Abstract
BackgroundThe effect of peer support on virologic and immunologic treatment outcomes among HIVinfected patients receiving antiretroviral therapy (ART) was assessed in a cluster randomized controlled trial in Vietnam.MethodsSeventy-one clusters (communes) were randomized in intervention or control, and a total of 640 patients initiating ART were enrolled. The intervention group received peer support with weekly home-visits. Both groups received first-line ART regimens according to the National Treatment Guidelines. Viral load (VL) (ExaVir™ Load) and CD4 counts were analyzed every 6 months. The primary endpoint was virologic failure (VL >1000 copies/ml). Patients were followed up for 24 months. Intention-to-treat analysis was used. Cluster longitudinal and survival analyses were used to study time to virologic failure and CD4 trends.ResultsOf 640 patients, 71% were males, mean age 32 years, 83% started with stavudine/lamivudine/nevirapine regimen. After a mean of 20.8 months, 78% completed the study, and the median CD4 increase was 286 cells/μl. Cumulative virologic failure risk was 7.2%. There was no significant difference between intervention and control groups in risk for and time to virologic failure and in CD4 trends. Risk factors for virologic failure were ART-non-naïve status [aHR 6.9;(95% CI 3.2–14.6); p < 0.01]; baseline VL ≥100,000 copies/ml [aHR 2.3;(95% CI 1.2–4.3); p < 0.05] and incomplete adherence (self-reported missing more than one dose during 24 months) [aHR 3.1;(95% CI 1.1–8.9); p < 0.05]. Risk factors associated with slower increase of CD4 counts were: baseline VL ≥100,000 copies/ml [adj.sq.Coeff (95% CI): −0.9 (−1.5;−0.3); p < 0.01] and baseline CD4 count <100 cells/μl [adj.sq.Coeff (95% CI): −5.7 (−6.3;−5.4); p < 0.01]. Having an HIV-infected family member was also significantly associated with gain in CD4 counts [adj.sq.Coeff (95% CI): 1.3 (0.8;1.9); p < 0.01].ConclusionThere was a low virologic failure risk during the first 2 years of ART follow-up in a rural low-income setting in Vietnam. Peer support did not show any impact on virologic and immunologic outcomes after 2 years of follow up.Trial registration NCT01433601.
Highlights
MethodsSeventy-one clusters (communes) were randomized in intervention or control, and a total of 640 patients initiating antiretroviral therapy (ART) were enrolled
The effect of peer support on virologic and immunologic treatment outcomes among HIVinfected patients receiving antiretroviral therapy (ART) was assessed in a cluster randomized controlled trial in Vietnam
We have shown that the communitybased peer support had an impact on reducing stigma and discrimination, increasing the access to counseling and testing, improving the quality of life, and enhancing adherence to ART among ART patients presenting at clinical stages 3 and 4 at baseline
Summary
Study setting Quang Ninh province is located along northeastern Vietnam with a population of 1.1 million and an area of 6100 km. Supervision meetings of peer-support activities were performed by project researchers Patients in both intervention and control groups received a set standard of care and treatment according to the National Guidelines [22] including pre-ART initiation, which consisted of three ART adherence training sessions in both individual and group settings. Once the data was collected, the models were adjusted for the following variables: randomized groups (control vs intervention); age (≥35 vs
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