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4. Impact of population based indoor residual spraying in combination with mass drug administration on malaria incidence and test positivity in a high transmission setting in north eastern Uganda

Author

Mulebeke Ronald, Wanzira Humphrey, Yeka Adoke, and Van Geertruyden Jean-Pierre

Subjects
Arctic medicine. Tropical medicine, RC955-962, Infectious and parasitic diseases, RC109-216
Abstract

Abstract Background Mass drug administration (MDA) and indoor residual spraying (IRS) are potent malaria burden reduction tools. The impact of combining MDA and IRS is not well documented. We evaluated the impact of MDA + IRS compared to IRS alone at a high transmission site in Eastern Uganda. Methods A quasi-experimental study was implemented in Toroma and Kapujan subcounties in north eastern Uganda. Both subcounties received four rounds of IRS using primiphos-methyl (Acttellic SC300) 6–8 months apart from December 2016 to December 2018. Eligible residents of Kapujan simultaneously received MDA using dihydroartemesinin-piperaquine (DHA-PQ). Health facility data was used to monitor malaria case incidence rate and test positivity rates. Results In the MDA + IRS arm, malaria incidence dropped by 83% (IRR: 0·17 (0.16–0.18); p

Published
2023
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8. Implementation research of a cluster randomized trial evaluating the implementation and effectiveness of intermittent preventive treatment for malaria using dihydroartemisinin-piperaquine on reducing malaria burden in school-aged children in Tanzania: methodology, challenges, and mitigation

Author

Makenga, Geofrey, Seth, Misago D., Baraka, Vito, Mmbando, Bruno P., Challe, Daniel P., Francis, Filbert, Mhina, Athanas, Minja, Daniel T. R., Chiduo, Mercy, Mandara, Celine, Liheluka, Edwin, Gesase, Samwel, Segeja, Method, Mtove, George, Kamugisha, Mathias, Lusasi, Abdallah, Chacky, Frank, David, Anna, Thawer, Sumaiyya, Mohamed, Ally, Lazaro, Samwel, Molteni, Fabrizio, Nkayamba, Alex, Van geertruyden, Jean-Pierre, and Lusingu, John P. A.

Published
2023
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11. Cost-Effectiveness of Peer-Delivered HIV Self-Tests for MSM in Uganda

Author

Okoboi, Stephen, Castelnuovo, Barbara, Van Geertruyden, Jean-Pierre, Lazarus, Oucul, Vu, Lung, Kalibala, Sam, Kamara, Yvonne, Ochanda, Perez N, King, Rachel, and Mujugira, Andrew

Subjects
Public Health, Health Sciences, Prevention, Cost Effectiveness Research, Health Services, Sexually Transmitted Infections, Comparative Effectiveness Research, Infectious Diseases, Clinical Trials and Supportive Activities, Clinical Research, Behavioral and Social Science, Mental Health, HIV/AIDS, Infection, Good Health and Well Being, Africa South of the Sahara, Cost-Benefit Analysis, HIV Infections, Homosexuality, Male, Humans, Male, Pilot Projects, Sexual and Gender Minorities, Uganda, MSM, HIV, self-testing, peers, cost-effectiveness, Public Health and Health Services, Health services and systems, Public health
Abstract

Introduction: Distribution of HIV self-testing (HIVST) kits through MSM peer networks is a novel and effective strategy to increase HIV testing coverage in this high-risk population. No study has evaluated the cost or cost effectiveness of peer distribution of HIVST strategies among MSM in sub-Saharan Africa. Methods: From June to August 2018, we conducted a pilot study of secondary MSM peer HIVST kit distribution at The AIDS Support Organization at Entebbe and Masaka. We used an ingredients approach to estimate the cost of MSM peer HIVST kit distribution relative to standard-of-care (SOC) hotspot testing using programme expenditure data reported in US dollars. The provider perspective was used to estimate incremental cost-effective ratios per HIV infection averted using the difference in HIV annual transmission rates between MSM with HIV who knew their status and were not virologically suppressed and MSM with HIV who did not know their status. Results: We enrolled 297 participants of whom 150 received MSM peer HIVST kit distribution (intervention group) and 147 received TASO standard of care HIV testing (control group). Provider cost for the intervention was $2,276 compared with $1,827 for SOC during the 3-month study period. Overall, the intervention resulted in higher HIV positivity yield (4.9 vs. 1.4%) and averted more HIV infections per quarter (0.364 vs. 0.104) compared with SOC. The cost per person tested was higher for the intervention compared to SOC ($15.90 vs. $12.40). Importantly, the cost per new HIV diagnosis ($325 vs. $914) and cost per transmission averted ($6,253 vs. $ 17,567) were lower for the intervention approach relative to SOC. The incremental cost per HIV transmission averted by the self-testing program was $1,727. The incremental cost to providers per additional HIV-positive person identified by the intervention was $147.30. Conclusion: The intervention strategy was cost-effective, and identified more undiagnosed HIV infections than SOC hotspot testing at a cost-effectiveness threshold of US $2,129. Secondary distribution of HIVST kits through peers should further be evaluated with longer duration aimed at diagnosing 95% of all persons with HIV by 2030; the first UNAIDS 95-95-95 target.

