Corrigendum to: Addressing tobacco smoking and drinking to improve TB treatment outcomes, in South Africa: a feasibility study of the ProLife program.

Alcohol and tobacco use may lead to negative treatment outcomes in tuberculosis (TB) patients, and even more so if they are HIV-infected. We developed and tested the feasibility of a complex behavioral intervention (ProLife) delivered by lay health workers (LHWs) to improve treatment outcomes in TB patients who smoke tobacco and/or drink alcohol, at nine clinics in South Africa. The intervention comprised three brief motivational interviewing (MI) sessions augmented with a short message service (SMS) program, targeting as appropriate: tobacco smoking, harmful or hazardous drinking and medication adherence. Patients received SMSs twice a week. We measured recruitment and retention rates and assessed fidelity to the MI technique (MI Treatment Integrity 4.1 tool). Finally, we explored LHWs' and patients' experiences through interviews and semistructured questionnaires, respectively. We screened 137 TB patients and identified 14 smokers, 13 alcohol drinkers, and 18 patients with both behaviors. Participants' mean age was 39.8 years, and 82.2% were men. The fidelity assessments pointed to the LHWs' successful application of key MI skills, but failure to reach MI competency thresholds. Nevertheless, most patients rated the MI sessions as helpful, ascribed positive attributes to their counselors, and reported behavioral changes. SMSs were perceived as reinforcing but difficult language and technical delivery problems were identified as problems. The LHWs' interview responses suggested that they (a) grasped the basic MI spirit but failed to understand specific MI techniques due to insufficient training practice; (b) perceived ProLife as having benefitted the patients (as well as themselves); (c) viewed the SMSs favorably; but (d) considered limited space and privacy at the clinics as key challenges. The ProLife program targeting multiple risk behaviors in TB patients is acceptable but LHW training protocol, and changes in wording and delivery of SMS are necessary to improve the intervention. Trial registration: ISRCTN14213432.

Effect of a brief motivational interview and text message intervention targeting tobacco smoking, alcohol use and medication adherence to improve tuberculosis treatment outcomes in adult patients with tuberculosis: a multicentre, randomised controlled trial of the ProLife programme in South Africa.

OBJECTIVE: To investigate the effectiveness of a complex behavioural intervention, ProLife, on tuberculosis (TB) treatment success, medication adherence, alcohol use and tobacco smoking. DESIGN: Multicentre, individual, randomised controlled trial where participants were assigned (1:1) to the ProLife intervention or usual care. SETTING: 27 primary care clinics in South Africa. PARTICIPANTS: 574 adults starting treatment for drug-sensitive pulmonary TB who smoked tobacco or reported harmful/hazardous alcohol use. INTERVENTIONS: The intervention, delivered by lay health workers (LHWs), consisted of three brief motivational interviewing (MI) sessions, augmented with short message service (SMS) messages, targeting medication adherence, alcohol use and tobacco smoking. OUTCOME MEASURES: The primary outcome was successful versus unsuccessful TB treatment at 6-9 months, from TB records. Secondary outcomes were biochemically confirmed sustained smoking cessation, reduction in the Alcohol Use Disorder Identification Test (AUDIT) score, improved TB and antiretroviral therapy (ART) adherence and ART initiation, each measured at 3 and 6 months by questionnaires; and cure rates in patients who had bacteriology-confirmed TB at baseline, from TB records. RESULTS: Between 15 November 2018 and 31 August 2019, 574 participants were randomised to receive either the intervention (n=283) or usual care (n=291). TB treatment success rates did not differ significantly between intervention (67.8%) and control (70.1%; OR 0.9, 95% CI 0.64% to 1.27%). There was no evidence of an effect at 3 and 6 months, respectively, on continuous smoking abstinence (OR 0.65, 95% CI 0.37 to 1.14; OR 0.76, 95% CI 0.35 to 1.63), TB medication adherence (OR 1.22, 95% CI 0.52 to 2.87; OR 0.89, 95% CI 0.26 to 3.07), taking ART (OR 0.79, 95% CI 0.38 to 1.65; OR 2.05, 95% CI 0.80 to 5.27) or AUDIT scores (mean score difference 0.55, 95% CI -1.01 to 2.11; -0.04, 95% CI -2.0 to 1.91) and adjusting for baseline values. Cure rates were not significantly higher (OR 1.16, 95% CI 0.83 to 1.63). CONCLUSIONS: Simultaneous targeting of multiple health risk behaviours with MI and SMS using LHWs may not be an effective approach to improve TB outcomes. TRIAL REGISTRATION NUMBER: ISRCTN62728852.

