This federal Project Grant award of $1,365,212 from the National Institute of Mental Health (CFDA 93.242 - Mental Health Research Grants) aims to optimize and test a peer-led dynamic choice HIV prevention intervention to increase coverage of biomedical prevention products among women at elevated HIV risk in southwestern Uganda. The project will refine the existing Search Dynamic Choice HIV Prevention (DCP) intervention to further engage women working in venues where transactional sex is...
This Project Grant award of $665,225 from the National Institute of Mental Health (NIMH), under the Mental Health Research Grants (CFDA 93.242) program, will fund the "SUUBI4PREP: Improving PrEP Access and Adherence among Adolescent Girls and Young Women in Uganda" project. The project aims to implement a multilevel combination intervention focused on increasing pre-exposure prophylaxis (PrEP) initiation and adherence among adolescent girls and young women living in HIV hotspots in...
This $715,041 Project Grant award from the National Institute of Mental Health (NIMH) under the Mental Health Research Grants program (CFDA 93.242) will support research to understand real-world choices, preferences, and outcomes related to the roll-out of oral and long-acting injectable PrEP (pre-exposure prophylaxis) among women in Malawi. The study, titled "Better Info on Women's PrEP Choices and Outcomes in Malawi", has three specific aims: 1) Evaluate longitudinal patterns of oral...
This federal Project Grant award from the National Institute of Allergy and Infectious Diseases (CFDA 93.855 - Allergy and Infectious Diseases Research) provides $381,487 to the University of Maryland, Baltimore (UMB) to assess the early implementation of long-acting injectable cabotegravir (CAB-LA) pre-exposure prophylaxis (PrEP) among adolescent girls and young women (AGYW) at high risk of HIV acquisition in Zambia. The key objectives are to: 1) Evaluate implementation determinants of CAB-LA...
The National Institute of Mental Health (NIMH) has awarded a $698,683 Project Grant (CFDA 93.242 - Mental Health Research Grants) to the University of Washington to conduct the "Scaling Up for Impact: HIV Testing Counselor-Led Pathway to Accelerate PrEP Delivery at Scale" research project. This project aims to simplify and diversify models for delivering pre-exposure prophylaxis (PrEP) for HIV prevention, with the goal of making these interventions more accessible and scalable to...
This Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID), under the Allergy and Infectious Diseases Research program (CFDA 93.855), provides $702,000 to support a 3-year project aimed at optimizing the implementation of long-acting injectable pre-exposure prophylaxis (LAI-PrEP) for HIV prevention. The key objectives are to: 1) Identify barriers and facilitators to LAI-PrEP implementation, 2) Determine optimal implementation strategies in partnership with...
The National Institute of Nursing Research (NINR), under the Nursing Research Federal Grant Program (CFDA 93.361), awarded a $1,606,442 Project Grant to Duke University to conduct a cluster randomized controlled trial of the "Using PREP, Doing It For Ourselves (UPDOS) Protective Styles" intervention. This e-health intervention aims to improve PrEP (pre-exposure prophylaxis) uptake among Black cisgender women in the southern United States, who have been disproportionately affected by...
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 Project Grant award from the National Institute of Mental Health (NIMH), under the Mental Health Research Grants program (CFDA 93.242), aims to adapt and evaluate the effectiveness of the Comprehensive Adherence Resource and Empowerment Support (CARES) intervention to increase pre-exposure prophylaxis (PrEP) continuation and adherence among adolescent girls and young women in South Africa and Zimbabwe. The total funding amount is $710,187, with an award date of September 11, 2024 and an...
This federal 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), is providing $573,475 to The Botswana Harvard Health Partnership (BHP) to conduct a randomized trial evaluating the effect of integrating sexually transmitted infection (STI) testing with expanded pre-exposure prophylaxis (PrEP) options on PrEP use among pregnant women in Botswana. The study aims to...
