Wang 2010 a.
Methods | Randomized controlled trial | |
Participants | The study location was Hengyang, Chenzhou and Yueyang in Hunan Province, China 58 participants were randomized to the intervention group and 58 participants were randomized to the control group The inclusion criteria were 1) a confirmed diagnosis of HIV infection, active or past heroin addicts, 2) 18 years or older, 3) received ART for at least 1 month prior to commencement of this study and continuing ART at study commencement, and 5) mentally competent to answer questions |
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Interventions | Intervention: NURSE‐DELIVERED HOME VISITS
4 home visits (every 2 months) were delivered by a qualified nurse and included 1) the provision of information about HIV/AIDS, 2) ART medication and adherence, and 3) skills to facilitate adherence, reinforcing motivation, mobilizing family support. Patients were provided with a pamphlet, electric pillbox with alarm, drug rehabilitation, methadone therapy, and stress management. In addition, tailored interventions were made based on the previous home visit and addressed barriers identified. Similarly, telephone calls were every 2 weeks including following each home visit to reinforce the effect of home visit and varied from 10 to 20 minutes to 1 hour during which adherence level, barriers and general emotional, sleeping and eating conditions were discussed. Control: USUAL CARE As part of the Chinese national ART management program, patients are seen twice in the first month of ART and receive medication for half a month at each visit and in the absence of side effects and presence of normal liver and renal function, visits are reduced to once a month. The clinic's pharmacy dispenses medication monthly. Clients on ART also receive free laboratory test for CD4+ T cell counts every 3– 6 months for evaluating the effectiveness of the treatment. HIV viral load test is not routinely provided in the national treatment program because of the limited fund. The patients visit the clinic once they have side effects or other health problems and need a laboratory test. The service of home visits or phone calls from health care providers are not routinely provided |
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Outcomes | The measures of adherence were the Community Programs for Clinical Research on AIDS (CPCRA) Antiretroviral Medication Self Report questionnaire and included the timing of doses by asking how often they took pills on time at study initiation and at 8 months follow‐up The patient outcomes were quality of life, measured by the Chinese version of WHO Quality of life (WHOQOL‐BREF) and symptoms of depression measured by the Chinese version of Self rating Depression Scale (SDS) developed by Zung in 1965. Data were collected at baseline and 8 months |
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Notes | ― | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Unclear. No details provided in article. (pg 2) "Study design" "Randomised trial and pretests and postintervention tests were used in this study." |
Allocation concealment (selection bias) | Unclear risk | Unclear. No details provided in article. (pg 2) "Study design" "Randomised trial and pretests and postintervention tests were used in this study." |
Selective reporting (reporting bias) | Unclear risk | None detected; protocol not available |
Other bias | High risk | Co‐intervention. Participants in the home visit group were given "an electric pillbox with an alarm" along with other strategies. The control group received standard care. The intervention itself is very complex with multiple components, so it seems inappropriately biased towards finding an effect |
Blinding of outcome assessment (detection bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
Blinding of outcome assessment (detection bias) Patient outcome | Unclear risk | (PRIMARY) QUALITY OF LIFE (WHOQOL‐BREF) ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ This is a subjective measure; there is no information on blinding |
Blinding of participants (performance bias) Patient outcome | Unclear risk | (PRIMARY) QUALITY OF LIFE (WHOQOL‐BREF) ‐ This is a subjective measure; there is no information on blinding |
Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
Blinding of personnel (performance bias) Patient outcome | Unclear risk | (PRIMARY) QUALITY OF LIFE (WHOQOL‐BREF) ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
Incomplete outcome data (attrition bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Attrition rate is not balanced; dissimilar reasons for dropouts are given |
Incomplete outcome data (attrition bias) Patient outcome | High risk | (PRIMARY) QUALITY OF LIFE (WHOQOL‐BREF) ‐ Attrition numbers are not balanced; dissimilar reasons for dropouts are given |