Addressing tobacco smoking and drinking to improve TB treatment outcomes, in South Africa: a feasibility study of the ProLife program.

Alcohol and tobacco use may lead to negative treatment outcomes in tuberculosis (TB) patients, and even more so if they are HIV-infected. We developed and tested the feasibility of a complex behavioral intervention (ProLife) delivered by lay health workers (LHWs) to improve treatment outcomes in TB patients who smoke tobacco and/or drink alcohol, at nine clinics in South Africa. The intervention comprised three brief motivational interviewing (MI) sessions augmented with a short message service (SMS) program, targeting as appropriate: tobacco smoking, harmful or hazardous drinking and medication adherence. Patients received SMSs twice a week. We measured recruitment and retention rates and assessed fidelity to the MI technique (MI Treatment Integrity 4.1 tool). Finally, we explored LHWs' and patients' experiences through interviews and semi-structured questionnaires, respectively. We screened 137 TB patients and identified 14 smokers, 13 alcohol drinkers, and 18 patients with both behaviors. Participants' mean age was 39.8 years, and 82.2% were men. The fidelity assessments pointed to the LHWs' successful application of key MI skills, but failure to reach MI competency thresholds. Nevertheless, most patients rated the MI sessions as helpful, ascribed positive attributes to their counselors, and reported behavioral changes. SMSs were perceived as reinforcing but difficult language and technical delivery problems were identified as problems. The LHWs' interview responses suggested that they (a) grasped the basic MI spirit but failed to understand specific MI techniques due to insufficient training practice; (b) perceived ProLife as having benefitted the patients (as well as themselves); (c) viewed the SMSs favorably; but (d) considered limited space and privacy at the clinics as key challenges. The ProLife program targeting multiple risk behaviors in TB patients is acceptable but LHW training protocol, and changes in wording and delivery of SMS are necessary to improve the intervention. Trial registration: ISRCTN62728852.

ImPROving TB outcomes by modifying LIFE-style behaviours through a brief motivational intervention followed by short text messages (ProLife): study protocol for a randomised controlled trial.

BACKGROUND: South Africa is among the seven highest tuberculosis (TB) burden countries. Harmful lifestyle behaviours, such as smoking and alcohol, and poor adherence to medication can affect clinical outcomes. Modification of these behaviours is likely to improve TB treatment outcomes and has proven possible using motivational interviewing (MI) techniques or use of short message service (SMS) text messaging. There have been no studies assessing the effect of combined MI and SMS interventions on multiple lifestyle factors and TB treatment outcomes. METHODS: This is a prospective, multicentre, two-arm individual randomised controlled trial looking at the effectiveness and cost-effectiveness of a complex behavioural intervention (the ProLife programme) on improving TB and lifestyle-related outcomes in three provinces of South Africa. The ProLife programme consists of an MI counselling strategy, delivered by lay health workers, augmented with subsequent SMS. We aim to recruit 696 adult participants (aged 18 years and over) with drug-sensitive pulmonary TB who are current smokers and/or report harmful or hazardous alcohol use. Patients will be consecutively enrolled at 27 clinics in three different health districts in South Africa. Participants randomised individually to the intervention arm will receive three MI counselling sessions one month apart. Each MI session will be followed by twice-weekly SMS messages targeting treatment adherence, alcohol use and tobacco smoking, as appropriate. We will assess the effect on TB treatment success, using standard World Health Organization (WHO) treatment outcome definitions (primary outcome), as well as on a range of secondary outcomes including smoking cessation, reduction in alcohol use, and TB medication and anti-retroviral therapy adherence. Secondary outcomes will be measured at the three-month and six-month follow-ups. DISCUSSION: This trial aligns with the WHO agenda of integrating TB care with the care for chronic diseases of lifestyle, such as provision of smoking cessation treatments, and with the use of digital technologies. If the ProLife programme is found to be effective and cost-effective, the programme could have significant implications for TB treatment globally and could be successfully implemented in a wide range of TB treatment settings. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN62728852. Registered on 13 April 2018.

