Li 2017.
| Study characteristics | |
| Methods |
Study design: cluster‐RCT Duration of study: the study was conducted from 2013 to 2017. Country: China Income classification: upper‐middle‐income country from 2010 Geographical scope: poor rural areas Healthcare setting: not specified |
| Participants | 1. Age: adults 18+, children aged 6‐18 2. Gender: both 3. Socioeconomic background: median annual income was 20,000 yuan (3030 USD) 4. Educational background: people living with HIV (PLH): 40% had no education, adult family members: 30% junior high school or above. Inclusion criteria a. PLH: age 18 or over, being a resident of one of the 24 selected villages, who is currently a HIV‐seropositive parent of a child between 6‐18 years in his/her family, and who provides informed consent; b. family members: 18 years and older, being a resident of one of the 24 selected villages, who is aware of PLA's HIV status, who has consent from participating PLH to be invited to join the study, and who provides informed consent. If there are two PLHs in a household, they both will be recruited as PLH participants; c. children: aged 6 to 18 years, being a resident of one of the 24 selected villages, who lives in an HIV‐affected family in which at least one or both parents is HIV‐positive, and who provides parent/guardian permission, child/youth assent forms or informed consent if aged 18. Exclusion criteria: a. those who cannot give informed consent (e.g. intoxicated); b. those who have a permanent disability (e.g. deaf, serious mental illness, mental retardation); c. anyone who does not meet the inclusion criteria. Note: at baseline, the intervention and control group scores for Zung Self‐Rating Depression Scale for PLH were, respectively, 22.3 (5.2) and 22.3 (5.5). Stated purpose: to evaluate the efficacy of an intervention aimed at improving the mental health of PLH and their family members. |
| Interventions |
Name: Together for Empowerment Activities (TEA) Title/name of PW and number: 2‐3 intervention facilitators for each facilitator team 1. Selection: a team of intervention facilitators recruited from a pool of health educators working at various agencies at provincial, country, and township levels 2. Educational background: local health educators 3. Training: they had no systematic training in mental health, but they understand that health includes both physical and mental health and know resources/services for mental health needs. All intervention facilitators went through intensive training and numerous mock sessions. 4. Supervision: not specified 5. Incentives/remuneration: not specified Prevention type: selective prevention – participants are PLH and their family members that reside in poor rural areas. The depressive symptoms at baseline are in the “normal range” (25‐49). Intervention details: the TEA intervention activities were delivered: 1) at the individual level, TEA Gathering—six separate intervention sessions were conducted for PLH and their family members to deal with their specific HIV‐related challenges. Interactive group activities, such as games, pair‐share, role‐plays, and discussions, were delivered to establish a healthy daily routine, improve physical and mental health, improve family and parent‐child relationships, and encourage community integration; 2) at the family level, TEA Time—six types of family activities were conducted at home after each TEA Gathering session. The family activities involved all members to strengthen family interaction and support; and 3) at the community level, TEA Garden—three community events consisting of a health fair, an amusing sports event, and a family talent show were organized by both intervention participants and community leaders to enhance community and social integration. These initial intervention activities took place between 6 and 8 weeks. To maintain the intervention effect, reunions were held every 2 months during the first 12 months and every 4 months during the remainder of the study period (10 total reunion sessions). The intervention was manualized. Control: usual care – PLH in the control group continued to receive the Chinese government’s standard of care for the population. In addition, limited programme activities were added to the control group to tease out intervention effects from the impact of attention. There were three group sessions once a week, with the content areas focused on healthy daily routine, antiretroviral drugs adherence and side effects, nutrition, and personal and family hygiene. These control group sessions were didactic lecture‐based health education, with no interactive activities between facilitators and participants nor between PLH and family members. In addition, village health workers visited the control group families once a week for the initial 3 weeks and once a month for 12 months. |
| Outcomes |
Participants’outcomes of interest for this review
Carers’ outcomes of interest for this review Nil Economic outcomes Nil Time points: baseline, post‐intervention (7 to 24 months) Note: data were not included in the meta‐analysis because they were not provided in the right format or were not available even after attempted author contact. |
| Notes |
Source of funding: this work was supported by the National Institute of Child Health & Human Development/National Institutes of Health under Grant [R01HD068165]. Notes on validation of instruments (screening and outcomes): Zung Self‐Rating Depression Scale: the scale has been validated among PLH and their family members in China in 2011 (Cronbach’s alpha = 0.81). Perceived Caregiver Burden Scale: used in the previous studies in Asia (Cronbach’s alpha = 0.88). Additional information: none Handling the data: not available Prospective trial registration number: NCT01762553 |