Prevention of recurrence of bacterial vaginosis using lactobacilli-containing vaginal tablets among women with HIV: a randomized, placebo-controlled, double-blinded phase IV trial.

OBJECTIVES: The effectiveness of lactobacilli-containing vaginal tablets (VT) in bacterial vaginosis (BV) recurrence prevention among women infected with HIV treated with standard oral metronidazole in Pune, India was studied. METHODS: Women infected with HIV with confirmed BV diagnosis (Nugent score ≥7 and Amsel criteria >3) were enrolled in a 12-month, double-blind, randomized, placebo-controlled, phase IV study between 2018 and 2021. After a standard course of oral metronidazole for 7 days (400 mg three times a day), women were randomly assigned to either lactobacilli-containing or placebo VT arms to receive VTs for 4 months. BV recurrence was assessed after the initial cure from BV. RESULTS: Of the 464 women infected with HIV, 80 women with confirmed BV were enrolled. The retention was affected due to the COVID-19 pandemic (6-month retention rates 78%). The cure was seen in 85% and 93.5% of participants from the treatment and placebo arms, respectively, after four VT cycles. BV recurrence was seen in 41.4% and 44.8% in the treatment and placebo arm, respectively, with no significant difference in the two groups. CONCLUSION: The lactobacilli-containing VT was acceptable and safe; however, the addition of VT over standard oral metronidazole did not show any additional benefit in the prevention of BV recurrence in women infected with HIV, indicating the need for long-term randomized trials among them. Registered at Clinical Trials Registry- India, (CTRI) Number: CTRI/2018/04/013298.

Challenges faced by ethics committee members in India during COVID-19 pandemic: A mixed-methods exploration.

Background & objectives: The COVID-19 pandemic had a distinct impact on scientific research and Ethics Committees (ECs). We conducted a mixed-methods investigation to understand the issues faced and solutions identified by ECs during this pandemic in India. Methods: A quantitative online survey form (30 members) and qualitative in-depth interviews (10 members) from various ECs were conducted. Thematic content analysis for qualitative and proportion analysis for quantitative data was carried out. Results: During the online survey, an average difficulty score, which was measured using the Visual Analogue Scale, was 5.3 (SD 2.1). Pressure for expedited approvals was felt by EC members with a drastic increase in the number of submission of research projects. The scarcity of information on investigational products (IPs) and requisite consent process posed major hurdles. Ongoing non-COVID studies and post-graduate dissertations were badly hit due to the shift in attention towards COVID-related research. Non-familiarity with virtual technology and lack of face-to-face interactions were highlighted as demerits. However, a few of the EC members welcomed newer methods, being time-saving, convenient and reducing travel hassles. Site monitoring and severe adverse event-related analyses were also negatively impacted upon. Solutions included the alternate methods of consenting (virtual, abbreviated), a detailed explanation of the protocol and IPs and benefits versus risk assessment. Interpretation & conclusions: Despite various challenges posed by the COVID-19 pandemic, the ECs in India steered well through the hurdles. Moreover, adapting a hybrid mode, technical training and updating guidelines were perceived as urgent by EC members.

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.