Predictors of tobacco smoking abstinence among tuberculosis patients in South Africa.

This study examines predictors of smoking cessation in tuberculosis patients with high HIV co-infection rates in a South African primary care setting. Current smokers were randomly allocated to brief motivational interviewing (n = 205) or receipt of a brief message (n = 204). Multi-level logistic regression was performed to identify predictors of sustained 3- and 6-month abstinence and 7-day point prevalence abstinence (PPA) at 1 month, with the facility as a random effect. The intervention was ineffective among smokers with high nicotine-dependence at 1 month, but was effective for all smokers over longer periods. Higher baseline self-efficacy predicted the 1-month 7-day PPA, but not sustained abstinence. HIV-positive participants' odds of sustained abstinence were about three times higher than those of their HIV-negative counterparts. Results support a more intensive motivational intervention and/or coping skills' training to increase self-efficacy and abstinence rates. Tobacco cessation services can be introduced in tuberculosis services where high HIV co-infection rates occur.

Efficacy of brief motivational interviewing on smoking cessation at tuberculosis clinics in Tshwane, South Africa: a randomized controlled trial.

BACKGROUND AND AIMS: Tuberculosis (TB) patients who smoke risk adverse TB outcomes and other long-term health effects of smoking. This study aimed to determine the efficacy of brief motivational interviewing by lay health-care workers (LHCWs) in assisting TB patients to quit smoking. DESIGN: Multi-centre two-group parallel individual randomized controlled trial. SETTING: Six primary care tuberculosis clinics in a South African township. PARTICIPANTS: Newly diagnosed adult TB patients identified as current smokers were randomized to brief motivational interviewing by a LHCW (intervention group, n = 205) or brief smoking cessation advice from a TB nurse (control group, n = 204). MEASUREMENTS: The primary outcome was self-reported sustained 6-month smoking abstinence. Exhaled carbon monoxide (CO) testing was offered to about half the participants. Secondary outcomes were sustained abstinence at 3 months; 7-day point prevalence abstinence at 1, 3 and 6 months; and quit attempts. Allocation was concealed. Primary analysis relied on intention to treat. Multi-level analysis accounted for site heterogeneity of effect. FINDINGS: Self-reported 6-month sustained abstinence was 21.5% for the intervention group versus 9.3% for the control group [relative risk (RR) = 2.29, 95% confidence interval (CI) = 1.34, 3.92]. Biochemically verified 6-month sustained abstinence was also higher in the intervention group (RR 2.21, 95% CI = 1.08, 4.51) for the 166 participants who were offered carbon monoxide testing. Self-reported 3-month sustained abstinence was 25.4% for the intervention group and 12.8% for the control group (RR = 1.98, 95% CI = 1.24, 3.18). CONCLUSIONS: Motivational interviewing by lay counsellors to promote smoking cessation in tuberculosis patients in South Africa approximately doubled sustained smoking abstinence for at least 6 months compared with brief advice alone.

Poverty and substance use in South African tuberculosis patients.

