Johnson 2011.

Methods	Randomized controlled trial
Participants	The study location was San Francisco, CA, USA 128 participants were randomized to the intervention group and 121 participants were randomized to the control group The inclusion criteria were at least 18 years of age, provide written informed consent, be taking a recognized ART regimen (verified by documentation from pharmacy, letter from provider, or examination of prescription bottles) for at least the prior 30 days, and report not being currently involved in another behavioral intervention study related to HIV. Participants were eligible for enrollment in the trial if they reported a level of side effect distress on a previously used symptom/side effect checklist equivalent to the upper 40% of a prior sample
Interventions	Intervention: BALANCE PROJECT EXPERIMENTAL INTERVENTION The intervention was 5 60‐minute individual counseling sessions with each session designed around topics relevant to ART side effects coping. Intervention sessions followed a standard structure and set of activities, but were individually tailored to participants' specific life contexts, stressors, and goals. Participants received USD 30 at the 3‐month assessment if they completed all 5 sessions prior to that assessment interview. The intervention was delivered between months 3 and 6 of the study Control: USUAL CARE Control group participants received treatment as usual and received no active psychosocial interventions prior to the final trial assessment interview
Outcomes	The measures of adherence were self reported Adult AIDS Clinical Trials Group and visual analog scale. Adult AIDS Clinical Trials Group assesses missed pills over the prior 3 days. This measure has been used widely with diverse samples and the short‐term recall period has been associated with long‐term clinical outcomes. The measure was computerized for ACASI administration to minimize the social desirability associated with adherence reporting. Mean 3‐day adherence was calculated by dividing the number of pills reported as being taken by the number of pills that were prescribed in the regimen. Secondly, visual analog scale assesses 30‐day adherence, reporting separately for each drug along a continuum anchored by "0%" to "100%".This measure has shown to be correlated with other measures of adherence, such as medication event monitoring systems and a 30‐day time frame has recently been supported as preferable to other approaches of self report. For the visual analog scale, the mean per cent adherence was calculated across all drugs in the participant's regimen. Assessments were completed at 1 week (baseline) and at 3, 6, 9, and 15 months for both intervention and control groups The patient outcomes were the extent to which patients took side effect medication, as measured by the SECope. Follow‐up assessment interviews were scheduled at 3 (second baseline interview), 6, 9, and 15 months for both the intervention and control groups. Interviews were conducted using laptop computers in private settings in research offices. Procedures involved a combination of audio computer‐assisted self interviewing (ACASI) and computer‐assisted personal interviewing (CAPI) using the Questionnaire Development System. The SECope is a 20‐item measure that assesses strategies for coping with HIV treatment side effects, and includes a scale for Taking Side Effect Medications
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Simple randomization was implemented immediately following the second baseline interview using the SAS System's random number generator under the uniform distribution, aligning treatments in order with consecutive participant ID." (pg 84)
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgment of 'Low risk' or 'High risk' of bias. Information about randomization is available but nothing about allocation concealment. "Simple randomization was implemented immediately following the second baseline interview using the SAS System's random number generator under the uniform distribution, aligning treatments in order with consecutive participant ID." (pg 84)
Selective reporting (reporting bias)	Unclear risk	No protocol is available
Other bias	Unclear risk	The authors note the following: "There are several noteworthy limitations in the current study. First, the experimental design used a treatment as usual comparison rather than a matched attention control condition, so it is impossible to determine the potential confounding effects of increased attention by trial staff in the experimental condition rather than the control condition. Further, the assessment did not capture comprehensive data on access and use of adherence resources outside of the trial, a construct that is gaining attention in adherence research. Second, the use of self reported adherence data, while supported by validity studies has been questioned in HIV research as being inflated because of recall, social desirability, and other biases. To minimize the biases inherent in self reported data, we employed several techniques. We used conservative cut‐offs of validated measures of adherence that have demonstrated meaningful relationships with important outcomes, such as viral load, in other studies. ACASI interviewing for the adherence portion of the interview was used, thereby removing the interviewer's presence and minimizing social desirability bias. Such approaches to computerized adherence assessment have shown favorable effects in other studies. Despite these strategies, it should be noted that the use of self reported adherence outcomes remains a limitation of the study, and results may have differed if other adherence assessment approaches had been used. Third, because the study used a convenience sample rather than a probability based sample, there are limits of the degree to which findings are generalizable to other populations. Related, the sample was predominately male, and thus caution should be exercised when generalizing the findings to women. Finally, because the eligibility criteria did not select based on levels of adherence at baseline, there was a limit of the degree to which patients could improve on their adherence, as some reported perfect adherence at study entry. However, even with the potential ceiling effect of adherence scores in the sample, the intervention was shown to significantly protect against the likelihood of subsequent nonadherence." (pg 89)
Blinding of outcome assessment (detection bias) Adherence measure	Low risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Data were collected via computerized interview. The lack of blinding of outcome assessors is not likely to affect the outcome
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) SECOPE QUESTIONNAIRE ‐ The outcome is self reported by participants. The lack of blinding of data collectors is not likely to affect the outcome
Blinding of participants (performance bias) Adherence measure	Unclear risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ it is not clear whether participants were blinded to the intervention (not explicitly stated in the paper). Therefore, insufficient information to permit judgment of 'Low risk' or 'High risk' of bias
Blinding of participants (performance bias) Patient outcome	Unclear risk	(PRIMARY) SECOPE QUESTIONNAIRE ‐ it is not clear whether participants were blinded to the intervention (not explicitly stated in the paper). Therefore, insufficient information to permit judgment of 'Low risk' or 'High risk' of bias
Blinding of personnel (performance bias) Adherence measure	Low risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Data were collected via computerized interview. The lack of blinding of key personnel is not likely to affect the outcome
Blinding of personnel (performance bias) Patient outcome	Low risk	(PRIMARY) SECOPE QUESTIONNAIRE ‐ The outcome is self reported by participants. The lack of blinding of study personnel is not likely to affect the outcome
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Missing data relatively balanced across conditions. (pg 86) Attrition rates across the 2 conditions were not different, suggesting that the extra incentive payment for intervention completion did not differentially affect study retention
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) SECOPE QUESTIONNAIRE ‐ Missing data relatively balanced across conditions