Sabin 2010.
| Methods | Randomized controlled trial | |
| Participants | The study location was Dali Second People's Hospital (DSPH) in Dali, Yunnan province, China 34 participants were randomized to the intervention group and 34 participants were randomized to the control group The inclusion criteria were: on ART and aged 18 years or above |
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| Interventions | Intervention: COUNSELING BASED ON ELECTRONIC DRUG MONITORING DATA
When intervention participants came to the clinic monthly, a study member downloaded and reviewed the subject's previous month's electronic drug monitoring device (EDM) data. Each subject found to be less than 95% adherent according to the EDM data was 'flagged' for counseling with a clinic physician or nurse utilizing the EDM information immediately following regular clinic visit activities. The data were provided to both the subject and his/her clinician as a printout summarizing the per cent of doses taken, the per cent of doses taken on time, and a visual display of doses taken by time. This process of flagging and counseling was specific to each clinic visit. In each counseling session, the clinician reviewed the EDM printout with the subject, explored reasons for missed or off‐time doses, and inquired about problems or challenges the subject might be having. Beyond this, counseling sessions did not follow a script. This was designed to accommodate each clinician's counseling style, allow for an individually focused discussion of adherence behavior, and encourage each subject‐clinician pair to devise personalized strategies to improving adherence. In this regard, the EDM feedback provided data to inform and thereby enhance the counseling, but did not dictate precisely how the counseling should be performed. In the event that subjects did not immediately offer reasons for missed or off‐time doses, clinicians were advised to say: ''Let's talk more about any problems that you had last month.'' Most counseling sessions were completed within 10 to 15 minutes. The intervention period was 7 to 12 months Control: STANDARD CARE Control group participants provided their electronic drug monitors (EDM) data at their monthly visits to the study team members and received standard care. Standard care in China included completing self reports of adherence and attending counseling session with clinician if self reported adherence indicated less than 95% adherence. In the counseling sessions with control subjects, which were guided by self reported adherence and clinicians inquired about recent problems that might have affected dose‐taking |
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| Outcomes | The measures of adherence were Electronic Drug Monitoring (EDM) during the preintervention period and self reported adherence during the intervention. Self reported adherence, used to identify low adherers in the control group during the intervention period, was assessed from subjects' written responses to questions on the monthly form. These included: (1) a visual analog scale (VAS) of proportion of ART medications taken in the previous month; (2) a series of 6 yes/no questions about medication‐taking behavior in the previous month (being careless, forgetting, stopping treatment due to feeling better, not taking medications while at work, taking pills early or late, sharing medications); and (3) 2 quantitative questions on the number of days medications were not taken and number of days medications were taken early or late. A subject in the control arm was flagged as a 'low adherer' if he/she reported < 95% on the VAS, answered 'yes' to any one of the 6 behavioral questions, or reported more than 0 days for either of the quantitative questions. During the intervention period (months 7 to 12), patients visited the clinic monthly. The adherence measure was calculated at 6 and 12 months. Additionally, adherence was also calculated as the proportion of patients achieving high (>/= 95%) adherence. The adherence self report measure was administered by study team members. The patient outcomes were CD4 count and HIV viral load tested at baseline, randomization (month 6), and post‐intervention (month 12). CD4 counts were measured at a local laboratory by flow cytometry. We calculated change in CD4 count for each subject by subtracting month 6 CD4 from month 12 CD4 count. HIV viral loads were measured with an Organon Teknica NucliSens analyzer, at the Center for Disease Control laboratory in Kunming, the provincial capital. The lower limit of the viral load assay was 400 copies per ml |
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| Notes | ― | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomization was performed on site, through a block randomization process. "Subjects within each adherence group were then randomized to the intervention or control arm, ensuring that equal numbers of high and low adherers were allocated to each arm. This was performed on site, through a block randomization process as follows: at each subject's month 6 visit, the subject pulled an unmarked allocation envelope, the inside of which had a single paper stamped with either ''intervention'' or ''control'', from a larger envelope that had originally held ten such allocation envelopes, five for each arm. When each large envelope was empty, it was replaced with another large envelope, similarly containing ten allocation envelopes." (pg 583) |
| Allocation concealment (selection bias) | High risk | Envelopes used were not sealed, described as opaque, or sequentially numbered |
| Selective reporting (reporting bias) | Unclear risk | No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol |
| Other bias | Low risk | The study seems to be free of other types of bias |
| Blinding of outcome assessment (detection bias) Adherence measure | Low risk | (PRIMARY) EDM (MED‐IC PILL BOTTLE) ‐ This is an objective measure of outcome |
| Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) CD4 CELL COUNT ‐ This is an objective measure of outcome |
| Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) EDM (MED‐IC PILL BOTTLE) ‐ Adherence for Life was a non‐blinded randomized controlled intervention trial (pg 581) |
| Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) CD4 CELL COUNT ‐ This is an objective measure of outcome |
| Blinding of personnel (performance bias) Adherence measure | Low risk | (PRIMARY) EDM (MED‐IC PILL BOTTLE) ‐ This is an objective measure of outcome |
| Blinding of personnel (performance bias) Patient outcome | Low risk | (PRIMARY) CD4 CELL COUNT ‐ This is an objective measure of outcome |
| Incomplete outcome data (attrition bias) Adherence measure | Low risk | (PRIMARY) EDM (MED‐IC PILL BOTTLE) ‐ Balanced dropout rates; reasons for dropouts were similar |
| Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) CD4 CELL COUNT ‐ Similar rate of attrition |