OBJECTIVES: To determine whether social support and depressive symptoms mediate the relationship between poverty and substance use in tuberculosis (TB) patients in South Africa. METHODS: We performed structural equation modeling with the latent constructs socioeconomic status (SES), social support and "substance use" (tobacco smoking, alcohol problem, illicit drug use) in 1005 male TB patients. RESULTS: Higher SES directly (standardized coefficient= -0.27) and indirectly reduced substance use. Indirectly SES provided increased social support (coefficient=0.37), which was associated with reduced substance use (coefficient=-0.15). Higher SES diminished depressive symptoms. Model fit was acceptable. Separate models for tobacco smoking, illicit drug use or alcohol problem produced similar findings. CONCLUSIONS: Poverty alleviation and social support-based interventions may benefit male TB patients with substance use.

Tobacco use patterns in tuberculosis patients with high rates of human immunodeficiency virus co-infection in South Africa.

BACKGROUND: Tuberculosis (TB) patients who smoke tobacco are at an increased risk for adverse TB treatment outcomes. This study describes tobacco use patterns among newly diagnosed TB patients, their readiness to quit, and their beliefs about tobacco-related health effects in a high HIV-burden setting in South Africa. Socio-economic and demographic factors associated with smoking were also determined. METHODS: This was a cross-sectional analysis of baseline data collected for a smoking cessation study at six large tuberculosis clinics in a South African township (N = 1926). We collected information on current and past tobacco use, socio-economic and demographic status, beliefs regarding the harmful effects of smoking and quit behaviour, and motivation, using structured interviewer-administered questionnaires. TB- and HIV-related information was obtained from patient records. Data analysis entailed descriptive statistics, followed by multivariate logistic regression with backward elimination, adjusted for clustering by facility. RESULTS: Just over one fifth of respondents (21.8%, 420/1924) reported currently smoking tobacco (males 37.6%, females 4.6%). By contrast, only 1.8% (35/1918) of all respondents reported being past smokers. Of the current smokers, about half (51.8%, 211/407) had previously attempted to quit, mainly for health reasons. The majority of respondents (89.3%, 1675/1875) believed tobacco smoking was harmful for their health and smokers were highly motivated to quit (median score 9, interquartile range 7-10). Smoking was less common among female respondents (Odds Ratio [OR] 0.10, 95% Confidence Interval [CI] 0.06-0.19) and respondents who had completed high school (OR 0.57, 95% CI 0.39-0.84), but was more common among respondents who do occasional work (OR 2.82, 95% CI 1.58-5.02), respondents who to bed hungry regularly (OR 4.19, 95% CI 2.42-7.25), those who have an alcohol problem (OR 5.79, 95% CI 3.24-10.34) and those who use illicit substances (OR 10.81, 95% CI 4.62-25.3). CONCLUSIONS: Despite documented evidence of its harmful effects, smoking is prevalent among male TB patients in this high HIV-prevalence population. Few patients have managed to quit smoking on their own. However, patients are highly motivated to stop smoking. We recommend implementing and evaluating a smoking cessation programme in tandem with TB services.

Comparative durability of nevirapine versus efavirenz in first-line regimens during the first year of initiating antiretroviral therapy among Swaziland HIV-infected adults.

