testing, condoms, and/or self-injection medroxyprogesterone, as desired.
PrEP My Way: Intervention components may be modified pending the input from Aim 1. As currently planned, the peer delivering the PrEP My Way kit will be trained to provide basic education and support use of the kit components. The peer will also have a smart phone to show an instructional video. Participants will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit delivery at Months 1, 3, and 6 via unmarked vehicles at home or a preferred safe site during reasonable hours. Two-way mobile phone communication will also be used to convey test results and provide on-going support and empowerment. Follow-up with the clinic will occur at Month 6 and as needed (e.g., treatment for positive tests).
This intervention aims to increase adherence/persistence on PrEP. We hypothesize that removing the structural barriers and stigma associated with going to the clinic, women may be more likely to continue on PrEP.
|
Control
These participants will continue to receive PrEP at the clinic.
|
|---|---|---|
|
Self-reported PrEP Adherence in the Past 30 Days
Month 1
|
92 percentage of doses taken
Interval 17.0 to 100.0
|
—
|
|
Self-reported PrEP Adherence in the Past 30 Days
Month 3
|
79 percentage of doses taken
Interval 0.0 to 100.0
|
—
|
|
Self-reported PrEP Adherence in the Past 30 Days
Month 6
|
68 percentage of doses taken
Interval 0.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: Study participants
PrEP use as measured by PrEP receipt in the kit (intervention) or pharmacy pick up (control) at 6 months
Outcome measures
| Measure |
PrEP My Way Intervention
n=75 Participants
PrEP My Way is an intervention that involves peer-delivery of a kit containing PrEP and other sexual health services. Participants will be offered PrEP if HIV-negative per a point-of-care test, pregnancy testing, vaginal swabs for gonorrhea and chlamydia testing, condoms, and/or self-injection medroxyprogesterone, as desired.
PrEP My Way: Intervention components may be modified pending the input from Aim 1. As currently planned, the peer delivering the PrEP My Way kit will be trained to provide basic education and support use of the kit components. The peer will also have a smart phone to show an instructional video. Participants will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit delivery at Months 1, 3, and 6 via unmarked vehicles at home or a preferred safe site during reasonable hours. Two-way mobile phone communication will also be used to convey test results and provide on-going support and empowerment. Follow-up with the clinic will occur at Month 6 and as needed (e.g., treatment for positive tests).
This intervention aims to increase adherence/persistence on PrEP. We hypothesize that removing the structural barriers and stigma associated with going to the clinic, women may be more likely to continue on PrEP.
|
Control
n=75 Participants
These participants will continue to receive PrEP at the clinic.
|
|---|---|---|
|
Number of Participants With PrEP Persistence (Kit Delivery/Pharmacy Refill)
|
50 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Months 1, 3, and 6Population: Participants who had STI testing done
Testing for gonorrhea and chlamydia
Outcome measures
| Measure |
PrEP My Way Intervention
n=75 Participants
PrEP My Way is an intervention that involves peer-delivery of a kit containing PrEP and other sexual health services. Participants will be offered PrEP if HIV-negative per a point-of-care test, pregnancy testing, vaginal swabs for gonorrhea and chlamydia testing, condoms, and/or self-injection medroxyprogesterone, as desired.
PrEP My Way: Intervention components may be modified pending the input from Aim 1. As currently planned, the peer delivering the PrEP My Way kit will be trained to provide basic education and support use of the kit components. The peer will also have a smart phone to show an instructional video. Participants will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit delivery at Months 1, 3, and 6 via unmarked vehicles at home or a preferred safe site during reasonable hours. Two-way mobile phone communication will also be used to convey test results and provide on-going support and empowerment. Follow-up with the clinic will occur at Month 6 and as needed (e.g., treatment for positive tests).
This intervention aims to increase adherence/persistence on PrEP. We hypothesize that removing the structural barriers and stigma associated with going to the clinic, women may be more likely to continue on PrEP.
|
Control
n=75 Participants
These participants will continue to receive PrEP at the clinic.
|
|---|---|---|
|
Rates of STI Testing
Month 1
|
67 Participants
|
0 Participants
|
|
Rates of STI Testing
Month 3
|
64 Participants
|
0 Participants
|
|
Rates of STI Testing
Month 6
|
62 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Months 1, 3, and 6Population: participants not using long-acting contraception (i.e., contraceptive implants or intrauterine devices)
Receipt of oral contraceptive pills or injections of medroxyprogesterone at least once among participants not using long-acting contraception (i.e., contraceptive implants or intrauterine devices)
Outcome measures
| Measure |
PrEP My Way Intervention
n=61 Participants
PrEP My Way is an intervention that involves peer-delivery of a kit containing PrEP and other sexual health services. Participants will be offered PrEP if HIV-negative per a point-of-care test, pregnancy testing, vaginal swabs for gonorrhea and chlamydia testing, condoms, and/or self-injection medroxyprogesterone, as desired.
PrEP My Way: Intervention components may be modified pending the input from Aim 1. As currently planned, the peer delivering the PrEP My Way kit will be trained to provide basic education and support use of the kit components. The peer will also have a smart phone to show an instructional video. Participants will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit delivery at Months 1, 3, and 6 via unmarked vehicles at home or a preferred safe site during reasonable hours. Two-way mobile phone communication will also be used to convey test results and provide on-going support and empowerment. Follow-up with the clinic will occur at Month 6 and as needed (e.g., treatment for positive tests).
