This protocol was designed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P), living review guidelines (4) and WHO and Cochrane rapid review guidelines (6, 9).
Identification of review questions:
Revelant HIV implementation science questions will be developed in consultation with HIV guideline development groups. This will include questions regarding effectiveness and efficacy of HIV implementation strategies. Individual review protocols will be published on PROSPERO the international prospective register of systematic reviews (https://www.crd.york.ac.uk/prospero/).
Eligibility criteria:
Studies eligible for inclusion in living rapid reviews include those conducted in any population group or age category from any setting. Randomized controlled trails (RCTs), cohort studies (with or without a comparison arm), cross-sectional studies and natural experiments are eligible for inclusion. Studies must evaluate implementation interventions (interventions aimed at implementing a change to the way HIV care and preventions strategies are delivered or modify patient behavior to improve outcomes) and report on at least one HIV cascade outcome (diagnosis, testing, linkage to ART, retention on ART, ART adherence, viral suppression, and survival) (Table 1). Eligible studies will be restricted to English language publications.
Table 1: Eligibility criteria for inclusion in LIVE rapid living reviews
Population
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All settings ; all ages
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Intervention
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Interventions aimed at: (1) implementing a change to the way HIV care and preventions strategies are delivered or (2) modify patient behavior
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Comparison
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Other intervention, standard of care, or no comparison
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Outcome
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HIV incidence, HIV testing uptake, ART initiation, ART adherence, viral suppression, mortality
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Database searches:
A search specialist will conduct searches of a minimum of two databases Medline and Embase, and will include CINAHL and other databases depending on the considered added value for the specified review question. Search outputs will be refined through an iterative process of cross-checking against known studies in the field and once finalized, automated searches, running at a pre-determined frequency (6 monthly), will generate updated lists of studies for screening and eligibility assessment and abstraction. Searches will include studies published between 2004 to present day, but may be be restricted to more recent studies depending on the specified review question. Search strategies will be re-evaluated and revised on a 12 monthly basis to ensure search terms reflect the current HIV implementation research terminology and that relevant studies are captured.
Gray literature searches:
At minimum the International AIDS Society conferences ( https://www.iasociety.org/Conferences) and Conference on Retroviruses and Opportunistic Infections (https://www.croiconference.org/) conference abstracts will be searched for the previous two years. Additional conference searches will depend on their relevance to review questions. Decisions regarding the searching of clinical trial registries such as Clinical trials.gov and WHO ICRTP Clinical trial registries will depend on the specific review, if few studies are known in the field, exploring trial regristries may be necessary.
Screening:
Several team members may be involved in screening processes. Abstract and full-text screening will be conducted using Covidence software (10). For abstract screening, two team members will screen the first 20% of abstracts with conflict resolution, once approaches to screening are calibrated, ongoing abstract screening will be conducted by one team member. Full-text screening will be conducted by one team member and excluded full-texts will be screened by a second. Conferences and clinical trial registry searches will be conducted by one team member with confirmation of eligibility of included abstracts by a second.
Data abstraction:
Study data will be abstracted into the LIVE database hosted on the Airtable platform (a relational database designed to be easily modified by end users and widely used commercially (11). Basic descriptive information will be extracted from each study (including details on publication, study design, setting, context and demographic characteristics) and additional data regarding the critical characteristics and components of implementation strategies are recorded using existing frameworks for evaluating implementation strategies to guide content extraction (12) as well as characterization of intervention mechanisms (13) (Table 2). Extracted study outcomes will include numerators and denominators, as well as adjusted and unadjusted effect estimates. Data abstraction and methological quality assessments will be conducted by one team member and reviewed by a second.
Table 2: Tools used to assess study quality and characterize intervention strategies for living rapid reviews
Assessment Tool
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Purpose
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Cochrane Risk of bias tool version 1 or 2 (14, 15)
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Methodological quality of randomized controlled trials
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Newcastle Ottawa scale (16)
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Assess methodological quality of cohort and cross-sectionals studies
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Standards for Reporting Implementation Studies
(StaRI) (17)
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Assess reporting of implementation science studies
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PRECIS-2 tool (13)
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Evaluate explanatory vs pragmatic approaches of studies
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