Table 1.
Intervention feasibility and acceptability outcomes
| Feasibility outcomes | |
| Recruitment | Our goal was to be able to recruit all 40 participants using study fliers, referrals from primary care providers, and if needed, a database of individuals from the clinic with chronic pain based on a recent patient reported outcome questionnaire. We determined the approach-to-enroll ratio, which we will use to estimate the number of participants needed to approach for the full-scale trial to achieve our desired sample size |
| Randomization | Not all pilot trials involve randomization, as the purpose of a pilot trial is to assess feasibility and acceptability rather than to assess the differences in outcomes between the intervention and a control group. However, there is a paucity of chronic pain intervention studies among individuals with HIV, who have an especially high burden of chronic pain. Therefore, we investigated the feasibility and acceptability of randomization to a usual care control among PLWH and chronic pain |
| Retention | Given the Center for Disease Control and Prevention’s benchmark for behavioral interventions for adherence and retention to HIV treatment and care, our goal was for participants to complete an average of 80% of all study visits. Individuals who missed sessions were called to ask about barriers to attendance |
| Completion in allotted time | Group sessions occurred every other week on a fixed schedule. However, one-on-one sessions were scheduled at the participant’s convenience. We determined what percentage of participants would be able to complete all one-on-one sessions within the study period (16 weeks) |
| Outcome assessment completion | The full-scale trial will assess distal outcomes including pain and pain-related functional impairment, as well as more proximal outcomes such as SCT constructs (e.g., self-efficacy), and potential confounders of effect (e.g., mood) identified in our previously published conceptual framework. A goal of the present study was to evaluate the feasibility of administering a battery of outcome assessments. Additionally, outcome assessments were conducted immediately following study completion. Our goal was to complete outcome assessments on 80% of individuals randomized to the study within 1 month of the participant’s last session |
| Acceptability outcomes | |
| Participant experience with the study | We conducted qualitative interviews with patient participants at the mid-point and end of the trial. The purpose of these interviews was to assess participants’ experience with the study and assess the need for modifications. Participants were asked what they liked and did not like about the intervention, what if anything they noticed changed during the intervention, and what they would change about the intervention in the future |
| Participant satisfaction | Participants completed a treatment satisfaction questionnaire after the intervention was completed |