Programme costs were taken to be third-party payer costs. Although there are several well-documented studies from non-HIV settings in low-income and middle-income countries that support the use of psychological interventions delivered by lay health workers, such task-shifting approaches have not been used to provide mental health care for people living with HIV. None of the studies were from sub-Saharan African. Chibanda and colleagues reviewed five randomised controlled trials based on the principles of cognitive behaviour therapy from low-income and middle-income countries for people living with HIV, which were effective in reducing depression and anxiety symptoms. Both reviews revealed a shortage of research in low-income and middle-income countries, and scarce data on longer-term effectiveness, cost-effectiveness, and effect on HIV treatment outcomes, particularly at the health system level. Chuah and colleagues reviewed 45 studies published worldwide before October, 2015, and described interventions and approaches to integrating HIV and mental health services.
A range of psychosocial intervention types including cognitive behaviour therapy, supportive interventions, and meditation seemed to be helpful in improving the mental health of people living with HIV, although the effect size was small. Van Luenen and colleagues reviewed 62 randomised clinical trials done since 1996, which investigated the effectiveness for people living with HIV of various psychosocial interventions aimed at decreasing depression and anxiety, and improving quality of life and psychological wellbeing. Cost-effectiveness estimates showed an incremental cost-effectiveness ratio of US$13♰ per disability-adjusted life-year averted, which can be considered very cost-effective in Uganda. The outcomes of these serious adverse events included 16 deaths, 4 of which were completed suicides (GSP=2 GHE=2), and 12 of which were HIV-related medical complications (GSP=8 GHE=4). 36 individuals had 63 serious adverse events, which included 25 suicide attempts and 22 hospital admissions for medical complications. The mean function scores 6 months post-treatment were 9♸5 (SD 0♷6) in the GSP group and 6♸3 (2♸5) in the GHE group (β=4♱2 95% CI 3♷5–4♴9, p<0♰001). Two (<1%) participants in the GSP group were diagnosed with major depression 6 months post-treatment compared with 160 (28%) in the GHE group (adjusted odds ratio=0♰1, 95% CI 0♰03–0♰12, p<0♰001). Findingsīetween Sept 13 and Dec 15, 2016, we assessed 1473 individuals, of whom 1140 were recruited from health centres offering GSP (n=578 ) or GHE (n=562 ).
#RED ALERT 3 ERROR GSP5 TRIAL#
This trial is registered with the Pan African Clinical Trials Registry, PACTR201608001738234. The primary outcomes were the proportion of participants with major depression and function scores at 6 months post-treatment, analysed by intention to treat by means of multilevel random effect regression analyses adjusting for clustering in health centres. Group sessions were led by trained lay health workers once a week for 8 weeks. Participants were people living with HIV, aged 19 years and older, with mild to moderate major depression assessed with the Mini International Neuropsychiatric Interview depression module, taking antiretroviral therapy, and antidepressant-naive.
Randomisation, in a ratio of 1:1, was achieved by health centre managers separately picking a paper containing the intervention allocation from a basket. These were randomly assigned to deliver either GSP or group HIV education (GHE).
In this cluster-randomised trial, we included 30 health centres offering HIV care.
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