| Methods |
37 patients were randomized 1:1 to either the home intervention or control group using the Small Table of Random Digits. The randomization process was number‐based, with patient names not identified. The randomization list was held by the clinical co‐ordinator of the HIV program and kept in a locked file |
| Participants |
All eligible HIV‐positive patients (n = 37) followed in the program. Informed consent was obtained from each participant's legal guardian. Children ranged in age between 1.5 to 12 years of age (mean 8.7 years) for the intervention group and 5 to 11 years (mean 8.4 years) in the control group. Assent was obtained from all minors older than 7 years of age |
| Interventions |
The intervention group received 8 structured home visits over a 3‐month period by the same home care experienced registered nurse. The visits were designed to improve knowledge and understanding of HIV infection, to identify and resolve real and potential barriers to medication adherence, and ultimately to improve adherence. Spanish‐speaking case managers, incentives, notebooks with stickers, and pill‐swallowing training were also part of the home visit training sessions. In the clinic setting for control group, the physician, nurse, and social worker provided standard medication adherence education at clinic appointments generally scheduled at 3‐month intervals. Phone follow‐ups and a single home visit were planned if the staff felt they were needed. Visual aids for remembering medications, medication boxes, beepers, and general technical and emotional support were regularly offered. The clinic nurse contacted the family by telephone when the patient was starting a new medication, was having difficulty with adherence, or needed clarification and support. A single home visit was planned when and if the clinic staff believed medication adherence was poor despite the implementation of the above listed techniques |
| Outcomes |
Knowledge and adherence were measured at the beginning of the study and at the end of the intervention. These were measures via self report and pharmacy fill record. Changes in viral load and CD4 counts were measured at baseline and after treatment, or for 6 to 11 months beyond the initial study period |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random number table was used. Hence low bias. (pg 356) "Patients were randomized 1:1 to either the home intervention or control group using the Small Table of Random Digits. The randomization process was number based, with patient names not identified". |
| Allocation concealment (selection bias) |
Low risk |
(pg 356) "Patients were randomized 1:1 to either the home intervention or control group using the Small Table of Random Digits. The randomization process was number based, with patient names not identified. The randomization list was held by the clinical coordinator of the HIV Program and kept in a locked file." |
| Selective reporting (reporting bias) |
Low risk |
Primary and secondary outcomes were explicitly stated. (pg 356) "Primary study outcomes included changes in patient knowledge of HIV and their medications, and changes in adherence, the latter being measured by self report and by pharmacy drug refill history". (pg 357) "Secondary outcomes included changes in viral load (Roche Amplicor HIV‐1 Monitor Test) and CD4= T‐cell percentages and counts". All those have been accounted in the results |
| Other bias |
Unclear risk |
None noted but insufficient information provided |
| Blinding of outcome assessment (detection bias)
Adherence measure |
High risk |
(PRIMARY) PHARMACY FILL RECORD ‐ Non‐blinded trial. (pg 356) "a randomized, nonblinded, pilot clinical study at CCMC's pediatric and youth HIV program." |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Unclear risk |
(PRIMARY) CD4+ T CELL PERCENTAGES AND COUNTS ‐ No details given about how these measures were collected |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) PHARMACY FILL RECORD ‐ Non‐blinded trial. (pg 356) "a randomized, nonblinded, pilot clinical study at CCMC's pediatric and youth HIV program." |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) CD4+ T CELL PERCENTAGES AND COUNTS ‐ No blinding but patient lack of blinding unlikely to impact this outcome |
| Blinding of personnel (performance bias)
Adherence measure |
High risk |
(PRIMARY) PHARMACY FILL RECORD ‐ Intervention provider was involved in evaluation steps also. Non‐blinded trial. (pg 356) "a randomized, non‐blinded, pilot clinical study at CCMC's pediatric and youth HIV program." |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) CD4+ T CELL PERCENTAGES AND COUNTS ‐ No details given about how these measures were collected |
| Incomplete outcome data (attrition bias)
Adherence measure |
Low risk |
(PRIMARY) PHARMACY FILL RECORD ‐ 3 patients were not included in analysis ‐ either dead or withdrew from the study; one from the intervention group and two from the control group. Missing data are accounted for and excluded from analysis. It is not known whether missing data would have made a plausible size effect. However, intention‐to‐treat analyses results were similar to the analysis which excluded the 3 missing data |
| Incomplete outcome data (attrition bias)
Patient outcome |
Low risk |
(PRIMARY) CD4+ T CELL PERCENTAGES AND COUNTS ‐ 3 patients were not included in analysis ‐ either dead or withdrew from the study; one from the intervention group and two from the control group. Missing data are accounted and excluded from analysis. It is not known whether missing data would have made a plausible size effect. However, intention‐to‐treat analyses results were similar to the analysis which excluded the 3 missing data |
