Development & validation of scales to assess stigma related to COVID-19 in India.

Background & objectives: COVID-19 pandemic has triggered social stigma towards individuals affected and their families. This study describes the process undertaken for the development and validation of scales to assess stigmatizing attitudes and experiences among COVID-19 and non-COVID-19 participants from the community. Methods: COVID-19 Stigma Scale and Community COVID-19 Stigma Scale constituting 13 and six items, respectively, were developed based on review of literature and news reports, expert committee evaluation and participants' interviews through telephone for a multicentric study in India. For content validity, 61 (30 COVID-19-recovered and 31 non-COVID-19 participants from the community) were recruited. Test-retest reliability of the scales was assessed among 99 participants (41 COVID-19 recovered and 58 non-COVID-19). Participants were administered the scale at two-time points after a gap of 7-12 days. Cronbach's alpha, overall percentage agreement and kappa statistics were used to assess internal consistency and test-retest reliability. Results: Items in the scales were relevant and comprehensible. Both the scales had Cronbach's α above 0.6 indicating moderate-to-good internal consistency. Test-retest reliability assessed using kappa statistics indicated that for the COVID-19 Stigma Scale, seven items had a moderate agreement (0.4-0.6). For the Community COVID-19 Stigma Scale, four items had a moderate agreement. Interpretation & conclusions: Validity and reliability of the two stigma scales indicated that the scales were comprehensible and had moderate internal consistency. These scales could be used to assess COVID-19 stigma and help in the development of appropriate stigma reduction interventions for COVID-19 infected, and mitigation of stigmatizing attitudes in the community.

Addressing knowledge gaps and prevention for tuberculosis-infected Indian adults: a vital part of elimination.

BACKGROUND: India plans to eliminate tuberculosis (TB) by 2025, and has identified screening and prevention as key activities. Household contacts (HHCs) of index TB cases are a high-risk population that would benefit from rapid implementation of these strategies. However, best practices for TB prevention and knowledge gaps among HHCs have not been studied. We evaluated TB knowledge and understanding of prevention among tuberculin skin-test (TST) positive HHCs. While extensive information is available in other high-burden settings regarding TB knowledge gaps, identifying how Indian adult contacts view their transmission risk and prevention options may inform novel screening algorithms and education efforts that will be part of the new elimination plan. METHODS: We approached adult HHC to administer a questionnaire on TB knowledge and understanding of infection. Over 1 year, 100 HHC were enrolled at a tertiary hospital in Pune, India. RESULTS: The study population was 61% (n = 61) female, with a mean age of 36.6 years (range 18-67, SD = 12). Education levels were high, with 78 (78%) having at least a high school education, and 23 (24%) had at least some college education. Four (4%) of our participants were HIV-infected. General TB knowledge among HHC was low, with a majority of participants believing that you can get TB from sharing dishes (70%) or touching something that has been coughed on (52%). Understanding of infection was also low, with 42% believing that being skin-test positive means you have disease. To assess readiness for preventive therapy, we asked participants whether they are at a higher risk of progressing to active disease because of their LTBI status. Fifty-four (55%) felt that they are at higher risk. Only 8% had heard of preventive therapy. CONCLUSION: Our TB knowledge survey among HHCs with evidence of recent exposure found that knowledge is poor and families are confused about transmission in the household. It is imperative that the Indian program develop tools and incentives that can be used to educate TB cases and their families on what infected HHCs can do to prevent disease, including preventive therapy.

How reliable and valid are the self-reports of sexual behavior among HIV discordant couples in Pune, INDIA.

Reliability of self-reported sexual and safe sex behavior among heterosexual HIV discordant couples was assessed by matching individual responses of couples to a common set of questions and validated by matching with pregnancy and seroconversion during study period. Demographic, clinical and sexual behavior information was collected individually from 457 consenting married discordant couples using structured questionnaires at screening, enrollment and at four quarterly visits. Reliability of self-reports tested using Kappa statistics. At screening, level of agreement about spouse being regular partner (Kappa = 0.96) and having had sexual intercourse with spouse in the last quarter (Kappa = 0.84) was noted. Moderate agreement observed about frequency of condom use (Kappa = 0.639) and condom tear (Kappa = 0.428). Agreement on reporting sexual contacts with spouse and consistent condom use increased (P < 0.001) over follow-ups. Four of 6 couples that seroconverted reported using condoms consistently, and 2 of these seroconverted. Couple histories of all 11 sero-discordant couples reporting pregnancy matched, of these 8 couples reported use of condoms and only 3 couples reported non-use of condoms during the preceding period. Sensitive sexual information can be collected using self-reports but it should be used with caution. Involving couples and using biological parameters concurrently may enhance validity of self-reports.