This intervention aims to increase adherence/persistence on PrEP. We hypothesize that removing the structural barriers and stigma associated with going to the clinic, women may be more likely to continue on PrEP.
|
Control
n=52 Participants
These participants will continue to receive PrEP at the clinic.
|
|---|---|---|
|
Rates of Hormonal Contraception
|
50 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Measured at 6 monthsPopulation: Women with ongoing HIV prevention needs, defined as meeting one of the following criteria: 1) PrEP use (per self-report and/or detectable TFVp-DP), 2) \>1 concurrent sexual partner, 3) condomless sex, and 4) indication of "some/a lot of concern about getting HIV)
Detectable TFV-DP among women with ongoing HIV prevention needs, defined as meeting one or more of the following criteria: 1) PrEP use (per self-report and/or detectable TFVp-DP), 2) \>1 concurrent sexual partner, 3) condomless sex, and 4) indication of "some/a lot of concern about getting HIV)
Outcome measures
| Measure |
PrEP My Way Intervention
n=67 Participants
PrEP My Way is an intervention that involves peer-delivery of a kit containing PrEP and other sexual health services. Participants will be offered PrEP if HIV-negative per a point-of-care test, pregnancy testing, vaginal swabs for gonorrhea and chlamydia testing, condoms, and/or self-injection medroxyprogesterone, as desired.
PrEP My Way: Intervention components may be modified pending the input from Aim 1. As currently planned, the peer delivering the PrEP My Way kit will be trained to provide basic education and support use of the kit components. The peer will also have a smart phone to show an instructional video. Participants will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit delivery at Months 1, 3, and 6 via unmarked vehicles at home or a preferred safe site during reasonable hours. Two-way mobile phone communication will also be used to convey test results and provide on-going support and empowerment. Follow-up with the clinic will occur at Month 6 and as needed (e.g., treatment for positive tests).
This intervention aims to increase adherence/persistence on PrEP. We hypothesize that removing the structural barriers and stigma associated with going to the clinic, women may be more likely to continue on PrEP.
|
Control
n=56 Participants
These participants will continue to receive PrEP at the clinic.
|
|---|---|---|
|
Prevention-effective Adherence at 6 Months
|
12 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Six monthsPopulation: Intervention participants
The PrEP My Way intervention will be considered feasible if \>70% (35/50) participants 1) receive a kit at Months 1, 3, and 6; and 2) have a readable HIV test, usable vaginal swab, and self-injection of medroxyprogesterone, if desired, per protocol at \>66% (2/3) of visits. The outcome indicates the number of participants at each time point who received a kit and were able to 1) read their HIV test (if testing was desired), 2) provide a vaginal swab that could be assessed for gonorrhea/chlamydia (if testing was desired), and 3) inject medroxyprogesterone (if the product was desired).
Outcome measures
| Measure |
PrEP My Way Intervention
n=75 Participants
PrEP My Way is an intervention that involves peer-delivery of a kit containing PrEP and other sexual health services. Participants will be offered PrEP if HIV-negative per a point-of-care test, pregnancy testing, vaginal swabs for gonorrhea and chlamydia testing, condoms, and/or self-injection medroxyprogesterone, as desired.
PrEP My Way: Intervention components may be modified pending the input from Aim 1. As currently planned, the peer delivering the PrEP My Way kit will be trained to provide basic education and support use of the kit components. The peer will also have a smart phone to show an instructional video. Participants will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit delivery at Months 1, 3, and 6 via unmarked vehicles at home or a preferred safe site during reasonable hours. Two-way mobile phone communication will also be used to convey test results and provide on-going support and empowerment. Follow-up with the clinic will occur at Month 6 and as needed (e.g., treatment for positive tests).
This intervention aims to increase adherence/persistence on PrEP. We hypothesize that removing the structural barriers and stigma associated with going to the clinic, women may be more likely to continue on PrEP.
|
Control
These participants will continue to receive PrEP at the clinic.
|
|---|---|---|
|
Feasibility of Intervention Use
Month 1
|
70 Participants
|
—
|
|
Feasibility of Intervention Use
Month 3
|
66 Participants
|
—
|
|
Feasibility of Intervention Use
Month 6
|
62 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Six monthsPopulation: Intervention participants completing the SUS at Month 6
The PrEP My Way intervention will be considered acceptable if \>70% (35/50) participants rate 70% (7/10) items on the Systems Usability Scale (SUS) as "very good" or higher. The scores on the SUS are normalized on a scale 0-100 (higher scores indicate higher usability).
Outcome measures
| Measure |
PrEP My Way Intervention
n=68 Participants
PrEP My Way is an intervention that involves peer-delivery of a kit containing PrEP and other sexual health services. Participants will be offered PrEP if HIV-negative per a point-of-care test, pregnancy testing, vaginal swabs for gonorrhea and chlamydia testing, condoms, and/or self-injection medroxyprogesterone, as desired.
PrEP My Way: Intervention components may be modified pending the input from Aim 1. As currently planned, the peer delivering the PrEP My Way kit will be trained to provide basic education and support use of the kit components. The peer will also have a smart phone to show an instructional video. Participants will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit delivery at Months 1, 3, and 6 via unmarked vehicles at home or a preferred safe site during reasonable hours. Two-way mobile phone communication will also be used to convey test results and provide on-going support and empowerment. Follow-up with the clinic will occur at Month 6 and as needed (e.g., treatment for positive tests).
This intervention aims to increase adherence/persistence on PrEP. We hypothesize that removing the structural barriers and stigma associated with going to the clinic, women may be more likely to continue on PrEP.
|
Control
These participants will continue to receive PrEP at the clinic.
|
|---|---|---|
|
Acceptability of Intervention
|
76 units on a scale
Interval 68.0 to 85.0
|
—
|
Adverse Events
PrEP My Way Intervention
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place