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1.  Correlates of lower comprehension of informed consent among participants enrolled in a cohort study in Pune, India 
International Health  2012;5(1):64-71.
Background
Optimum comprehension of informed consent by research participants is essential yet challenging. This study explored correlates of lower comprehension of informed consent among 1334 participants of a cohort study aimed at estimating HIV incidence in Pune, India.
Methods
As part of the informed consent process, a structured comprehension tool was administered to study participants. Participants scoring ≥90% were categorised into the ‘optimal comprehension group’, whilst those scoring 80–89% were categorised into the ‘lower comprehension group’. Data were analysed to identify sociodemographic and behavioural correlates of lower consent comprehension.
Results
The mean ± SD comprehension score was 94.4 ± 5.00%. Information pertaining to study-related risks was not comprehended by 61.7% of participants. HIV-negative men (adjusted OR [AOR] = 4.36, 95% CI 1.71–11.05) or HIV-negative women (AOR = 13.54, 95% CI 6.42–28.55), illiteracy (AOR= 1.65, 95% CI 1.19–2.30), those with a history of multiple partners (AOR = 1.73, 95% CI 1.12–2.66) and those never using condoms (AOR = 1.35, 95% CI 1.01–1.82) were more likely to have lower consent comprehension.
Conclusions
We recommend exploration of domains of lower consent comprehension using a validated consent comprehension tool. Improved education in these specific domains would optimise consent comprehension among research participants.
doi:10.1093/inthealth/ihs009
PMCID: PMC3889625  PMID: 24029848
Informed consent process; Comprehension; Consent comprehension tool; Illiteracy; Study related risks; India
2.  Evaluation of a Multimodal, Distance Learning HIV Management Course for Clinical Care Providers in India 
Distance learning is an important tool for training HIV health workers. However, there is limited evidence on design and evaluation of distance learning HIV curricula and tools. We therefore designed, implemented, and evaluated a distance learning course on HIV management for clinical care providers in India. After course completion, participant scores rose significantly from a pretest (78.4% mean correct) compared with the posttest (87.5%, P < .001). After course completion, participants were more likely to be confident in starting an initial antiretroviral (ARV) regimen, understanding ARV toxicities, encouraging patient adherence, diagnosing immune reconstitution syndrome, and monitoring patients on ARV medications (P ≤ .05). All participants (100%) strongly agreed/agreed that they would recommend this course to others, and most of them (96%) strongly agreed/agreed that they would take a course in this format again. A pragmatic approach to HIV curriculum development and evaluation resulted in reliable learning outcomes, as well as learner satisfaction and improvement in knowledge.
doi:10.1177/1545109712451330
PMCID: PMC3856228  PMID: 22802357
HIV; distance learning; India; evaluation; Internet
3.  The Exposure Assessment in Current Time Study: Implementation, Feasibility, and Acceptability of Real-Time Data Collection in a Community Cohort of Illicit Drug Users 
AIDS Research and Treatment  2013;2013:594671.
Objective. We describe the study design and evaluate the implementation, feasibility, and acceptability of an ecological momentary assessment (EMA) study of illicit drug users. Design. Four sequential field trials targeting observation of 30 individuals followed for a four week period. Participants. Participants were recruited from an ongoing community-cohort of current or former injection drug users. Of 113 individuals enrolled, 109 completed study procedures during four trials conducted from November 2008 to May 2013. Methods. Hand-held electronic diaries used in the initial trials were transitioned to a smartphone platform for the final trial with identical data collection. Random-prompts delivered five times daily assessed participant location, activity, mood, and social context. Event-contingent data collection involved participant self-reports of illicit drug use and craving. Main Outcome Measures. Feasibility measures included participant retention, days of followup, random-prompt response rates, and device loss rate. Acceptability was evaluated from an end-of-trial questionnaire. Sociodemographic, behavioral, clinical, and trial characteristics were evaluated as correlates of weekly random-prompt response rates ≥80% using logistic regression with generalized estimating equations. Results. Study participants were a median of 48.5 years old, 90% African American, 52% male, and 59% HIV-infected with limited income and educational attainment. During a median followup of 28 days, 78% of 11,181 random-prompts delivered were answered (mean of 2.8 responses daily), while 2,798 participant-initiated events were reported (30% drug use events; 70% craving events). Self-reported acceptability to study procedures was uniformly favorable. Device loss was rare (only 1 lost device every 190 person-days of observation). Higher educational attainment was consistently associated with a higher response rate to random-prompts, while an association of HIV infection with lower response rates was not observed after accounting for differences in trial recruitment procedures. Conclusion. Near real-time EMA data collection in the field is feasible and acceptable among community-dwelling illicit drug users. These data provide the basis for future studies of EMA-informed interventions to prevent drug relapse and improve HIV treatment outcomes in this population.
