R01TW013189

A MULTILEVEL INTERVENTION TO REDUCE PREP STIGMA AND INCREASE EFFECTIVE PREP USE AMONG ADOLESCENT GIRLS AND YOUNG WOMEN IN KENYA - PROJECT SUMMARY/ABSTRACT THE GOAL OF THIS SMALL R01 APPLICATION IS TO DEVELOP AND PILOT TEST A MULTILEVEL, COMMUNITY-BASED INTERVENTION TO REDUCE PRE-EXPOSURE PROPHYLAXIS (PREP) STIGMA AND INCREASE PREP UPTAKE AND CONTINUATION AMONG ADOLESCENT GIRLS AND YOUNG WOMEN (AGYW) IN WESTERN KENYA. AGYW AGES 15–24 REPRESENT 10% OF THE POPULATION BUT ACCOUNT FOR MORE THAN 25% OF NEW HIV INFECTIONS IN EAST AND SOUTHERN AFRICA. DESPITE THE EFFECTIVENESS OF DAILY ORAL PREP IN REDUCING HIV ACQUISITION, UPTAKE, ADHERENCE, AND CONTINUATION REMAIN LOW IN THIS REGION. IN OUR FORMATIVE WORK, AGYW REPORTED SIGNIFICANT STIGMA AROUND PREP USE FROM FRIENDS, MALE PARTNERS, AND THE BROADER COMMUNITY (I.E., “KEY INFLUENCERS”), WHICH WAS ASSOCIATED WITH 30–50% LOWER PREP ADHERENCE. TO ADDRESS THIS CHALLENGE, WE PROPOSE TO DEVELOP AN INTERVENTION TO REDUCE PREP STIGMA AMONG KEY INFLUENCERS AND MITIGATE THE IMPACT OF STIGMA AMONG AGYW (AIM 1) USING EDUCATION, SKILLS-BUILDING, EMPATHY-BUILDING, AND PSYCHOSOCIAL SUPPORT STRATEGIES AT THE COMMUNITY, INTERPERSONAL, AND INDIVIDUAL LEVELS. GUIDED BY THE SIX ESSENTIAL ACTIONS FOR QUALITY INTERVENTION DEVELOPMENT FRAMEWORK, OUR FORMATIVE RESEARCH, AND ESTABLISHED BEST PRACTICES FOR STIGMA REDUCTION, WE WILL CONDUCT PARTICIPATORY CO-DESIGN WORKSHOPS WITH 30 AGYW AND STAKEHOLDERS TO IDENTIFY CHANGE MECHANISMS AND EFFECTIVE DELIVERY PLATFORMS TO TARGET THE DRIVERS OF PREP STIGMA. WE WILL DRAFT AN INTERVENTION MANUAL AND TRAINING MATERIALS AND PRE-TEST THEM WITH APPROXIMATELY 12 AGYW, 56 KEY INFLUENCERS, AND 8 INTERVENTION PROVIDERS. WE WILL THEN ASSESS THE FEASIBILITY, ACCEPTABILITY, AND PRELIMINARY EVIDENCE OF INTERVENTION EFFECTIVENESS THROUGH A PILOT CLUSTER-RANDOMIZED CONTROLLED TRIAL (CRCT) IN FOUR COMMUNITIES (AIM 2). WE WILL ENROLL 20 AGYW AGES 15–24 FROM EACH COMMUNITY (N=80 TOTAL) WITH FOLLOW-UP AT INTERVENTION MIDPOINT (3 MONTHS) AND ENDPOINT (6 MONTHS), SUPPLEMENTED BY PRE-POST-INTERVENTION SURVEYS WITH 80 KEY INFLUENCERS AND POST-INTERVENTION QUALITATIVE DATA FROM 16 AGYW, 12 KEY INFLUENCERS, AND ALL INTERVENTION PROVIDERS. PRIMARY OUTCOMES ARE INTERVENTION FEASIBILITY; ACCEPTABILITY TO AGYW, KEY INFLUENCERS, AND PROVIDERS; AND PREP STIGMA SCORES AMONG AGYW. SECONDARY OUTCOMES INCLUDE STIGMA AMONG KEY INFLUENCERS AND PREP UPTAKE, PREP CONTINUATION (MEASURED WITH A URINE TENOFOVIR BIOMARKER), AND DEPRESSION AND ANXIETY SYMPTOMS AMONG AGYW. THE PROPOSED STUDY BUILDS DIRECTLY ON OUR FORMATIVE RESEARCH ESTABLISHING THE HIGH PREVALENCE OF PREP STIGMA AND ITS ASSOCIATION WITH LOW PREP ADHERENCE. IF SUCCESSFUL, IT WILL PROVIDE ROBUST DATA TO SUPPORT A FULLY POWERED CRCT TO EVALUATE THE INTERVENTION’S EFFECTIVENESS ON PREP STIGMA, PREP UPTAKE AND CONTINUATION, AND BIOMARKERS OF PREP ADHERENCE.

Impact Research And Development Organisation

THE JOHN E. FOGARTY INTERNATIONAL CENTER (FIC) SUPPORTS RESEARCH AND RESEARCH TRAINING TO REDUCE DISPARITIES IN GLOBAL HEALTH AND TO FOSTER PARTNERSHIPS BETWEEN U.S. SCIENTISTS AND THEIR COUNTERPARTS ABROAD. FIC SUPPORTS BASIC BIOLOGICAL, BEHAVIORAL, AND SOCIAL SCIENCE RESEARCH, AS WELL AS RELATED RESEARCH TRAINING AND CAREER DEVELOPMENT. THE RESEARCH PORTFOLIO IS DIVIDED INTO SEVERAL PROGRAMS THAT SUPPORT A WIDE VARIETY OF FUNDING MECHANISMS TO MEET PROGRAMMATIC OBJECTIVES.

93.989 - International Research and Research Training

Fogarty International Center (FIC) [HHS - NIH]

Research Triangle Park, North Carolina 277092194 United States

Single Zip Code

Interventions for Stigma Reduction to Improve HIV/AIDS Prevention, Treatment and Care in Low- and Middle- Income Countries (R01 - Clinical Trial Optional) (PAR-23-190)