Nevirapine (NVP) and Efavirenz (EFV) have generally comparable clinical and virologic efficacy. However, data comparing NVP durability to EFV are imprecise. We analyzed cohort data to compare durability of NVP to EFV among patients initiating ART in Mbabane, Swaziland. The primary outcome was poor regimen durability defined as any modification of NVP or EFV to the ART regimen. Multivariate Cox proportional hazards models were employed to estimate the risk of poor regimen durability (all-cause) for the two regimens and also separately to estimate risk of drug-related toxicity. We analyzed records for 769 patients initiating ART in Mbabane, Swaziland from March 2006 to December 2007. 30 patients (3.9%) changed their NVP or EFV-based regimen during follow up. Cumulative incidence for poor regimen durability was 5.3% and 2.7% for NVP and EFV, respectively. Cumulative incidence for drug-related toxicity was 1.9% and 2.7% for NVP and EFV, respectively. Burden of TB was high and 14 (46.7%) modifications were due to patients substituting NVP due to beginning TB treatment. Though the estimates were imprecise, use of NVP - based regimens seemed to be associated with higher risk of modifications compared to use of EFV - based regimens (HR 2.03 95%CI 0.58 - 7.05) and NVP - based regimens had a small advantage over EFV - based regimens with regard to toxicity - related modifications (HR 0.87 95%CI 0.26 - 2.90). Due to the high burden of TB and a significant proportion of patients changing their ART regimen after starting TB treatment, use of EFV as the preferred NNRTI over NVP in high TB endemic settings may result in improved first-line regimen tolerance. Further studies comparing the cost-effectiveness of delivering these two NNRTIs in light of their different limitations are required.

Water pipe and smokeless tobacco use among medical students in South Africa.

INTRODUCTION: This study sought to determine the sociodemographic and behavioral factors associated with water pipe and smokeless tobacco (SLT) use among a population of medical students in the Pretoria area, South Africa. METHODS: Undergraduate medical students (N = 722) in their 2nd and 6th year of study in 2 medical schools in South Africa completed a self-administered questionnaire during 2008. Information on ever and current use of water pipe and SLT was obtained along with information on sociodemographic variables, alcohol use, and cigarette smoking status. Multiple logistic regression analysis were used to determine factors associated with current use of water pipe and SLT. RESULTS: The mean age of study participants was 23 years. Of the participants, 53% were female and 55% were self-identified as Black Africans. Of the study participants, 18.6% were current water pipe users, 3.1% were current SLT users, while 17.3% were current cigarette smokers. Factors independently associated with current water pipe use were having an alcohol drinking-problem (odds ratio [OR] = 2.43; 95% CI = 1.48-3.40), currently smoking cigarettes (3.40; 2.04-5.67), and reporting exposure to smoking in places other than home (2.51; 1.29-4.90). Compared with Black students, White medical students were more likely to have smoked a water pipe in the past month (3.14; 1.74-5.70) but less likely to have ever used SLT (0.37; 0.19-0.73). CONCLUSIONS: These findings suggest that the use of alternative tobacco products is common among South African medical students and may form part of a pattern of risk-taking behavior. Furthermore, there appear to be cultural differences in the use of certain tobacco products.

Factors associated with female high-risk drinking in a rural and an urban South African site.

OBJECTIVE: To assess and compare the extent of high-risk drinking and factors associated with high-risk drinking in the adult female population of a rural and an urban region in South Africa. DESIGN: Cross-sectional household survey using multistage sampling methods. Setting. A rural wine farming area of the Western Cape and an urban site in Gauteng. Subjects. Women of reproductive age (18 - 44 years). Outcome measures. The extent of risky alcohol consumption measured using the Alcohol Use Disorders Identification Test (AUDIT) scale which categorises current drinkers into high- and low-risk drinkers. RESULTS: Twenty-seven per cent (166/606) and 46% (188/412) of the women interviewed in Gauteng and the Western Cape respectively were current drinkers. In turn, 20% (33/166) of the Gauteng current drinkers and 68% (128/188) of the Western Cape current drinkers were classified as high-risk drinkers. Multivariate analysis indicated that employed people in Gauteng were less likely to be high-risk drinkers (odds ratio (OR) 0.3, 95% confidence interval (CI) 0.1 - 0.8). Living in a household that never/seldom went hungry was inversely associated with risky drinking for both sites (OR 0.3, 95% CI 0.1 - 0.9 for Gauteng and OR 0.2, 95% CI 0.3 - 1.2 for the Western Cape). Current smokers (Western Cape) (OR 7.6, 95% CI 3.1 - 18.9) and respondents with an alcohol problem in one or more family members (both sites) (OR 6.0, 95% CI 2.3 - 15.7 and OR 3.1, 95% CI 1.5 - 6.4) were more likely to be high-risk drinkers. CONCLUSIONS: High-risk drinking by women is a major problem, especially in the Western Cape. Targeted interventions are needed for women with alcohol problems in the family setting, lower socio-economic status, and concurrent substance abuse.

