Screening and brief interventions for hazardous and harmful alcohol use among patients with active tuberculosis attending primary public care clinics in South Africa: results from a cluster randomized controlled trial

Screening and brief interventions for alcohol use disorders

Increasing emphasis has been placed on the detection and treatment of hazardous and harmful drinking disorders, particularly among patients who are seen in primary health care settings [11]. Screening instruments such as the AUDIT, CAGE (Cut Down, Annoyed, Guilty and Eye Opener), and Screening and Brief Interventions (SBIs) have been found to be useful in detecting and treating alcohol use disorders in a number of settings [13, 16, 17]. The interventions are based on cognitive-behavioural interventions and motivational interviewing techniques and have been found to be effective and efficient in the treatment of alcohol use disorders in most chronic conditions. In previous studies screening and brief intervention for alcohol problems have been successfully implemented by nurses in demonstration projects in South Africa as part of a WHO strategy to expand screening and brief intervention for alcohol problems in developing countries funded by WHO and NIAAA [16, 18]. Community health workers have been identified as strategic implementation agents for screening and brief intervention of alcohol problems in primary care in South Africa [16].

Whilst there have been studies conducted on screening for alcohol misuse and brief interventions producing favourable results [19, 20], there is a dearth of scientific literature on evidence-based best practice methods to screen for alcohol misuse and brief interventions amongst individuals with active TB [21]. In South Africa the target rate set by the WHO for TB cure has not been met, and the fact that alcohol use and misuse is known to be one of the causal factors in TB onset, there is an urgent need to interrogate behavioural models that address reduction in alcohol consumption. Given that the sample for the current study was from three districts with the highest TB burden in South Africa, reducing alcohol consumption will be valuable in that, it will reduce the participants’ vulnerability to unfavourable TB treatment outcomes, such as treatment failure, a high treatment default rate, TB re-infection and the development of resistant forms of TB. Thus reducing the incidence rate for the population at large.

Aim of the study

The aim of this study was to conduct a cluster randomized control trial to assess the effectiveness of SBI for alcohol use disorders among TB patients in public primary care clinics. Consenting patients who started TB treatment and screened for risky consumption of alcohol using a standardized tool were randomized, with the public primary care clinic being the unit of randomization into one of two arms: The first arm being a Brief Intervention for alcohol misuse arm (treatment arm) and the second arm being the treatment as usual in addition to receiving an alcohol education leaflet (control arm). We hypothesized that compared to the control group, patients receiving brief alcohol intervention in the intervention group would reduce the overall AUDIT score and would increase screening negative on the AUDIT. The null hypothesis of the study was that the mean AUDIT scores and those screening negative on the AUDIT between those in the intervention and control groups will not be statistically significantly different.

Setting

Three provinces, in South Africa, with the highest TB caseload were selected for inclusion in the study. One district in each province (N = 3) with the highest TB caseloads were consequently included. These districts were Siyanda in the Northern Cape Province, Nelson Mandela Metro in the Eastern Cape Province, and eThekwini in KwaZulu-Natal Province. Within each of these three study districts 14 public primary health care facilities were selected based on the highest TB caseloads per clinic (N = 42). The type of health facility was a primary health care clinic or community health centre. The study catchment areas within the study health districts and randomization procedures enabled a broad coverage of major population groups.

Design

In order to assess the effectiveness of the Screening and Brief Interventions (SBI) among tuberculosis patients found to be misusing alcohol, a cluster randomized controlled trial design was implemented. All new TB and retreatment patients were screened using the AUDIT. TB patients who met the cut-off for misusing alcohol both in the intervention and control arms were reassessed after baseline assessment at time 2 (3 months following intervention) and time 3 (6 months following intervention). The intervention comprised the following: personalized feedback on AUDIT results, a health education leaflet, simple advice and brief counselling about reducing excessive drinking, during one −20 minute- session. The trial incorporated cluster randomization of public primary health care facilities to avoid the risk of contamination.

Principles for recruitment

Randomisation

Randomisation was conducted using a secure remote randomization service. Within each district in each of the three provinces the 14 public primary health clinics with the highest TB caseloads were randomly assigned to the treatment and control arms. A secure remote randomisation service carried out randomisation. Twenty one allocations were initially generated for each of the possible factorial combinations of clinic type, TB case load, and intervention. Randomisation was stratified by clinic type (clinic and community health centre) and TB case load. The standby and reallocated clinics were subsequently randomly allocated in a similar manner. TB patients misusing alcohol in intervention clinics were receiving treatment and those in control clinics received a health education leaflet. At the clinic level all consecutive new and retreatment TB patients were systematically recruited over a period of six months from mid- April to mid- October 2011.

Blinding

Participants (clinic staff members and TB patients) were not blinded to their intervention or control status. However, to protect against information biases in the reporting of alcohol use and TB treatment adherence behaviour, the data collection team who assessed the outcomes were blinded to the clinic’s status as intervention or control group.

