T a 20 difference in HIV RNA suppression between the study armsT a 20

T a 20 difference in HIV RNA suppression between the study arms
T a 20 difference in HIV RNA suppression between the study arms at 12 months. However, enrollment was slower than anticipated because limited numbers subjects met the eligibility criteria. When addition of new study sites failed to fully rectify slow recruitment, we revised our primary outcome to viral suppression at three time points during active intervention (3, 6, and 12 months), rather than at a single time point (12 months). Using a repeated measures analytic approach, we calculated that a sample size of 120, assuming 15 loss to follow-up (i.e. effective sample size PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/28045099 of 50 in each arm) and an intra-subject correlation of 0.2, will provide EPZ004777 web greater than 84 power to detect a 20 average difference in viral load suppression between the arms, given SAT viral suppression rates between 25 and 40 . Secondary outcomes include HIV RNA < 400 copies/ mL, change in log 10 HIV RNA, change in CD4 cell count, cumulative use of ART, retention to the OTP, and acquisition of new antiretroviral resistance mutations. We will also evaluate differences in viral suppression at 18 months (6 months following the conclusion of the intervention) to assess for persistence of interventional effects. Finally, we will compare EAM in the study arms. We will use chi-squared and Wilcoxon rank sum tests to compare categorical and continuous variables, respectively. We will use mixed effects logistic and linear models to assess longitudinal outcomes. The primary analysis of viral suppression will be intent-totreat, with missing values excluded. In sensitivity analyses, we will consider missing values to be failures and construct bounds for the potential bias.Participant Enrollment and DispositionA total of 457 individuals were screened for the study (Figure 1). Of these, 338 were ineligible after screening and record review and 12 declined to participate. The most common reason for ineligibility was current ART use with suppressed viral load (n = 237), followed by disengagement in HIV care, lack of medication insurance, or failure to obtain an ART prescription (n = PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/26509685 59). A total of 107 participants were enrolled, with 51 assigned to SAT and 56 assigned to DAART. Compared to participants enrolled to the trial, the 12 individuals who declined to participate were more likely to be from site 4 and less likely to be African American (Table). Joiners and non-joiners were similar with respect to sex and age.Study sample characteristicsThe primary study outcome is suppression of HIV RNA < 50 copies/mL. We hypothesize that DAART willA median of 14 participants were enrolled at each of the five participating OTPs (range 8 to 39). StudyMullen et al. BMC Infectious Diseases 2011, 11:45 http://www.biomedcentral.com/1471-2334/11/Page 5 ofScreened for eligibility (n = 457) Ineligible after screening and record review (n= 338) HIV-negative (n=1) Not receiving or discontinuing methadone or buprenorphine (n=31) Not engaged in HIV care, no medication insurance coverage, or did not obtain ART prescription (n=59) Treatment na e and did not meet DHHS guidelines for ART initiation (n=6) Stable ART use with suppressed viral load (n=237) Enrolled in another directly administered therapy program (n=3) Documented drug resistance with fewer than 1.5 drugs in regimen predicted to be active (n=1) Total enrolled (n = 107)Declined to participate (n=12)DAART (n = 56)SAT (n = 51)Figure 1 Disposition of individuals screened for a trial comparing directly administered antiretroviral therapy to self-a.