The effectiveness and cost-effectiveness of 3- vs. 6-monthly dispensing of antiretroviral treatment (ART) for stable HIV patients in community ART-refill groups in Zimbabwe: study protocol for a pragmatic, cluster-randomized trial

Fatti, Geoffrey; Ngorima‐Mabhena, Nicoletta; Chirowa, Frank; Chirwa, Benson; Takarinda, Kudakwashe C; Tafuma, Taurayi A.; Mahachi, Nyikadzino; Chikodzore, Rudo; Nyadundu, Simon; Ajayi, Charles A; Mutasa‐Apollo, Tsitsi; Mugurungi, Owen; Mothibi, Eula; Hoffman, Risa M.; Grimwood, Ashraf

doi:10.1186/s13063-018-2469-y

Cited by 14 publications

(15 citation statements)

References 18 publications

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“…The proportion of LTFU among the Test and Treat patients was much larger than has been observed in previous evaluations of ART retention outcomes conducted before the adoption of the Treat All guidelines in Nigeria [14]. Identifying optimal intervals between patient visits and multiple measures of retention could help evaluate treatment programs [13, 15]. Our findings could be used to identify quality improvement initiatives to retain Test and Treat patients as the Treat All guidelines are implemented nationwide.…”

Section: Discussionmentioning

confidence: 66%

Evaluation of the clinical outcomes of the Test and Treat strategy to implement Treat All in Nigeria: Results from the Nigeria Multi-Center ART Study

Stafford

Odafe

et al. 2019

PLoS ONE

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In December 2016, the Nigerian Federal Ministry of Health updated its HIV guidelines to a Treat All approach, expanding antiretroviral therapy (ART) eligibility to all individuals with HIV infection, regardless of CD4+ cell count, and recommending ART be initiated within two weeks of HIV diagnosis (i.e., the Test and Treat strategy). The Test and Treat policy was first piloted in 32 local government areas (LGAs). The primary objective of this study was to evaluate the clinical outcomes of adult patients initiated on ART within two weeks of HIV diagnosis during this pilot. We conducted a retrospective cohort analysis of patients who initiated ART within two weeks of new HIV diagnosis between October 2015 and September 2016 in eight randomly selected LGAs participating in the Test and Treat pilot study. 2,652 adults were newly diagnosed and initiated on ART within two weeks of HIV diagnosis. Of these patients, 8% had documentation of a 12-month viral load measurement, and 13% had documentation of a six-month viral load measurement. Among Test and Treat patients with a documented viral load, 79% were suppressed (≤400 copies/ml) at six months and 78% were suppressed at 12 months. By 12 months post-ART initiation, 34% of the patients who initiated ART under the Test and Treat strategy were lost to follow-up. The median CD4 cell count among patients initiating ART within two weeks of HIV diagnosis was 323 cells/mm 3 (interquartile range, 161–518). While randomized controlled trials have demonstrated that Test and Treat strategies can improve patient retention and increase viral suppression compared to standard of care, these findings indicate that the effectiveness of Test and Treat in some settings may be far lower than the efficacy demonstrated in randomized controlled trials. Significant attention to the way Test and Treat strategies are implemented, monitored, and improved particularly related to early retention, can help expand access to ART for all patients.

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Section: Discussionmentioning

confidence: 66%

Evaluation of the clinical outcomes of the Test and Treat strategy to implement Treat All in Nigeria: Results from the Nigeria Multi-Center ART Study

Stafford

Odafe

et al. 2019

PLoS ONE

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“…A full description of the trial design is published elsewhere. 22 Briefly, each arm consisted of ten clusters (health facilities and associated CARGs) as follows:…”

