Does Intensive Treatment Select for Praziquantel Resistance in High-Transmission Settings? Parasitological Trends and Treatment Efficacy Within a Cluster-Randomized Trial

Abstract Background Praziquantel mass drug administration (MDA) is recommended in schistosomiasis-endemic areas. Animal models demonstrate Schistosoma parasite resistance to praziquantel after repeated exposure. Methods We conducted a parasitological survey in 26 fishing communities in Uganda after 4 years of quarterly (13 communities) or annual (13 communities) praziquantel MDA, with Schistosoma infection detected by single-stool-sample Kato-Katz. A test of cure was done in participants who were positive on both urine circulating cathodic antigen test and 3-sample Kato-Katz. We calculated cure rates (CRs) and egg reduction rates (ERRs) based on 3-sample Kato-Katz and infection intensity using worm-specific circulating anodic antigen (CAA) in blood, comparing these between quarterly and annually treated participants. Results Single-sample Kato-Katz Schistosoma mansoni prevalence was 22% in 1,056 quarterly treated participants and 34% in 1,030 annually treated participants (risk ratio, 0.62; 95% confidence interval [CI], 0.40 to 0.94). Among 110 test-of-cure participants, CRs were 65% and 51% in annually and quarterly treated villages, respectively (odds ratio, 0.65; 95% CI, 0.27 to 1.58); ERRs were 94% and 81% (difference, –13%; 95% CI, –48% to 2%). There was no impact of quarterly vs annual praziquantel on S. mansoni by CAA. Conclusions In this schistosomiasis hot spot, there was little evidence of decreased praziquantel efficacy. However, in the absence of alternative therapies, there remains a need for continued vigilance of praziquantel efficacy in the MDA era.

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Strategies for Improving Vaccine Delivery: A Cluster-Randomized Trial

10.1542/9781610022774-strategies ◽

2018 ◽

pp. 101-109

Author(s):

Linda Y. Fu ◽

Kathleen Zook ◽

Janet A. Gingold ◽

Catherine W. Gillespie ◽

Christine Briccetti ◽

...

Keyword(s):

Confidence Interval ◽

Randomized Trial ◽

Financial Incentives ◽

Odds Ratio ◽

Adjusted Odds Ratio ◽

Immunization Coverage ◽

Virtual Learning ◽

Cluster Randomized Trial ◽

Learning Collaborative ◽

Cluster Randomized

OBJECTIVE New emphasis on and requirements for demonstrating health care quality have increased the need for evidence-based methods to disseminate practice guidelines. With regard to impact on pediatric immunization coverage, we aimed to compare a financial incentive program (pay-for-performance [P4P]) and a virtual quality improvement technical support (QITS) learning collaborative. METHODS This single-blinded (to outcomes assessor), cluster-randomized trial was conducted among unaffiliated pediatric practices across the United States from June 2013 to June 2014. Practices received either the P4P or QITS intervention. All practices received a Vaccinator Toolkit. P4P practices participated in a tiered financial incentives program for immunization coverage improvement. QITS practices participated in a virtual learning collaborative. Primary outcome was percentage of all needed vaccines received (PANVR). We also assessed immunization up-to-date (UTD) status. RESULTS Data were analyzed from 3, 147 patient records from 32 practices. Practices in the study arms reported similar QI activities (∼6 to 7 activities). We found no difference in PANVR between P4P and QITS (mean ± SE, 90.7% ± 1.1% vs 86.1% ± 1.3%, P = 0.46). Likewise, there was no difference in odds of being UTD between study arms (adjusted odds ratio 1.02, 95% confidence interval 0.68 to 1.52, P = .93). In within-group analysis, patients in both arms experienced nonsignificant increases in PANVR. Similarly, the change in adjusted odds of UTD over time was modest and nonsignificant for P4P but reached significance in the QITS arm (adjusted odds ratio 1.28, 95% confidence interval 1.02 to 1.60, P = .03). CONCLUSIONS Participation in either a financial incentives program or a virtual learning collaborative led to self-reported improvements in immunization practices but minimal change in objectively measured immunization coverage.

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Design and Implementation of a Community Health Worker HIV Treatment and Prevention Intervention in an HIV Hot Spot Fishing Community in Rakai, Uganda

Journal of the International Association of Providers of AIDS Care (JIAPAC) ◽

10.1177/2325957417709089 ◽

2017 ◽

Vol 16 (5) ◽

pp. 499-505 ◽

Cited By ~ 4

Author(s):

Amanda Long ◽

Ismail Mbabali ◽

Heidi E. Hutton ◽

Alvin G. Thomas ◽

Eva Bugos ◽

...

