Earns what other components (and other forms of intervention/treatment) a
Earns what other components (and other forms of intervention/treatment) a fellow participant is receiving. One potential form of contamination would be “resentful demoralization;” that is, participants feeling disappointed or disgruntled by PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/28381880 their treatment in the study relative to other participants, which could then possibly reduce their motivation to engage in the study [158]. A second concern would be that a participant would be triggered to pursue similar types of activities outside of the study to compensate for what is not being received in the study. There are two main places that contamination could occur: in study waiting areas, and in the focused support group component, when participants from different experimental conditions come together. To prevent contamination from either the “waiting room” or support group component, participants will be informed at enrollment that study involvement and compensation varies across participants, in order to manage expectations. Further, at enrollment we will ask that participants not discuss the specifics of study components with other participants. Then, within the context of the focus support groups, the facilitator will attend to and discourage discussion of other components by participants in the groups. We may not be able to eliminate contamination entirely, but we can takes steps to minimize it.Blinding of staff members to intervention contentTo foster fidelity to the intervention manuals and maintain the integrity of each separate component, interventionists will each deliver only one type of component and will not be trained in the specific content of other components. For example, interventionists trained to provide navigation will not be trained in the specifics of the other four components, and will not deliver any other component. Further, staff will be blind to participants’ intervention arm assignments where possible.Intervention quality assurancenavigation, with the intervention periods ranging from 3.25 to 8 months. Participants receive modest compensation for intervention activities (e.g., 25 for a session, group, or other activity plus funds for two-way public transportation).We will establish and maintain treatment fidelity to the 16 conditions and the core elements of each component. A Research Electronic Data Capture (REDCap) database will be MLN9708 site programmed to reflect the participant’s intervention assignments and will prompt interventionist action steps. REDCap is a secure web application for building and managing online surveys and databases. After each contact, interventionists will complete fidelity checklists. Audiotaped sessions will be randomly selected and rated for treatment fidelity by independent raters using the MI Treatment Integrity (MITI) coding system or a similar coding system. A clinical supervisor will review recordings of group sessions. Interventionist fidelity will be reviewed in bimonthly individual supervision meetings.Gwadz et al. BMC Public Health (2017) 17:Page 11 ofSample sizeAssessing ART adherence PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/26240184 levels in hairA total of 512 participants will be enrolled in the experiment. For the primary outcome, HIV viral suppression at the final follow-up, we used PASS [159] to estimate the sample size needed for individual main effects of intervention components corresponding to odds ratios (OR) of 1.9 in logistic regression, given = .05. A transition from viremia to viral suppression has clear clinical significance for individual patients, and the e.