Impact of peer support on virologic failure in HIV-infected patients on antiretroviral therapy - a cluster randomized controlled trial in Vietnam

Duy, Cuong; Sönnerborg, Anders; Tam, Vu Van; El‐Khatib, Ziad; Santacatterina, Michele; Marrone, Gaetano; Chúc, Nguyễn Thị Kim; Diwan, Vinod; Thorson, Anna; Le, Nicole K.; An, Pham Nhat; Larsson, Mattias

doi:10.1186/s12879-016-2017-x

Cited by 13 publications

(10 citation statements)

References 46 publications

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“…Among patients alive and on ART at six months, death or Stage 4 events occurred in only 3.7% of patients and more than 97% of patients had a VL below 400 copies/mL at 36 months. These outcomes are significantly better than those reported in previous studies in Vietnam , including reports of 8.1% mortality from six to thirty‐six months on ART nationally , and virological non‐suppression of 28% in Hanoi . The study's primary outcome, therefore, occurred at a rate much lower than was expected in both study arms, leaving the study underpowered to detect a difference in the primary outcome.…”

Section: Discussionsupporting

confidence: 89%

Routine versus Targeted Viral Load Strategy among Patients Starting Antiretroviral in Hanoi, Vietnam

et al. 2019

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Introduction HIV viral load (VL) testing is recommended by the WHO as the preferred method for monitoring patients on antiretroviral therapy (ART). However, evidence that routine VL (RVL) monitoring improves clinical outcomes is lacking. Methods We conducted a prospective, randomized controlled trial of RVL monitoring every six months versus a targeted VL (TVL) strategy (routine CD4 plus VL testing if clinical or immunological failure) in patients starting ART between April 2011 and April 2014 at Bach Mai Hospital in Hanoi. Six hundred and forty‐seven subjects were randomized to RVL (n = 305) or TVL monitoring (n = 342) and followed up for three years. Primary endpoints were death or WHO clinical Stage 4 events between six and thirty‐six months of ART and rate of virological suppression at three years. Results Overall, 37.1% of subjects were female, median age was 33.4 years (IQR: 29.5 to 38.6), and 47% had a CD4 count ≤100 cells/mm3 at time of ART initiation. Approximately 44% of study events (death, LTFU, withdrawal, or Stage 4 event) and 68% of deaths occurred within the first six months of ART. Among patients on ART at six months, death or Stage 4 event occurred in 3.6% of RVL and 3.9% of TVL (p = 0.823). Survival analysis showed no significant difference between the groups (p = 0.825). Viral suppression at 36 months of ART was 97.2% in RVL and 98.9% in TVL (p = 0.206) at a threshold of 400 copies/mL and was 98.0% in RVL and 98.9% in TVL (p = 0.488) at 1000 copies/mL. In ITT analysis, 20.7% in RVL and 21.9% in TVL (p = 0.693) were unsuppressed at 1000 copies/mL. Conclusions We found no significant difference in rates of death or Stage 4 events and virological failure in patients with RVL monitoring compared to those monitored with a TVL strategy after three years of follow‐up. Viral suppression rates were high overall and there were few study events among patients alive and on ART after six months, limiting the study's power to detect a difference among study arms. Nonetheless, these data suggest that the choice of VL monitoring strategy may have less impact on patient outcomes compared to efforts to reduce early mortality and improve ART retention.

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Section: Discussionsupporting

confidence: 89%

Routine versus Targeted Viral Load Strategy among Patients Starting Antiretroviral in Hanoi, Vietnam

et al. 2019

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“…As shown in Fig 1, of 5470 unique records, we screened 219 full-texts and included 20 RCTs [38][39][40][41][42][43][44][45][46][47][48][49][50][51][52][53][54][55][56][57]. Most excluded studies were excluded for two or more reasons, but the most common primary reasons for exclusion were that the intervention was not peer-support as per our inclusion criteria, providers were not individuals living with HIV, and the study design was not RCT.…”

Section: Resultsmentioning

confidence: 99%

The effectiveness of peer-support for people living with HIV: A systematic review and meta-analysis

