'What do I know? Should I participate?' Considerations on participation in HIV related research among HIV infected adults in Bangalore, South India.

BACKGROUND: India has the highest number of HIV infected persons in the world after South Africa. Much HIV related behavioral, clinical and laboratory based research is ongoing in India. Yet little is known on Indian HIV patients' knowledge of research, their processes of decision making and motives for participation. We aimed to explore these areas among HIV infected individuals to understand their reasons for participating in research. METHODOLOGY/PRINCIPAL FINDINGS: This is a cross sectional survey among 173 HIV infected adults at a tertiary level hospital in Bangalore, India, done between October 2010 and January 2011. A pre-tested questionnaire was administered to the participants by trained research assistants to assess their knowledge regarding research, willingness to participate, decision making and determinants of participation. Participants were presented with five hypothetical HIV research studies. Each study had a different level of intervention and time commitment. Of respondents, 103(60%), said that research meant 'to discover something new' and 138(80%) were willing to participate in research. A third of the respondents were unaware of their right to refuse participation. Willingness to participate in research varied with level of intervention. It was the lowest for the hypothetical study involving sensitive questions followed by the hypothetical drug trial; and was the highest for the hypothetical cross sectional questionnaire based study (p<0.0015). Individual health benefits and altruism were the primary motives for participation in research and indicate the presence of therapeutic misconception. Women were less likely to make autonomous decisions for participation in interventional studies. CONCLUSIONS/SIGNIFICANCE: Despite a majority willing to participate, over a third of respondents did not have any knowledge of research or the voluntary nature of participation. This has ethical implications. Researchers need to focus on enabling potential research participants understand the concepts of research, promote autonomous decisions, especially by women and restrict therapeutic misconception.

Supporting adherence to antiretroviral therapy with mobile phone reminders: results from a cohort in South India.

BACKGROUND: Adherence is central to the success of antiretroviral therapy. Supporting adherence has gained importance in HIV care in many national treatment programs. The ubiquity of mobile phones, even in resource-constrained settings, has provided an opportunity to utilize an inexpensive, contextually feasible technology for adherence support in HIV in these settings. We aimed to assess the influence of mobile phone reminders on adherence to antiretroviral therapy in South India. Participant experiences with the intervention were also studied. This is the first report of such an intervention for antiretroviral adherence from India, a country with over 800 million mobile connections. STUDY DESIGN: Quasi-experimental cohort study involving 150 HIV-infected individuals from Bangalore, India, who were on antiretroviral therapy between April and July 2010. The intervention: All participants received two types of adherence reminders on their mobile phones, (i) an automated interactive voice response (IVR) call and (ii) A non-interactive neutral picture short messaging service (SMS), once a week for 6 months. Adherence measured by pill count, was assessed at study recruitment and at months one, three, six, nine and twelve. Participant experiences were assessed at the end of the intervention period. RESULTS: The mean age of the participants was 38 years, 27% were female and 90% urban. Overall, 3,895 IVRs and 3,073 SMSs were sent to the participants over 6 months. Complete case analysis revealed that the proportion of participants with optimal adherence increased from 85% to 91% patients during the intervention period, an effect that was maintained 6 months after the intervention was discontinued (p = 0.016). Both, IVR calls and SMS reminders were considered non-intrusive and not a threat to privacy. A significantly higher proportion agreed that the IVR was helpful compared to the SMS (p<0.001). CONCLUSION: Mobile phone reminders may improve medication adherence in HIV infected individuals in this setting, the effect of which was found to persist for at least 6 months after cessation of the intervention.

Growth patterns and anaemia status of HIV-infected children living in an institutional facility in India.