Exploring access to HIV-related services and programmatic gaps for Men having Sex with Men (MSM) in rural India- a qualitative study.

BACKGROUND: Despite the Link Worker Scheme to address the HIV risk and vulnerabilities in rural areas, reaching out to unreached men having sex with men (MSM) remains a challenge in rural India. This study explored issues around health care access and programmatic gaps among MSM in rural settings of India. METHODS: We conducted eight Focused Group Discussions (FGDs), 20 Key Informant Interviews (KIIs), and 20 In-Depth Interviews (IDIs) in four rural sites in Maharashtra, Odisha, Madhya Pradesh, and Uttar Pradesh between November 2018 and September 2019. The data in the local language were audio-recorded, transcribed, and translated. Data were analyzed in NVivo version 11.0 software using the grounded theory approach. RESULTS: Primary barriers to health care access were lack of knowledge, myths and misconceptions, not having faith in the quality of services, program invisibility in a rural setting, and anticipated stigma at government health facilities. Government-targeted intervention services did not seem to be optimally advertised in rural areas as MSM showed a lack of information about it. Those who knew reported not accessing the available government facilities due to lack of ambient services, fear of the stigma transforming into fear of breach of confidentiality. One MSM from Odisha expressed, "…they get fear to go to the hospital because they know that hospital will not maintain confidentiality because they are local people. If society will know about them, then family life will be disturbed" [OR-R-KI-04]. Participants expressed the desire for services similar to those provided by the Accredited Social Health Activists (ASHA), frontline health workers for MSM. CONCLUSION: Programme invisibility emerges as the most critical issue for rural and young MSM. Adolescent and panthis emerged as Hidden MSM and they need focused attention from the programme. The need for village-level workers such as ASHA specifically for the MSM population emerged. MSM-friendly health clinics would help to improve healthcare access in rural MSMs under Sexual and Reproductive Health Care.

Predicting product adherence in a topical microbicide safety trial in Pune, India.

The inconclusive results of past trials and recent findings of partial protection of Tenofovir 1% gel underscore the need to better understand product adherence in microbicide trials. This study aimed to identify factors predicting couples' ability to sustain topical gel and condom use during clinical trial participation. We enrolled 100 Indian participants of a randomized, controlled safety trial of Tenofovir 1% gel (CT cohort) and 100 similar women who were ineligible or declined trial participation (NCT cohort). Compared to the NCT cohort, CT women reported higher baseline condom use, more positive attitudes towards condoms and higher levels of protection efficacy. While NCT condom use remained low, CT condom use increased dramatically during the study. Reported gel consistency was higher than condom consistency. Individual and couple-related factors predicted condom consistency and interest in future gel use, but not gel consistency. Findings could inform trial recruitment strategies and product introduction.

Indian married men's interest in microbicide use.

Research suggests that the HIV/AIDS epidemic has spread to monogamous women in India. Gender inequalities prevent women from asserting control over the circumstances that increase their vulnerability to infection. Men control most of the sexual decision-making. The present study explores views on use of microbicides by men and circumstances in which they might find microbicide use with their wives acceptable. Progressive in-depth interviews were conducted among 15 consenting men from Pune, India. Men felt that women with identifiable HIV risk, such as being a sex worker, having an HIV infected husbands or being educated; were more likely to use microbicides. Most high-risk men would permit or force their wives to use microbicides and had a higher intention to use microbicides compared with low-risk men probably due to perceived susceptibility. The majority of men with previous experience of microbicide use mentioned that privacy was important for gel use. Most low-risk men believed that they would be angry with covert gel use by their wives. They felt that covert use was impossible since their wives were under their control and they would notice the gel due to a change in their sexual experience. Low-risk men also opined that husband's permission was not required if he was HIV-infected or having extra-marital sex. Some men stressed the need for exercising sexual control while women inserted gel before sex. Men's risk-perception, knowledge about their safety concerns, as well as their behavior may affect acceptability of gel use, hence men's involvement and cooperation is imperative for microbicide gel use by women in India.

