4,447
Participants
Start Date
January 15, 2018
Primary Completion Date
January 15, 2021
Study Completion Date
January 15, 2021
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.
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."
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
Kenyatta National Hospital
OTHER_GOV
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
University of Washington
OTHER