Integration of Mental Health Care in Communities Affected by the COVID-19 Pandemic in Central Uganda

Study design: The investigators will use a multi-stage open-label cluster-randomized trial of 24 randomly chosen villages (n=12 intervention and n=12 control) in Kampala (n=15), Wakiso (n=3), Mukono (n=4) and Masaka (n=2) districts. Intervention and control villages are at least 20km apart to avoid contamination

Study procedure:

(i) Randomization and sampling: The investigators shall employ an open label cluster-randomized trial design, with each village as a cluster, to conduct the study in 24 villages (12 intervention and 12 control villages) in Kampala (n= 15), Wakiso (n= 3), Masaka (n= 2) and Mukono (n= 4) districts. To ensure balance between the two study arms, villages underwent stratified randomization on the basis of rural vs urban population. The second level of stratification will be achieved by a separate randomization procedure performed within each stratum to ensure gender balance within each cluster

The investigators shall employ the multistage open label sampling approach to select 840 participants from 24 randomly selected villages located in the 362 parishes (5250 villages) that span the study districts. Study villages will be selected using the probability proportional to size approach (based on number of parishes/villages per district). Thus, the investigators shall select 15 villages from Kampala district (3297 villages), 4 villages from Mukono district (813 villages), 2 villages from Masaka district (436 villages) and 3 villages from Wakiso district (704 villages). The villages are at least 20km apart to avoid contamination (individuals interacting during the intervention).

(ii) Participant identification: The investigators shall engage the VHT and village Local Chairpersons to distribute leaflets describing the study to every 12th household in their catchment area till they accrue 38 participants in their village who express interest in participating in the study. This figure is based on an average of 4710 households per village. Thus 4710/38 is approximately every 12th household. Individuals who express interest in the study will be given 2 consent forms which they will read and sign should they decide to participate; they will retain one copy. VHTs will read out the consent form to individuals who can neither read nor write and obtain informed consent (participants will use their thumb print soaked in an inkpad to consent). Consent forms will be translated into Luganda. The VHT will then get the participant's telephone contact and provide it to the project administrator who will pass them to research assistants. Individuals who don't have phones will be asked to provide a phone number of a friend or relative through which the interviews can be conducted- interviews could also be conducted using the VHTs' phone if the participants comfortable receiving calls on the VHT's telephone. The VHT will inform the project administrator of participants without personal phones and indicate how that participant can be contacted. The investigators will conduct a times and motions assessment to document the duration of the interventions as well as the amount of money spent on transport refunds for the VHTs and the airtime costs