Screening and baseline assessment

To identify drinking and other health behaviours, interviews with potential study volunteers were conducted by trained research assistants using a standardized questionnaire. The 10-item AUDIT [23] assessed alcohol consumption level (3 items), symptoms of alcohol dependence (3 items), and problems associated with alcohol use (4 items). Responses to items in the AUDIT were rated on a 4-point Likert scale from 0 to 4, for a maximum score of 40 points. Higher AUDIT scores indicate more severe levels of risk: a score of 8 or more indicates a tendency for problematic drinking, and a score of 20 or above probable alcohol dependence [26]. Heavy episodic drinking is defined as the consumption of six standard drinks (10 g alcohol) or more on a single occasion [26]. In South Africa a standard drink is 12 g alcohol. Because AUDIT is reported to be less sensitive at identifying risk drinking in women [17], the cut-off points of binge drinking for women (4 units) were reduced by one unit as compared with men (5 units), as recommended by Freeborn and others [17]. The AUDIT has been validated in HIV patients in South Africa showing excellent sensi-tivity and specificity in detecting MINI-defined dependence/abuse (sensitivity, 100% and correctly classified 79% of individuals who did not have alcohol abuse or dependence) [27] and among TB and HIV patients in primary care in Zambia demonstrating good discriminatory ability in detecting MINI-defined current AUDs (AUDIT = 0.98 for women and 0.75 for men) [28]. To comply with the timeline of this study, all subjects were asked for their alcohol consumption in the previous 3 months rather than in the past 12 months.

Interventions

Counsellor training and intervention quality assurance

The intervention counsellors consisted of lay HIV counsellors from the study clinics who spoke the predominant languages, namely English, Afrikaans, i-Zulu, i-Xhosa and Tswana, in the respective areas. These counsellors delivered the interventions to the participants of the study in addition to the “treatment as usual”. The treatment “as usual” consisted of the provision of standardised short-course chemotherapy under direct observation of treatment (DOT) for at least the initial phase of treatment to all identified smear-positive TB cases in all study clinics [34]. All lay counsellors and up to four nurses per study clinic who were suitable to deliver the brief counselling intervention received formal training (lay counsellors 3 days and nurses 2 days) and supervision prior to the start of the study. It was agreed that the HIV lay counsellors would implement the intervention and the trained nurses will assist when necessary. The training took a practical, systems approach, aiming to facilitate the implementation of SBI in clinic operations rather than merely educating staff. The training curriculum contained modules addressing practical issues deemed essential to implementing the programme. For early identification of alcohol problems in public primary care the AUDIT [26] and for the brief intervention the WHO brief intervention package for hazardous and harmful drinking [35] was used. Both were adapted to the South African context, e.g. in terms of standard unit of alcoholic drink and drinking limits. The AUDIT was translated and back translated according to scientific standard procedures [26] into four of the major languages (Tsonga, Northern Sotho, Venda, and Afrikaans) [16, 18] and also translated into additional languages (Xhosa, Zulu and Tswana). The self-help booklet for patients and a hand-out on “cutting back” showing the drinking limits and health effects of risky alcohol consumption were also made available in the languages relevant for the study. The AUDIT manual explains the purpose of screening for alcohol problems in primary care, the context of alcohol screening, the development and validation of the AUDIT, administration guidelines, scoring and interpretation. The Brief Intervention manual defines concepts and terms, roles and responsibilities of Public Primary Health Care, SBI: a risk management and case finding approach, alcohol education for low-risk drinkers, abstainers and others, and simple advice a brief counselling for risk zone drinkers, self-help booklet and training sources. Critical administrative activities included administration and scoring of the screening instruments, assuring availability of patient brochures, sequencing of interventions with treatment of presenting health problems, the essential elements of an intervention, and the management of SBI records.

The training comprised of four elements: orientation to the relevant practice, standardised power point presentation, tape recorded simulated consultations with trained actors and on-going clinical supervision by experienced HSRC staff. The simulated consultations were recorded and rated by two independent clinical assessors. The brief intervention counsellor was assessed for adherence to the brief counselling protocol in addition to their behaviour and skills using a Behaviour Change Counselling Index [36].

Assessors submitted the ratings, comments and supervision points for each consultation. This information supported clinical supervision and training until the brief intervention counsellor reached a required standard of practice agreed by the assessors [37].

To help protect against counsellor drift (deviating from the existing treatment intervention protocol), the brief intervention was completely manualized and was used to guide the counsellor through the content of the session. Lay counsellors received bi-weekly support visits by the project trainers during the implementation of the project. Monthly visits were paid by research staff to the clinics in support for the project to assist them with any technical aspects of the counselling intervention. In terms of control around the quality and consistency of the implementation of the intervention, intervention counsellors filled in a patient monitoring form for each counselling session conducted. It included sections on the client’s AUDIT score, stage of change, action and intervention plan, handing of action plan to client and comments. A readiness ladder was used to assess a patients’ readiness to change their drinking, i.e. their stage of change. Patients were asked to rate on a ladder from ‘not at all’, ‘a little’, ‘somewhat’, ‘very’ to ‘extremely’, “How important is it for you to change your drinking?” Patients who score in the lower end (‘not at all’) of the scale were classified as pre-contemplators, those who score in the middle range (‘a little’ – ‘somewhat’) as contemplators, and those scoring in the higher range were considered as ready to take action. Intervention counsellors were compensated with R20 (US$2.6) for each counselling session conducted and monitoring form completed. In addition, study fieldworkers were able to report to their coordinators regarding any problems they may be having in implementing the brief interventions. Regular meetings between the researchers and the project managers allowed for any problems to be resolved timeously.

