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

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

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

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

Perceptions of a Community Sample about Participation in Future HIV Vaccine Trials in South India

Focus group discussions were conducted to assess factors that might impact participation of subgroups in Chennai for future HIV vaccine trials. The participants were 112 men and women representing the following: (1) transport workers; (2) clients who attended a sexually transmitted disease clinic; (3) injection drug users; (4) men having sex with men; (5) women in sex work; and (6) monogamous married women. Participants expressed an intense interest in future HIV vaccine trials. Willingness to participate in future trials included altruism and the desire to have a protective vaccine for the future. Assurances regarding stigma and confidentiality, and compensation for families in the event of a poor outcome with a future HIV vaccine trial were reported. Concerns also centered on the impact of seroconverting, and a possible increase in risk behaviors. The need for education and counseling about the dangers of engaging in risky behavior during and after participating in a future HIV vaccine trial is discussed

Factors associated with willingness to participate in HIV vaccine trials among high-risk populations in South India.

Abstract Successful conduct of any HIV vaccine trial (HIVVT) requires a high level of preparedness in the community. A cross-sectional study was conducted in Tamilnadu, India among 501 participants from six different risk groups to investigate their willingness to participate (WTP) in future preventive HIVVTs and to explore their knowledge and attitude toward preventive HIV vaccines. In total, 82% were willing to participate and the desire to be protected from HIV was the main reason for WTP. Perception of not being at risk was the major reason for refusal among married women. The knowledge scale showed a significant increase in scores after vaccine education. In all, 76% revealed the hope that there would be an effective vaccine in a few years and 71% hoped that the HIV vaccine would protect them from HIV infection. The main concern was the unknown efficacy of the vaccine (50%) and the effects of an HIV vaccine on participants' lives (51%). Overall, 76% agreed that sex without a condom would not be safe whether or not there was an HIV vaccine. To conclude, it is likely that high-risk volunteers will be willing to enroll in preventive HIVVTs. Addressing barriers and concerns by providing information through appropriate agencies will spell out success for preventive HIVVTs in India