This $393,142 Project Grant award from the National Institute of Child Health and Human Development (NICHD) under the Child Health and Human Development Extramural Research program (CFDA 93.865) will support a study to explore synergies in pharmacy-based delivery of pre-exposure prophylaxis (PrEP) and contraception for adolescent girls and young women (AGYW) in Kenya. The study will be conducted by the University of Washington and involve a cluster randomized clinical trial at 20 pharmacies in...
This Project Grant award from the National Institute of Mental Health (NIMH) under the Mental Health Research Grants program (CFDA 93.242) provides $1,981,481 to The General Hospital Corporation (doing business as Massachusetts General Hospital) to conduct a Type 1 clinical effectiveness-implementation trial of the "PREP My Way" intervention. The intervention aims to promote pre-exposure prophylaxis (PrEP) persistence among young Kenyan women, a high-priority population for HIV...
The University of South Florida (USF) received a $389,527 Project Grant award from the National Institute of Mental Health (NIMH) under the Mental Health Research Grants program (CFDA 93.242) to conduct a study examining strategies and contextual factors that optimize the delivery of pre-exposure prophylaxis (PrEP) for HIV prevention in Kenya. The key products and services to be delivered through this two-year project include: Identifying implementation strategies and contextual factors that...
This federal Project Grant award of $547,321 from the National Institute of Mental Health (NIMH), under CFDA 93.242 Mental Health Research Grants program, aims to develop and pilot test an intervention called "Kayungirizi" to promote pre-exposure prophylaxis (PrEP) initiation and persistence among male clients of female sex workers (FSW) in Kampala, Uganda. The key components of the intervention involve: 1) Secondary distribution of HIV self-testing (HIVST) kits by FSW to their male...
The National Institute of Mental Health (NIMH) awarded a $698,683 Project Grant (CFDA 93.242 - Mental Health Research Grants) to the University of Washington on September 10, 2024 for the project "Scaling Up for Impact: HIV Testing Counselor-Led Pathway to Accelerate PrEP Delivery at Scale." This grant will fund research to simplify and diversify PrEP delivery models in Kenya, leveraging existing family planning clinic infrastructure and staff to significantly increase PrEP screening...
This Project Grant award from the National Institutes of Health (NIH) Office of the Director under the Trans-NIH Research Support program (CFDA 93.310) provides $360,000 to Northwestern University to adapt and pilot test a technology-enabled, primary care-based strategy to empower cisgender women with increased vulnerability to HIV to make informed decisions about pre-exposure prophylaxis (PrEP). The key products and services to be delivered under this 2-year award include: Developing an...
The National Institute of Allergy and Infectious Diseases (NIAID) awarded a $381,487 Project Grant (CFDA 93.855 - Allergy and Infectious Diseases Research) to the University of Maryland, Baltimore (UMB) to assess the implementation and outcomes of introducing long-acting injectable cabotegravir (CAB-LA) pre-exposure prophylaxis (PrEP) among adolescent girls and young women at high risk of HIV acquisition in Zambia. The study, titled "Scaling Comprehensively Access to Long-Acting for...
This Project Grant award from the National Institutes of Health (NIH) Office of the Director (CFDA 93.310 - Trans-NIH Research Support) provides $844,564 to Emory University for a project titled "MEETING SOUTH AFRICAN ADOLESCENT GIRLS AND YOUNG WOMEN WHO EXPERIENCE INTIMATE PARTNER VIOLENCE WHERE THEY ARE: DEVELOPING AN IMPLEMENTATION STRATEGY FOR LINKAGE TO PREP OPTIONS." The project aims to conduct formative research to develop a multi-component implementation strategy to link...
The National Institute of Mental Health (NIMH) awarded a five-year, $710,187 Project Grant (CFDA 93.242) to Research Triangle Institute (RTI International) to adapt and evaluate the Comprehensive Adherence Resource and Empowerment Support (CARES) intervention for increasing pre-exposure prophylaxis (PrEP) adherence and continuation among adolescent girls and young women in South Africa and Zimbabwe. The key objectives are to: 1) adapt the CARES intervention to incorporate injectable PrEP and...
This federal Project Grant award from the National Institutes of Health (NIH) Office of the Director under the Trans-NIH Research Support program (CFDA 93.310) provides $196,881 to San Diego State University Foundation to adapt and pilot an intervention to reduce alcohol use and improve HIV care outcomes among men living with HIV who have serodiscordant pregnant partners in Uganda. The key objectives are to: 1) engage stakeholders to co-adapt an existing intervention called...
