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Reducing time to differentiated service delivery for newly diagnosed people living with HIV in Kigali, Rwanda: study protocol for a pilot, unblinded, randomised controlled study.

作者信息

Ross Jonathan, Murenzi Gad, Hill Sarah, Remera Eric, Ingabire Charles, Umwiza Francine, Munyaneza Athanase, Muhoza Benjamin, Habimana Dominique Savio, Mugwaneza Placidie, Zhang Chenshu, Yotebieng Marcel, Anastos Kathryn

机构信息

Division of General Internal Medicine, Montefiore Health System, Bronx, New York, USA

Division of General Internal Medicine, Yeshiva University Albert Einstein College of Medicine, Bronx, New York, USA.

出版信息

BMJ Open. 2021 Apr 24;11(4):e047443. doi: 10.1136/bmjopen-2020-047443.


DOI:10.1136/bmjopen-2020-047443
PMID:33895720
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8074553/
Abstract

INTRODUCTION: Current HIV guidelines recommend differentiated service delivery (DSD) models that allow for fewer health centre visits for clinically stable people living with HIV (PLHIV). Newly diagnosed PLHIV may require more intensive care early in their treatment course, yet frequent appointments can be burdensome to patients and health systems. Determining the optimal parameters for defining clinical stability and transitioning to less frequent appointments could decrease patient burden and health system costs. The objectives of this pilot study are to explore the feasibility and acceptability of (1) reducing the time to DSD from 12 to 6 months after antiretroviral therapy (ART) initiation,and (2) reducing the number of suppressed viral loads required to enter DSD from two to one. METHODS AND ANALYSES: The present study is a pilot, unblinded trial taking place in three health facilities in Kigali, Rwanda. Current Rwandan guidelines require PLHIV to be on ART for ≥12 months with two consecutive suppressed viral loads in order to transition to less frequent appointments. We will randomise 90 participants to one of three arms: entry into DSD at 6 months after one suppressed viral load (n=30), entry into DSD at 6 months after two suppressed viral loads (n=30) or current standard of care (n=30). We will measure feasibility and acceptability of this intervention; clinical outcomes include viral suppression at 12 months (primary outcome) and appointment attendance (secondary outcome). ETHICS AND DISSEMINATION: This clinical trial was approved by the institutional review board of Albert Einstein College of Medicine and by the Rwanda National Ethics Committee. Findings will be disseminated through conferences and peer-reviewed publications, as well as meetings with stakeholders. TRIAL REGISTRATION NUMBER: NCT04567693.

摘要

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引用本文的文献

[1]
Reducing time to differentiated service delivery for newly-diagnosed people living with HIV in Kigali, Rwanda: a pilot, unblinded, randomized controlled trial.

BMC Health Serv Res. 2024-4-30

[2]
Association Between Clinical Encounter Frequency and HIV-Related Stigma Among Newly-Diagnosed People Living with HIV in Rwanda.

AIDS Behav. 2024-4

[3]
Community-based differentiated service delivery models incorporating multi-month dispensing of antiretroviral treatment for newly stable people living with HIV receiving single annual clinical visits: a pooled analysis of two cluster-randomized trials in southern Africa.

J Int AIDS Soc. 2021-10

本文引用的文献

[1]
Retention in care and viral suppression in differentiated service delivery models for HIV treatment delivery in sub-Saharan Africa: a rapid systematic review.

J Int AIDS Soc. 2020-11

[2]
Twelve-Month Outcomes of Community-Based Differentiated Models of Multimonth Dispensing of ART Among Stable HIV-Infected Adults in Lesotho: A Cluster-Randomized Noninferiority Trial.

J Acquir Immune Defic Syndr. 2020-11-1

[3]
High levels of viral load monitoring and viral suppression under Treat All in Rwanda - a cross-sectional study.

J Int AIDS Soc. 2020-6

[4]
Provider experiences with three- and six-month antiretroviral therapy dispensing for stable clients in Zambia.

AIDS Care. 2021-4

[5]
Outcomes of Three- Versus Six-Monthly Dispensing of Antiretroviral Treatment (ART) for Stable HIV Patients in Community ART Refill Groups: A Cluster-Randomized Trial in Zimbabwe.

J Acquir Immune Defic Syndr. 2020-6-1

[6]
Cost of Differentiated HIV Antiretroviral Therapy Delivery Strategies in Sub-Saharan Africa: A Systematic Review.

J Acquir Immune Defic Syndr. 2019-12

[7]
Differentiated Care Preferences of Stable Patients on Antiretroviral Therapy in Zambia: A Discrete Choice Experiment.

J Acquir Immune Defic Syndr. 2019-8-15

[8]
Retention in care among clinically stable antiretroviral therapy patients following a six-monthly clinical consultation schedule: findings from a cohort study in rural Malawi.

J Int AIDS Soc. 2018-11

[9]
HIV-Related Stigma, Social Support, and Psychological Distress Among Individuals Initiating ART in Ethiopia.

AIDS Behav. 2018-12

[10]
Multi-month prescriptions, fast-track refills, and community ART groups: results from a process evaluation in Malawi on using differentiated models of care to achieve national HIV treatment goals.

J Int AIDS Soc. 2017-7-21

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