Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Proportion of participants who attend week 1 intervention session |
Intervention session attended by participants (MMT clients and identified social support persons) |
Week 1 of intervention |
|
Primary |
Proportion of participants who attend week 2 intervention session |
Intervention session attended by participants (MMT clients and identified social support persons) |
Week 2 of intervention |
|
Primary |
Proportion of participants who attend week 3 intervention session |
Intervention session attended by participants (MMT clients and identified social support persons) |
Week 3 of intervention |
|
Primary |
Proportion of participants who attend week 4 intervention session |
Intervention session attended by participants (MMT clients and identified social support persons) |
Week 4 of intervention |
|
Primary |
Proportion of participants who attend week 5 intervention session |
Intervention session attended by participants (MMT clients and identified social support persons) |
Week 5 of intervention |
|
Primary |
Proportion of participants who attend week 6 intervention session |
Intervention session attended by participants (MMT clients and identified social support persons) |
Week 6 of intervention |
|
Primary |
Proportion of sessions with > 80% fidelity |
An Integrity of Intervention checklist will be created for the study to assess intervention delivery fidelity, including facilitator adherence to manual instructions, specifically information and content that is intended to be covered for each session. An intervention fidelity score that ranges from 0 to 100%, with 100% indicating 100% fidelity or 100% adherence to intervention manual, will be created. |
Post-intervention up to 1 month |
|
Primary |
Perceptions of intervention fidelity |
Perceptions of intervention fidelity will be assessed through qualitative interviews with facilitators and participants. Perceptions of intervention fidelity, including facilitators and barriers to intervention fidelity will be summarized thematically. |
Post-intervention up to 1 month |
|
Primary |
Intervention session acceptability score (week 1) |
Acceptability of interventions sessions, specifically content, activities, and delivery (i.e., group or individual format, social support persons involvement), will be measured through the exit surveys developed by the study team. Each of the four exit survey items will be assessed as 0 for not acceptable and 1 for acceptable. Scores will be created for each participant and averaged over all intervention sessions. |
Week 1 of intervention |
|
Primary |
Intervention session acceptability score (week 2) |
Acceptability of interventions sessions, specifically content, activities, and delivery (i.e., group or individual format, social support persons involvement), will be measured through the exit surveys developed by the study team. Each of the four exit survey items will be assessed as 0 for not acceptable and 1 for acceptable. Scores will be created for each participant and averaged over all intervention sessions. |
Week 2 of intervention |
|
Primary |
Intervention session acceptability score (week 3) |
Acceptability of interventions sessions, specifically content, activities, and delivery (i.e., group or individual format, social support persons involvement), will be measured through the exit surveys developed by the study team. Each of the four exit survey items will be assessed as 0 for not acceptable and 1 for acceptable. Scores will be created for each participant and averaged over all intervention sessions. |
Week 3 of intervention |
|
Primary |
Intervention session acceptability score (week 4) |
Acceptability of interventions sessions, specifically content, activities, and delivery (i.e., group or individual format, social support persons involvement), will be measured through the exit surveys developed by the study team. Each of the four exit survey items will be assessed as 0 for not acceptable and 1 for acceptable. Scores will be created for each participant and averaged over all intervention sessions. |
Week 4 of intervention |
|
Primary |
Intervention session acceptability score (week 5) |
Acceptability of interventions sessions, specifically content, activities, and delivery (i.e., group or individual format, social support persons involvement), will be measured through the exit surveys developed by the study team. Each of the four exit survey items will be assessed as 0 for not acceptable and 1 for acceptable. Scores will be created for each participant and averaged over all intervention sessions. |
Week 5 of intervention |
|
Primary |
Intervention session acceptability score (week 6) |
Acceptability of interventions sessions, specifically content, activities, and delivery (i.e., group or individual format, social support persons involvement), will be measured through the exit surveys developed by the study team. Each of the four exit survey items will be assessed as 0 for not acceptable and 1 for acceptable. Scores will be created for each participant and averaged over all intervention sessions. |
Week 6 of intervention |
|
Primary |
Intervention feasibility assessed by qualitative interviews |
Intervention feasibility will be assessed through qualitative interviews with intervention facilitators and participants. Questions will include experiences delivery or participating in the intervention, barriers and facilitators to delivering the intervention or participating in the intervention session, and recommendations for improvements. |
Post-intervention up to 1 month |
|
Secondary |
Changes in missed methadone doses |
Number of missed methadone doses in the past 30 days as assessed by MMT client clinical records |
Pre- and post-intervention up to 1 month |
|
Secondary |
Changes in antiretroviral therapy (ART) adherence |
ART pharmacy refills in the past 3 months |
Pre- and post-intervention up to 1 month |
|