Evaluating the integration of HIV self-testing into low-resource health systems: study protocol for a cluster-randomized control trial from EQUIP Innovations.

BACKGROUND: Throughout sub-Saharan Africa HIV-testing rates remain low. Barriers to testing, such as inconvenient service hours and long wait times, lack of privacy, and fear of unwanted disclosure, continue to impede service utilization. HIV self-testing (HIVST) is one strategy that addresses these barriers and has been shown to increase use of HIV-testing when distributed through community-based settings. However, the scalability of HIVST is limited because it has yet to be fully integrated into existing health systems and routine care. To address this gap, we designed a study to test the effect of offering HIVST to routine outpatient department (OPD) clients on uptake of HIV-testing as compared to standard of care and optimized standard of care. METHODS/DESIGN: This is a non-blinded, multi-site, cluster-randomized control trial. The health facility is the unit of randomization (cluster). Fifteen facilities were randomized to one of three arms: (1) Standard of care using routine provider-initiated testing and counseling (PITC); (2) Optimized standard of care using optimized PITC defined by additional training, job aids, and monitoring of PITC strategies with OPD providers and support staff; and (3) HIVST defined by HIVST demonstrations for OPD clients, HIVST kit distribution, and private spaces for HIVST kit use and/or interpretation. The primary outcome is the proportion of OPD clients tested for HIV on the day that they accessed OPD services. Secondary outcome measures are the proportion of OPD clients newly identified as HIV-positive and antiretroviral therapy (ART) initiation. Costs and cost-effectiveness will be evaluated. Nested studies will determine the acceptability of facility-based HIVST among OPD clients and health care providers, the presence of adverse events, such as coercion to test or unwanted status disclosure, and a process evaluation to determine feasibility and scale-up of facility-based HIVST for the future. DISCUSSION: This study protocol tests whether facility-based HIVST can positively contribute to HIV-testing among OPD clients in resource-limited settings. This will be one of the first studies to test the integration of HIVST into facility-based, primary health services in sub-Saharan Africa. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03271307 . Registered on 31 August 2017. Pan African Clinical Trials: PACTR201711002697316 . Registered on 1 November 2017.

American ginseng (Panax quinquefolius) administration does not affect performance of the Roche COBAS Ampliprep/Taqman HIV-1 RNA assay.

BACKGROUND: Previous data indicate that purified components of ginseng can inhibit HIV reverse transcriptase in vitro, suggesting that ginseng components in plasma may interfere with HIV-1 RNA detection assays. METHODS: Pre- and post-dose plasma from three volunteers dosed with 3000 mg American ginseng was spiked with HIV and analyzed by the Roche COBAS Ampliprep/Taqman v2.0 HIV-1 RNA assay. RESULTS: Presence of American ginseng had no significant effect on measured HIV-1 RNA concentration. Variation within pre- and post-dose plasma pair was insignificant and within assay performance limits. CONCLUSION: Plasma from subjects dosed with 3000 mg American ginseng does not interfere with the Roche COBAS Ampliprep/Taqman v2.0 HIV-1 RNA assay. This implies that in vitro inhibition of HIV reverse transcriptase by American ginseng components is unlikely to be clinically relevant.

The Global Drug Facility: a unique, holistic and pioneering approach to drug procurement and management.

In January 2006, the Stop TB Partnership launched the Global Plan to Stop TB 2006-2015, which describes the actions and resources needed to reduce tuberculosis (TB) incidence, prevalence and deaths. A fundamental aim of the Global Plan is to expand equitable access to affordable high-quality anti-tuberculous drugs and diagnostics. A principal tool developed by the Stop TB Partnership to achieve this is the Global Drug Facility (GDF). This paper demonstrates the GDFs unique, holistic and pioneering approach to drug procurement and management by analysing its key achievements. One of these has been to provide 9 million patient-treatments to 78 countries in its first 6 years of operation. The GDF recognized that the incentives provided by free or affordable anti-tuberculosis drugs are not sufficient to induce governments to improve their programmes standards and coverage, nor does the provision of free or affordable drugs guarantee that there is broad access to, and use of, drug treatment in cases where procurement systems are weak, regulatory hurdles exist or there are unreliable distribution and storage systems. Thus, the paper also illustrates how the GDF has contributed towards making sustained improvements in the capacity of countries worldwide to properly manage their anti-TB drugs. This paper also assesses some of the limitations, shortcomings and risks associated with the model. The paper concludes by examining the GDFs key plans and strategies for the future, and the challenges associated with implementation.

