van Servellen 2005.

Study characteristics
Methods	Study design: RCT (pilot), 2 arms Geographic location: California, USA Ethical approval: yes Recruitment setting: 2 administratively linked HIV community‐based not‐for‐profit clinics Method of recruitment: clinical trial staff screened medical records of the clinic and approached eligible patients by phone and/or letter. Length of follow‐up: 6 months (total programme duration) Dropouts: 9 in the intervention group, thereof 2 after 6 weeks (reason: unable to be reached initially after the instructional component of the programme) and 7 after 6 months; 7 in the control group, thereof 2 after 6 weeks (reason: unable to be reached initially after the instructional component of the programme) and 5 after 6 months A priori calculation of effect size/power?: yes
Participants	Description: Latinos with HIV‐infection Health topic HIV Inclusion criteria Male or female, ≥ 18 years of age, Spanish speaking, detectable viral load, stated problem with adherence, taking antiretroviral medications for at least 3 months Exclusion criteria Adherence problems with undetectable viral loads Intervention group HIV treatment adherence enhancement programme “Es por la vida” (43 randomised and 41 analysed at 6 weeks and 34 analysed at 6 months) Control group Standard clinic care (42 randomised and 40 analysed at 6 weeks and 35 analysed at 6 months) Note: 93 participants were randomised either to intervention or control group. Authors did not provide numbers on participants randomised to different treatment groups. PROGRESS‐Plus Place of residence: urban, USA Race/ethnicity: Latinos Gender: Intervention: 11.6% female Control: 7.1% female Education (years): 81.0% < 12 y Socioeconomic status/income (per month): 41.0% ≤ USD 500 Age (years), mean, range: 40.7, 21 to 78 Health literacy (baseline) Assessment tool, range, level: modified REALM (24 additional HIV‐relevant medical terms), higher score is better Intervention group, mean: 17.07 (recognition), 12.49 (understand) Control group, mean: 18.64 (recognition), 13.62 (understand)
Interventions	Intervention: HIV treatment adherence enhancement programme “Es por la vida” Theoretical framework: no specific Description: the intervention consisted of modular group sessions including (1) basic HIV/AIDS information, (2) barriers and facilitators of adherence management, (3) maintaining quality of life and controlling illness‐related stress, (4) reducing risks related to transmitting HIV and management of substance use (5) and communication skills with healthcare providers and maintaining effective family and community support systems. All materials were read and discussed. There were additional follow‐up phone calls and face‐to‐face conversations with a nurse practitioner focussing on barriers to HIV treatment adherence and strategies to reduce those barriers. Problem‐solving and motivational interviewing strategies were used by reviewing content that has not been fully understood and identifying ways to lower barriers of adherence management, or to identify support systems. Intervention provider: nurse practitioner and health educator; trained foreign medical student (only assessment) Delivery method/mode: 5 weekly face‐to‐face group sessions (with 3 to 7 participants), 6 months of telephone or face‐to‐face counselling Language of delivery: language concordant (bilingual) Format: individually tailored Setting/location: 2 administratively linked clinics Consumer involvement: indicated, but missing information Comparator Type: no health literacy intervention Description: standard clinic care, no additional intervention
Outcomes	Outcomes assessed in the study: functional HIV health literacy, HIV‐related knowledge, adherence self‐efficacy, medication adherence (self‐report), general health status (self‐report), viral load, relationship and communication with healthcare provider Outcomes considered in this review Health literacy Functional HIV health literacy (recognition and understanding of HIV‐related terms) Health‐related knowledge (HIV‐related knowledge) Health outcome (general health status) Health behaviour (medication adherence) Self‐efficacy (adherence self‐efficacy) Methods of assessing outcomes Questionnaires administered by a bilingual foreign medical HIV health literacy: modified REALM, 24 additional HIV‐relevant medical terms (recognition of terms and understanding of HIV terms), higher score is better Reliability/validity: validated within study sample, Cronbach's α = 0.81 (recognition scale, baseline), 0.82 (6 weeks), and 0.74 (6 months); Cronbach's α = 0.79 (understanding scale, baseline), 0.84 (6 weeks), and 0.79 (6 months) Note: health literacy measures and questions were designed by clinic staff in collaboration with the study team. 24 HIV terms were added to the original set of medical terms of the REALM by keeping with the original format. For example, terms ranged from HIV, virus and symptoms (lower level of difficulty) to terms such as viral replication, protease inhibitors, HIV‐resistant strains (higher level difficulty). Participants were asked first if they had heard these terms (global recognition) and second, whether they could explain them (global understanding). HIV‐related knowledge: HIV illness and treatment knowledge and misconceptions scale, 17 items, 0 to 17, higher score is better Reliability/validity: validated within target population Adherence self‐efficacy: 1 item from the Adult AIDS Clinical Trials Group (ACTG) Adherence Baseline Questionnaire, 3‐point Likert scale, (0 = not at all sure to 3 = extremely sure), higher score is better Medication adherence: ACTG Adherence behaviours Adherence Baseline Questionnaire (self‐report), dichotomous variables were created for those who had greater than 90.0% and greater than 95.0% adherence to their antiretroviral medication regimen in the past 4 days Note: we prioritised the variable '95% adherence to antiretroviral medication regimen in the past 4 days' over '90.0% adherence in the past 4 days'. General health status: 1 item assessing perceived level of general health status in the past week, range of score and direction of score is not reported Note: "Most measures were already translated into Spanish but were reviewed again by the bilingual research assistant to ensure proper translation of ideas and concepts. Questions not previously translated were submitted for translation by an independent linguistic and cultural consultant who used the standard multi‐step forward/backward translation with additional evaluation by our bilingual research staff." (van Servellen 2003, p. 288) Language of assessment: Spanish Translation procedure (if necessary): not reported Reliability/validity: no psychometric properties reported (applies to adherence self‐efficacy, medication adherence and health status) Timing of outcome assessment: baseline, at 6 weeks (after group sessions) and at 6 months (short‐term) after randomisation
Health literacy	Definition: "According to various reports, the accepted distinguishing characteristics of health‐literate individuals include the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions (IOM, 2004) Furthermore, individuals’ health literacy skills and capacities are influenced by their education, culture, and language (Adams, 2003). It follows that HIV‐related health literacy would include those skills and knowledge to obtain, process, and understand HIV‐related information, and that these skills and knowledge are influenced by the particular educational level, culture, and language of the group in question.” (van Servellen 2005, p. 747) Health literacy components addressed by the intervention Prerequisites and tools Knowledge Motivation Competences Steps of information processing Access Understand Appraise Apply Health domain: health care
Notes	Trial ID: not reported Funding: funding was provided by a grant from the University‐wide AIDS Research programme and State Office of AIDS (no. R00‐LA‐112). Additional notes: we tried to contact the authors to ask for additional information but without success.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Upon enrollment, all participants received a code number from a published table of random numbers and assigned to either the pilot intervention group or comparison group.”
Allocation concealment (selection bias)	Low risk	The method of randomisation indicates a low risk of bias.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the study, participants and personnel were not blinded; results of subjectively measured outcomes might be biased.
Blinding of outcome assessment (detection bias) subjective outcome measures	High risk	Subjective outcomes were measured with repeated questionnaires and participants were not blinded to group allocation.
Blinding of outcome assessment (detection bias) objective outcome measures	Low risk	Participants and personnel were not blinded but health literacy and knowledge were objectively measured and not subject to interpretation.
Incomplete outcome data (attrition bias) All outcomes	Low risk	"Baseline and 6 weeks (immediately after instructional modular programme) data were available for 41 intervention and 40 comparison group patients. From 6 weeks to 6 months, an additional 5 participants in the comparison group and 7 participants in the pilot group were lost to follow‐up, for an attrition rate of 21% for the intervention group and 17% for the comparison group. Analysis of the characteristics of these 16 patients revealed that they had a poorer understanding of HIV terms (11.00 versus 13.38) [F(1,82) 3.96, p 0.05] and a statistically significant higher viral load than those who remained (99,328 versus 36,973) [F(1,83) 4.34, p 0.04]. They were also less apt to take part in decisions about their care (1.88 versus 2.41) [F(1,82) 4.62, p 0.03]. The numbers of and reasons for participants lost to follow‐up are reported and equal for both the control and intervention group.
Selective reporting (reporting bias)	Low risk	All prespecified outcomes reported in the methods section are reported in the results of the paper.