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

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%

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

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

Percentages, Process, and Patterns of HIV Disclosure Among the Spouses of HIV-Infected Men in South India

Most studies have described the outcome of HIV status disclosure rather than the process of disclosure. Hence, a study was conducted among 201 women who accompanied their spouses and children to 3 hospitals at Chennai and Vellore, Tamil Nadu, India, during January to June 2007. Majority of the respondents were sero-positive (69%) and marriage was the only risk factor for them. Of 201 women, 49% did not know the reason for their husbands’ HIV infection. Confidentiality of the patient was often breached during disclosure as family members were drawn into the process without consulting the patient. Only for 117 (50%) respondents, HIV diagnosis was disclosed directly by the health providers. There was a considerable delay for men in disclosing their HIV status to their spouses. Apart from the spouses, 122 (61%) shared their diagnosis with other family members. Disgrace to self and family (54%), fear of discrimination (27%), and fear of rejection (9%) were reported for nondisclosure