Social Factors Associated With Adherence to Preventive Behaviors Related to COVID-19 Among Rural and Semi-urban Communities in Western Maharashtra, India.

Background: To control the transmission of the coronavirus disease 2019 (COVID-19) infection, the Government of India (GoI) had taken stringent precautionary measures during the lockdown period. This study aimed to explore determinants affecting adherence to protective measures against COVID-19 infection among rural and semi-urban settings of Maharashtra, India. Methods: A cross-sectional telephonic survey among 1,016 adults from randomly selected households was conducted between June 5 and July 16, 2020. The data were explored for knowledge, awareness, practices related to protective measures, and self-risk perception. Socio-demographic and attitudinal correlates of failure to use protective measures against COVID-19 were measured. Results: In the survey, 72% of the participants were men. The mean age was 46 years (SD: 13.8). The main source of information was television (91%); however, information from healthcare providers (65%) and mass media announcements (49%) was trustworthy. Washing hands immediately with soap after returning from outdoors was reported by 95% of the respondents, always using a mask while outdoors by 94%, never attended social gatherings by 91%, always using hand sanitizer while outside by 77%, and 68% of the respondents followed all protective measures. The knowledge score [mean score 20.3 (SD: 2.4) out of 24] was independently associated with the risk of not using protective measures, with each unit increase in knowledge score, the risk of not using protective measures reduced by 16%. No source of income was independently associated with not using protective measures [AOR 1.5 95% CI (1.01-2.3)]. Conclusions: The COVID-19 public health interventions and behavior change communication strategies should be specifically directed towards the low socio-economic populations through trusted sources. The association between knowledge and practices demonstrates the importance of accurate public health communication to optimally follow preventive measures, such as structural interventions to address poverty and employment policies to address the unemployment crisis are required. Surveillance activity is needed to understand the actual behavior change among the population.

Sexual communication among married couples in the context of a microbicide clinical trial and acceptability study in Pune, India.

Previous research in India indicates that there is little communication within marriage about sex. Lack of communication about safe sexual behaviours may increase couples' vulnerability to HIV. This study explores couple level sexual communication and socio-cultural norms that influence couples' communication about sex and its implications for HIV prevention. Data derive from in-depth interviews at two points in time with 10 couples. Secondary qualitative analyses of the interviews were conducted using inductive and deductive coding techniques. Half of the couples described improved communication about sex and HIV and AIDS after participation in the clinical trial and/or acceptability study, as well as increased sexual activity, improved relationships by alleviating doubts about their partner's fidelity and forgiving their partners. The findings show that creating safe spaces for couples where they can ask frank questions about HIV and AIDS, sex and sexuality potentially can improve couples' communication about sex and reduce their risk for HIV infection.

Tuberculosis preventive treatment should be considered for all household contacts of pulmonary tuberculosis patients in India.

