Primary outcomes |
|
Major depression |
The Mini International Neuropsychiatric Interview [32] |
✓ |
|
✓ |
✓ |
✓ |
✓ |
|
Functioning level |
5-item locally developed function assessment method [39] |
✓ |
|
✓ |
✓ |
✓ |
✓ |
Secondary outcomes |
|
Depression symptoms |
Self-Reporting Questionnaire [34] |
✓ |
|
✓ |
✓ |
✓ |
✓ |
|
Posttraumatic stress symptoms |
Locally adapted Harvard Trauma Questionnaire [40] |
✓ |
|
✓ |
✓ |
✓ |
✓ |
|
Alcohol use |
10-item Alcohol Use Disorders Identification Test [44] |
✓ |
|
✓ |
✓ |
✓ |
✓ |
|
Disability days |
Single question “How many working days have you lost due to depression-related symptoms in the previous 30 days? |
✓ |
|
✓ |
✓ |
✓ |
✓ |
|
Cost-effectiveness |
Estimation of incremental costs of the GSP intervention arm as compared to the control arm |
✓ |
|
✓ |
|
|
✓ |
|
Poverty index scores |
Questions on indicators of socioeconomic status such as the building materials of the household dwelling unit, access to electricity, type of cooking fuel, source of lighting, household remoteness (distance to nearest health facility), household food security, household durable assets such as radios, televisions, and mobile phones |
✓ |
|
✓ |
|
|
✓ |
|
Adherence to ART |
One question: “During the past week, on how many days have you missed taking all your medication doses?” |
✓ |
|
✓ |
✓ |
✓ |
✓ |
|
Viral load |
Medical charts of study participants |
✓ |
|
✓ |
|
✓ |
|
Potential effect modifiers |
|
Sociodemographic variables |
Standardized Demographic Questionnaire |
✓ |
|
|
|
|
|
|
Trauma events |
Locally developed 16-item trauma event checklist |
✓ |
|
|
|
|
|
Potential effect mediators |
|
Self-esteem |
Rosenberg Self-Esteem Scale [41] |
✓ |
|
✓ |
✓ |
✓ |
✓ |
|
Social support |
12-item Multi-Dimensional Perceived Social Support scale [42] |
✓ |
|
✓ |
✓ |
✓ |
✓ |
|
HIV-related stigma |
HIV-related stigma scale [43] |
✓ |
|
✓ |
✓ |
✓ |
✓ |
|
Coping skills |
COPE Inventory [45] |
✓ |
|
✓ |
✓ |
✓ |
✓ |
|
The therapeutic relationship |
The Scale to Assess the Therapeutic Relationships–Patient version [46] |
|
✓ |
|
|
|
|
Process evaluation outcomes |
|
Indicators of feasibility |
The proportion of eligible participants who take up either intervention (Reach), the proportion who attended all 8 sessions of either intervention (dose delivered), and the proportion who are lost to follow-up (attrition) will be determined from the attendance registers |
|
✓ |
|
|
|
|
|
Indicators of acceptability |
A 9-item questionnaire [47] will assess participant’s satisfaction, the group facilitators’ knowledge and attitudes, and the participant evaluation of the intervention’s ability to reduce depression. |
|
|
✓ |
|
|
|
|
Fidelity |
A semistructured self-administered questionnaire completed by group facilitators will assess whether or not the interventions were delivered as planned. |
|
✓ |
|
|
|
|
|
Contextual influences |
A semistructured self-administered questionnaire completed by group facilitators will assess any facilitators or barriers to intervention delivery that they observed during group sessions. |
|
|
✓ |
|
|
|
|
Causal mechanisms |
A semistructured interviewer-administered questionnaire will assess participant’s knowledge, skills, or assets acquired during and after the interventions, which will give an indication as to whether or not the interventions influenced targeted risk factors for depression. |
|
|
✓ |
|
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