TESTING A LAY COUNSELOR-LED PREP DELIVERY MODEL IN PUBLIC HEALTH FACILITIES IN KENYA - PROJECT SUMMARY/ABSTRACT THE OVERALL GOAL OF THE PROPOSED K43 AWARD EMERGING GLOBAL LEADER AWARD IS TO SUPPORT DR. ELIZABETH IRUNGU'S RESEARCH TRAINING TO DEVELOP AS AN INDEPENDENT GLOBAL HEALTH HIV RESEARCHER. CONDUCTING THE STUDY PROPOSED IN THIS APPLICATION WILL FACILITATE HER TRAINING GOALS TO: 1) GAIN EXPERTISE IN THE DESIGN AND CONDUCT QUASI-EXPERIMENTAL STUDIES IN REAL WORLD SETTINGS, 2) GAIN A SOLID FOUNDATION IN ORGANIZATIONAL BEHAVIOR THEORY AND RESEARCH, AND 3) ACQUIRE EXPERTISE IN CONDUCTING STAKEHOLDER ANALYSIS. THIS PROPOSAL BUILDS ON UNIQUE SKILLS SHE ALREADY HAS IN CLINICAL TRIALS, EPIDEMIOLOGY AND IMPLEMENTATION SCIENCE. THE RESEARCH GOAL OF THIS PROPOSAL IS TO TEST A NOVEL PREP DELIVERY APPROACH THAT MAY IMPROVE THE FLOW AND UPTAKE OF PREP IN PUBLIC HIV CLINICS IN KENYA. IN AFRICA, PREP IS BEING ADDED TO AN ALREADY-BURDENED HEALTH INFRASTRUCTURE AND THE ABILITY OF THE HEALTH SYSTEMS TO BUILD SUSTAINABLE PREP PROGRAMS WILL NECESSITATE MAKING SERVICE DELIVERY BOTH TIME-EFFICIENT AND PATIENT-CENTERED. WHILE THERE IS HIGH ENTHUSIASM AND UPTAKE FOR PREP DELIVERED IN PUBLIC HIV CLINICS, THE DELIVERY OF PREP IN THESE CLINICS, HOWEVER, CAN BE BURDENSOME WITH MULTIPLE STOPS (FOR HIV TESTING, TRIAGE, CLINICAL REVIEW, AND DISPENSING) AND LONG WAITING TIMES BETWEEN STOPS AND STIGMA ASSOCIATED WITH BEING IN A HIV CLINIC. TO ADDRESS THESE PREP IMPLEMENTATION GAPS, DR IRUNGU WILL CONDUCT A QUASI-EXPERIMENTAL STUDY TO TEST IF A LAY COUNSELOR-LED PREP DELIVERY MODEL WILL RESULT IN REDUCED WAITING TIME IN CLINICS, IMPROVED PREP UPTAKE AND CONTINUATION AND BE DELIVERED WITH FIDELITY (AIM 1). UP TO 300 PREP USERS - BOTH NEWLY INITIATING AND CONTINUING PREP - WILL BE ENROLLED DURING TWO SERIAL, TWELVE-MONTH OBSERVATION PERIODS (N=150/PERIOD): 1) A STANDARD-OF-CARE PREP DELIVERY PERIOD (TO SERVE AS A NEAR- CONTEMPORANEOUS CONTROL) AND 2) A LAY-COUNSELOR LED PREP DELIVERY PERIOD. IN-DEPTH INTERVIEWS WITH HEALTH PROVIDERS IN PARTICIPATING PILOT CLINICS WILL BE CONDUCTED TO ELUCIDATE ORGANIZATIONAL DETERMINANTS OF IMPLEMENTATION OF THIS NOVEL PREP DELIVERY MODEL (AIM 2). IN ADDITION, KEY PREP DELIVERY STAKEHOLDERS IN KENYA, IDENTIFIED THROUGH STAKEHOLDER ANALYSIS, WILL BE INTERVIEWED TO CATEGORIZE THEIR INTEREST IN LAY COUNSELOR PREP DELIVERY AND POWER TO INFLUENCE PREP DELIVERY POLICIES, AND TO UNDERSTAND THEIR PERSPECTIVES ABOUT TASK SHIFTING OF PREP SERVICES TO LAY COUNSELORS. DR IRUNGU'S RESEARCH GOALS ALIGN WITH HER TRAINING GOALS AND AT THE COMPLETION OF THIS AWARD, SHE WILL BE IN AN EXCELLENT POSITION TO SUBMIT AN R01 APPLICATION TO FURTHER ADVANCE HIV PREVENTION IMPLEMENTATION RESEARCH.