Nannungi 2013.
Methods | Longitudinal, prospective cohort Study (CBA study) | |
Participants | 482 participants were recruited (July 2008 to August 2009) as consecutive, new clinic patients recently evaluated for ART from 2 HIV clinics in Kampala, Uganda (Reach Out Mbuya and Mulago Immune Suppression Syndrome Clinic). Index: 257 HIV+ persons initiating ART with CD4 count < 250 cells/mm3(WHO disease stage III or IV) Control: 225 HIV+ persons pre‐ART with CD4 count < 400 cells/mm3 |
|
Interventions | All participants received HIV primary medical care (monitoring and treatment of infections and prescription of prophylactic medications). Index: ART plus HIV primary medical care Control: HIV primary medical care |
|
Outcomes | All participants underwent structured interview concerning background characteristics, physical and mental health status, and economic outcomes. Health data abstracted from patient medical records and Medical Outcomes Study HIV Health Survey. Assessments taken at 0, 6, and 12 months. Employment: 1. Work status; having engaged in work activity in previous 7 days (binary yes or no) 2. Weekly income; last payment and number of weeks worked for this payment Other health‐related economic outcomes: 3. Health interefence with ability to work in last month (4‐point scale from 'never' to 'most of the time') |
|
Notes | Infectious Diseases Institute Makerere University (Kampala, Uganda) Uganda National Council of Science and Technology (Uganda) Rand Corporation (CA, USA) Participants received 6000 Uganda Shillings (˜USD 2.50) for completion of each assessment |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
14. Blinding (Subjects) | Unclear risk | No blinding, however due to a dichotomous outcome of employed or unemployed in past 7 days, this should not have affected the results. |
15. Blinding (outcome assessors) | Low risk | No blinding, objective outcomes should have been unaffected by lack of outcome assessor blinding. |
16. Retrospective unplanned subgroup analysis | Low risk | No evidence of retrospective unplanned subgroup analysis. |
17. Follow‐up | Unclear risk | Follow‐up conducted at 0, 6, and 12 months. 36% attrition. |
18. Statistical tests | Low risk | Two‐tailed t‐tests, Chi2 tests, paired t‐test, McNemar's test. |
19. Compliance | Unclear risk | As ART adherence is required for survival, compliance, although not monitored. is highly likely. |
20. Outcome measures | Low risk | All predetermined outcome measures were reported. |
21. Selection Bias (population) | Low risk | Non‐randomized, non‐blinded recruitment of consecutive new clinic clients recently evaluated for ART. |
22. Selection bias (time) | Low risk | All participant recruitment July 2008 to August 2009. |
23. Randomization | Low risk | Non‐randomized, ART group and control group predetermined by health status and WHO stages of disease criteria. |
24. Allocation concealment | High risk | Non‐randomization. Did not report the use of adequate sequence generation or allocation concealment techniques. |
25. Adjustment for confounding | Unclear risk | Study adjusted for changes in physical health status, age, gender, education, relationship status, and CD4 count. However, did not account for SES or mental health confounders. |
26. Incomplete outcome data | Unclear risk | 36% attrition, analysis included attrition weights for dropouts derived from study completion and baseline measures associated with ART. |
Baseline comparability | High risk | As expected, baseline health differences were present between the index and reference groups due to disease progression and need for treatment. Higher percentage of index group was married or in a committed relationship than control group. Higher percentage of control group working and higher weekly income at baseline than index group. Analysis adjusted for change in physical health status. |