HIV/AIDSNCT06566430
PrEP My Way: A Hybrid Type 1 Clinical Effectiveness-implementation Trial to Promote PrEP Persistence Among Young Kenyan Women
A study testing PrEP My Way intervention and PrEP My Way intervention without STI testing in people with HIV/AIDS, run by Massachusetts General Hospital at 1 site in Kenya.
Trial summary
PrEP My Way is a novel PrEP delivery system consisting of clinic-based PrEP initiation, followed by peer-delivered kits for HIV self-testing, PrEP refills, vaginal swabs for gonorrhea and chlamydia self-sampling, pregnancy tests, and contraception refills, if desired. Read more about this study
- Who is it for?
- Ages 16 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- PrEP My Way intervention and PrEP My Way intervention without STI testing
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteKenya
- Study dates
- 3 Mar 2025to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- young women (age 16-24 years)
- initiating PrEP at the recruitment site (this criterion subsumes all necessary safety assessments for starting PrEP, including HIV-negative status and for those taking FTC/TDF normal renal function and lack of Hepatitis B infection)
- resident in Kisumu County
- phone ownership
- ability to understand KiSwahili, DhoLuo, and/or English
Who cannot join
- inability to provide informed consent (e.g., intoxication)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jessica Haberer, MD, MS contact
Kenya1 site, 1 recruiting
- Recruiting
Kenya Medical Research Institute
Kisumu
Kevin Oware, +45 0723873505, kkamolloh@kemri-rctp.org
About this study
PrEP My Way is a novel PrEP delivery system consisting of clinic-based PrEP initiation, followed by peer-delivered kits for HIV self-testing, PrEP refills, vaginal swabs for gonorrhea and chlamydia self-sampling, pregnancy tests, and contraception refills, if desired. Based on Social Cognitive Theory, the overall hypothesis is that PrEP My Way will overcome critical stigma and structural barriers that currently limit PrEP use and thus empower young women to promote their sexual health.
Preliminary testing of PrEP My Way in Kisumu, Kenya found it to be highly feasible and acceptable, but PrEP use as an oral medication was lower than expected. Now that newer PrEP formulations are becoming available, the team is adding choice of PrEP formulation (i.e., oral tenofovir/emtricitabine, injectable cabotegravir-long acting [CAB-LA], or dapivirine ring) as well as choice of adherence support from peers (e.g., SMS [short message service], routine check-ins and/or WhatsApp groups) to the intervention. The study team will then test the effectiveness of the augmented PrEP My Way intervention (with and without testing for gonorrhea and chlamydia due to cost concerns) on PrEP persistence in women with ongoing HIV prevention needs (i.e., self-reported desire for PrEP, self-reported HIV risk, condomless sex, and/or multiple sexual partners). The team will also track implementation, service, and client metrics per Proctor's framework and determine cost-effectiveness of the intervention
Read the detailed description
- Augment PrEP My Way to include choice of PrEP formulation (CAB-LA, dapivirine ring, or oral FTC/ TDF) and adherence support. With a Kenyan design firm, the study team will conduct 28 individual interviews and 2 workshops with young women, young men (as sexual partners), caregivers, nurses, and community health workers to adapt the kit, product guides, and delivery systems. The study team will use a nurse-delivered model for injections per Kenya regulations and a peer-delivered model for rings/oral PrEP. The Kenya National AIDS/STI Control Program will review the design to optimize potential uptake and sustainability in routine care.
- Conduct a type 1 effectiveness-implementation trial of PrEP My Way. The study team will enroll 432 women (age 16-24) in Kisumu, Kenya, and randomize them 1:1:1 to the full intervention vs the intervention without STI testing (i.e., to assess marginal impact of the most costly kit component beyond PrEP) vs enhanced standard of care. Women in the intervention will choose bimonthly (CAB-LA) or quarterly (ring/oral) delivery. The primary outcome will be PrEP persistence by recorded injection (CAB-LA) or drug levels (ring/oral) at 9 months in women with ongoing HIV prevention needs (i.e., self-reported desire for PrEP, self-reported HIV risk, condomless sex, and/or multiple sexual partners). Secondary/additional outcomes will be persistence and adherence at other time points and with alternative definitions of HIV prevention needs, STI (sexually transmitted infection) testing, and family planning use. Investigators will also track implementation, service, and client metrics per Proctor's framework.
- Determine cost and cost-effectiveness of PrEP My Way. Analysts will conduct micro-costing analyses through time and motion studies and use published cost data, internal reports, and supply-chain data to determine the cost of delivering each PrEP formulation and support option and the marginal cost of STI testing. The team will also estimate the incremental cost-effectiveness ratio in terms of cost per woman with PrEP persistence.