doi:10.1155/2013/594671
PMCID: PMC3836292  PMID: 24307943
4.  Incident HIV Infection among Men Attending STD Clinics in Pune, India: Pathways to Disparity and Interventions to Enhance Equity 
Systematic disparities in rates of HIV incidence by socioeconomic status were assessed among men attending three sexually transmitted disease (STD) clinics in Pune, India, to identify key policy-intervention points to increase health equity. Measures of socioeconomic status included level of education, family income, and occupation. From 1993 to 2000, 2,260 HIV-uninfected men who consented to participate in the study were followed on a quarterly basis. Proportional hazards regression analysis of incident HIV infection identified a statistically significant interaction between level of education and genital ulcer disease. Compared to the lowest-risk men without genital ulcer disease who completed high school, the relative risk (RR) for acquisition of HIV was 7.02 (p<0.001) for illiterate men with genital ulcer disease, 3.62 (p<0.001) for men with some education and genital ulcer disease, and 3.02 (p<0.001) for men who completed high school and had genital ulcer disease. For men with no genital ulcer disease and those with no education RR was 1.09 (p=0.84), and for men with primary/middle school it was 1.70 (p=0.03). The study provides evidence that by enhancing access to treatment and interventions that include counselling, education, and provision of condoms for prevention of STDs, especially genital ulcer disease, among disadvantaged men, the disparity in rates of HIV incidence could be lessened considerably. Nevertheless, given the same level of knowledge on AIDS, the same level of risk behaviour, and the same level of biological co-factors, the most disadvantaged men still have higher rates of HIV incidence.
PMCID: PMC3516674  PMID: 14717571
Health equity; HIV; Acquired immunodeficiency syndrome; Sexually transmitted infections; Sexually transmitted diseases; Socioeconomic status; Prospective studies; India
5.  Symptom Screening Among HIV-Infected Pregnant Women Is Acceptable and Has High Negative Predictive Value for Active Tuberculosis 
We evaluated tuberculosis (TB) screening among 799 human immunodeficiency virus (HIV)–infected pregnant women in India. Eleven (1.4%) had active TB. The negative predictive value of screening using cough, fever, night sweats, or weight loss was 99.3%. Tuberculin skin test and targeted chest radiography provided no substantial benefit. TB symptom screening, as recommended by the World Health Organization, is effective for ruling out TB in HIV-infected pregnant women.
doi:10.1093/cid/cir605
PMCID: PMC3193828  PMID: 21940417
6.  Building a Global Health Education Network for Clinical Care and Research: The Benefits and Challenges of Distance Learning Tools 
doi:10.1016/j.idc.2011.02.006
PMCID: PMC3107515  PMID: 21628053
Distance learning; mHealth; research; clinical; education; global health
7.  Pooled Individual Data Analysis of 5 Randomized Trials of Infant Nevirapine Prophylaxis to Prevent Breast-Milk HIV-1 Transmission 
A pooled analysis of individual data from >5000 human immunodeficiency virus type 1 (HIV-1)–infected mothers and their infants from Africa and India who participated in 5 randomized trials shows that extended prophylaxis with nevirapine or with nevirapine and zidovudine significantly reduces postnatal HIV-1 infection.
Background. In resource-limited settings, mothers infected with human immunodeficiency virus type 1 (HIV-1) face a difficult choice: breastfeed their infants but risk transmitting HIV-1 or not breastfeed their infants and risk the infants dying of other infectious diseases or malnutrition. Recent results from observational studies and randomized clinical trials indicate daily administration of nevirapine to the infant can prevent breast-milk HIV-1 transmission.
Methods. Data from 5396 mother-infant pairs who participated in 5 randomized trials where the infant was HIV-1 negative at birth were pooled to estimate the efficacy of infant nevirapine prophylaxis to prevent breast-milk HIV-1 transmission. Four daily regimens were compared: nevirapine for 6 weeks, 14 weeks, or 28 weeks, or nevirapine plus zidovudine for 14 weeks.
Results. The estimated 28-week risk of HIV-1 transmission was 5.8% (95% confidence interval [CI], 4.3%–7.9%) for the 6-week nevirapine regimen, 3.7% (95% CI, 2.5%–5.4%) for the 14-week nevirapine regimen, 4.8% (95% CI, 3.5%–6.7%) for the 14-week nevirapine plus zidovudine regimen, and 1.8% (95% CI, 1.0%–3.1%) for the 28-week nevirapine regimen (log-rank test for trend, P < .001). Cox regression models with nevirapine as a time-varying covariate, stratified by trial site and adjusted for maternal CD4 cell count and infant birth weight, indicated that nevirapine reduces the rate of HIV-1 infection by 71% (95% CI, 58%–80%; P < .001) and reduces the rate of HIV infection or death by 58% (95% CI, 45%–69%; P < .001).