Keyword(s):

Motivational Interviewing ◽

Hot Spot ◽

Cluster Randomized Trial ◽

Hiv Treatment ◽

Hiv Care ◽

Fishing Community ◽

Hiv Intervention ◽

Treatment And Prevention ◽

Novel Theory ◽

Cluster Randomized

Innovative approaches are needed to increase engagement in HIV treatment and prevention services, particularly in HIV hot spots. Here, we detail our design, training approach, and early implementation experiences of a community-based HIV intervention called “health scouts.” The intervention, utilizing a novel, theory-based approach, trained 10 community residents in an HIV hot spot fishing community to use motivational interviewing strategies and a mobile phone–based counseling application. During the first 3 months, 771 residents (median 82/health scout, range 27-160) were counseled. A directly observed Motivational Interviewing Treatment Integrity scale–based evaluation found adequate performance (median score 20/25, range 11-23). The health scout intervention was feasible to implement in a high HIV-prevalence fishing community, and its impact on HIV care outcomes will be evaluated in an ongoing cluster randomized trial. If found to be effective, it may be an important strategy for responding to HIV in high-burden settings.

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Test Non-Inferiority and Sample Size Determination Based on the Odds Ratio Under a Cluster Randomized Trial with Noncompliance

Journal of Biopharmaceutical Statistics ◽

10.1080/10543401003602623 ◽

2010 ◽

Vol 21 (1) ◽

pp. 94-110 ◽

Cited By ~ 3

Author(s):

Kung-Jong Lui ◽

Kuang-Chao Chang

Keyword(s):

Randomized Trial ◽

Sample Size ◽

Odds Ratio ◽

Cluster Randomized Trial ◽

Sample Size Determination ◽

Size Determination ◽

Cluster Randomized

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The Impact of Intensive Versus Standard Anthelminthic Treatment on Allergy-related Outcomes, Helminth Infection Intensity, and Helminth-related Morbidity in Lake Victoria Fishing Communities, Uganda: Results From the LaVIISWA Cluster-randomized Trial

Clinical Infectious Diseases ◽

10.1093/cid/ciy761 ◽

2018 ◽

Vol 68 (10) ◽

pp. 1665-1674 ◽

Cited By ~ 7

Author(s):

Richard E Sanya ◽

Gyaviira Nkurunungi ◽

Remy Hoek Spaans ◽

Margaret Nampijja ◽

Geraldine O’Hara ◽

...

Keyword(s):

Single Dose ◽

Randomized Trial ◽

Low Income ◽

Immunoglobulin E ◽

Lake Victoria ◽

Infection Intensity ◽

Cluster Randomized Trial ◽

Fishing Communities ◽

Cluster Randomized ◽

The Impact

Abstract Background The prevalence of allergy-related diseases is increasing in low-income countries. Parasitic helminths, common in these settings, may be protective. We hypothesized that intensive, community-wide, anthelminthic mass drug administration (MDA) would increase allergy-related diseases, while reducing helminth-related morbidity. Methods In an open, cluster-randomized trial (ISRCTN47196031), we randomized 26 high-schistosomiasis-transmission fishing villages in Lake Victoria, Uganda, in a 1:1 ratio to receive community-wide intensive (quarterly single-dose praziquantel plus albendazole daily for 3 days) or standard (annual praziquantel plus 6 monthly single-dose albendazole) MDA. Primary outcomes were recent wheezing, skin prick test positivity (SPT), and allergen-specific immunoglobulin E (asIgE) after 3 years of intervention. Secondary outcomes included helminths, haemoglobin, and hepatosplenomegaly. Results The outcome survey comprised 3350 individuals. Intensive MDA had no effect on wheezing (risk ratio [RR] 1.11, 95% confidence interval [CI] 0.64–1.93), SPT (RR 1.10, 95% CI 0.85–1.42), or asIgE (RR 0.96, 95% CI 0.82–1.12). Intensive MDA reduced Schistosoma mansoni infection intensity: the prevalence from Kato Katz examinations of single stool samples from each patient was 23% versus 39% (RR 0.70, 95% CI 0.55–0.88), but the urine circulating cathodic antigen test remained positive in 85% participants in both trial arms. Hookworm prevalence was 8% versus 11% (RR 0.55, 95% CI 0.31–1.00). There were no differences in anemia or hepatospenomegaly between trial arms. Conclusions Despite reductions in S. mansoni intensity and hookworm prevalence, intensive MDA had no effect on atopy, allergy-related diseases, or helminth-related pathology. This could be due to sustained low-intensity infections; thus, a causal link between helminths and allergy outcomes cannot be discounted. Intensive community-based MDA has a limited impact in high-schistosomiasis-transmission fishing communities, in the absence of other interventions. Clinical Trials Registration ISRCTN47196031.

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