Multicenter comparison of Roche COBAS AMPLICOR MONITOR version 1.5, Organon Teknika NucliSens QT with Extractor, and Bayer Quantiplex version 3.0 for quantification of human immunodeficiency virus type 1 RNA in plasma.

The performance and characteristics of Roche COBAS AMPLICOR HIV-1 MONITOR version 1.5 (CA MONITOR 1.5) UltraSensitive (usCA MONITOR 1. 5) and Standard (stCA MONITOR 1.5) procedures, Organon Teknika NucliSens HIV-1 RNA QT with Extractor (NucliSens), and Bayer Quantiplex HIV RNA version 3.0 (bDNA 3.0) were compared in a multicenter trial. Samples used in this study included 460 plasma specimens from human immunodeficiency virus (HIV) type 1 (HIV-1)-infected persons, 100 plasma specimens from HIV antibody (anti-HIV)-negative persons, and culture supernatants of HIV-1 subtype A to E isolates diluted in anti-HIV-negative plasma. Overall, bDNA 3.0 showed the least variation in RNA measures upon repeat testing. For the Roche assays, usCA MONITOR 1.5 displayed less variation in RNA measures than stCA MONITOR 1.5. NucliSens, at an input volume of 2 ml, showed the best sensitivity. Deming regression analysis indicated that the results of all three assays were significantly correlated (P < 0.0001). However, the mean difference in values between CA MONITOR 1.5 and bDNA 3.0 (0.274 log(10) RNA copies/ml; 95% confidence interval, 0.192 to 0.356) was significantly different from 0, indicating that CA MONITOR 1.5 values were regularly higher than bDNA 3.0 values. Upon testing of 100 anti-HIV-negative plasma specimens, usCA MONITOR 1.5 and NucliSens displayed 100% specificity, while bDNA 3.0 showed 98% specificity. NucliSens quantified 2 of 10 non-subtype B viral isolates at 1 log(10) lower than both CA MONITOR 1.5 and bDNA 3.0. For NucliSens, testing of specimens with greater than 1,000 RNA copies/ml at input volumes of 0.1, 0.2, and 2.0 ml did not affect the quality of results. Additional factors differing between assays included specimen throughput and volume requirements, limit of detection, ease of execution, instrument work space, and costs of disposal. These characteristics, along with assay performance, should be considered when one is selecting a viral load assay.

Occult blood screening for colorectal carcinoma: a critical review.

The author reviews the literature on occult blood surveillance for colorectal carcinoma. The guaiac-based Hemoccult (SmithKline Diagnostics, Sunnyvale, Calif.) test is the most reliable and widely used. However, testing is complicated by several technical issues that can affect clinical results, and even successful screening programs will miss a high proportion of tumors. Public compliance is often poor, and a number of indirect and "hidden" costs make surveillance programs much more expensive than is usually claimed. Almost all published screening trials are uncontrolled. They generally detect about 3-20 colorectal malignancies for every 10,000 people enrolled, but only about 5%-10% of occult blood reactions are due to cancer. Though screen-detected tumors tend to be at a relatively early stage, this does not imply any benefit of surveillance because of lead time and length biases inherent in the screening process. Only controlled trials can answer the central question of whether screening decreases mortality from bowel cancer. Two such trials are underway, but mortality data are not yet available from either.