Comparing a standard and tailored approach to scaling up an evidence-based intervention for antiretroviral therapy for people who inject drugs in Vietnam: study protocol for a cluster randomized hybrid type III trial

Autor: Ngoc H. Bui, Son H. Vo, Byron J. Powell, Minh Nguyen, Brian W. Pence, Irving F. Hoffman, Vivian F. Go, Carl A. Latkin, Teerada Sripaipan, Long H. Nguyen, David W. Dowdy, Kathryn E. Lancaster, Ha V. Tran, Manh Duc Pham, Anh V. Chu, An T. M. Dao, William C. Miller
Rok vydání: 2020
Předmět:
Counseling
medicine.medical_specialty
Evidence-based practice
Cost effectiveness
Psychological intervention
HIV Infections
Intervention
Health Informatics
Psychosocial counseling
law.invention
Study Protocol
03 medical and health sciences
Intervention mapping
0302 clinical medicine
Randomized controlled trial
law
Humans
Medicine
Medical physics
030212 general & internal medicine
Tailoring implementation strategies
Health policy
Randomized Controlled Trials as Topic
lcsh:R5-920
Evidence-Based Medicine
business.industry
030503 health policy & services
Health Policy
Public Health
Environmental and Occupational Health
Health services research
HIV
System navigation
General Medicine
Economic evaluation
Pharmaceutical Preparations
Vietnam
Implementation science
Cost-effectiveness
lcsh:Medicine (General)
0305 other medical science
business
People who inject drugs
Implementation strategies
Zdroj: Implementation Science, Vol 15, Iss 1, Pp 1-16 (2020)
Implementation Science : IS
ISSN: 1748-5908
DOI: 10.1186/s13012-020-01020-z
Popis: Background People who inject drugs (PWID) bear a disproportionate burden of HIV infection and experience poor outcomes. A randomized trial demonstrated the efficacy of an integrated System Navigation and Psychosocial Counseling (SNaP) intervention in improving HIV outcomes, including antiretroviral therapy (ART) and medications for opioid use disorder (MOUD) uptake, viral suppression, and mortality. There is limited evidence about how to effectively scale such intervention. This protocol presents a hybrid type III effectiveness-implementation trial comparing two approaches for scaling-up SNaP. We will evaluate the effectiveness of SNaP implementation approaches as well as cost and the characteristics of HIV testing sites achieving successful or unsuccessful implementation of SNaP in Vietnam. Methods Design: In this cluster randomized controlled trial, two approaches to scaling-up SNaP for PWID in Vietnam will be compared. HIV testing sites (n = 42) were randomized 1:1 to the standard approach or the tailored approach. Intervention mapping was used to develop implementation strategies for both arms. The standard arm will receive a uniform package of these strategies, while implementation strategies for the tailored arm will be designed to address site-specific needs. Participants: HIV-positive PWID participants (n = 6200) will be recruited for medical record assessment at baseline; of those, 1500 will be enrolled for detailed assessments at baseline, 12, and 24 months. Site directors and staff at each of the 42 HIV testing sites will complete surveys at baseline, 12, and 24 months. Outcomes: Implementation outcomes (fidelity, penetration, acceptability) and effectiveness outcomes (ART, MOUD uptake, viral suppression) will be compared between the arms. To measure incremental costs, we will conduct an empirical costing study of each arm and the actual process of implementation from a societal perspective. Qualitative and quantitative site-level data will be used to explore key characteristics of HIV testing sites that successfully or unsuccessfully implement the intervention for each arm. Discussion Scaling up evidence-based interventions poses substantial challenges. The proposed trial contributes to the field of implementation science by applying a systematic approach to designing and tailoring implementation strategies, conducting a rigorous comparison of two promising implementation approaches, and assessing their incremental costs. Our study will provide critical guidance to Ministries of Health worldwide regarding the most effective, cost-efficient approach to SNaP implementation. Trial registration NCT03952520 on Clinialtrials.gov. Registered 16 May 2019.
Databáze: OpenAIRE
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