Published
2021

13. Population pharmacokinetics of amodiaquine and piperaquine in African pregnant women with uncomplicated Plasmodium falciparum infections.

Author

Ding, Junjie, Hoglund, Richard M., Tagbor, Harry, Tinto, Halidou, Valéa, Innocent, Mwapasa, Victor, Kalilani‐Phiri, Linda, Van Geertruyden, Jean‐Pierre, Nambozi, Michael, Mulenga, Modest, Hachizovu, Sebastian, Ravinetto, Raffaella, D'Alessandro, Umberto, and Tarning, Joel

Subjects
SECOND trimester of pregnancy, PREGNANT women, THIRD trimester of pregnancy, GESTATIONAL age, PLASMODIUM falciparum
Abstract

Artemisinin‐based combination therapy (ACT) is the first‐line recommended treatment for uncomplicated malaria. Pharmacokinetic (PK) properties in pregnant women are often based on small studies and need to be confirmed and validated in larger pregnant patient populations. This study aimed to evaluate the PK properties of amodiaquine and its active metabolite, desethylamodiaquine, and piperaquine in women in their second and third trimester of pregnancy with uncomplicated P. falciparum infections. Eligible pregnant women received either artesunate‐amodiaquine (200/540 mg daily, n = 771) or dihydroartemisinin‐piperaquine (40/960 mg daily, n = 755) for 3 days (NCT00852423). Population PK properties were evaluated using nonlinear mixed‐effects modeling, and effect of gestational age and trimester was evaluated as covariates. 1071 amodiaquine and 1087 desethylamodiaquine plasma concentrations, and 976 piperaquine plasma concentrations, were included in the population PK analysis. Amodiaquine concentrations were described accurately with a one‐compartment disposition model followed by a two‐compartment disposition model of desethylamodiaquine. The relative bioavailability of amodiaquine increased with gestational age (1.25% per week). The predicted exposure to desethylamodiaquine was 2.8%–32.2% higher in pregnant women than that reported in non‐pregnant women, while day 7 concentrations were comparable. Piperaquine concentrations were adequately described by a three‐compartment disposition model. Neither gestational age nor trimester had significant impact on the PK of piperaquine. The predicted exposure and day 7 concentrations of piperaquine were similar to that reported in non‐pregnant women. In conclusion, the exposure to desethylamodiaquine and piperaquine was similar to that in non‐pregnant women. Dose adjustment is not warranted for women in their second and their trimester of pregnancy. [ABSTRACT FROM AUTHOR]

Published
2024
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15. Evaluating the effectiveness of enhanced family planning education on knowledge and use of family planning in fishing communities of Lake Victoria in Uganda: a randomized controlled trial

Author

Nanvubya, Annet, Wanyenze, Rhoda K., Abaasa, Andrew, Nakaweesa, Teddy, Mpendo, Juliet, Kawoozo, Barbarah, Matovu, Francis, Nabukalu, Sarah, Omoding, Geoffrey, Kaweesi, Jed, Ndugga, John, Bagaya, Bernard, Chinyenze, Kundai, Price, Matt A., and Van Geertruyden, Jean Pierre

Published
2022
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19. An ancillary care policy in a vaccine trial conducted in a resource-constrained setting: evaluation and policy recommendations

Author

Lemey, Gwen, primary, Larivière, Ynke, additional, Osang'ir, Bernard Isekah, additional, Zola, Trésor, additional, Kimbulu, Primo, additional, Milolo, Solange, additional, Danoff, Engbu, additional, Tchuma, Yves, additional, Maketa, Vivi, additional, Mitashi, Patrick, additional, Ravinetto, Raffaella, additional, Van Damme, Pierre, additional, Van geertruyden, Jean-Pierre, additional, and Muhindo-Mavoko, Hypolite, additional

Published
2024
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23. Effectiveness and safety of intermittent preventive treatment for malaria using either dihydroartemisinin-piperaquine or artesunate-amodiaquine in reducing malaria related morbidities and improving cognitive ability in school-aged children in Tanzania: A study protocol for a controlled randomised trial

Author

Makenga, Geofrey, Baraka, Vito, Francis, Filbert, Nakato, Swabra, Gesase, Samwel, Mtove, George, Madebe, Rashid, Kyaruzi, Edna, Minja, Daniel T.R., Lusingu, John P.A., and Van geertruyden, Jean-Pierre

