A retrospective study of 'non-compliant' patients in controlled clinical trials of short course chemotherapy

In a total of 2,332 pulmonary short-course chemotherapy studies conducted during 1975-1985, there were 60 ‘noncompliant’ patients who had received less than 75% of the prescribed treatment. A retrospective study was undertaken to find out the reasons for default in these patients since the Tuberculosis Research Centre has very stringent criteria of selection of patients for their, studies, an adequate system. of motivation of the patients and well organised infrastructure for retrieval of the defaulters. Unwillingness for treatment was stated as the reason for default by 20 patients and adverse reactions to the drugs by 16 patients. Other major reasons given were pressure of work (14 patients), frequent outstation visits (13) and migration (12)

Feasibility of community DOT providers for tuberculosis treatment in HIV infected individuals - A pilot study

Background: This paper summarises our experiences about the role of community DOT providers in management of TB treatment in HIV infected persons in a mainly rural population of Tamilnadu. Objectives: To evaluate the feasibility of employing Community DOT providers for the treatment of tuberculosis in HIV infected persons, to study patients’ acceptance of Community DOT providers in the closely-knit village communities and to find out the attitude and awareness of DOT Providers on TB and DOT. Method: A total of 62 tuberculosis patients (58 males and 4 females) with HIV infection attending the Government Hospital for Thoracic Medicine, Tambaram and Chennai between July 1999 and July 2002 were selected for this study. Patients were given all the doses under supervision (clinic-based DOT) during the initial intensive phase and through Community DOT providers in the continuation phase. Data was collected both from the patients and their DOT providers about their views on DOT, advantages of DOTS, drug intake, treatment adherence, problems faced by the patients and their DOT Providers in addition to the level of awareness of Community DOT Providers on tuberculosis and DOTS. Results: Regarding treatment adherence, 95% of 62 patients had taken >75% of drugs and 39% had taken 100% drugs. DOT was appreciated both by the patients and their DOTS Providers since it is cost-effective and patient-friendly. Conclusions: Community contribution to TB care even among HIV infected population is feasible, affordable and costeffective. There is a need for greater health education and training on tuberculosis and DOTS for community DOT Providers

A pilot study on willingness to participate in future preventive HIV vaccine trials

Background & objectives: In India, phase-I human clinical trials for a preventive HIV vaccine are being conducted at Pune and Chennai Centres. In order to find out the willingness of populations at risk to participate in future preventive HIV vaccine trials (HIVVTs) and to assess the factors that enhance or deter them from participation, a study was conducted at Chennai and Madurai in Tamil Nadu. Methods: This cross-sectional study was conducted among transport workers, people attending sexually transmitted infection clinics, injection drug users, men having sex with men, women in sex industry and a representative sample of monogamous married women, by employing measurement scales. A structured questionnaire on knowledge and attitudes about the HIV vaccine was used to measure the participants’ knowledge and attitudes about HIV vaccine and HIVVTs. Results: Of the 112 participants, 67 (60%) were men. Mean age of the respondents was 32 yr; 68 per cent were high school educated. Majority of respondents were willing to participate in a future HIVVT and the reasons were altruism, protection from HIV, and support for the researchers. Major concerns were vaccine efficacy, side effects of the vaccine and the impact of a HIV vaccine on the participants’ lives. Majority (85%) agreed that sex without condom would not be safe despite the availability of an HIV vaccine. Interpretation & conclusion: It is likely that high-risk volunteers will be willing to enroll in HIVVTs. Barriers and concerns should be dealt with carefully by providing correct information. Also there is a need for more education to ensure participants’ understanding of key concepts of HIV vaccine trial

Feasibility of an Alcohol Intervention Programme for TB Patients with Alcohol Use Disorder (AUD) - A Qualitative Study from Chennai, South India

The negative influences of alcohol on TB management with regard to delays in seeking care as well as non compliance for treatment has been well documented. This study is part of a larger study on the prevalence of AUD (Alcohol Use Disorder) among TB patients which revealed that almost a quarter of TB patients who consumed alcohol could be classified as those who had AUD. However there is dearth of any effective alcohol intervention programme for TB patients with Alcohol Use Disorder (AUD).This qualitative study using the ecological system model was done to gain insights into the perceived effect of alcohol use on TB treatment and perceived necessity of an intervention programme for TB patients with AUD. We used purposive sampling to select 44 men from 73 TB patients with an AUDIT score >8. Focus group discussions (FGDs) and interviews were conducted with TB patients with AUD, their family members and health providers.TB patients with AUD report excessive alcohol intake as one of the reasons for their vulnerability for TB. Peer pressure has been reported by many as the main reason for alcohol consumption. The influences of alcohol use on TB treatment has been elaborated especially with regard to the fears around the adverse effects of alcohol on TB drugs and the fear of being reprimanded by health providers. The need for alcohol intervention programs was expressed by the TB patients, their families and health providers. Suggestions for the intervention programmes included individual and group sessions, involvement of family members, audiovisual aids and the importance of sensitization by health staff.The findings call for urgent need based interventions which need to be pilot tested with a randomized control trial to bring out a model intervention programme for TB patients with AUD