PREP MY WAY: A HYBRID TYPE 1 CLINICAL EFFECTIVENESS-IMPLEMENTATION TRIAL TO PROMOTE PREP PERSISTENCE AMONG YOUNG KENYAN WOMEN - PROJECT SUMMARY. SIGNIFICANCE: YOUNG WOMEN ACCOUNT FOR 63% OF ALL NEW HIV INFECTIONS IN SUB-SAHARAN AFRICA AND ARE THUS A HIGH PRIORITY POPULATION FOR PRE-EXPOSURE PROPHYLAXIS (PREP). BECAUSE ADHERENCE AND PERSISTENCE TO PREP AS ORAL EMTRICITABINE/TENOFOVIR HAVE GENERALLY BEEN LOW, NEW INTERVENTIONS ARE NEEDED TO FACILITATE PREP USE. INJECTABLE CABOTEGRAVIR (CAB-LA) AND THE DAPIVIRINE VAGINAL RING, AS WELL AS CHOICE OF ADHERENCE SUPPORT, ARE PROMISING APPROACHES TO INCREASE PREP USE; HOWEVER, A KEY REMAINING NEED IS A MECHANISM TO EFFECTIVELY ENGAGE WITH YOUNG WOMEN OVER TIME. INTERVENTION: PREP MY WAY IS A NOVEL PREP DELIVERY SYSTEM BASED ON SOCIAL COGNITIVE THEORY INVOLVING CLINIC-BASED PREP INITIATION, FOLLOWED BY PEER- DELIVERED KITS FOR HIV SELF-TESTING, PREP REFILLS, VAGINAL SWABS FOR SEXUALLY TRANSMITTED INFECTION (STI) SELF- SAMPLING, PREGNANCY TESTS, AND FAMILY PLANNING, IF DESIRED. PILOT RESEARCH DEMONSTRATED HIGH FEASIBILITY AND ACCEPTABILITY OF PREP MY WAY AS AN EFFECTIVE MEANS TO ENGAGE YOUNG WOMEN IN CARE. PREP USE WAS MODEST OVERALL ALTHOUGH IMPROVED COMPARED TO CLINIC-BASED DELIVERY. WHEN COMBINED WITH CHOICE OF PREP FORMULATION AND ADHERENCE SUPPORT TOOLS, PREP MY WAY IS WELL POSITIONED TO CREATE AN OPTIMIZED MEANS TO PROMOTE PREP USE FOR YOUNG WOMEN IN SUB-SAHARAN AFRICA. INNOVATION: PREP MY WAY IS THE FIRST, TO OUR KNOWLEDGE, PEER- DELIVERED KIT FOR HOLISTIC SEXUAL HEALTH SERVICES THAT ENABLES CHOICE OF PREP FORMULATION AND ADHERENCE SUPPORT, COMBINING KEY COMPLEMENTARY EVIDENCE-BASED APPROACHES FOR PROMOTING PREP USE AMONG YOUNG WOMEN. APPROACH: IN AIM 1, WE WILL AUGMENT PREP MY WAY TO INCLUDE CAB-LA AND THE DAPIVIRINE VAGINAL RING, AS WELL AS CHOICE OF PEER-BASED ADHERENCE SUPPORT (SMS, ROUTINE CHECK-INS, OR WHATSAPP GROUPS). IN AIM 2, WE WILL CONDUCT A TYPE 1 EFFECTIVENESS-IMPLEMENTATION TRIAL OF PREP MY WAY VS ENHANCED STANDARD OF CARE IN KISUMU, KENYA IN 432 YOUNG WOMEN OVER 1 YEAR. WE WILL ASSESS THE INTERVENTION WITH AND WITHOUT STI TESTING TO ASSESS THE MARGINAL IMPACT OF THE MOST COSTLY KIT COMPONENT BEYOND PREP. OUR PRIMARY OUTCOME WILL BE PREVENTION- EFFECTIVE PREP PERSISTENCE (I.E., CONTINUED USE BY THOSE WITH ONGOING HIV PREVENTION NEEDS) BY DOCUMENTED INJECTION (CAB-LA) OR DRUG LEVELS (RING, ORAL) AT MONTH 9. SECONDARY OUTCOMES WILL BE PREVENTION-EFFECTIVE PERSISTENCE AND ADHERENCE AT OTHER TIME POINTS, STI TESTING, AND USE OF FAMILY PLANNING. WE WILL ALSO TRACK IMPLEMENTATION, SERVICE, AND PARTICIPANT METRICS USING THE PROCTOR FRAMEWORK. IN AIM 3, WE WILL CONDUCT COST AND COST-EFFECTIVENESS ANALYSES OF THE INTERVENTION WITH AND WITHOUT STI TESTING. INVESTIGATORS/ENVIRONMENT: OUR TEAM HAS THE CRITICAL EXPERTISE NEEDED FOR THE SUCCESS OF THIS PROPOSAL: PREP ADHERENCE/PERSISTENCE AND IMPLEMENTATION SCIENCE (DR. HABERER), PREP/SEXUAL HEALTH SERVICE DELIVERY (DR. BUKUSI), PREP FORMULATION AND ADHERENCE SUPPORT CHOICE (DR. NGURE), COST-EFFECTIVENESS ANALYSIS (DR. BARNABAS), AND INTERVENTION DESIGN (ARK AFRICA, DR. SIEGLER). FUTURE DIRECTIONS: THE KENYA NATIONAL AIDS/STD CONTROL PROGRAM (DR. WAFULA) WILL BE INVOLVED WITH ALL STAGES OF THIS PROPOSAL TO FACILITATE RAPID INTEGRATION AND SCALE-UP SHOULD IT PROVE EFFECTIVE.