Published
2020
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29. Low seroprevalence of Ebola virus in health care providers in an endemic region (Tshuapa province) of the Democratic Republic of the Congo

Author

Zola Matuvanga, Trésor, primary, Mariën, Joachim, additional, Larivière, Ynke, additional, Osang’ir, Bernard Isekah, additional, Milolo, Solange, additional, Meta, Rachel, additional, Esanga, Emmanuel, additional, Maketa, Vivi, additional, Matangila, Junior, additional, Mitashi, Patrick, additional, Ahuka Mundeke, Steve, additional, Muhindo-Mavoko, Hypolite, additional, Muyembe Tamfum, Jean-Jacques, additional, Van Damme, Pierre, additional, and Van Geertruyden, Jean-Pierre, additional

Published
2023
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31. Efficacy and safety of re-treatment with the same artemisinin-based combination treatment (ACT) compared with an alternative ACT and quinine plus clindamycin after failure of first-line recommended ACT (QUINACT): a bicentre, open-label, phase 3, randomised controlled trial

Author

Mavoko, Hypolite Muhindo, Nabasumba, Carolyn, da Luz, Raquel Inocêncio, Tinto, Halidou, D'Alessandro, Umberto, Kambugu, Andrew, Baraka, Vito, Rosanas-Urgell, Anna, Lutumba, Pascal, and Van geertruyden, Jean-Pierre

Published
2017
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36. Researchers' responsibilities in resource-constrained settings: experiences of implementing an ancillary care policy in a vaccine trial in the Democratic Republic of the Congo.

Author

Lemey, Gwen, Zola, Trésor, Larivière, Ynke, Milolo, Solange, Danoff, Engbu, Bakonga, Lazarre, Esanga, Emmanuel, Vermeiren, Peter, Maketa, Vivi, Matangila, Junior, Mitashi, Patrick, Van Damme, Pierre, Van geertruyden, Jean-Pierre, Ravinetto, Raffaella, and Muhindo-Mavoko, Hypolite

Subjects
VACCINE trials, RESEARCH personnel, INSURANCE policies, INFORMED consent (Medical law), TRADITIONAL medicine, INSURANCE crimes, TRAFFIC accidents, WELL-being
Abstract

In this paper, we discuss challenges associated with implementing a policy for Ancillary Care (AC) for related and unrelated (serious) adverse events during an Ebola vaccine trial conducted in a remote area of the Democratic Republic of the Congo. Conducting clinical trials in resourceconstrained settings can raise context-related challenges that have implications for study participants' health and wellbeing. During the Ebola vaccine study, three participants were injured in road traffic accidents, but there were unexpected difficulties when trying to apply the AC policy. First, because of the nature of the adverse events, the insurer refused to cover the costs. Second, the AC policy did not address treatments by traditional medicine, even though traditional medicines are frequently used and highly trusted in the study community. This highlighted a contrast between the researchers' well-intentioned AC approach and the participants' legitimate preferences. The way in which researchers should address their responsibility to provide AC is not straightforward; it requires contextualization. Our experience highlights the importance of involving community representatives and the local ethics committee to ensure development of an AC policy that is culturally and ethically appropriate. Additionally, the insurance contract should clearly stipulate which adverse events are linked to the trial participation, and thus eligible for coverage, to avoid controversies when claims are made. [ABSTRACT FROM AUTHOR]

Published
2024
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39. Implementation research of a cluster randomized trial evaluating the implementation and effectiveness of intermittent preventive treatment for malaria using dihydroartemisinin-piperaquine on reducing malaria burden in school-aged children in Tanzania:methodology, challenges, and mitigation

Author

Makenga, Geofrey, Seth, Misago D., Baraka, Vito, Mmbando, Bruno P., Challe, Daniel P., Francis, Filbert, Mhina, Athanas, Minja, Daniel T.R., Chiduo, Mercy, Mandara, Celine, Liheluka, Edwin, Gesase, Samwel, Segeja, Method, Mtove, George, Kamugisha, Mathias, Lusasi, Abdallah, Chacky, Frank, David, Anna, Thawer, Sumaiyya, Mohamed, Ally, Lazaro, Samwel, Molteni, Fabrizio, Nkayamba, Alex, Van geertruyden, Jean Pierre, Lusingu, John P.A., Makenga, Geofrey, Seth, Misago D., Baraka, Vito, Mmbando, Bruno P., Challe, Daniel P., Francis, Filbert, Mhina, Athanas, Minja, Daniel T.R., Chiduo, Mercy, Mandara, Celine, Liheluka, Edwin, Gesase, Samwel, Segeja, Method, Mtove, George, Kamugisha, Mathias, Lusasi, Abdallah, Chacky, Frank, David, Anna, Thawer, Sumaiyya, Mohamed, Ally, Lazaro, Samwel, Molteni, Fabrizio, Nkayamba, Alex, Van geertruyden, Jean Pierre, and Lusingu, John P.A.