Conclusions. Extended prophylaxis with nevirapine or with nevirapine and zidovudine significantly reduces postnatal HIV-1 infection. Longer duration of prophylaxis results in a greater reduction in the risk of infection.
doi:10.1093/cid/cis808
PMCID: PMC3518881  PMID: 22997212
breast milk; HIV; nevirapine
8.  An assessment of Makerere University College of Health Sciences: optimizing health research capacity to meet Uganda’s priorities 
Background
Health research is critical to the institutional mission of the Makerere College of Health Sciences (MakCHS). Optimizing the alignment of health research capacity at MakCHS with the health needs and priorities of Uganda, as outlined in the country’s Health Sector Strategic Plan (HSSP), is a deliberate priority, a responsibility, and a significant opportunity for research. To guide this strategic direction, an assessment of MakCHS’s research grants and publication portfolio was conducted.
Methods
A survey of all new and ongoing grants, as well as all publications, between January 2005 and December 2009 was conducted. Research, training, and education grants awarded to MakCHS’ constituent faculties and departments, were looked for through financial records at the college or by contact with funding organizations. Published manuscripts registered with PubMed, that included MakCHS faculty authors, were also analyzed.
Results
A total of 58 active grants were identified, of which 18 had been initiated prior to 2005 and there were an average of about eight new grants per year. Most grants funded basic and applied research, with major focus areas being HIV/AIDS (44%), malaria (19%), maternal and child health (14%), tuberculosis (11%), mental health (3%), and others (8%). MakCHS faculty were identified as Principal Investigators (PIs) in only 22 (38%) active grants. Grant funding details were only available for one third of the active grants at MakCHS. A total of 837 publications were identified, with an average of 167 publications per year, most of which (66%) addressed the country’s priority health areas, and 58% had MakCHS faculty or students as first authors.
Conclusions
The research grants and publications at MakCHS are generally well-aligned with the Ugandan Health Ministry priorities. Greater efforts to establish centralized and efficient grants management procedures are needed. In addition, greater efforts are needed to expand capacity for MakCHS faculty leadership of grants, as well as to continue to expand the contribution of MakCHS faculty to lead research publications.
doi:10.1186/1472-698X-11-S1-S12
PMCID: PMC3059471  PMID: 21410999
9.  A grander challenge: the case of how Makerere University College of Health Sciences (MakCHS) contributes to health outcomes in Africa 
Background
“Grand challenges” in global health have focused on discovery and development of technologies to save lives. The “grander challenge” involves building institutions, systems, capacity and demand to effectively deliver strategies to improve health. In 2008, Makerere University began a radical institutional change to bring together four schools under one College of Health Sciences. This paper’s objective is to demonstrate how its leadership in training, research, and services can improve health in Uganda and internationally, which lies at the core of the College’s vision.
Methods
A comprehensive needs assessment involved five task forces that identified MakCHS’s contribution to the Ugandan government health priorities. Data were collected through analysis of key documents; systematic review of MakCHS publications and grants; surveys of patients, students and faculty; and key informant interviews of the College’s major stakeholders. Four pilot projects were conducted to demonstrate how the College can translate research into policy and practice, extend integrated outreach community-based education and service, and work with communities and key stakeholders to address their priority health problems.
Results
MakCHS inputs to the health sector include more than 600 health professionals graduating per year through 23 degree programs, many of whom assume leadership positions. MakCHS contributions to processes include strengthened approaches to engaging communities, standardized clinical care procedures, and evidence-informed policy development. Outputs include the largest number of outpatients and inpatient admissions in Uganda. From 2005-2009, MakCHS also produced 837 peer-reviewed research publications (67% in priority areas). Outcomes include an expanded knowledge pool, and contributions to coverage of health services and healthy behaviors. Impacts include discovery and applications of global significance, such as the use of nevirapine to prevent HIV transmission in childbirth and male circumcision for HIV prevention. Pilot projects have applied innovative demand and supply incentives to create a rapid increase in safe deliveries (3-fold increase after 3 months), and increased quality and use of HIV services with positive collateral improvements on non-HIV health services at community clinics.
Conclusion
MakCHS has made substantial contributions to improving health in Uganda, and shows great potential to enhance this in its new transformational role – a model for other Universities.
doi:10.1186/1472-698X-11-S1-S2
PMCID: PMC3059474  PMID: 21411002
10.  Stigmatizing attitudes and low levels of knowledge but high willingness to participate in HIV management: A community-based survey of pharmacies in Pune, India 
BMC Public Health  2010;10:517.
Background
The World Health Organization (WHO) recommends that the role of pharmacists in low-income settings be expanded to address the increasing complexity of HIV antiretroviral (ARV) and co-infection drug regimens. However, in many such settings including in India, many pharmacists and pharmacy workers are often neither well trained nor aware of the intricacies of HIV treatment. The aims of our study were; to determine the availability of ARVs, provision of ARVs, knowledge about ARVs, attitudes towards HIV-infected persons and self-perceived need for training among community-based pharmacies in an urban area of India.
Methods
We performed a survey of randomly selected, community-based pharmacies located in Pune, India, in 2004-2005 to determine the availability of ARVs at these pharmacies, how they were providing ARVs and their self-perceived need for training. We also assessed knowledge, attitudes and perceptions on HIV and ARVs and factors associated with stocking ARVs.
Results
Of 207 pharmacies included in the survey, 200 (96.6%) were single, private establishments. Seventy-three (35.3%) pharmacies stocked ARVs and 38 (18.4%) ordered ARVs upon request. The reported median number of ARV pills that patients bought at one time was 30, a two week supply of ARVs (range: 3-240 pills). Six (2.9%) pharmacy respondents reported selling non-allopathic medicines (i.e. Ayurvedic, homeopathy) for HIV. Ninety (44.2%) pharmacy respondents knew that ARVs cannot cure HIV, with those stocking ARVs being more likely to respond correctly (60.3% vs. 34.8%, p = 0.001). Respondents of pharmacies which stocked ARVs were also more likely to believe it was a professional obligation to provide medications to HIV-infected persons (91.8% vs. 78.8%, p = 0.007) but they were also more likely to believe that HIV-infected persons are unable to adhere to their medicines (79.5% vs. 40.9%, p < 0.01). Knowledge of the most common side effects of nevirapine, abnormal liver enzyme profile and skin rash, was reported correctly by 8 (3.9%) and 23 (11.1%) respondents, respectively. Seven (3.4%) respondents reported that they had received special training on HIV, 3 (1.5%) reported receipt of special training on ART and 167 (80.7%) reported that they believed that pharmacy staff should get special training on ART.
Conclusion
There is a high willingness to participate in HIV management among community-based pharmacies but there is a tremendous need for training on HIV therapies. Furthermore, stigmatizing attitudes towards HIV-infected persons persist and interventions to reduce stigma are needed, particularly among those that stock ARVs.
doi:10.1186/1471-2458-10-517
PMCID: PMC2939646  PMID: 20799948
11.  Effect of Peer Health Workers on AIDS Care in Rakai, Uganda: A Cluster-Randomized Trial 
PLoS ONE  2010;5(6):e10923.
Background
Human resource limitations are a challenge to the delivery of antiretroviral therapy (ART) in low-resource settings. We conducted a cluster randomized trial to assess the effect of community-based peer health workers (PHW) on AIDS care of adults in Rakai, Uganda.
Methodology/Principal Findings
15 AIDS clinics were randomized 2∶1 to receive the PHW intervention (n = 10) or control (n = 5). PHW tasks included clinic and home-based provision of counseling, clinical, adherence to ART, and social support. Primary outcomes were adherence and cumulative risk of virologic failure (>400 copies/mL). Secondary outcomes were virologic failure at each 24 week time point up to 192 weeks of ART. Analysis was by intention to treat. From May 2006 to July 2008, 1336 patients were followed. 444 (33%) of these patients were already on ART at the start of the study. No significant differences were found in lack of adherence (<95% pill count adherence risk ratio [RR] 0.55, 95% confidence interval [CI] 0.23–1.35; <100% adherence RR 1.10, 95% CI 0.94–1.30), cumulative risk of virologic failure (RR 0.81, 95% CI 0.61–1.08) or in shorter-term virologic outcomes (24 week virologic failure RR 0.93, 95% CI 0.65–1.32; 48 week, RR 0.83, 95% CI 0.47–1.48; 72 week, RR 0.81, 95% CI 0.44–1.49). However, virologic failure rates ≥96 weeks into ART were significantly decreased in the intervention arm compared to the control arm (96 week failure RR 0.50, 95% CI 0.31–0.81; 120 week, RR 0.59, 95% CI 0.22–1.60; 144 week, RR 0.39, 95% CI 0.16–0.95; 168 week, RR 0.30, 95% CI 0.097–0.92; 192 week, RR 0.067, 95% CI 0.0065–0.71).
Conclusions/Significance
A PHW intervention was associated with decreased virologic failure rates occurring 96 weeks and longer into ART, but did not affect cumulative risk of virologic failure, adherence measures, or shorter-term virologic outcomes. PHWs may be an effective intervention to sustain long-term ART in low-resource settings.
Trial Registration
ClinicalTrials.gov NCT00675389
doi:10.1371/journal.pone.0010923
PMCID: PMC2880005  PMID: 20532194
12.  Strategies for gender-equitable HIV services in rural India 
Health Policy and Planning  2009;24(3):197-208.
The emergence of HIV in rural India has the potential to heighten gender inequity in a context where women already suffer significant health disparities. Recent Indian health policies provide new opportunities to identify and implement gender-equitable rural HIV services. In this review, we adapt Mosley and Chen's conceptual framework of health to outline determinants for HIV health services utilization and outcomes. Examining the framework through a gender lens, we conduct a comprehensive literature review for gender-related gaps in HIV clinical services in rural India, focusing on patient access and outcomes, provider practices, and institutional partnerships. Contextualizing findings from rural India in the broader international literature, we describe potential strategies for gender-equitable HIV services in rural India, as responses to the following three questions: (1) What gender-specific patient needs should be addressed for gender-equitable HIV testing and care? (2) What do health care providers need to deliver HIV services with gender equity? (3) How should institutions enforce and sustain gender-equitable HIV services? Data at this early stage indicate substantial gender-related differences in HIV services in rural India, reflecting prevailing gender norms. Strategies including gender-specific HIV testing and care services would directly address current gender-specific patient needs. Rural care providers urgently need training in gender sensitivity and HIV-related communication and clinical skills. To enforce and sustain gender equity, multi-sectoral institutions must establish gender-equitable medical workplaces, interdisciplinary HIV services partnerships, and oversight methods, including analysis of gender-disaggregated data. A gender-equitable approach to rural India's rapidly evolving HIV services programmes could serve as a foundation for gender equity in the overall health care system.
doi:10.1093/heapol/czp004
PMCID: PMC2727142  PMID: 19244284
HIV; rural India; gender equity; health services; access to care; utilization
13.  Highly complex neutralization determinants on a monophyletic lineage of newly transmitted subtype C HIV-1 Env clones from India 
Virology  2009;385(2):505-520.
Little is known about the neutralization properties of HIV-1 in India to optimally design and test vaccines. For this reason, a functional Env clone was obtained from each of ten newly acquired, heterosexually transmitted HIV-1 infections in Pune, Maharashtra. These clones formed a phylogenetically distinct genetic lineage within subtype C. As Env-pseudotyped viruses the clones were mostly resistant to IgG1b12, 2G12 and 2F5 but all were sensitive to 4E10. When compared to a large multi-subtype panel of Env-pseudotyped viruses (subtypes B, C and CRF02_AG) in neutralization assays with a multi-subtype panel of HIV-1-positive plasma samples, the Indian Envs were remarkably complex antigenically. With the exception of the Indian Envs, results of a hierarchical clustering analysis showed a strong subtype association with the patterns of neutralization susceptibility. From these patterns we were able to identify 19 neutralization cluster-associated amino acid signatures in gp120 and 14 signatures in the ectodomain and cytoplasmic tail of gp41. We conclude that newly transmitted Indian Envs are antigenically complex in spite of close genetic similarity. Delineation of neutralization-associated amino acid signatures provides a deeper understanding of the antigenic structure of HIV-1 Env.
doi:10.1016/j.virol.2008.12.032
PMCID: PMC2677301  PMID: 19167740
14.  Telecommunications and Health Care: An HIV/AIDS Warmline for Communication and Consultation in Rakai, Uganda 
Hotlines and warmlines have been successfully used in the developed world to provide clinical advice; however, reports on their replicability in resource-limited settings are limited. A warmline was established in Rakai, Uganda, to support an antiretroviral therapy program. Over a 17-month period, a database was kept of who called, why they called, and the result of the call. A program evaluation was also administered to clinical staff. A total of 1303 calls (3.5 calls per weekday) were logged. The warmline was used mostly by field staff and peripherally based peer health workers. Calls addressed important clinical issues, including the need for urgent care, medication side effects, and follow-up needs. Most clinical staff felt that the warmline made their jobs easier and improved the health of patients. An HIV/AIDS warmline leveraged the skills of a limited workforce to provide increased access to HIV/AIDS care, advice, and education.
doi:10.1177/1545109708318525
PMCID: PMC2674571  PMID: 18441254
HIV; antiretroviral therapy; Africa; telecommunications; hotline
15.  High risk for occupational exposure to HIV and utilization of post-exposure prophylaxis in a teaching hospital in Pune, India 
Background
The risk for occupational exposure to HIV has been well characterized in the developed world, but limited information is available about this transmission risk in resource-constrained settings facing the largest burden of HIV infection. In addition, the feasibility and utilization of post-exposure prophylaxis (PEP) programs in these settings are unclear. Therefore, we examined the rate and characteristics of occupational exposure to HIV and the utilization of PEP among health care workers (HCW) in a large, urban government teaching hospital in Pune, India.
Methods
Demographic and clinical data on occupational exposures and their management were prospectively collected from January 2003–December 2005. US Centers for Diseases Control guidelines were utilized to define risk exposures, for which PEP was recommended. Incidence rates of reported exposures and trends in PEP utilization were examined using logistic regression.
Results
Of 1955 HCW, 557 exposures were reported by 484 HCW with an incidence of 9.5 exposures per 100 person-years (PY). Housestaff, particularly interns, reported the greatest number of exposures with an annual incidence of 47.0 per 100 PY. Personal protective equipment (PPE) was used in only 55.1% of these exposures. The incidence of high-risk exposures was 6.8/100 PY (n = 339); 49.1% occurred during a procedure or disposing of equipment and 265 (80.0%) received a stat dose of PEP. After excluding cases in which the source tested HIV negative, 48.4% of high-risk cases began an extended PEP regimen, of whom only 49.5% completed it. There were no HIV or Hepatitis B seroconversions identified. Extended PEP was continued unnecessarily in 7 (35%) of 20 cases who were confirmed to be HIV-negative. Over time, there was a significant reduction in proportion of percutaneous exposures and high-risk exposures (p < 0.01) and an increase in PEP utilization for high risk exposures (44% in 2003 to 100% in 2005, p = 0.002).
Conclusion
Housestaff are a vulnerable population at high risk for bloodborne exposures in teaching hospital settings in India. With implementation of a hospital-wide PEP program, there was an encouraging decrease of high-risk exposures over time and appropriate use of PEP. However, overall use of PPE was low, suggesting further measures are needed to prevent occupational exposures in India.
doi:10.1186/1471-2334-8-142
PMCID: PMC2588594  PMID: 18939992
16.  Full-Length Human Immunodeficiency Virus Type 1 Genomes from Subtype C-Infected Seroconverters in India, with Evidence of Intersubtype Recombination 
Journal of Virology  1999;73(1):152-160.
The development of an effective human immunodeficiency virus type 1 (HIV-1) vaccine is likely to depend on knowledge of circulating variants of genes other than the commonly sequenced gag and env genes. In addition, full-genome data are particularly limited for HIV-1 subtype C, currently the most commonly transmitted subtype in India and worldwide. Likewise, little is known about sequence variation of HIV-1 in India, the country facing the largest burden of HIV worldwide. Therefore, the objective of this study was to clone and characterize the complete genome of HIV-1 from seroconverters infected with subtype C variants in India. Cocultured HIV-1 isolates were obtained from six seroincident individuals from Pune, India, and virtually full-length HIV-1 genomes were amplified, cloned, and sequenced from each. Sequence analysis revealed that five of the six genomes were of subtype C, while one was a mosaic of subtypes A and C, with multiple breakpoints in env, nef, and the 3′ long terminal repeat as determined by both maximal χ2 analysis and phylogenetic bootstrapping. Sequences were compared for preservation of known cytotoxic T lymphocyte (CTL) epitopes. Compared with those of the HIV-1LAI sequence, 38% of well-defined CTL epitopes were identical. The proportion of nonconservative substitutions for Env, at 61%, was higher (P < 0.001) than those for Gag (24%), Pol (18%), and Nef (32%). Therefore, characterized CTL epitopes demonstrated substantial differences from subtype B laboratory strains, which were most pronounced in Env. Because these clones were obtained from Indian seroconverters, they are likely to facilitate vaccine-related efforts in India by providing potential antigens for vaccine candidates as well as for assays of vaccine responsiveness.
PMCID: PMC103818  PMID: 9847317
17.  Peer Health Workers and AIDS Care in Rakai, Uganda: A Mixed Methods Operations Research Evaluation of a Cluster-Randomized Trial 
AIDS Patient Care and STDs  2011;25(12):719-724.
Abstract
Settings with limited health care workers are challenging environments for delivery of antiretroviral therapy. One strategy to address this human resource crisis is to task shift through training selected patients as peer health workers (PHWs) to provide care to other individuals receiving antiretroviral therapy. To better understand processes of a cluster-randomized trial on the effect of these PHWs on AIDS care, we conducted a mixed methods operations research evaluation. Qualitative methods involved patients, PHWs, and clinic staff and included 38 in-depth interviews, 8 focus group discussions, and 11 direct observations. Quantitative methods included staff surveys, process, and virologic data analyses. Results showed that task shifting to PHWs positively affected structural and programmatic functions of care delivery—improving clinical organization, medical care access, and patient-provider communication—with little evidence for problems with confidentiality and inadvertent disclosure. Additionally, this evaluation elucidated trial processes including evidence for direct and indirect control arm contamination and evidence for mitigation of antiretroviral treatment fatigue by PHWs. Our results support the use of PHWs to complement conventional clinical staff in delivering AIDS care in low-resource settings and highlight how mixed methods operations research evaluations can provide important insights into community-based trials.
doi:10.1089/apc.2010.0349
PMCID: PMC3216066  PMID: 21391828
18.  Growth patterns among HIV-exposed infants receiving nevirapine prophylaxis in Pune, India 
BMC Infectious Diseases  2012;12:282.
Background
India has among the highest rates of infant malnutrition. Few studies investigating the growth patterns of HIV-exposed infants in India or the impact of timing of HIV infection on growth in settings such as India exist.
Methods
We used data from the Six Week Extended Nevirapine (SWEN) trial to compare the growth patterns of HIV-infected and HIV-exposed but uninfected infants accounting for timing of HIV infection, and to identify risk factors for stunting, underweight and wasting. Growth and timing of HIV infection were assessed at weeks 1, 2, 4, 6, 10, 14 weeks and 6, 9, 12 months of life. Random effects multivariable logistic regression method was used to assess factors associated with stunting, underweight and wasting.