- Conditions
- HIV/AIDS
- Being tested
- PrEP My Way intervention, PrEP My Way intervention without STI testing, Enhanced standard of care
- Keywords
- prevention
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP My Way interventionBehavioural
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, 6, 9, and 12 for those choosing the oral or ring formulations of PrEP. If the participant chooses to use injections, she will communicate with the peers to arrange for kit delivery at Months 1, 3, 5, 7, 9, 11, and 12. All deliveries will be made 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 12 and as needed (e.g., treatment for positive tests).
PrEP My Way intervention without STI testingBehavioural
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. This kit will not contain STI testing. 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, 6, 9, and 12 for those choosing the oral or ring formulations of PrEP. If the participant chooses to use injections, she will communicate with the peers to arrange for kit delivery at Months 1, 3, 5, 7, 9, 11, and 12. All deliveries will be made 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 12 and as needed (e.g., treatment for positive tests).
Enhanced standard of careBehavioural
These participants will receive PrEP (choice of oral, ring, or injection formulation), STI testing, and family planning at the clinic, as requested.
| Study group | Role | What they receive |
|---|---|---|
| PrEP My Way intervention | Experimental | 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.
Prior to randomization, participants will decide which form of PrEP they would like to take (oral FTC/TDF, dapivirine ring, injectable cabotegravir) and adherence support. Receives: Behavioral: PrEP My Way intervention |
| PrEP My Way intervention without STI testing | Experimental | 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, condoms, and/or self-injection medroxyprogesterone, as desired.
Prior to randomization, participants will decide which form of PrEP they would like to take (oral FTC/TDF, dapivirine ring, injectable cabotegravir) and adherence support. Receives: Behavioral: PrEP My Way intervention without STI testing |
| Enhanced standard of care | Experimental | Prior to randomization, participants will decide which form of PrEP they would like to take (oral FTC/TDF, dapivirine ring, injectable cabotegravir). Receives: Behavioral: Enhanced standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Months of PrEP persistence
We will consider receipt of CAB-LA injections as count data, we will analyze the amount of dapivirine loaded in the ring minus the residual ring level, and we will analyze the TFV-DP concentrations from dried blood spots in those participants who took oral PrEP. Each measure reflects ~8 weeks of drug coverage, such that an equivalent measure is available for all formulations.
Measured: 9 months
Secondary outcomes (1)
Months of prevention-effective persistence
We will consider receipt of CAB-LA injections as count data, we will analyze the amount of dapivirine loaded in the ring minus the residual ring level, and we will analyze the TFV-DP concentrations from dried blood spots in those participants who took oral PrEP. Each measure reflects ~8 weeks of drug coverage, such that an equivalent measure is available for all formulations. Data will only be considered for those reporting ongoing HIV prevention needs.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start3 Mar 2025
- Primary completion1 May 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, Jomo Kenyatta University of Agriculture and Technology, Kenya National AIDS & STI Control Programme, Emory University
- Responsible party
- Principal investigator, Jessica Haberer, MD, Massachusetts General Hospital
- Investigators
- Jessica Haberer, MD, MS, Principal investigator, Director of Research, Center for Global Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566430
- Sponsor's protocol ID
- 2024P002284
- Status last verified
- Apr 2026
- First submitted
- 19 Aug 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrEP My Way: A Hybrid Type 1 Clinical Effectiveness-implementation Trial to Promote PrEP Persistence Among Young Kenyan Women
- ClinicalTrials.gov ID
- NCT06566430
- Acronym / sponsor ID
- 2024P002284
- Conditions
- HIV/AIDS
- Keywords
- prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, Jomo Kenyatta University of Agriculture and Technology, Kenya National AIDS & STI Control Programme, Emory University
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PrEP My Way is a novel PrEP delivery system consisting of clinic-based PrEP initiation, followed by peer-delivered kits for HIV self-testing, PrEP refills, vaginal swabs for gonorrhea and chlamydia self-sampling, pregnancy tests, and contraception refills, if desired. Based on Social Cognitive Theory, the overall hypothesis is that PrEP My Way will overcome critical stigma and structural barriers that currently limit PrEP use and thus empower young women to promote their sexual health.
Preliminary testing of PrEP My Way in Kisumu, Kenya found it to be highly feasible and acceptable, but PrEP use as an oral medication was lower than expected. Now that newer PrEP formulations are becoming available, the team is adding choice of PrEP formulation (i.e., oral tenofovir/emtricitabine, injectable cabotegravir-long acting [CAB-LA], or dapivirine ring) as well as choice of adherence support from peers (e.g., SMS [short message service], routine check-ins and/or WhatsApp groups) to the intervention. The study team will then test the effectiveness of the augmented PrEP My Way intervention (with and without testing for gonorrhea and chlamydia due to cost concerns) on PrEP persistence in women with ongoing HIV prevention needs (i.e., self-reported desire for PrEP, self-reported HIV risk, condomless sex, and/or multiple sexual partners). The team will also track implementation, service, and client metrics per Proctor's framework and determine cost-effectiveness of the intervention
Detailed description
- Augment PrEP My Way to include choice of PrEP formulation (CAB-LA, dapivirine ring, or oral FTC/ TDF) and adherence support. With a Kenyan design firm, the study team will conduct 28 individual interviews and 2 workshops with young women, young men (as sexual partners), caregivers, nurses, and community health workers to adapt the kit, product guides, and delivery systems. The study team will use a nurse-delivered model for injections per Kenya regulations and a peer-delivered model for rings/oral PrEP. The Kenya National AIDS/STI Control Program will review the design to optimize potential uptake and sustainability in routine care.
