HIV/AIDS
Conditions
Keywords
prevention
Brief summary
The investigators will first develop, tailor, and refine PrEP My Way for use with young women in Kisumu, Kenya (Aim 1). The design firm will use a client-centered, iterative approach, involving up to 15 individual interviews and two focus group discussions (with up to 5 women each) to optimally design the PrEP My Way kit (with instructional materials) and peer delivery system (including communication and kit delivery plans). The investigators will then test the intervention for feasibility, acceptability, and preliminary impact on PrEP adherence and program retention (Aim 2). The study team will randomize 100 Kenyan women to PrEP My Way versus standard of care (i.e., clinic-based delivery of PrEP and sexual health services) and follow them for 6 months. Feasibility will be assessed by receipt of the kit at 1, 3, and 6 months and ability to use its components per protocol. Acceptability will be determined through a mixed-methods interview at 6 months. Preliminary impact will be evaluated by dried blood spot tenofovir levels (adherence) and kit use/clinic attendance at 6 months (retention) as primary outcomes. Mediators and moderators of PrEP use (e.g., empowerment and mental health) will be explored through questionnaires at baseline and 6 months.
Detailed description
1. Develop PrEP My Way. Using a client-centered approach, the study team will iteratively conduct individual interviews and focus group discussions with up to 25 Kenyan women (age 16-24) to optimally design PrEP My Way (the kit with instructional materials) and peer delivery system (including phone communication and kit delivery plans). 2. Assess PrEP My Way for feasibility, acceptability, and preliminary impact on PrEP adherence and program retention. The investigators will randomize 100 Kenyan women (age 16-24) to PrEP My Way versus standard of care (i.e., clinic-based delivery of PrEP and sexual health services) and follow them for 6 months. Feasibility will be assessed by receipt of the kit at 1, 3, and 6 months and ability to use its components per protocol. Acceptability will be determined through a mixed-methods interview. Preliminary impact will be evaluated by dried blood spot tenofovir levels (adherence) and kit use/clinic attendance at 6 months (retention). Potential influencing and mediating socio-behavioral factors will be explored with questionnaires at 0 and 6 months.
Interventions
OTHERPrEP 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.
Sponsors
Kenya Medical Research Institute
Emory University
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* Young woman (age 16-24 years); we will enroll emancipated minors (e.g., those who have not yet attained the age of legal competency as defined by state law, but who are entitled to treatment as if they had by virtue of assuming adult responsibilities, such as self-support, marriage, or procreation) per Kenyan national guidelines \[39\]) or 16-17 year-olds with parental consent * Reported sexual activity within the past 3 months * Interest in taking PrEP (actual PrEP uptake is not a requirement for Aim 1) * Residence in the Kisumu region * Phone ownership * Ability to understand KiSwahili, DhoLuo, and/or English
Exclusion criteria
* Inability to provide informed consent (e.g., intoxication, mental disability)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Adherence | Six months | PrEP adherence as measured by detectable tenofovir-diphosphate (TFV-DP) in dried blood spots |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported PrEP Adherence in the Past 30 Days | Months 1, 3, 6 (intervention arm) | PrEP adherence as measured by questionnaires at kit delivery. |
| Number of Participants With PrEP Persistence (Kit Delivery/Pharmacy Refill) | At 6 months | PrEP use as measured by PrEP receipt in the kit (intervention) or pharmacy pick up (control) at 6 months |
| Rates of STI Testing | Months 1, 3, and 6 | Testing for gonorrhea and chlamydia |
| Rates of Hormonal Contraception | Months 1, 3, and 6 | 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) |
| Prevention-effective Adherence at 6 Months | Measured at 6 months | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Intervention Use | Six months | 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). |
| Acceptability of Intervention | Six months | 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). |
Countries
Kenya
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 75 |
| Control These participants will continue to receive PrEP at the clinic. | 75 |
| Total | 150 |
Baseline characteristics
| Characteristic | PrEP My Way Intervention | Total | Control |
|---|---|---|---|
| Age, Continuous | 21.6 years | 22.3 years | 22.6 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 75 Participants | 150 Participants | 75 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Kenya | 75 participants | 150 participants | 75 participants |
| Sex: Female, Male Female | 75 Participants | 150 Participants | 75 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 75 |
| other Total, other adverse events | 0 / 75 | 0 / 75 |
| serious Total, serious adverse events | 0 / 75 | 0 / 75 |
Outcome results
Primary
PrEP Adherence
PrEP adherence as measured by detectable tenofovir-diphosphate (TFV-DP) in dried blood spots
Time frame: Six months
Population: TFV-DP detection at 6 months per dried blood spots
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PrEP My Way Intervention | PrEP Adherence | 12 Participants |
| Control | PrEP Adherence | 4 Participants |
Secondary
Number of Participants With PrEP Persistence (Kit Delivery/Pharmacy Refill)
PrEP use as measured by PrEP receipt in the kit (intervention) or pharmacy pick up (control) at 6 months
Time frame: At 6 months
Population: Study participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PrEP My Way Intervention | Number of Participants With PrEP Persistence (Kit Delivery/Pharmacy Refill) | 50 Participants |
| Control | Number of Participants With PrEP Persistence (Kit Delivery/Pharmacy Refill) | 11 Participants |
Secondary
Prevention-effective Adherence at 6 Months
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)
Time frame: Measured at 6 months
Population: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PrEP My Way Intervention | Prevention-effective Adherence at 6 Months | 12 Participants |
| Control | Prevention-effective Adherence at 6 Months | 4 Participants |
Secondary
Rates of Hormonal Contraception
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)
Time frame: Months 1, 3, and 6
Population: participants not using long-acting contraception (i.e., contraceptive implants or intrauterine devices)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PrEP My Way Intervention | Rates of Hormonal Contraception | 50 Participants |
| Control | Rates of Hormonal Contraception | 6 Participants |
Secondary
Rates of STI Testing
Testing for gonorrhea and chlamydia
Time frame: Months 1, 3, and 6
Population: Participants who had STI testing done
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PrEP My Way Intervention | Rates of STI Testing | Month 1 | 67 Participants |
| PrEP My Way Intervention | Rates of STI Testing | Month 3 | 64 Participants |
| PrEP My Way Intervention | Rates of STI Testing | Month 6 | 62 Participants |
| Control | Rates of STI Testing | Month 1 | 0 Participants |
| Control | Rates of STI Testing | Month 3 | 0 Participants |
| Control | Rates of STI Testing | Month 6 | 0 Participants |
Secondary
Self-reported PrEP Adherence in the Past 30 Days
PrEP adherence as measured by questionnaires at kit delivery.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PrEP My Way Intervention | Self-reported PrEP Adherence in the Past 30 Days | Month 1 | 92 percentage of doses taken |
| PrEP My Way Intervention | Self-reported PrEP Adherence in the Past 30 Days | Month 3 | 79 percentage of doses taken |
| PrEP My Way Intervention | Self-reported PrEP Adherence in the Past 30 Days | Month 6 | 68 percentage of doses taken |
Other Pre-specified
Acceptability of Intervention
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).
Time frame: Six months
Population: Intervention participants completing the SUS at Month 6
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PrEP My Way Intervention | Acceptability of Intervention | 76 units on a scale |
Other Pre-specified
Feasibility of Intervention Use
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).
Time frame: Six months
Population: Intervention participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PrEP My Way Intervention | Feasibility of Intervention Use | Month 1 | 70 Participants |
| PrEP My Way Intervention | Feasibility of Intervention Use | Month 3 | 66 Participants |
| PrEP My Way Intervention | Feasibility of Intervention Use | Month 6 | 62 Participants |