RCT to reduce HIV acquisition and viral load among migrants, Rakai, Uganda

旨在减少乌干达拉凯移民中艾滋病毒感染和病毒载量的随机对照试验

• 批准号: 10408017
• 负责人: Larry William Chang
• 金额: $ 58.2万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10408017
• 关键词: AIDS prevention; Achievement; Address; Adoption; Africa; Africa South of the Sahara; Area; Caring; Clinic; Cohort Studies; Communities; Consent; Counseling; Couples; Data; Economics; Elements; Epidemic; Evaluation Studies; Fishes; Future; General Population; Geography; Goals; HIV; HIV Seronegativity; Health; Health Sciences; Health Services; Human immunodeficiency virus test; Incidence; Individual; Interruption; Intervention; Intervention Studies; Intervention Trial; Interview; Link; Male Circumcision; Medical; Methods; Migrant; Participant; Persons; Population; Population Surveillance; Prevalence; Process; Randomized; Randomized Controlled Trials; Reach Effectiveness Adoption Implementation and Maintenance; Reporting; Research; Risk; Risk Behaviors; Rural; Services; Sex Behavior; Social isolation; Surveys; Training; Translating; Transportation; Uganda; Viral Load result; Vulnerable Populations; aged; antiretroviral therapy; arm; base; cohort; comparison intervention; cost; cost effectiveness; effectiveness evaluation; flexibility; follow-up; high risk sexual behavior; implementation evaluation; implementation measures; implementation science; improved; innovation; intervention cost; migration; motivational enhancement therapy; novel; outreach; pragmatic implementation; pragmatic trial; pre-exposure prophylaxis; prevent; prevention service; primary endpoint; primary outcome; process evaluation; programs; randomized trial; secondary outcome; service providers; testing services; theories; transmission process; trial design; uptake; voucher

PROJECT SUMMARY (ABSTRACT) The Rakai Health Sciences Program (RHSP), Uganda, proposes an implementation science community- randomized controlled trial (CRCT) of a novel intervention to newly in-migrated individuals (“Welcome In- coming Neighbor” [WIN]), to optimize their rapid linkage to combination HIV prevention (CHP) services. RHSP data show that within the first 36 months after in-migration, compared to residents, HIV-negative in-migrants are at increased risk of HIV acquisition and HIV+ in-migrants underutilize antiretroviral therapy (ART) increasing the risk of onward transmission. The theory-based WIN intervention includes community sensitization, community-based WIN scouts (WINs), and enhanced, differentiated clinic services for in- migrants. WINs will conduct active community surveillance to rapidly identify and welcome in-migrants, provide them with information about the availability of CHP and high rates of use by residents (to “normalize” uptake), utilize a motivational interviewing approach to encourage CHP adoption, refer in-migrants to free services, provide vouchers enabling them to receive priority clinic services, and follow-up in-migrants to assess and further encourage engagement in CHP. Specific Aims: Aim 1: To randomize 40 individually matched communities in a 1:1 ratio to the WIN intervention or control arm. In-migrants aged 15-49 in each arm will undergo a baseline and 2 follow-up surveys at ~18-month intervals. Primary end points are HIV incidence in initially HIV-negative in-migrants (n ~3,800 py per arm), and viral load suppression in HIV+ (n ~740 per arm). CHP coverage rates and sexual behaviors will also be compared (secondary outcomes). Aim 2a: To use a mixed methods approach (in-depth interviews, process & survey data) and RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) to (i) guide interim intervention adaptation as necessary; (ii) interpret trial results; and, (iii) translate the research into future action. Aim 2b: To conduct cost studies to provide information on affordability and sustainability. Innovation and Impact: This novel intervention will rapidly engage a vulnerable priority population of in-migrants, to optimize CHP and HIV impact in rural Uganda.

项目总结（摘要）