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

ConditionHiv
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-30
SponsorUniversity of Alabama at Birmingham

About this trial

Following on the heels of large implementation science projects that participated in the launch of widespread daily oral PrEP availability, investigators 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. investigators will support participating clinics to add dapivirine ring into their existing PrEP services offered to women seeking reproductive health care. The primary aim of the study will be to determine whether the availability of multiple PrEP products to young women will result in greater frequency of PrEP initiation and persistence.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Multiple Product PrEP Program

    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.

  • Routine Oral PrEP

    Drug

    Daily oral PrEP

Treatment groups

1,400 Participants
are divided into 2 treatment groups
Group A: Routine PrEP ProgramActive comparator 1 intervention
Group B: Multiple Product PrEP ProgramExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

PrEP initiation

Women who start to use PrEP

Time frame
From enrolment to 6 months

Secondary outcomes

1

PrEP persistence at 3 months

Women who continue to use PrEP 3 months since they initiated PrEP

Time frame
From enrolment to 3 months

Other outcomes

1

PrEP persistence at 6 months

Women who continue to use PrEP 6 months since they initiated PrEP

Time frame
Enrolment to 6 months

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Kenya Medical Research Institute and Partners in Health & Research DevelopmentRecruiting Thika, Kiambu CountyKenyaKenya

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

University of Washington

Collaborator

Kenya Medical Research Institute

Collaborator

National Institute of Mental Health (NIMH)

Collaborator