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

The University of Alabama at Birmingham

Status and phase: Enrolling; Phase 4

Conditions: Hiv

Treatments: Drug: Multiple Product PrEP Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07076043

KEMRI/SERU/CCR/0361/5052

R01MH134681 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 1,400 estimated patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Adolescent Girls and Young Women seeking reproductive health services:

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,400 participants in 2 patient groups

Standard of Care PrEP Program

No Intervention group

Description:

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

Multiple Product PrEP Program

Active Comparator group

Description:

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.

Treatment:

Drug: Multiple Product PrEP Program