Balancing collective responsibility, individual opportunities and risks: a qualitative study on how police officers reason around volunteering in an HIV vaccine trial in Dar es Salaam, Tanzania

Results from HIV vaccine trials on potential volunteers will contribute to global efforts to develop an HIV vaccine. The purpose of this study among police officers in Dar es Salaam, Tanzania, was to explore the underlying reasons that induce people to enrol in an HIV vaccine trial.\ud We conducted discussions with eight focus groups, containing a total of 66 police officers. The information collected was analyzed using interpretive description. The results showed that participants were motivated to participate in the trial by altruism, and that the participants experienced some concerns about their participation. They stated that altruism in the fight against HIV infection was the main reason for enrolling in the trial. However, young participants were seriously concerned about a possible loss of close relationships if they enrolled in the HIV vaccine trial. Both men and women feared the effect of the trial on their reproductive biology, and they feared interference with pregnancy norms. They were unsure about risks such as the risks of acquiring HIV infection and of suffering physical harm, and they were unsure of the intentions of the researchers conducting the trial. Further, enrolling in the trial required medical examination, and this led some participants to fear that unknown diseases would be revealed. Other participants, however, saw an opportunity to obtain free health services.\ud We have shown that specific fears are important concerns when recruiting volunteers to an HIV vaccine trial. More knowledge is needed to determine participants' views and to ensure that they understand the conduct of the trial and the reasons it is being carried out

Willingness to volunteer in a Phase I/II HIV vaccine trial: a study among police officers in Dar es Salaam, Tanzania

Background: As HIV infection continues to be a public health problem, development of an effective preventive HIV vaccine is a priority. For the ultimate development of an AIDS vaccine, clinical trials are being conducted throughout the world. However, the process of developing the vaccine does not only depend on identification of suitable trial candidates, but also requires knowledge of incentives to participate in the community where the trial is being conducted. Therefore, the studies presented in this thesis are components of a HIV/AIDS and HIV vaccine trial project in Dar es Salaam, Tanzania to address motivations and deterrents of participating in an HIV vaccine trial. Aim: To examine the motivations and deterrents for participating in preventive HIV vaccine trials. Methods: Data were collected from participants and volunteers who were considered for participation or participated in a phase I/II HIV vaccine trial. Four studies with different designs were conducted. In Study I, a semi-structured interview administered questionnaire was used to assess willingness to volunteer for a phase I/II HIV vaccine trial. A convenience sample of 329 individuals from the police force cohort was recruited for the study in 2005-2006. In Study II, focus group discussions were conducted to explore factors that would influence participation in an HIV vaccine trial among members of the police force in 2006-2007. In Study III, face-to-face interviews were used to identify reasons for declining to enrol in an HIV vaccine trial among those who agreed to enrol at the start and were randomized for the trial in 2007-2009. In Study IV, we used focus group discussions to evaluate the experiences of those who participated in the phase I/II trial in 2009. Results: Willingness to volunteer for an HIV vaccine trial was associated with intention to tell others, positive outcome of the trial, personal decision and expectation of obtaining protection against HIV infection. Participation in an HIV vaccine trial would be negatively influenced by sexual partners, friends, family members, relatives or parents (significant others) and fear of vaccine side-effects. Personal fears and negative influences from significant others were the main reasons for declining to enrol in an HIV vaccine trial. Despite the negative comments from significant others, volunteers in the HIV vaccine trial managed to stay on until the end of the trial as a result of personal decision and trial-related interventions. Conclusion: Personal decision is both a motivation to participate in an HIV vaccine trial and a reason to stay on until the end of trial. On the contrary, significant others are the deterrents to participation in the HIV vaccine trial and the reason for declining to enrol in the HIV vaccine trial. Awareness of these issues before trial implementation may help to maximize resource use and enhance retention of those who volunteer in the HIV vaccine trials

Efficacy of a 6-month versus 9-month Intermittent Treatment Regimen in HIV-infected Patients with Tuberculosis: A Randomized Clinical Trial

