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Shahs’ Donation of Mobile Clinic Brings Healthcare to Patients in India
Care in the Community
Since it was first deployed in 2015, the Mobile Health and Wellness Clinic has been a workhorse for delivering health care in local Pune, India, communities, at the point of need. The clinic was a philanthropic gift of Raj and Bharti Shah, CTIS, and the NB Shah Charitable Trust, and it operates out of Byramjee Jeejeebhoy Government Medical College (BJGMC) in support of the Indo-JHU clinical Research Partnership.
The Mobile Clinic provides the same services as the brick and mortar clinic—study eligibility assessment, counselling, medical history documentation, physical examinations, and specimen collection. Mobile Clinic capabilities also include chest radiograph for suspected tuberculosis. Ill patients are referred into the traditional care setting, as warranted.
Unlike the brick and mortar clinic, however, the Mobile Clinic offers agility and addresses obstacles to participant engagement in care. One such hurdle is travel distance and time from home to the clinic. Deployment of the Mobile Clinic into communities makes it easier and much more convenient for participants to stay linked to care. Social stigma associated with disease is another obstacle, and patient confidentiality can be compromised through home or clinic visits. The Mobile Clinic offers patients access to care in revolving locations where there are greater opportunities for anonymity.
Preventing Vascular Events in People Living with HIV
The REPRIEVE Trial (REPRIEVE- Randomized Trial to Prevent Vascular Events in HIV) is a multicenter, multi-network, randomized, double blind, placebo-controlled trial being conducted to determine if the drug Pitavastatin as an effective primary prevention strategy to prevent major adverse cardiovascular events in HIV-infected participants. From August 2017 through January 2019, the BJGMC Clinical Research Site has enrolled 250 participants in this international study, and participants are being followed for 96 months.
The Mobile Health and Wellness Clinic has been instrumental in conducting recruitment and community outreach activities, and study staff prescreened potential participants at the Rajiv Gandhi Hospital Anti-Retroviral Treatment center located in Yeravada , on alternate days. More than 300 people were screened, and 50 participants were enrolled in this trial. Additionally, because standard clinic facilities alone are inadequate to accommodate participants in this study and others, the Mobile Clinic was deployed to expand clinical capacity for individual and group counseling and phlebotomy procedures.
The REPRIEVE Trial study team at BJGMC recently received international recognition for its efforts on study participant retention from the AIDS Clinical Trials Group (ACTG). The ACTG is the international network that sets standards of care for HIV infection and supports and oversees clinical research on HIV prevention, treatment, care, and complications. The REPRIEVE Team convened an awareness event and luncheon that included nearly 140 study participants. The event promoted healthy behaviors and engagement in care, featured banners on maintaining health as well as information about tobacco and alcohol use, and provided messaging about exercise and a balanced diet. It included uplifting musical performances, and an energetic and very well-received open microphone forum for participants to share their experiences and perspectives if they wished.
The most powerful part of the event was hearing from participants, who were enthusiastic and eager to share their perspectives about research and the REPRIEVE Team. Their stories were personal and heartfelt. One person viewed participation as a public service: “Being HIV infected, we cannot donate blood or any organ, however we can participate in clinical trials that address important public health concerns [for the] betterment of society and mankind.” Another participant explained how inclusion in the study offered rapid access to urgent lifesaving care: “. . . I had severe abdominal pain. I am thankful to the study team for prompt assistance in investigations, diagnosis and the swift surgery. I am here today only because of the study team.” One woman shared a particularly inspiring reflection on her decades-long journey with HIV: “I came know about my HIV-infected status when I was pregnant 20 years back. Today my son is graduating as an engineer. I am taking my medicines regularly. The study staff take very good care of us.”
Tuberculosis Screenings and Women’s Health
Tuberculosis is the leading cause of maternal mortality, particularly among HIV+ women, so the Indo-JHU research team at BJGMC deployed the Mobile Clinic in support of the PRACHITI Study, which is looking at immune changes that happen to HIV+ women during pregnancy that render them more susceptible to severe TB disease.
Additionally, in support of women’s health, the Mobile Health and Wellness Clinic was used to conduct 3 important health camps, in the communities of Hadapsar, Dattawadi, and Warje Malwadi. Nearly 100 women were served during these camps, in which health education was provided on tuberculosis, and personal and menstrual hygiene. Wellness screenings were conducted (including glucose screenings for diabetes), and patients were referred to follow-up care at the clinic, as warranted.
Impact of Diabetes on TB Treatment Outcomes
The Mobile Clinic has been an integral part of community outreach efforts in conducting health camps, recruiting participants, conducting study visits, and referring patients into care for two of our largest efforts. All told, approximately 2,000 participants have been enrolled in a tuberculosis diabetes cohort, and in an international effort to identify biomarkers that signal progression of latent tuberculosis into active and contagious disease.
Having diabetes increases the risk for tuberculosis, and screening people with diabetes for tuberculosis is now recommended in India. CCGHE, the Center for TB Research, and BJGMC in Pune are collaborating on a study that evaluates treatment outcomes among Indian patients who have both diabetes mellitus and active TB. We are assessing the prevalence of impaired glucose or frank diabetes, and then comparing diabetes and TB treatment outcomes among patients who have both TB and diabetes, and patients who have just TB.
Perhaps the most impactful use of the Mobile Health and Wellness Clinic is in support of RePORT India, a large, country-wide tuberculosis research consortium that is part of a multi-national network of countries conducting TB research. The aim of RePORT is to conduct a wide range of basic and clinical research to identify TB biomarkers, and promising vaccines, drugs, and diagnostics.
A joint venture funded by the governments of India and the U.S., RePORT India includes 7 India clinical research institutions that are paired with U.S. research institutions. India- and US-based investigators implement individual cohort studies of active and latent TB in India and household contacts of active TB cases. The sites are all experienced in TB clinical research, represent a mix of urban and rural, geographically disparate populations, and bring unique interests and expertise to their parent projects. BJGMC, the National Institute for Research in Tuberculosis (Chennai), and Johns Hopkins University comprise one such member team of the collaboration and is investigating host and microbial factors associated with active and latent TB infection in adults and children.
A5300/IMPAACT2003: Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial Design
The World Health Organization has identified treatment of household contacts of multidrug-resistant tuberculosis patients as a priority for TB control. To that end, the Indo-JHU Clinical Research Partnership conducted a study to describe the feasibility of identifying, recruiting, and characterizing adult MDR TB index cases and their adult and child household contacts, and to describe the prevalence of latent tuberculosis infection, TB disease, and HIV infection among adult and child household contacts. The Mobile Health and Wellness Clinical was instrumental in screening and enrolling participants for this international study. The team enrolled 119 household contacts of 35 MDR-TB index cases during January 2016 to May 2016—the second highest enrolling site in the world. The Mobile Clinic proved particularly helpful in conducting 1-year follow-up visits to more than 100 participants. Because of the team’s ability to reach and retain participants, the research site has been selected as a site for the main PHOENIx study.
Strategies that improve health outcomes are not fixed or rigid; they are creative, innovative, and adaptive to meet the needs of individual patients. The Shah’s generous gift of the Mobile Health and Wellness Clinic has proven itself a powerful tool for keeping patients engaged in life saving healthcare in India.