The World Health Organization (WHO) recently changed its guidance for tuberculosis (TB) preventive treatment (TPT) recommending TPT for all pulmonary TB (PTB) exposed household contacts (HHC) to prevent incident TB disease (iTBD), regardless of TB infection (TBI) status. However, this recommendation was conditional as the strength of evidence was not strong. We assessed risk factors for iTBD in recently-exposed adult and pediatric Indian HHC, to determine which HHC subgroups might benefit most from TPT. We prospectively enrolled consenting HHC of adult PTB patients in Pune and Chennai, India. They underwent clinical, microbiologic and radiologic screening for TB disease (TBD) and TBI, at enrollment, 4-6, 12 and 24 months. TBI testing was performed by tuberculin skin test (TST) and Quantiferon®- Gold-in-Tube (QGIT) assay. HHC without baseline TBD were followed for development of iTBI and iTBD. Using mixed-effect Poisson regression, we assessed baseline characteristics including TBI status, and incident TBI (iTBI) using several TST and/or QGIT cut-offs, as potential risk factors for iTBD. Of 1051 HHC enrolled, 42 (4%) with baseline TBD and 12 (1%) with no baseline TBI test available, were excluded. Of the remaining 997 HHC, 707 (71%) had baseline TBI (TST #x2265; 5 mm or QGIT #x2265; 0.35 IU/ml). Overall, 20 HHC (2%) developed iTBD (12 cases/1000 person-years, 95%CI: 8-19). HIV infection (aIRR = 29.08, 95% CI: 2.38-355.77, p = 0.01) and undernutrition (aIRR = 6.16, 95% CI: 1.89-20.03, p = 0.003) were independently associated with iTBD. iTBD was not associated with age, diabetes mellitus, smoking, alcohol, and baseline TBI, or iTBI, regardless of TST (#x2265; 5 mm, #x2265; 10 mm, #x2265; 6 mm increase) or QGIT (#x2265; 0.35 IU/ml, #x2265; 0.7 IU/ml) cut-offs. Given the high overall risk of iTBD among recently exposed HHCs, and the lack of association between TBI status and iTBD, our findings support the new WHO recommendation to offer TPT to all HHC of PTB patients residing in a high TB burden country such as India, and do not suggest any benefit of TBI testing at baseline or during follow-up to risk stratify recently-exposed HHC for TPT.

Correction: Smoking, alcohol use disorder and tuberculosis treatment outcomes: A dual co-morbidity burden that cannot be ignored.

[This corrects the article DOI: 10.1371/journal.pone.0220507.].

Smoking, alcohol use disorder and tuberculosis treatment outcomes: A dual co-morbidity burden that cannot be ignored.

BACKGROUND: More than 20% of tuberculosis (TB) disease worldwide may be attributable to smoking and alcohol abuse. India is the second largest consumer of tobacco products, a major consumer of alcohol particularly among males, and has the highest burden of TB globally. The impact of increasing tobacco dose, relevance of alcohol misuse and past versus current or never smoking status on TB treatment outcomes remain inadequately defined. METHODS: We conducted a multi-centric prospective cohort study of newly diagnosed adult pulmonary TB patients initiated on TB treatment and followed for a minimum of 6 months to assess the impact of smoking status with or without alcohol abuse on treatment outcomes. Smokers were defined as never smokers, past smokers or current smokers. Alcohol Use Disorder Identification Test (AUDIT) scores were used to assess alcohol misuse. The association between smoking status and treatment outcomes was assessed in univariate and multivariate random effects poisson regression models. RESULTS: Of 455 enrolled, 129 (28%) had a history of smoking with 94 (20%) current smokers and 35 (8%) past smokers. Unfavourable treatment outcomes were significantly higher among past and current smokers as compared to never smokers. Specifically, the risk of treatment failure was significantly higher among past smokers (aIRR = 2.66, 95% CI: 1.41-4.90, p = 0.002), recurrent TB among current smokers (aIRR = 2.94, 95% CI: 1.30-6.67, p = 0.010) and death among both past (2.63, 95% CI: 1.11-6.24, p = 0.028) and current (aIRR = 2.59, 95% CI: 1.29-5.18, p = 0.007) smokers. Furthermore, the combined effect of alcohol misuse and smoking on unfavorable treatment outcomes was significantly higher among past smokers (aIRR: 4.67, 95% CI: 2.17-10.02, p<0.001) and current smokers (aIRR: 3.58, 95% CI: 1.89-6.76, p<0.001). CONCLUSION: Past and current smoking along with alcohol misuse have combined effects on increasing the risk of unfavourable TB treatment outcomes. Innovative interventions that can readily address both co-morbidities are urgently needed.

Correction: Assessment of lung function in successfully treated tuberculosis reveals high burden of ventilatory defects and COPD.

[This corrects the article DOI: 10.1371/journal.pone.0217289.].

Infection free "resisters" among household contacts of adult pulmonary tuberculosis.

Despite substantial exposure to infectious pulmonary tuberculosis (TB) cases, some household contacts (HHC) never acquire latent TB infection (LTBI). Characterizing these "resisters" can inform who to study immunologically for the development of TB vaccines. We enrolled HHCs of culture-confirmed adult pulmonary TB in India who underwent LTBI testing using tuberculin skin test (TST) and QuantiFERON TB Gold Test-in-tube (QFT-GIT) at baseline and, if negative by both (<5mm TST and <0.35IU/mL QFT-GIT), underwent follow-up testing at 4-6 and/or 12 months. We defined persons with persistently negative LTBI tests at both baseline and followup as pLTBI- and resisters as those who had a high exposure to TB using a published score and remained pLTBI-. We calculated the proportion of resisters overall and resisters with complete absence of response to LTBI tests (0mm TST and/or QFT-GIT <0.01 IU/ml). Using random effects Poisson regression, we assessed factors associated with pLTBI-. Of 799 HHCs in 355 households, 67 (8%) were pLTBI- at 12 months; 52 (6.5%) pLTBI- in 39 households were resisters. Complete absence of response to LTBI tests was found in 27 (53%) resisters. No epidemiological characteristics were associated with the pLTBI- phenotype. LTBI free resisters among HHC exist but are uncommon and are without distinguishing epidemiologic characteristics. Assessing the genetic and immunologic features of such resister individuals is likely to elucidate mechanisms of protective immunity to TB.

Assessment of lung function in successfully treated tuberculosis reveals high burden of ventilatory defects and COPD.

BACKGROUND: Burden, phenotype and risk-factors of lung function defects in successfully treated tuberculosis cases are unclear. METHODS: We performed spirometry with bronchodilators in new drug-sensitive adult (≥18 years) pulmonary tuberculosis cases during the 12 months following successful treatment in India. Airflow obstruction was defined as pre-bronchodilator FEV1/FVC<5th percentile of Global Lung Initiative mixed-ethnicity reference (lower limit of normal [LLN]). Chronic obstructive pulmonary disease (COPD) was defined as post-bronchodilator FEV1/FVC

Tuberculin skin test and QuantiFERON-Gold In Tube assay for diagnosis of latent TB infection among household contacts of pulmonary TB patients in high TB burden setting.

BACKGROUND: World Health Organization (WHO) recommends systematic screening of high-risk populations, including household contacts (HHCs) of adult pulmonary tuberculosis (TB) patients, as a key strategy for elimination of TB. QuantiFERON-TB Gold In-Tube (QFT-GIT) assay and tuberculin skin test (TST) are two commonly used tools for the detection of latent tuberculosis infection (LTBI) but may yield differential results, affecting eligibility for TB preventive therapy. MATERIALS AND METHODS: A prospective cohort study of adult pulmonary TB patients and their HHCs were recruited in 2 cities of India, Pune and Chennai. HHCs underwent QFT-GIT (QIAGEN) and TST (PPD SPAN 2TU/5TU). A positive QFT-GIT was defined as value ≥0.35 IU/ml and a positive TST as an induration of ≥5 mm. A secondary outcome of TST induration ≥10mm was explored. Proportion positive by either or both assays, discordant positives and negatives were calculated; test concordance was assessed using percentage agreement and kappa statistics; and risk factors for concordance and discordance including age categories were assessed using logistic regression. Sensitivity and specificity was estimated by latent class model. RESULTS: Of 1048 HHCs enrolled, 869 [median (IQR) age: 27 years (15-40)] had both TST and QFT-GIT results available and prevalence of LTBI by QFT-GIT was 54% [95% CI (51, 57)], by TST was 55% [95% CI (52, 58)], by either test was 74% [95% CI (71, 77) and by both tests was 35% [95% CI (31, 38)]. Discordance of TST+/QFT-GIT- was 21% while TST-/QFT-GIT+ was 26%. Poor to fair agreement occurred with TST 5mm or 10mm cutoff (60 and 61% agreement with kappa value of 0.20 and 0.25 respectively). Test agreement varied by age, TST strength and induration cut-off. In multivariate analysis, span PPD was a risk factor for QFT-GIT+ and TST- while absence of BCG scar was for TST+ and QFT-GIT-. Being employed and exposure to TB case outside the household case were associated with positivity by both the tests. Sensitivity of TST and QFT-GIT to diagnose LTBI was 77% and 69%. Probability of having LTBI was >90% when both tests were positive irrespective of exposure gradient. CONCLUSION: Prevalence of LTBI among HHCs of adult pulmonary TB patients in India is very high and varies by test type, age, and exposure gradient. In our high TB burden setting, a strategy to treat all HHCs or a targeted strategy whereby an exposure index is used should be assessed in future preventive therapy and vaccine studies as HHCs have several factors that place them at high risk for progression to TB disease.

Cohort for Tuberculosis Research by the Indo-US Medical Partnership (CTRIUMPH): protocol for a multicentric prospective observational study.

INTRODUCTION: Tuberculosis disease (TB) remains an important global health threat. An evidence-based response, tailored to local disease epidemiology in high-burden countries, is key to controlling the global TB epidemic. Reliable surrogate biomarkers that predict key active disease and latent TB infection outcomes are vital to advancing clinical research necessary to 'End TB'. Well executed longitudinal studies strengthening local research capacity for addressing TB research priorities and advancing biomarker discovery are urgently needed. METHODS AND ANALYSIS: The Cohort for Tuberculosis Research by the Indo-US Medical Partnership (CTRIUMPH) study conducted in Byramjee Jeejeebhoy Government Medical College (BJGMC), Pune and National Institute for Research in Tuberculosis (NIRT), Chennai, India, will establish and maintain three prospective cohorts: (1) an Active TB Cohort comprising 800 adults with pulmonary TB, 200 adults with extrapulmonary TB and 200 children with TB; (2) a Household Contact Cohort of 3200 adults and children at risk of developing active disease; and (3) a Control Cohort consisting of 300 adults and 200 children with no known exposure to TB. Relevant clinical, sociodemographic and psychosocial data will be collected and a strategic specimen repository established at multiple time points over 24 months of follow-up to measure host and microbial factors associated with (1) TB treatment outcomes; (2) progression from infection to active TB disease; and (3) Mycobacterium tuberculosis transmission among Indian adults and children. We anticipate CTRIUMPH to serve as a research platform necessary to characterise some relevant aspects of the TB epidemic in India, generate evidence to inform local and global TB control strategies and support novel TB biomarker discovery. ETHICS AND DISSEMINATION: This study is approved by the Institutional Review Boards of NIRT, BJGMC and Johns Hopkins University, USA. Study results will be disseminated through peer-reviewed journals and research conferences. FUNDING: NIH/DBT Indo-US Vaccine Action Programme and the Indian Council of Medical Research.

Attitudes of married men to the use of vaginal microbicides by their female partners in Pune, India.

The availability of female-initiated HIV prevention options does not necessarily lead to their uptake. We investigated if married men were willing to support open or covert use of microbicides by their spouses in Pune, India. Data was collected using an interview-administered questionnaire from 151 consenting married men with a mean age of 34 years. Logistic regression analysis was used to examine the relationships between sociodemographic and behavioural factors. One hundred and thirty-seven men (71.5%) were educated and 146 men (96.7%) were employed. Men aged <34 years were eight times (p=0.024) and those in a harmonious relationship were seven times (p=0.008) more willing to use microbicides compared with men aged ≥34 years and men in less harmonious relationships, respectively. Men practicing high-risk sexual behaviour were twice (p=0.049) and men with a history of using contraceptives were three times (p=0.05) more likely to support the covert use of microbicides compared with those reporting no or low-risk sexual behaviour and those who had never used contraceptives, respectively. This suggests that sociodemographic and behavioural factors relating to men as well as women should be considered when developing and marketing microbicides.

Acceptability of coitally-associated versus daily use of 1% tenofovir vaginal gel among women in Pune, India.