Rationale: The outcome of fully intermittent thrice-weekly antituberculosis treatment of various durations in HIV-associated tuberculosis is unclear. Objectives: To compare the efficacy of an intermittent 6-month regimen (Reg6M: 2EHRZ(3)/4HR(3) [ethambutol, 1,200 mg; isoniazid, 600 mg; rifampicin, 450 or 600 mg depending on body weight or =60 kg; and pyrazinamide, 1,500 mg for 2 mo; followed by 4 mo of isoniazid and rifampicin at the same doses]) versus a 9-month regimen (Reg9M: 2EHRZ(3)/7HR(3)) in HIV/tuberculosis (TB). Methods: HIV-infected patients with newly diagnosed pulmonary or extrapulmonary TB were randomly assigned to Reg6M (n = 167) or Reg9M (n = 160) and monitored by determination of clinical, immunological, and bacteriological parameters for 36 months. Primary outcomes included favorable responses at the end of treatment and recurrences during follow-up, whereas the secondary outcome was death. Intent-to-treat and on-treatment analyses were performed. All patients were antiretroviral treatment-naive during treatment. Measurements and main results: Of the patients, 70% had culture-positive pulmonary TB; the median viral load was 155,000 copies/ml and the CD4(+) cell count was 160 cells/mm(3). Favorable response to antituberculosis treatment was similar by intent to treat (Reg6M, 83% and Reg9M, 76%; P = not significant). Bacteriological recurrences occurred significantly more often in Reg6M than in Reg9M (15 vs. 7%; P < 0.05) although overall recurrences were not significantly different (Reg6M, 19% vs. Reg9M, 13%). By 36 months, 36% of patients undergoing Reg6M and 35% undergoing Reg9M had died, with no significant difference between regimens. All 19 patients who failed treatment developed acquired rifamycin resistance (ARR), the main risk factor being baseline isoniazid resistance. Conclusions: Among antiretroviral treatment-naive HIV-infected patients with TB, a 9-month regimen resulted in a similar outcome at the end of treatment but a significantly lower bacteriological recurrence rate compared with a 6-month thrice-weekly regimen. ARR was high with these intermittent regimens and neither mortality nor ARR was altered by lengthening TB treatment. Clinical Trials Registry Information: ID# NCT00376012 registered at www.clinicaltrials.gov

Alcohol Use Disorders (AUD) among Tuberculosis Patients: A Study from Chennai, South India

BACKGROUND: Alcohol Use Disorders (AUDs) among tuberculosis (TB) patients are associated with nonadherence and poor treatment outcomes. Studies from Tuberculosis Research Centre (TRC), Chennai have reported that alcoholism has been one of the major reasons for default and mortality in under the DOTS programme in South India. Hence, it is planned to conduct a study to estimate prevalence of alcohol use and AUDs among TB patients attending the corporation health centres in Chennai, India. METHODOLOGY: This is a cross-sectional cohort study covering 10 corporation zones at Chennai and it included situational assessment followed by screening of TB patients by a WHO developed Alcohol Use Disorders Identification Test AUDIT scale. Four zones were randomly selected and all TB patients treated during July to September 2009 were screened with AUDIT scale for alcohol consumption. RESULTS: Out of 490 patients, 66% were males, 66% were 35 years and above, 57% were married, 58% were from the low monthly income group of <Rs 5000 per month. No females reported alcohol use. Overall, out of 490 TB pts, 29% (141) were found to consume alcohol. Among 141 current drinkers 52% (73) had an AUDIT score of >8. Age (>35 years), education (less educated), income (<Rs 5000 per month), marital status (separated/divorced) and treatment category (Category 2) were statistically significant for TB patients with alcohol use than those TB patients without alcohol use. CONCLUSIONS: AUD among TB patients needs to be addressed urgently and the findings suggest the importance of integrating alcohol treatment into TB care

Status of AIDS Orphans in Chennai, South India

As the AIDS epidemic progresses, there is a shift from focusing on the individual to the family. Often described as a family disease, the AIDS pandemic is leaving millions orphaned in its wake. AIDS Orphans are children who have lost one or both parents to AIDS. In the Indian context, little is known about what happens to these children. This study was planned to assess the status of AIDS orphans. The sample was from a population of HIV-positive patients enrolled in clinical trials at the division of HIV / AIDS of the Tuberculosis Research Center, Chennai, India. Some of the patients had succumbed to the illness and left behind children. Caregivers of these children were interviewed using a semi structured interview schedule. This paper discusses the status of 140 AIDS orphans belonging to 67 families who had lost one or both parent due to AIDS. Twenty six percent had lost both parents and 50% of the surviving parents were sero positive. Ten percent of the children were sero positive while the sero status of 41% was not known. Their mothers cared more than half of the orphans for, while maternal relatives cared for 24%