Section: Methodsmentioning

confidence: 99%

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

Fatti

Ngorima‐Mabhena

Mothibi

et al. 2020

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Introduction: Multimonth dispensing (MMD) of antiretroviral treatment (ART) aims to reduce patient-related barriers to access long-term treatment and improve health system efficiency. However, randomized evidence of its clinical effectiveness is lacking. We compared MMD within community ART refill groups (CARGs) vs. standard-of-care facility-based ART delivery in Zimbabwe. Methods: A three-arm, cluster-randomized, pragmatic noninferiority trial was performed. Thirty health care facilities and associated CARGs were allocated to either ART collected three-monthly at facility (3MF, control); ART delivered three-monthly in CARGs (3MC); or ART delivered six-monthly in CARGs (6MC). Stable adults receiving ART $six months with baseline viral load (VL) ,1000 copies/ml were eligible. Retention in ART care (primary outcome) and viral suppression (VS) 12 months after enrollment were compared, using regression models specified for clustering (ClinicalTrials.gov: NCT03238846). Results: 4800 participants were recruited, 1919, 1335, and 1546 in arms 3MF, 3MC, and 6MC, respectively. For retention, the prespecified noninferiority limit (-3.25%, risk difference [RD]) was met for comparisons between all arms, 3MC (94.8%) vs. 3MF (93.0%), adjusted RD = 1.1% (95% CI:-0.5% to 2.8%); 6MC (95.5%) vs. 3MF: aRD = 1.2% (95% CI:-1.0% to 3.6%); and 6MC vs. 3MC: aRD = 0.1% (95% CI:-2.4% to 2.6%). VL completion at 12 months was 49%, 45%, and 8% in 3MF, 3MC, and 6MC, respectively. VS in 3MC (99.7%) was high and not different to 3MF (99.1%), relative risk = 1.0 (95% CI: 1.0-1.0). VS was marginally reduced in 6MC (92.9%) vs. 3MF, relative risk = 0.9 (95% CI: 0.9-1.0). Conclusion: Retention in CARGs receiving three-and six-monthly MMD was noninferior versus standard-of-care facility-based ART delivery. VS in 3MC was high. VS in six-monthly CARGs requires further evaluation.

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“…Focusing specifically on inadequate health staff as a main barrier to Treat All implementation, the government could resolve this challenge by scaling up a variety of approaches including the use of six-month prescriptions that give stable patients up to six months’ drug refills at a time, drastically reducing the frequency for clinic visits [39]. Moreover, the current treatment guidelines in Nigeria supports the use of multi-month scripting [8].…”

Section: Discussionmentioning

confidence: 99%

Health workers’ perspectives on the outcomes, enablers, and barriers to the implementation of HIV “Treat All” guidelines in Abuja Nigeria

Odafe

Stafford

Aliyu

et al. 2019

Preprint

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Introduction To improve access to lifesaving treatment for all people living with HIV (PLHIV), Nigeria implemented the Treat All guidelines in 2016. However, health workers' perspectives on the implementation of the guidelines have not been evaluated. Methods We conducted in-depth interviews to explore health workers' perspectives on the Treat All guidelines. Using purposive sampling, 20 health workers providing HIV patient care were recruited from six primary health care hospitals in Abuja to participate in semi-structured interviews. Data exploration was conducted using thematic content analysis. Results The five main themes that emerged were (1) the perceived benefits of guidelines use, (2) the perceived disadvantages of using the guidelines, (3) reported patients' response to guideline change, (4) perceived barriers/enablers to guideline use and (5) health workers' recommendations for improvement. Health workers perceived that the implementation of the Treat All guidelines has considerably improved patient care, particularly in increasing access to skilled health care, reducing stress on patients, and increasing hope for a better health outcome among patients. Other perceived benefits were reduced mortality, reduced pre-treatment attrition, reduction in delays between case detection and initiation on treatment. Perceived major disadvantages were increased workload and overcrowded clinics. Health workers reported that most patients were willing to start treatment early. Perceived key factors enabling guidelines use were health workers' interest, patient benefits, training and availability of tools for implementation of guidelines, government supervisory visits and hospital management support. Perceived key barriers were poverty, inadequate human resources, lack of familiarity with guidelines, and lack of consistent supply of HIV test kits at some sites. Conclusions Implementation of the Treat All guidelines led to perceived improvement in patient care. Further improvements could be achieved by implementing an efficient supply chain system for HIV rapid test kits, and through guidelines distribution and training. Additionally, implementing differentiated approaches that decongest clinics, and programs that economically empower patients could improve access to treatment.

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The effectiveness and cost-effectiveness of 3- vs. 6-monthly dispensing of antiretroviral treatment (ART) for stable HIV patients in community ART-refill groups in Zimbabwe: study protocol for a pragmatic, cluster-randomized trial

Cited by 14 publications

References 18 publications

Evaluation of the clinical outcomes of the Test and Treat strategy to implement Treat All in Nigeria: Results from the Nigeria Multi-Center ART Study

Evaluation of the clinical outcomes of the Test and Treat strategy to implement Treat All in Nigeria: Results from the Nigeria Multi-Center ART Study

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

Health workers’ perspectives on the outcomes, enablers, and barriers to the implementation of HIV “Treat All” guidelines in Abuja Nigeria

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