- Conduct a type 1 effectiveness-implementation trial of PrEP My Way. The study team will enroll 432 women (age 16-24) in Kisumu, Kenya, and randomize them 1:1:1 to the full intervention vs the intervention without STI testing (i.e., to assess marginal impact of the most costly kit component beyond PrEP) vs enhanced standard of care. Women in the intervention will choose bimonthly (CAB-LA) or quarterly (ring/oral) delivery. The primary outcome will be PrEP persistence by recorded injection (CAB-LA) or drug levels (ring/oral) at 9 months in women with ongoing HIV prevention needs (i.e., self-reported desire for PrEP, self-reported HIV risk, condomless sex, and/or multiple sexual partners). Secondary/additional outcomes will be persistence and adherence at other time points and with alternative definitions of HIV prevention needs, STI (sexually transmitted infection) testing, and family planning use. Investigators will also track implementation, service, and client metrics per Proctor's framework.
- Determine cost and cost-effectiveness of PrEP My Way. Analysts will conduct micro-costing analyses through time and motion studies and use published cost data, internal reports, and supply-chain data to determine the cost of delivering each PrEP formulation and support option and the marginal cost of STI testing. The team will also estimate the incremental cost-effectiveness ratio in terms of cost per woman with PrEP persistence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PrEP My Way intervention | Experimental | Behavioral: PrEP My Way interventionPrEP 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. Prior to randomization, participants will decide which form of PrEP they would like to take (oral FTC/TDF, dapivirine ring, injectable cabotegravir) and adherence support. |
| PrEP My Way intervention without STI testing | Experimental | Behavioral: PrEP My Way intervention without STI testingPrEP 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, condoms, and/or self-injection medroxyprogesterone, as desired. Prior to randomization, participants will decide which form of PrEP they would like to take (oral FTC/TDF, dapivirine ring, injectable cabotegravir) and adherence support. |
| Enhanced standard of care | Experimental | Behavioral: Enhanced standard of carePrior to randomization, participants will decide which form of PrEP they would like to take (oral FTC/TDF, dapivirine ring, injectable cabotegravir). |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- young women (age 16-24 years)
- initiating PrEP at the recruitment site (this criterion subsumes all necessary safety assessments for starting PrEP, including HIV-negative status and for those taking FTC/TDF normal renal function and lack of Hepatitis B infection)
- resident in Kisumu County
- phone ownership
- ability to understand KiSwahili, DhoLuo, and/or English
Key exclusion criteria (1 listed)
- inability to provide informed consent (e.g., intoxication)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEP My Way interventionIntervention 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, 6, 9, and 12 for those choosing the oral or ring formulations of PrEP. If the participant chooses to use injections, she will communicate with the peers to arrange for kit delivery at Months 1, 3, 5, 7, 9, 11, and 12. All deliveries will be made 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 12 and as needed (e.g., treatment for positive tests). | Behavioural | PrEP My Way intervention |
| PrEP My Way intervention without STI testingIntervention 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. This kit will not contain STI testing. 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, 6, 9, and 12 for those choosing the oral or ring formulations of PrEP. If the participant chooses to use injections, she will communicate with the peers to arrange for kit delivery at Months 1, 3, 5, 7, 9, 11, and 12. All deliveries will be made 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 12 and as needed (e.g., treatment for positive tests). | Behavioural | PrEP My Way intervention without STI testing |
| Enhanced standard of careThese participants will receive PrEP (choice of oral, ring, or injection formulation), STI testing, and family planning at the clinic, as requested. | Behavioural | Enhanced standard of care |
Primary outcome
Months of PrEP persistence
Time frame: 9 months
We will consider receipt of CAB-LA injections as count data, we will analyze the amount of dapivirine loaded in the ring minus the residual ring level, and we will analyze the TFV-DP concentrations from dried blood spots in those participants who took oral PrEP. Each measure reflects ~8 weeks of drug coverage, such that an equivalent measure is available for all formulations.
1 secondary outcome
Months of prevention-effective persistence
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Haberer, MD, MS contact
Jessica Haberer, MD, MS principal investigator
Director of Research, Center for Global Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEP My Way intervention and PrEP My Way intervention without STI testing in people with HIV/AIDS, run by Massachusetts General Hospital at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lindsey Garrison, MPH (617-643-9195, legarrison@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Months of PrEP persistence (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.