Multi-product PrEP Delivery to Young Women Seeking Reproductive Health Services and Coverage of HIV Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-03

Study Completion Date

2029-12-30

Brief Summary

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Following on the heels of large implementation science projects that participated in the launch of widespread daily oral PrEP availability, we will launch and study the integration of novel PrEP products - beginning with the dapivirine ring- into existing PrEP programs that reach women seeking reproductive health care at health facilities in Kenya. Intervention delivery will be launched among 12 participating clinics with approximately 1400 AGYW seeking reproductive health services and counseled about PrEP through a stepped wedge cluster randomized trial. We will support participating clinics to add dapivirine ring into their existing PrEP services offered to women seeking reproductive health care. Our primary aim will be to determine whether the availability of multiple PrEP products to young women will result in greater frequency of PrEP initiation and persistence.

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Detailed Description

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Conditions

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Hiv

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard of Care PrEP Program

In the control phase, clinics will offer standard of care PrEP program, which includes daily oral PrEP, for young women.

Group Type NO_INTERVENTION

No interventions assigned to this group

Multiple Product PrEP Program

In the intervention phase, clinics will offer a multi-product PrEP program, which includes daily oral PrEP and other forms of PrEP that are available. To start, the dapivirine vaginal ring will be included among the other forms of PrEP that are available. Others will be added as they become available in Kenya.

Group Type ACTIVE_COMPARATOR

Multiple Product PrEP Program

Intervention Type DRUG

In the intervention phase, clinics will offer a multi-product PrEP program, which includes daily oral PrEP and other forms of PrEP that are available. To start, the dapivirine vaginal ring will be included among the other forms of PrEP that are available. Others will be added as they become available in Kenya.

Interventions

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Multiple Product PrEP Program

In the intervention phase, clinics will offer a multi-product PrEP program, which includes daily oral PrEP and other forms of PrEP that are available. To start, the dapivirine vaginal ring will be included among the other forms of PrEP that are available. Others will be added as they become available in Kenya.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Age ≥18 years and ≤30years. Seeking a reproductive health service from one of the project facilities (reproductive health services include but are not limited to family planning, maternal and child health, postnatal care).

AGYW receiving reproductive health-related services through OPD, or other departments are eligible. AGYW receiving reproductive health-related services through other departments are eligible.

Willing and able to partake in an informed consent process. Able to speak and read in Kiswahili or English.

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes