PrEP Implementation for Mothers in Antenatal Care

PHASE4CompletedINTERVENTIONAL
Enrollment

4,447

Participants

Timeline

Start Date

January 15, 2018

Primary Completion Date

January 15, 2021

Study Completion Date

January 15, 2021

Conditions
HIV InfectionsPregnancy Related
Interventions
OTHER

Universal PrEP Counseling

Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown.

OTHER

Targeted PrEP Counseling

"Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met:~1. Risk Score \>6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors~2. participant declines partner self-tests regardless of partner HIV status, and/or~3. their partner declines self-testing or tests positive."

Trial Locations (20)

Unknown

Ambira Hospital, Ambira

Bondo Subcounty Hospital, Bondo

Homabay Teaching and Referral Hospital, Homa Bay

Kandiege Subcounty Hospital, Kandege

Kendu Bay Subcounty Hospital, Kendu Bay

Madiany Subcounty Hospital, Madiany

Malanga Subcounty Hospital, Malanga

Marindi Subcounty Hospital, Marinde

Mbita Subcounty Hospital, Mbita

Ndhiwa Subcounty Hospital, Ndhiwa

Ober Subcounty Hospital, Ober

Ongielo Subcounty Hospital, Ongielo

Rachuonyo South Subcounty Hospital, Rachuonyo South

Rangwe Subcounty Hospital, Rangwe

Rwambwa Subcounty Hospital, Rwambwa

Siaya Teaching and Referral Hospital, Siaya

Suba Subcounty Hospital, Suba

Usigu Subcounty Hospital, Usigu

Uyawi Subcounty Hospital, Uyawi

Yala Subcounty Hospital, Yala

All Listed Sponsors
collaborator

Kenyatta National Hospital

OTHER_GOV

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

University of Washington

OTHER

NCT03070600 - PrEP Implementation for Mothers in Antenatal Care | Biotech Hunter | Biotech Hunter