Background Global HIV treatment programs have sought to lengthen the interval between clinical encounters for people living with HIV (PLWH) who are established on antiretroviral treatment (ART) to reduce the burden of seeking care and to decongest health facilities. The overall effect of reduced visit frequency on HIV treatment outcomes is however unknown. We conducted a systematic review and meta-analysis to evaluate the effect of implementation strategies that reduce the frequency of clinical appointments and ART refills for PLWH established on ART. Methods and findings We searched databases between 1 January 2010 and 9 November 2021 to identify randomized controlled trials (RCTs) and observational studies that compared reduced (6- to 12-monthly) clinical consultation or ART refill appointment frequency to 3- to 6-monthly appointments for patients established on ART. We assessed methodological quality and real-world relevance, and used Mantel–Haenszel methods to generate pooled risk ratios (RRs) with 95% confidence intervals for retention, viral suppression, and mortality. We evaluated heterogeneity quantitatively and qualitatively, and overall evidence certainty using GRADE. Searches yielded 3,955 records, resulting in 10 studies (6 RCTs, 3 observational studies, and 1 study contributing observational and RCT data) representing 15 intervention arms with 33,599 adults (≥16 years) in 8 sub-Saharan African countries. Reduced frequency clinical consultations occurred at health facilities, while reduced frequency ART refills were delivered through facility or community pharmacies and adherence groups. Studies were highly pragmatic, except for some study settings and resources used in RCTs. Among studies comparing reduced clinical consultation frequency (6- or 12-monthly) to 3-monthly consultations, there appeared to be no difference in retention (RR 1.01, 95% CI 0.97–1.04, p = 0.682, 8 studies, low certainty), and this finding was consistent across 6- and 12-monthly consultation intervals and delivery strategies. Viral suppression effect estimates were markedly influenced by under-ascertainment of viral load outcomes in intervention arms, resulting in inconclusive evidence (RR 0.74, 95% CI 0.59–0.94, p = 0.015, 4 RCTs, very low certainty). There was similarly insufficient evidence to draw conclusions on mortality (RR 1.12, 95% CI 0.75–1.66, p = 0.592, 6 studies, very low certainty). For ART refill frequency, there appeared to be little to no difference in retention (RR 1.01, 95% CI 0.98–1.06, p = 0.473, 4 RCTs, moderate certainty) or mortality (RR 1.45, 95% CI 0.63–3.35, p = 0.382, 4 RCTs, low certainty) between 6-monthly and 3-monthly visits. Similar to the analysis for clinical consultations, no conclusions could be drawn on viral suppression (RR 0.60, 95% CI 0.41–0.88, p = 0.009, 3 RCTs, very low certainty). This systematic review was limited by the small number of studies available to compare 12- versus 6-monthly clinical consultations, insufficient data to compare implementation strategies, and lack of evidence for children, key populations, and low- and middle-income countries outside of sub-Saharan Africa. Conclusions Based on this synthesis, extending clinical consultation intervals to 6 or 12 months and ART dispensing intervals to 6 months appears to result in similar retention to 3-month intervals, with less robust conclusions for viral suppression and mortality. Future research should ensure complete viral load outcome ascertainment, as well as explore mechanisms of effect, outcomes in other populations, and optimum delivery and monitoring strategies to ensure widespread applicability.
Background HIV implementation research evolves rapidly and is often complex and poorly characterized, which makes the synthesis of data on HIV implementation strategies inherently difficult. This is further compromised by prolonged data abstraction processes due to variable interventions, outcomes, and context, and delays in the publication of review findings; this can all result in outdated and irrelevant systematic reviews. Objective The LIVE project (A Living Database of HIV Implementation Research) aims to overcome these challenges by applying an implementation science lens to the conduct of rapid living systematic reviews and meta-analyses to inform HIV service delivery priorities and guideline development. Methods The LIVE project will generate a series of living systematic reviews exploring implementation strategies for improving HIV cascade outcomes (HIV infection, HIV diagnosis, linkage and retention in HIV care, viral suppression, and mortality). We will search Embase and MEDLINE as well databases specific to review questions for studies conducted after 2004 using predefined search terms to identify studies conducted in any age group or setting, and using implementation strategies that target policy makers, society, health organizations, health workers, and beneficiaries of care and their families. Both randomized controlled trials and observational studies will be included to ensure reviews include pragmatic data. In addition to assessments of methodological quality, features of the implementation strategies, relevance for implementation, and evidence quality will be determined using recognized frameworks. After initial publication, knowledge gaps will be identified, and review questions and search strategies revised to address ongoing critical areas of inquiry. Updated searches will be conducted every 6 months, with subsequent ongoing screening, data abstraction, and revision of meta-analyses. Results As of July 2022, five reviews are at various stages of development within the LIVE project. Three systematic reviews are underway and living review processes are in development for two reviews with estimated completion over the next 12 months. Conclusions This project and resulting systematic reviews will provide critical insights for HIV service delivery to inform international guideline development. International Registered Report Identifier (IRRID) DERR1-10.2196/37070
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