Results
Among 737 HIV-exposed infants, 93 (13%) were HIV-infected by 12 months of age. Among HIV-infected and uninfected infants, baseline prevalence of stunting (48% vs. 46%), underweight (27% vs. 26%) and wasting (7% vs. 11%) was similar (p>0.29), but by 12 months stunting and underweight, but not wasting, were significantly higher in HIV-infected infants (80% vs. 56%, 52% vs. 29%, p< 0.0001; 5% vs. 6%, p=0.65, respectively). These differences rapidly manifested within 4–6 weeks of birth. Infants infected in utero had the worst growth outcomes during the follow-up period. SWEN was associated with non-significant reductions in stunting and underweight among HIV-infected infants and significantly less wasting in HIV-uninfected infants. In multivariate analysis, maternal CD4 < 250, infant HIV status, less breastfeeding, low birth weight, non-vaginal delivery, and infant gestational age were significant risk factors for underweight and stunting.
Conclusion
Baseline stunting and underweight was high in both HIV-infected and uninfected infants; growth indices diverged early and were impacted by timing of infection and SWEN prophylaxis. Early growth monitoring of all HIV-exposed infants is an important low-cost strategy for improving health and survival outcomes of these infants.
Trial Registration
NCT00061321
doi:10.1186/1471-2334-12-282
PMCID: PMC3556061  PMID: 23114104
HIV-exposed infants; Growth patterns; India; Extended use of nevirapine; Risk factors; Timing of HIV Infection
19.  Maternal Tuberculosis: A Risk Factor for Mother-to-Child Transmission of Human Immunodeficiency Virus 
The Journal of Infectious Diseases  2011;203(3):358-362.
Background. Maternal human immunodeficiency virus (HIV) RNA load, CD4 cell count, breast-feeding, antiretroviral use, and malaria are well-established factors associated with mother-to-child transmission (MTCT) of HIV; the role of maternal tuberculosis (TB), however, has not been well established.
Methods. The study population was 783 HIV-infected Indian mother-infant pair participants in randomized and ancillary HIV-infected cohorts of the Six Week Extended-Dose Nevirapine (SWEN) Study, a study comparing extended nevirapine versus single-dose nevirapine, to reduce MTCT of HIV among breast-fed infants. Using multivariable logistic regression, we assessed the impact of maternal TB occurring during pregnancy and through 12 months after delivery on risk of MTCT.
Results. Of 783 mothers, 3 had prevalent TB and 30 had incident TB at 12 months after delivery. Of 33 mothers with TB, 10 (30%) transmitted HIV to their infants in comparison with 87 of 750 mothers without TB (12%; odds ratio [OR], 3.31; 95% confidence interval [CI], 1.53–7.29; P = .02). In multivariable analysis, maternal TB was associated with 2.51-fold (95% CI, 1.05–6.02; P = .04) increased odds of HIV transmission adjusting for maternal factors (viral load, CD4 cell count, and antiretroviral therapy) and infant factors (breast-feeding duration, infant nevirapine administration, gestational age, and birth weight) associated with MTCT of HIV.
Conclusions. Maternal TB is associated with increased MTCT of HIV. Prevention of TB among HIV-infected mothers should be a high priority for communities with significant HIV/TB burden.
doi:10.1093/jinfdis/jiq064
PMCID: PMC3071111  PMID: 21208928
20.  Impact of a mHealth Intervention for Peer Health Workers on AIDS Care in Rural Uganda: A Mixed Methods Evaluation of a Cluster-Randomized Trial 
AIDS and Behavior  2011;15(8):1776-1784.
Mobile phone access in low and middle-income countries is rapidly expanding and offers an opportunity to leverage limited human resources for health. We conducted a mixed methods evaluation of a cluster-randomized trial exploratory substudy on the impact of a mHealth (mobile phone) support intervention used by community-based peer health workers (PHW) on AIDS care in rural Uganda. 29 PHWs at 10 clinics were randomized by clinic to receive the intervention or not. PHWs used phones to call and text higher level providers with patient-specific clinical information. 970 patients cared for by the PHWs were followed over a 26 month period. No significant differences were found in patients’ risk of virologic failure. Qualitative analyses found improvements in patient care and logistics and broad support for the mHealth intervention among patients, clinic staff, and PHWs. Key challenges identified included variable patient phone access, privacy concerns, and phone maintenance.
doi:10.1007/s10461-011-9995-x
PMCID: PMC3265752  PMID: 21739286
mHealth; Community health workers; HIV; Cluster-randomized trial; Mixed methods research
21.  High Rates of All-cause and Gastroenteritis-related Hospitalization Morbidity and Mortality among HIV-exposed Indian Infants 
BMC Infectious Diseases  2011;11:193.
Background
HIV-infected and HIV-exposed, uninfected infants experience a high burden of infectious morbidity and mortality. Hospitalization is an important metric for morbidity and is associated with high mortality, yet, little is known about rates and causes of hospitalization among these infants in the first 12 months of life.
Methods
Using data from a prevention of mother-to-child transmission (PMTCT) trial (India SWEN), where HIV-exposed breastfed infants were given extended nevirapine, we measured 12-month infant all-cause and cause-specific hospitalization rates and hospitalization risk factors.