Sample size calculation

Using the Practihc Trial Protocol tool sample size is calculated with cluster size as a binary outcome based on an average cluster size of 350, an intra-cluster correlation coefficient of 0.2, with 90% power and 5% significance level. A previous review [39] found a clinically important difference in negative status on AUDIT between brief intervention and controls of 13% (5% reduction in controls and 18% in brief intervention recipients). With an expected 20% AUDIT negative in the intervention and 5% in the control, a minimum of 200 sample per group (total 400), with 20 clusters per group, would be needed. Assuming a loss to follow-up of 40%, the sample size was inflated to 280 per group (total 560). As initially only new TB patients were considered in the trial but later new retreatment patients were also included in the trial the sample size was doubled to 1120.

Data management and analyses

Data were captured by dedicated data capturers. Data cleaning and data verification was supervised by key project staff, including the principal investigator and methodologist. The verification process included double data entry of all questionnaires and its fields, doing programmed range checks by computer to identify outlying values, checking for missing values, and checking for inconsistencies in the data. Cluster-specific methods of data analysis (Generalized Estimating Equations) were used because we randomized clinics rather than patients. Data were analysed using STATA Version 11.

Screening and randomization

Figure 1 summarizes patient identification, recruitment, randomization, and follow-up numbers. We identified 4955 public primary care TB patients of which 3684 screened negative for alcohol, 51 refused to participate and 24 were found ineligible, resulting in 1196 patients across 40 primary care clinics. Of the 4880 screened for alcohol and agreed to participate in the trial 1196 (24.6%) tested positive for the AUDIT. Participants in clinics were randomized into 20 control and 20 intervention clinics using the clinic as a unit of randomization to 455 patients in the control group and 741 in the intervention group. As illustrated in Figure 1, response rates were higher in the intervention than in the control group at both follow-ups. At the 3-month follow-up, response rates for the control and intervention were 39% and 54%, respectively, and at 6 months, the control and intervention group response rates were 59% and 79%, respectively. In the control group 41% did not complete the last follow-up survey (i.e., the dropout rate was 41%); in the intervention group, 21% did not complete the last follow-up survey. The main difference between groups was in the dropout rate (percentage of participants that did not complete the last follow-up survey): 21% in the intervention group versus 41% in the control group.

Attrition analyses were conducted to check for differential attrition by examining the condition by dropout interactions at baseline. Dropout was significantly related to the condition (P < 0.001) and poverty (P = 0.003), indicating a relationship between these variables and dropout status depending on condition: 21% in the intervention group versus 41% in the control group dropped out and the poverty index was 9.9 in the intervention versus 8.9 in the control group. Dropout was not related to gender (P = 0.308), age (P = 0.078), education (P = 0.866), AUDIT score (P = 0.958), AUDIT (7–40) (P = 0.516), AUDIT (7–19) (P = 0.952), AUDIT (20–40) (P = 0.918), heavy episodic drinking (P = 0.192), daily or almost daily tobacco use (P = 0.929), HIV status (P = 0.488), and TB new or retreatment patient (P = 0.082).

Brief intervention implementation fidelity analysis

Assessment of intervention fidelity via the patient monitoring forms found that the intervention was delivered with sufficient fidelity. In 75% of the intervention sessions, the lay counsellors implemented at least 6 of the 7 requisite intervention steps (including, e.g., to describe drinking diary cards, stage of change, action and intervention plan). In addition, it was found that in 96% of the cases of brief intervention, only one session was conducted despite having scheduled a follow-up session, and in 4% of cases two sessions. Further analysis of the monitoring form assessing the stage of change in the intervention group found that 7.4% were at the precontemplation, 38.9% at the contemplation, 34% preparation and 19.7% at the action stage.

Participant characteristics

Drinking and TB treatment outcomes

Study limitations

Our study has several limitations, including the loss of patients at each follow-up point. Despite randomization there were baseline differences between the two groups on several covariate measures. This may be due to the relatively large variation of the sample size on the level of group assignment. Although we controlled for these differences, we cannot exclude that there are additional unmeasured baseline differences that confound the effect, a fact that reduces internal validity of the study. The high dropout rate in the control compared to the intervention group represents a threat to the validity of the findings of this study and the most likely source of bias. Further, alcohol use was only assessed by self-report. The consensus in the research community that self-reported alcohol consumption was valid derives mainly from conclusions drawn from studies undertaken in treatment contexts [45]. It is not clear whether influences on the validity of self-report may be different in South Africa. Bias in alcohol consumption may have resulted from self-reported outcome measures. Future studies should consider assessing alcohol consumption by both self-report and objective measures, such as blood alcohol level. Further, the study only assessed short-term intervention effects (6 months) and longer term assessments (12 months) would be needed, especially because TB patients after having been cured may start drinking again.