Delivering integrated strategies from a mobile unit to address the intertwining epidemics of HIV and addiction in people who inject drugs: the HPTN 094 randomized controlled trial protocol (the INTEGRA Study).

BACKGROUND: Persons with opioid use disorders who inject drugs (PWID) in the United States (US) face multiple and intertwining health risks. These include interference with consistent access, linkage, and retention to health care including medication for opioid use disorder (MOUD), HIV prevention using pre-exposure prophylaxis (PrEP), and testing and treatment for sexually transmitted infections (STIs). Most services, when available, including those that address substance misuse, HIV prevention, and STIs, are often provided in multiple locations that may be difficult to access, which further challenges sustained health for PWID. HPTN 094 (INTEGRA) is a study designed to test the efficacy of an integrated, "whole-person" strategy that provides integrated HIV prevention including antiretroviral therapy (ART), PrEP, MOUD, and STI testing and treatment from a mobile health delivery unit ("mobile unit") with peer navigation compared to peer navigation alone to access these services at brick and mortar locations. METHODS: HPTN 094 (INTEGRA) is a two-arm, randomized controlled trial in 5 US cities where approximately 400 PWID without HIV are assigned either to an experimental condition that delivers 26 weeks of "one-stop" integrated health services combined with peer navigation and delivered in a mobile unit or to an active control condition using peer navigation only for 26 weeks to the same set of services delivered in community settings. The primary outcomes include being alive and retained in MOUD and PrEP at 26 weeks post-randomization. Secondary outcomes measure the durability of intervention effects at 52 weeks following randomization. DISCUSSION: This trial responds to a need for evidence on using a "whole-person" strategy for delivering integrated HIV prevention and substance use treatment, while testing the use of a mobile unit that meets out-of-treatment PWID wherever they might be and links them to care systems and/or harm reduction services. Findings will be important in guiding policy for engaging PWID in HIV prevention or care, substance use treatment, and STI testing and treatment by addressing the intertwined epidemics of addiction and HIV among those who have many physical and geographic barriers to access care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04804072 . Registered on 18 March 2021.

Evaluating the cost-effectiveness of preventive zinc supplementation.

BACKGROUND: Even though the WHO currently recommends zinc for diarrhea management, no consensus has been reached with respect to routine distribution of zinc for preventive reasons. We reviewed the health impact of preventive zinc interventions, and evaluated the relative cost effectiveness of currently feasible interventions. METHODS: Using the latest relative risk estimates reported in the literature, we parameterized a health impact model, and calculated the expected benefits of zinc supplementation in a representative low-income country. We then computed the cost and cost-effectiveness for three delivery mechanisms: the direct distribution of zinc supplements, the distribution of micronutrient biscuits including zinc, and the distribution of zinc through water filtration systems. RESULTS: Combining all health outcomes and impact estimates, we find that systematic zinc supplementation among children of ages one to five would avert 1.423 DALYs per 100 households and year in least developed countries. The estimated cost per DALY is US$ 606 for pill supplementation, US$ 1211 for micronutrient biscuits, and US$ 879 per DALY saved for water filtration systems. CONCLUSIONS: Preventive zinc supplementation to children of ages 1-5 appears to be a highly cost-effective intervention in typical developing country settings. More research will be needed to determine the most effective mechanism to deliver zinc to this target population.