R01HD108041

Enhancing Prep Outcomes Among Kenyan Adolescent Girls and Young Women with a Novel Pharmacy-Based Prep Delivery Platform

HIV incidence remains unacceptably high for Adolescent Girls and Young Women (AGYW). Pre-Exposure Prophylaxis (Prep) HIV prevention tools are promising, with tenofovir (TFV)-based daily oral Prep and the dapivirine vaginal ring (DPV-VR) recommended by WHO for cisgender women at-risk for HIV. Kenya is a leader for Prep delivery in Africa, and efforts are ongoing to increase Prep access with AGYW as a priority group.

Our team pioneered integrated Prep delivery in Family Planning (FP) clinics in Kenya. However, 40% of Kenyan women access contraception without interfacing with facilities, including at retail pharmacies, and would be missed by facility-based Prep platforms. Retail pharmacies can increase options for reaching at-risk individuals with Prep, and efforts are underway to define pathways for pharmacy-delivered Prep in Kenya.

We adapted our FP clinic-based Prep model and piloted Prep delivery facilitated by nurse-navigators for AGYW seeking contraception at pharmacies. AGYW offered daily oral Prep frequently initiated, planned to continue use, and were willing to pay for Prep at pharmacies. Pill burden was a common reason for declining oral Prep and could be addressed by offering DPV-VR.

Through close collaboration with the Kenya Ministry of Health, both national and county-level, we propose a cluster RCT at 20 pharmacies in Kisumu, Kenya – a region with an HIV prevalence of up to 28% among women – to test the effectiveness of utilizing nurse-navigators at retail pharmacies to enhance AGYW Prep use. We will expand on our successful pilot to offer both daily oral Prep and the DPV-VR and prospectively ascertain Prep outcomes (initiation, persistence, adherence) among AGYW. This effectiveness-implementation hybrid RCT is designed to expedite translation into practice by evaluating clinical effectiveness alongside implementation and cost outcomes.

We hypothesize that combining nurse-navigators with pharmacy-based Prep will provide a cost-effective strategy for delivering novel HIV prevention tools to AGYW in HIV high-burden settings.

Aim 1: Determine the effect of nurse-navigators on Prep initiation, persistence, and adherence among AGYW seeking contraception within a pharmacy-based Prep delivery model through a 2-arm cluster RCT among HIV-negative AGYW at 20 retail pharmacies in Kisumu, Kenya. AGYW seeking contraception will be offered Prep and self-select daily oral Prep or the DPV-VR. Primary outcomes will be the proportion of AGYW accessing contraception that initiate Prep, persist with use at 10 months, and adhere (quantified by TFV or DPV hair levels). Secondary outcomes will include Prep selection (Prep pills vs. DPV-VR), STI incidence, and adherence cofactors.

Aim 2: Identify potential barriers and facilitators to acceptability, feasibility, and client satisfaction of nurse-navigators and DPV-VR delivery for AGYW accessing Prep at retail pharmacies through a qualitative evaluation guided by Proctor et al.

Aim 3: Estimate the cost-effectiveness of implementing pharmacy-based Prep delivery with nurse-navigators.

This will be the first study aiming to improve Prep access for AGYW using a pharmacy-based model and will prime pharmacies to deliver novel Prep agents in the pipeline.

University Of Washington

TO CONDUCT AND SUPPORT LABORATORY RESEARCH, CLINICAL TRIALS, AND STUDIES WITH PEOPLE THAT EXPLORE HEALTH PROCESSES. NICHD RESEARCHERS EXAMINE GROWTH AND DEVELOPMENT, BIOLOGIC AND REPRODUCTIVE FUNCTIONS, BEHAVIOR PATTERNS, AND POPULATION DYNAMICS TO PROTECT AND MAINTAIN THE HEALTH OF ALL PEOPLE. TO EXAMINE THE IMPACT OF DISABILITIES, DISEASES, AND DEFECTS ON THE LIVES OF INDIVIDUALS. WITH THIS INFORMATION, THE NICHD HOPES TO RESTORE, INCREASE, AND MAXIMIZE THE CAPABILITIES OF PEOPLE AFFECTED BY DISEASE AND INJURY. TO SPONSOR TRAINING PROGRAMS FOR SCIENTISTS, DOCTORS, AND RESEARCHERS TO ENSURE THAT NICHD RESEARCH CAN CONTINUE. BY TRAINING THESE PROFESSIONALS IN THE LATEST RESEARCH METHODS AND TECHNOLOGIES, THE NICHD WILL BE ABLE TO CONDUCT ITS RESEARCH AND MAKE HEALTH RESEARCH PROGRESS UNTIL ALL CHILDREN, ADULTS, FAMILIES, AND POPULATIONS ENJOY GOOD HEALTH. THE MISSION OF THE NICHD IS TO ENSURE THAT EVERY PERSON IS BORN HEALTHY AND WANTED, THAT WOMEN SUFFER NO HARMFUL EFFECTS FROM REPRODUCTIVE PROCESSES, AND THAT ALL CHILDREN HAVE THE CHANCE TO ACHIEVE THEIR FULL POTENTIAL FOR HEALTHY AND PRODUCTIVE LIVES, FREE FROM DISEASE OR DISABILITY, AND TO ENSURE THE HEALTH, PRODUCTIVITY, INDEPENDENCE, AND WELL-BEING OF ALL PEOPLE THROUGH OPTIMAL REHABILITATION.

93.865 - Child Health and Human Development Extramural Research

National Institute of Child Health and Human Development (NICHD) [HHS - NIH]

Seattle, Washington 981951016 United States

Single Zip Code

Research Project Grant (Parent R01 Clinical Trial Required) (PA-20-183)

Amendment Since initial award the total obligations have increased 438% from $615,425 to $3,313,701.