Results
Among 737 HIV-exposed Indian infants, 93 (13%) were HIV-infected, 15 (16%) were on HAART, and 260 (35%) were hospitalized 381 times by 12 months of life. Fifty-six percent of the hospitalizations were attributed to infections; gastroenteritis was most common accounting for 31% of infectious hospitalizations. Gastrointestinal-related hospitalizations steadily increased over time, peaking around 9 months. The 12-month all-cause hospitalization, gastroenteritis-related hospitalization, and in-hospital mortality rates were 906/1000 PY, 229/1000 PY, and 35/1000 PY respectively among HIV-infected infants and 497/1000 PY, 107/1000 PY, and 3/1000 PY respectively among HIV-exposed, uninfected infants. Advanced maternal age, infant HIV infection, gestational age, and male sex were associated with higher all-cause hospitalization risk while shorter duration of breastfeeding and abrupt weaning were associated with gastroenteritis-related hospitalization.
Conclusions
HIV-exposed Indian infants experience high rates of all-cause and infectious hospitalization (particularly gastroenteritis) and in-hospital mortality. HIV-infected infants are nearly 2-fold more likely to experience hospitalization and 10-fold more likely to die compared to HIV-exposed, uninfected infants. The combination of scaling up HIV PMTCT programs and implementing proven health measures against infections could significantly reduce hospitalization morbidity and mortality among HIV-exposed Indian infants.
doi:10.1186/1471-2334-11-193
PMCID: PMC3161884  PMID: 21762502
Infant; HIV; India; Hospitalization; In-hospital Mortality; gastroenteritis; pneumonia
22.  A Comparison of Online versus On-site Training in Health Research Methodology: A Randomized Study 
BMC Medical Education  2011;11:37.
Background
Distance learning may be useful for building health research capacity. However, evidence that it can improve knowledge and skills in health research, particularly in resource-poor settings, is limited. We compared the impact and acceptability of teaching two distinct content areas, Biostatistics and Research Ethics, through either on-line distance learning format or traditional on-site training, in a randomized study in India. Our objective was to determine whether on-line courses in Biostatistics and Research Ethics could achieve similar improvements in knowledge, as traditional on-site, classroom-based courses.
Methods
Subjects: Volunteer Indian scientists were randomly assigned to one of two arms.
Intervention: Students in Arm 1 attended a 3.5-day on-site course in Biostatistics and completed a 3.5-week on-line course in Research Ethics. Students in Arm 2 attended a 3.5-week on-line course in Biostatistics and 3.5-day on-site course in Research Ethics. For the two course formats, learning objectives, course contents and knowledge tests were identical.
Main Outcome Measures: Improvement in knowledge immediately and 3-months after course completion, compared to baseline.
Results
Baseline characteristics were similar in both arms (n = 29 each). Median knowledge score for Biostatistics increased from a baseline of 49% to 64% (p < 0.001) 3 months after the on-site course, and from 48% to 63% (p = 0.009) after the on-line course. For the on-site Research Ethics course, median score increased from 69% to 83% (p = 0.005), and for the on-line Research Ethics course from 62% to 80% (p < 0.001). Three months after the course, median gains in knowledge scores remained similar for the on-site and on-line platforms for both Biostatistics (16% vs. 12%; p = 0.59) and Research Ethics (17% vs. 13%; p = 0.14).
Conclusion
On-line and on-site training formats led to marked and similar improvements of knowledge in Biostatistics and Research Ethics. This, combined with logistical and cost advantages of on-line training, may make on-line courses particularly useful for expanding health research capacity in resource-limited settings.
doi:10.1186/1472-6920-11-37
PMCID: PMC3141795  PMID: 21682858
23.  Predictors of Retention among Men Attending STI Clinics in HIV Prevention Programs and Research: A Case Control Study in Pune, India 
PLoS ONE  2011;6(3):e17448.
Background
Retention is critical in HIV prevention programs and clinical research. We studied retention in the three modeled scenarios of primary prevention programs, cohort studies and clinical trials to identify predictors of retention.
Methodology/Principal Findings
Men attending Sexually Transmitted Infection (STI) clinics (n = 10, 801) were followed in a cohort study spanning over a ten year period (1993–2002) in Pune, India. Using pre-set definitions, cases with optimal retention in prevention program (n = 1286), cohort study (n = 940) and clinical trial (n = 896) were identified from this cohort. Equal number of controls matched for age and period of enrollment were selected. A case control analysis using conditional logistic regression was performed.
Being employed was a predictor of lower retention in all the three modeled scenarios. Presence of genital ulcer disease (GUD), history of commercial sex work and living away from the family were predictors of lower retention in primary prevention, cohort study and clinical trial models respectively. Alcohol consumption predicted lower retention in cohort study and clinical trial models. Married monogamous men were less likely to be retained in the primary prevention and cohort study models.
Conclusions/Significance
Predicting potential drop-outs among the beneficiaries or research participants at entry point in the prevention programs and research respectively is possible. Suitable interventions might help in optimizing retention. Customized counseling to prepare the clients properly may help in their retention.
doi:10.1371/journal.pone.0017448
PMCID: PMC3055872  PMID: 21412414

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