Effectiveness of antiretroviral treatment in a South African program: a cohort study.

BACKGROUND: The effectiveness of the South African government's expanding antiretroviral treatment program is unknown. Observational studies of treatment effectiveness are prone to selection bias, rarely compare patients receiving antiretroviral treatment with similar patients not receiving antiretroviral treatment, and underestimate mortality rates unless patients are actively followed up. METHODS: We followed up 14 267 patients in the Public Sector Anti-Retroviral Treatment project in Free State, South Africa, for up to 20 months after enrollment. A total of 3619 patients received highly active triple antiretroviral treatment (HAART) for up to 19 months (median, 6 months; interquartile range, 3-9 months) after enrollment. Patients' clinical data were linked with the national mortality register. Marginal structural regression models adjusted for baseline and time-varying covariates. RESULTS: Of 4570 patients followed up for at least 1 year, 53.2% died. Eighty-seven percent of patients who died had not received HAART. HAART was associated with lower mortality (hazard ratio, 0.14; 95% confidence interval [CI], 0.11-0.18) and with the presence of tuberculosis (hazard ratio, 0.61; 95% CI, 0.46-0.81) after adjusting for age, sex, weight, clinic, district, CD4 cell count, cotrimoxazole therapy, tuberculosis at baseline, and previous antiretroviral therapy. Cotrimoxazole therapy was associated with lower mortality (hazard ratio, 0.37; 95% CI, 0.32-0.42). Each month of HAART was associated with an increase in CD4 cell count of 15.1 cells/microL (95% CI, 14.7-15.5 cells/microL) and with an increase in body weight of 602 g (95% CI, 548-658 g). CONCLUSIONS: HAART provided through these South African government health services seems as effective as that provided in high-income countries. Delays starting HAART contributed to high mortality rates. Faster expansion and timely commencement of HAART are needed.

Highly active antiretroviral treatment and health related quality of life in South African adults with human immunodeficiency virus infection: A cross-sectional analytical study.

BACKGROUND: Health Related Quality of Life (HRQoL) is an important outcome in times of Highly Active Antiretroviral Treatment (HAART). We compared the HRQoL of HIV positive patients receiving HAART with those awaiting treatment in public sector facilities in the Free State province in South Africa. METHODS: A stratified random sample of 371 patients receiving or awaiting HAART were interviewed and the EuroQol-profile, EuroQol-index and Visual Analogue Scale (VAS) were compared. Independent associations between these outcomes and HAART, socio-demographic, clinical and health service variables were estimated using linear and ordinal logistic regression, adjusted for intra-clinic clustering of outcomes. RESULTS: Patients receiving HAART reported better HRQoL for 3 of the 5 EuroQol-dimensions, for the VAS score and for the EuroQol index in bivariable analysis. They had a higher mean EuroQol index (0.11 difference, 95% confidence interval [CI] 0.04; 0.23), and were more likely to have a higher index (odds ratio 1.9, 95% CI 1.1; 1.3), compared to those awaiting HAART, in multivariate analysis. Higher mean VAS scores were reported for patients who were receiving HAART (6.5 difference, 95% CI 1.3; 11.7), were employed (9.1, 95% CI 4.3; 13.7) or were female (4.7, 95% CI 0.79; 8.5). CONCLUSION: HAART was associated with improved HRQoL in patients enrolled in a public sector treatment program in South Africa. Our finding that the EuroQol instrument was sensitive to HAART supports its use in future evaluation of HIV/AIDS care in South Africa. Longitudinal studies are needed to evaluate changes in individuals' HRQoL.