NCT06566430 PrEP My Way: A Hybrid Type 1 Clinical Effectiveness-implementation Trial to Promote PrEP Persistence Among Young Kenyan Women
| NCT ID | NCT06566430 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | HIV/AIDS |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2028-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2025-03-03 with a primary completion date of 2028-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * inability to provide informed consent (e.g., intoxication)
Contact & Investigator
Jessica Haberer, MD, MS
PRINCIPAL INVESTIGATOR
Director of Research, Center for Global Health
Frequently Asked Questions
Who can join the NCT06566430 clinical trial?
This trial is open to female participants only, aged 16 Years or older, up to 24 Years, studying HIV/AIDS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06566430 currently recruiting?
Yes, NCT06566430 is actively recruiting participants. Contact the research team at legarrison@mgh.harvard.edu for enrollment information.
Where is the NCT06566430 trial being conducted?
This trial is being conducted at Kisumu, Kenya.
Who is sponsoring the NCT06566430 clinical trial?
NCT06566430 is sponsored by Massachusetts General Hospital. The principal investigator is Jessica Haberer, MD, MS at Director of Research, Center for Global Health. The trial plans to enroll 500 participants.
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