PrEP Implementation for Mothers in Antenatal Care

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.

Conditions

• HIV Infections
• Pregnancy 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.

Sponsors & Collaborators

• Kenyatta National Hospital

  collaborator OTHER_GOV

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• University of Washington

  lead OTHER

Principal Investigators

• Grace John-Stewart, MD, PhD · University of Washington

• Jared Baeten, MD, PhD · University of Washington

• John Kinuthia, MBChB, MMed · Kenyatta National Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-15

Primary Completion

2021-01-15

Completion

2021-01-15

FDA Drug

Yes

Countries

• Kenya

Study Locations