OBJECTIVE: To understand the health status of HIV orphans in a well-structured institutional facility in India. METHOD: Prospective longitudinal analysis of growth and anaemia prevalence among these children, between June 2008 and May 2011. RESULTS: A total of 85 HIV-infected orphan children residing at Sneha Care Home, Bangalore, for at least 1 year, were included in the analysis. Prevalence of anaemia at entry into the home was 40%, with the cumulative incidence of anaemia during the study period being 85%. At baseline, 79% were underweight and 72% were stunted. All children, irrespective of their antiretroviral therapy (ART) status, showed an improvement in nutritional status over time as demonstrated by a significant increase in weight (median weight-for-age Z-score: -2.75 to -1.74, P < 0.001) and height Z-scores (median height-for-age Z-score: -2.69 to -1.63, P < 0.001). CONCLUSION: These findings suggest that good nutrition even in the absence of ART can bring about improvement in growth. The Sneha Care Home model indicates that the holistic approach used in the Home may have been helpful in combating HIV and poor nutritional status in severely malnourished orphaned children.

The prevalence and etiology of anemia among HIV-infected children in India.

UNLABELLED: In this report, the prevalence and multifactorial etiology of anemia among Indian human immunodeficiency virus (HIV)-infected children are described. HIV-infected children aged 2-12 years were prospectively enrolled in 2007-2008. Measured parameters included serum ferritin, vitamin B(12), red-cell folate, soluble transferrin receptor, and C-reactive protein. Children received antiretroviral therapy (ART), iron and, folate supplements as per standard of care. Among 80 enrolled HIV-infected children (mean age 6.8 years), the prevalence of anemia was 52.5%. Etiology of anemia was found to be iron deficiency alone in 38.1%, anemia of inflammation alone in 38.1%, combined iron deficiency and anemia of inflammation alone in 7.1%, vitamin B(12) deficiency in 7.1%, and others in 9.5%. Median iron intake was 5.7 mg/day (recommended dietary allowance 18-26 mg/day). Compared to nonanemic children, anemic children were more likely to be underweight (weight Z-score -2.5 vs. -1.9), stunted (height Z-score -2.6 vs. -1.9), with lower CD4 counts (18% vs. 24%, p < 0.01), and higher log viral load (11.1 vs. 7.1, p < 0.01). Hemoglobin (Hb) improved significantly among those who started ART (baseline Hb 11.6 g/dl, 6-month Hb 12.2 g/dl, p = 0.03). Children taking ART combined with iron supplements experienced a larger increase in Hb compared to those receiving neither ART nor iron supplements (mean Hb change 1.5 g/dl, p < 0.01). CONCLUSION: Anemia, particularly iron deficiency anemia and anemia of inflammation, is highly prevalent among children with HIV infection. Micronutrient supplements combined with ART improved anemia in HIV-infected children.

Supporting patient adherence to antiretrovirals using mobile phone reminders: patient responses from South India.

There has been exponential growth in the use of mobile phones in India over the last few years, and their potential benefits as a healthcare tool has raised tremendous interest. We used mobile phone reminders to help support adherence to antiretroviral therapy (ART) among HIV patients at an infectious disease clinic in a tertiary hospital in Bangalore. Between March and June 2010, 139 adult HIV patients taking regular ART for at least a month received weekly reminders to support adherence. These reminders consisted of a weekly interactive call and a non-interactive neutral pictorial short message service (SMS). After four weeks of the intervention, participants were interviewed to study perceptions on preference, usefulness, potential stigma and privacy concerns associated with this intervention. Majority of the participants were urban (89%), and had at least a secondary education (85%). A total of 744 calls were made, 545 (76%) of which were received by the participants. In addition, all participants received the weekly pictorial SMS reminder. A month later, 90% of participants reported the intervention as being helpful as medication reminders, and did not feel their privacy was intruded. Participants (87%) reported that they preferred the call as reminders, just 11% favoured SMS reminders alone. Only 59% of participants viewed all the SMSs that were delivered, while 15% never viewed any at all. Participants also denied any discomfort or stigma despite 20% and 13%, respectively, reporting that another person had inadvertently received their reminder call or SMS. Mobile phone interventions are an acceptable way of supporting adherence in this setting. Voice calls rather than SMSs alone seem to be preferred as reminders. Further research to study the influence of this intervention on adherence and health maintenance is warranted.