PrEP Implementation for Mothers in Antenatal Care
Condition: HIV Infections; Pregnancy Related
MeSH terms: HIV Infections
Intervention: Universal PrEP Counseling; Targeted PrEP Counseling
Intervention description: 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.; 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:
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
participant declines partner self-tests regardless of partner HIV status, and/or
their partner declines self-testing or tests positive.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: We will select 20 clinics from Western Kenya. Ten clinics will be randomized to universal PrEP and ten to targeted PrEP (Table 2). To ensure balance between study arms in terms of key site characteristics, sites will be categorized on HIV prevalence and ANC volume, and restricted randomization will be used for site (cluster) allocation to intervention and control arms (68).
Masking: None (Open Label)
Enrollment: 4447.0
Sex: Female
Minimum age: 15 Years
Healthy volunteers: No
Keywords: PrEP

Summary:

      In a region with 15-20% HIV prevalence, an estimated 20% of HIV-uninfected women could have
      HIV exposures in pregnancy. In a theoretical scenario of perfect PrEP coverage, all women at
      risk receive PrEP while no women not at HIV risk receive PrEP (Figure 4). With mandatory PrEP
      given to all women (similar to the approaches used for malaria prophylaxis), all women at
      risk would be covered but many women not at risk receive unnecessary PrEP. Our premise is
      that a targeted PrEP model may be closer to perfect coverage than a universal
      offer/self-select model. Implementing targeted PrEP through strategies that include
      facilitation of partner testing with self-tests could add HIV prevention benefit by
      increasing partner HIV diagnosis and treatment similar to the initiation of PrEP among
      pregnant women. By implementing these strategies and measuring uptake, use, and HIV
      incidence, we can inform the best health systems model for PrEP delivery in pregnancy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligibility for enrollment will include age ≥15 years

          -  Pregnant at any gestational age

          -  Tuberculosis negative

          -  Plans to reside in area for at least one year postpartum

          -  Plans to receive postnatal and infant care at the study facility

          -  Not currently enrolled in any other studies.

        Exclusion Criteria:

          -  HIV+ at time of enrollment