Kalichman 2011.

Methods	Randomized controlled trial
Participants	The study location was AIDS service providers in Atlanta, Georgia, USA 217 participants were randomized to the intervention group and 219 participants were randomized to the control group The inclusion criteria were (1) aged 18 years or older and (2) name‐matching proof of positive HIV status and photo identification
Interventions	Intervention: INTEGRATED INTERVENTION Intervention was an integrated risk reduction and adherence intervention based on the conflict theory of decision making. It consisted of a 45‐minute one to one orientation and goal setting with 1 of the group facilitators before 5 120‐minute group sessions and a 60‐minute post group one to one counseling session, conducted by facilitators/interventionists. Assessment was done at baseline, 3, 6, and 9 month intervals for a total of 12 months of follow‐up Control: ATTENTION CONTROL CONDITION Comparison intervention group received 45‐minute one‐on‐one orientation (with 1 facilitator), 5 120‐minute group sessions (with male‐female facilitator pairs containing 8 to 10 participants of mixed gender and sexual orientation) and a 60‐minute one‐on‐one post‐group counseling session.The first group session focused on building group cohesion and discussed how to access quality health information. The remaining 4 group sessions covered detecting early warning signs of cancer, breast and testicular self examination, nutrition decision making, healthy food selection, planning exercise, and relaxation. The final individual counseling session set personalized health improvement goals
Outcomes	The measures of adherence were unannounced pill counts. Participants were called at unscheduled times by a telephone assessor. Participants were given training on pill counting procedure and were asked count pills during the call. Pill counts were taken over 21‐ to 35‐day intervals and for each antiretroviral medication the participants were taking. Pharmacy information from pill bottles were collected to verify the number of pills dispensed between calls. Adherence was calculated as the ratio of pills counted to pills prescribed, taking into account the number of pills dispensed. 2 consecutive pill counts were necessary for computing adherence. This information was collected by telephone assessors who were blind to the assigned treatment condition. The patient outcomes were patient‐reported monthly viral load collected by telephone assessors, sexual risk behaviors and STIs measured by questionnaire and adherence and prevention strategies and risk compensation beliefs measured by a 5‐point scale
Notes	In the results section(pg 536) there is a reference to table 3; there is no table 3 in the manuscript
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information about how the randomization was performed is reported
Allocation concealment (selection bias)	Low risk	"The project director performed the allocation, manually drawing equal numbers of condition‐coded markers without replacement." (pg 534)
Selective reporting (reporting bias)	Unclear risk	No obvious reporting bias. No protocol available, hence judged as unclear
Other bias	Unclear risk	The authors noted the following: (pg 537) "Although adherence improvements were relatively stable over the 9 months of followup, the sexual risk reduction outcomes were shorter lived, dissipating before 9 months after the intervention. The durability of behavioral outcomes may prove more optimistic when the intervention is delivered in clinical care given the opportunities for ongoing support. Another limitation of this trial was its reliance on self reported measures for sexual risk and biological outcomes. Although the consistency of findings supports the study's internal validity, further testing of this intervention should be undertaken with biological endpoints. We emphasized ecological validity in designing the intervention, focusing on simple and lowcost strategies for reducing risk and improving adherence. Although we strived to maintain implementation simplicity, the intervention included 2 individual and 5 group sessions. Operations research is needed to examine whether the intervention can be shortened and whether it can be infused within existing clinical services, such as support groups, medication adherence groups, and case management." Also the final individual session was attended by 62 and 63 per cent of participants from the intervention and control groups respectively
Blinding of outcome assessment (detection bias) Adherence measure	Low risk	(PRIMARY) UNANNOUNCED PILL COUNTS ‐ Telephone assessors were blind to assigned treatment condition (pg 532). Blinding of outcome assessment ensured and unlikely that the blinding could have been broken
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) ADHERENCE AND PREVENTION STRATEGIES AND RISK COMPENSATION BELIEFS ‐ Participants were asked these questions at 3‐, 6‐, and 9‐month follow‐ups using audio computer‐assisted self interviews. Blinding of outcome assessment ensured and unlikely that the blinding could have been broken
Blinding of participants (performance bias) Adherence measure	Low risk	(PRIMARY) UNANNOUNCED PILL COUNTS ‐ They state that "unannounced pill counts are reliable and valid in assessing HIV treatment adherence when conducted in participants' home and on the telephone." Further, "they collected pharmacy information from pill bottles to verify the number of pills dispensed between calls."(pg 532). Although the paper does not explicitly state that the participants were blinded, the structure of intervention received by participants in integrated intervention and comparison intervention were very similar. "We implemented the 2 conditions in this trial using the same operational procedures" (pg 532). No blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding
Blinding of participants (performance bias) Patient outcome	Unclear risk	(PRIMARY) ADHERENCE AND PREVENTION STRATEGIES AND RISK COMPENSATION BELIEFS ‐ Participant blinding not described
Blinding of personnel (performance bias) Adherence measure	Low risk	(PRIMARY) UNANNOUNCED PILL COUNTS ‐ (pg 534) "Recruitment, screening, office‐based assessment, and telephone assessment staff remained blinded to condition throughout the study, and interventionists never conducted assessments."
Blinding of personnel (performance bias) Patient outcome	Low risk	(PRIMARY) ADHERENCE AND PREVENTION STRATEGIES AND RISK COMPENSATION BELIEFS ‐ Participants were asked these questions at 3‐, 6‐, and 9‐month follow‐ups using audio computer‐assisted self interviews. Blinding of outcome assessment ensured and unlikely that the blinding could have been broken
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) UNANNOUNCED PILL COUNTS ‐ Reasons for missing data unlikely to be related to outcome. Low attrition rate, balanced across groups at all time points except 9 months
Incomplete outcome data (attrition bias) Patient outcome	Unclear risk	(PRIMARY) ADHERENCE AND PREVENTION STRATEGIES AND RISK COMPENSATION BELIEFS ‐ Reasons for missing data unlikely to be related to outcome. Low attrition rate, balanced across groups at all time points except 9 months