To be eligible for the trial, the primary care health centers had to offer HIV care and treatment services, nominate at least four LHWs (2 men and 2 women) who are actively involved in HIV care, able to read and write, and reside within the villages served by the PHC. PHCs that do not offer HIV care services and those unable to nominate literate LHWs were excluded from the study.
To recruit PHCs, the project team worked with the district health officials in each of the three participating districts and identified a total of 38 PHCs that offered HIV care and treatment services. The health center managers of these centers were informed about the trial and asked to nominate health workers to participate in the trial. The first 10 PHCs in each district that expressed interest in the trial and nominated the required number of health workers were recruited to the trial. The health center managers of the 10 eligible PHCs in each district were invited to a stakeholders’ meeting held at the district’s local government offices with political leaders, district health officials, religious leaders, and community leaders. Study purpose and procedures were explained to facilitate district leadership understanding of the trial activities. At the end of the meeting, the eligible PHCs were randomly allocated with a 1:1 ratio to intervention and control arms. Randomization was done by urn randomization picked by each health center manager or their representative who attended the stakeholders’ meeting.
To be eligible for the study, PLWH had to be 19 years and older, diagnosed with major depression assessed with the MINI depression module [32], antidepressant naïve, using ART, and residing in the villages where the trained LHWs lived. Individuals with high suicide risk [33], a severe medical disorder such as pneumonia or active tuberculosis, psychotic symptoms, and hearing or visual impairment were excluded from the study.
On a given clinic day, project research assistants worked with primary care health workers of a participating PHC in the center’s HIV clinic. The primary care health worker gave a health talk on depression to clients in the waiting area. Clients who felt that they had experienced symptoms of depression described in the health talk were invited for further evaluations using the Luo version of the 20-item self-reporting questionnaire [34] and the MINI depression module. This procedure was repeated until a total of 40 PLWH diagnosed with major depression were obtained from a given PHC.
Clients diagnosed with major depression were approached by research assistants who explained study procedures, determined eligibility, and then obtained informed consent. Each client who gave informed consent received baseline assessments with a standardized questionnaire. Recruited participants from the same village were assigned to a trained LHW residing in or near their village to receive the intervention they had been trained to deliver (ie, either GSP or GHE).
By design, both experimental and control interventions were identifiable to participants but will be masked to outcome assessors, the Data and Safety Monitoring Board, and data analysts.
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