Tests a PrEP support program to help young Kenyan women keep taking HIV prevention
Tests a peer-supported PrEP program to help young women in Kenya continue HIV prevention.
Plain-language title generated from the registry record
Registry title: PrEP My Way: A Hybrid Type 1 Clinical Effectiveness-implementation Trial to Promote PrEP Persistence Among Young Kenyan Women
Key facts
- Where
- Kisumu, KenyaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for young women in Kisumu County, Kenya, aged 16 to 24, who are starting PrEP (medicine that helps prevent HIV) at the recruitment site.
- Age
- 16 to 24 years
- Sex
- Women only
- Earlier treatment
- Must be starting PrEP at the recruitment site. This includes being HIV-negative. For those taking FTC/TDF, it also includes normal kidney function and no hepatitis B infection.
Main reasons for not taking part
- Cannot give informed consent (for example, because of intoxication)
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 24 years old?
Source: NCT06566430, who can take part
Where in Kenya
- Kenya Medical Research InstituteKisumu, KenyaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Massachusetts General Hospital
- Trial code
- NCT06566430
- Record updated
- 22 April 2026
- Original description
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.Read full original descriptionShow less
PrEP My Way: A Hybrid Type 1 Clinical Effectiveness-implementation Trial to Promote PrEP Persistence Among Young Kenyan Women
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
Inclusion: 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: inability to provide informed consent (e.g., intoxication).