Berg

Page²,

Øgård-Repål

2021

PLoS ONE

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Background The practice of involving people living with HIV in the development and provision of healthcare has gained increasing traction. Peer-support for people living with HIV is assistance and encouragement by an individual considered equal, in taking an active role in self-management of their chronic health condition. The objective of this systematic review was to assess the effects of peer-support for people living with HIV. Methods We conducted a systematic review in accordance with international guidelines. Following systematic searches of eight databases until May 2020, two reviewers performed independent screening of studies according to preset inclusion criteria. We conducted risk of bias assessments and meta-analyses of the available evidence in randomised controlled trials (RCTs). The certainty of the evidence for each primary outcome was evaluated with the Grading of Recommendations Assessment, Development, and Evaluation system. Results After screening 219 full texts we included 20 RCTs comprising 7605 participants at baseline from nine different countries. The studies generally had low risk of bias. Main outcomes with high certainty of evidence showed modest, but superior retention in care (Risk Ratio [RR] 1.07; Confidence Interval [CI] 95% 1.02–1.12 at 12 months follow-up), antiretroviral therapy (ART) adherence (RR 1.06; CI 95% 1.01–1.10 at 3 months follow-up), and viral suppression (Odds Ratio up to 6.24; CI 95% 1.28–30.5 at 6 months follow-up) for peer-support participants. The results showed that the current state of evidence for most other main outcomes (ART initiation, CD4 cell count, quality of life, mental health) was promising, but too uncertain for firm conclusions. Conclusions Overall, peer-support with routine medical care is superior to routine clinic follow-up in improving outcomes for people living with HIV. It is a feasible and effective approach for linking and retaining people living with HIV to HIV care, which can help shoulder existing services. Trial registration CRD42020173433.

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“…This retrospective cohort study collected information from HIV-infected patients on first-line ART from a cluster randomized controlled trial carried out in a rural resource-limited setting of Quang Ninh, Vietnam between July 2007 and November 2011 [ 24 ]. The inclusion criteria for the 605 patients of this study was ART-naïve HIV-infected patients.…”

Section: Methodsmentioning

confidence: 99%

“…Patients were stratified into groups that have or don’t have peer support. Peer support involved home-based adherence counseling by fellow HIV-infected peer supporters [ 24 ]. Adherence to ARV was stratified into no missed doses and one or more missed doses.…”

Section: Methodsmentioning

confidence: 99%

Assessment of WHO criteria for identifying ART treatment failure in Vietnam from 2007 to 2011

Riggi

Marrone

et al. 2017

PLoS ONE

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ObjectiveWe evaluated the sensitivity and specificity of the WHO immunological criteria for detecting antiretroviral therapy (ART) treatment failure in a cohort of Vietnamese patients. We conducted a stratified analysis to determine the effects of BMI, peer support, adherence to antiretroviral (ARV) drugs, age, and gender on the sensitivity and specificity of the WHO criteria.MethodsWe conducted a retrospective cohort study of 605 HIV-infected patients using data previously collected from a cluster randomized control trial study. We compared the sensitivity and specificity of CD4+ counts to the gold standard of virologic testing as a diagnostic test for ART failure at different time points of 12, 18, and 24 months.ResultsThe sensitivity [95% confidence interval (CI)] of the WHO immunological criteria based on a viral load ≥ 1000 copies/mL was 12% (5%-23%), 14% (2%-43%), and 12.5% (2%-38%) at 12, 18, and 24 months, respectively. In the same order, the specificity was 93% (90%-96%), 98% (96%-99%), and 98% (96%-100%). The positive predictive values (PPV) at 12, 18, and 24 months were 22% (9%-40%), 20% (3%-56%), and 29% (4%-71%); the negative predictive values (NPV) at the same time points were 87% (84%-90%), 97% (95%-98%), and 96% (93%-98%). The stratified analysis revealed similar sensitivities and specificities.ConclusionThe sensitivity of the WHO immunological criteria is poor, but the specificity is high. Although testing costs may increase, we recommend that Vietnam and other similar settings adopt viral load testing as the principal method for determining ART failure.

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Impact of peer support on virologic failure in HIV-infected patients on antiretroviral therapy - a cluster randomized controlled trial in Vietnam

Cited by 13 publications

References 46 publications

Routine versus Targeted Viral Load Strategy among Patients Starting Antiretroviral in Hanoi, Vietnam

Routine versus Targeted Viral Load Strategy among Patients Starting Antiretroviral in Hanoi, Vietnam

The effectiveness of peer-support for people living with HIV: A systematic review and meta-analysis

Assessment of WHO criteria for identifying ART treatment failure in Vietnam from 2007 to 2011

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