This study reports on the acceptability of 1% tenofovir microbicide gel among participants randomised to the coitally-associated use (n = 50) or daily use (n = 50) arms of a Phase II clinical trial in Pune, India. In a 6-month follow-up study, information on behavioural domains was collected on a 6-point Likert scale and gel acceptability was measured on a 5-point Likert scale. Random intercept logistic modelling was performed to examine the simultaneous effects of study arm, follow-up time, sociodemographic factors and behavioural domains on gel acceptability. The mean age of female participants was 32.7 years. Women in both study arms had similar sociodemographic profiles. Women liked features such as easy use of the gel and its protective effect against HIV. Messiness was the most disliked feature. Gel acceptability increased during subsequent follow-up visits in both arms, especially in the coitally-associated use arm. Non-acceptability of the gel was almost two and a half times higher in daily users (adjusted odds ratio 2.55, 95% CI 1.18-5.51; p = 0.017). Acceptability differed significantly between the two study arms at 2 months (68% vs 40%; p = 0.006) and 6 months (64% vs 46%; p = 0.07). Acceptability was significantly lower in those participants who reported 'messiness' as the most disliked feature (odds ratio 2.42, 95% CI 1.02-5.72; p = 0.045). In conclusion, microbicides were more acceptable in coitally-associated users than in daily users. Leakage was a problem that requires attention. Positioning of the product in a setting such as India where the majority of decision-making is done by men would need extensive and systematic education of men.

Caring for caregivers of people living with HIV in the family: a response to the HIV pandemic from two urban slum communities in Pune, India.

INTRODUCTION: In low resource settings, the vast majority of 'Person/people Living with HIV' (PLHIV/s) and inadequate healthcare delivery systems to meet their treatment and care needs, caregivers play a vital role. Home based caregivers are often unrecognized with limited AIDS policies and programs focusing on them. We explored the perceptions and norms regarding care being provided by family caregivers of PLHIVs in India. METHODOLOGY: A community based qualitative study to understand the issues pertaining to home based care for PLHIV was conducted in urban settings of Pune city, in Maharashtra, India. Eight Focus Group Discussions (FGDs) among men, women and peer educators were carried out. A total of 44 in-depth Interviews (IDIs) with PLHIVs (20) and their caregivers (24), were conducted using separate guides respectively. Data was analyzed thematically. RESULTS: Home based care was perceived as economically viable option available for PLHIVs. 'Care' comprised of emotional, adherence, nursing and financial support to PLHIV. Home based care was preferred over hospital based care as it ensured confidentiality and patient care without hampering routine work at home. Women emerged as more vital primary caregivers compared to men. Home based care for men was almost unconditional while women had no such support. The natal family of women also abandoned. Their marital families seemed to provide support. Caregivers voiced the need for respite care and training. DISCUSSION: Gender related stigma and discrimination existed irrespective of women being the primary family caregivers. The support from marital families indicates a need to explore care and support issues at natal and marital homes of the women living with HIV respectively. Home based care training and respite care for the caregivers is recommended. Gender sensitive interventions addressing gender inequity and HIV related stigma should be modeled while designing interventions for PLHIVs and their family caregivers.

The development of PROQOL-HIV: an international instrument to assess the health-related quality of life of persons living with HIV/AIDS.

OBJECTIVES: Health-related quality of life (HRQL) is an important outcome in HIV/AIDS infection and treatment. However, most existing HIV-HRQL instruments miss important issues (eg, sleeping problems, lipodystrophy). They were developed before highly active antiretroviral therapy (pre-HAART), and in a single language. We sought to develop a contemporary HIV-HRQL instrument (PROQOL-HIV) in multiple languages that accounts for HAART treatment and side effects. This article details the 3-stage content validation phase of PROQOL-HIV. METHODS: In stage 1, we developed a conceptual model of HIV-HRQL and questionnaire item bank from thematic analysis of 152 patient interviews conducted simultaneously across 9 countries. In stage 2, pilot items were selected by an expert panel to form the pilot instrument. Stage 3 involved linguistic validation and harmonization of selected items to form an equivalent instrument in 9 target languages. RESULTS: Analysis of 3375 pages of interview text revealed 11 underlying themes: general health perception, social relationships, emotions, energy/fatigue, sleep, cognitive functioning, physical and daily activity, coping, future, symptoms, and treatment. Seven issues new to HIV-HRQL measurement were subsumed by these themes: infection fears, future concerns, satisfaction with care, self-esteem problems, sleep problems, work disruption, and treatment issues. Of the 442 theme-related items banked, 70 items met the retention criteria and formed the pilot PROQOL-HIV instrument. CONCLUSIONS: HIV patients across 11 countries attributed a wide range of physical, mental, and social issues to their condition, many of which were not measured by existing HIV-HRQL instruments. The pilot PROQOL-HIV instrument captures these issues, is sensitive to sociocultural context, disease stage, and HAART.