Abstract

Background: It has been more than 20 years since the malaria epidemiologic shift to school-aged children was noted. In the meantime, school-aged children (5–15 years) have become increasingly more vulnerable with asymptomatic malaria prevalence reaching up to 70%, making them reservoirs for subsequent transmission of malaria in the endemic communities. Intermittent Preventive Treatment of malaria in schoolchildren (IPTsc) has proven to be an effective tool to shrink this reservoir. As of 3rd June 2022, the World Health Organization recommends IPTsc in moderate and high endemic areas. Even so, for decision-makers, the adoption of scientific research recommendations has been stifled by real-world implementation challenges. This study presents methodology, challenges faced, and mitigations used in the evaluation of the implementation of IPTsc using dihydroartemisinin-piperaquine (DP) in three councils (Handeni District Council (DC), Handeni Town Council (TC) and Kilindi DC) of Tanga Region, Tanzania so as to understand the operational feasibility and effectiveness of IPTsc on malaria parasitaemia and clinical malaria incidence. Methods: The study deployed an effectiveness-implementation hybrid design to assess feasibility and effectiveness of IPTsc using DP, the interventional drug, against standard of care (control). Wards in the three study councils were the randomization unit (clusters). Each ward was randomized to implement IPTsc or not (control). In all wards in the IPTsc arm, DP was given to schoolchildren three times a year in four-month intervals. In each council, 24 randomly selected wards (12 per study arm, one school per ward) were chosen as representatives for intervention impact evaluation. Mixed design methods were used to assess the feasibility and acceptability of implementing IPTsc as part of a more comprehensive health package for schoolchildren. The study reimagined an existing school health programme for Neglected Tropical Diseases (NT

Published
2023

46. Artemisinin-based combination therapy during pregnancy: outcome of pregnancy and infant mortality: a cohort study

Author

Nambozi, Michael, Tinto, Halidou, Mwapasa, Victor, Tagbor, Harry, Kabuya, Jean-Bertin Bukasa, Hachizovu, Sebastian, Traoré, Maminata, Valea, Innocent, Tahita, Marc Christian, Ampofo, Gifty, Buyze, Jozefien, Ravinetto, Raffaella, Arango, Diana, Thriemer, Kamala, Mulenga, Modest, van Geertruyden, Jean-Pierre, and D’Alessandro, Umberto

Published
2019
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47. Malaria Molecular Surveillance in the Peruvian Amazon with a Novel Highly Multiplexed Plasmodium falciparum AmpliSeq Assay

Author

Kattenberg, Johanna Helena, primary, Fernandez-Miñope, Carlos, additional, van Dijk, Norbert J., additional, Llacsahuanga Allcca, Lidia, additional, Guetens, Pieter, additional, Valdivia, Hugo O., additional, Van geertruyden, Jean-Pierre, additional, Rovira-Vallbona, Eduard, additional, Monsieurs, Pieter, additional, Delgado-Ratto, Christopher, additional, Gamboa, Dionicia, additional, and Rosanas-Urgell, Anna, additional

Published
2023
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49. Additional file 9 of Implementation research of a cluster randomized trial evaluating the implementation and effectiveness of intermittent preventive treatment for malaria using dihydroartemisinin-piperaquine on reducing malaria burden in school-aged children in Tanzania: methodology, challenges, and mitigation

Author

Makenga, Geofrey, Seth, Misago D., Baraka, Vito, Mmbando, Bruno P., Challe, Daniel P., Francis, Filbert, Mhina, Athanas, Minja, Daniel T. R., Chiduo, Mercy, Mandara, Celine, Liheluka, Edwin, Gesase, Samwel, Segeja, Method, Mtove, George, Kamugisha, Mathias, Lusasi, Abdallah, Chacky, Frank, David, Anna, Thawer, Sumaiyya, Mohamed, Ally, Lazaro, Samwel, Molteni, Fabrizio, Nkayamba, Alex, Van geertruyden, Jean-Pierre, and Lusingu, John P. A.

Abstract

Additional file 9: Appendix S9. Clinical episodes recording form.

Published
2023
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50. Additional file 2 of Implementation research of a cluster randomized trial evaluating the implementation and effectiveness of intermittent preventive treatment for malaria using dihydroartemisinin-piperaquine on reducing malaria burden in school-aged children in Tanzania: methodology, challenges, and mitigation

Author

Makenga, Geofrey, Seth, Misago D., Baraka, Vito, Mmbando, Bruno P., Challe, Daniel P., Francis, Filbert, Mhina, Athanas, Minja, Daniel T. R., Chiduo, Mercy, Mandara, Celine, Liheluka, Edwin, Gesase, Samwel, Segeja, Method, Mtove, George, Kamugisha, Mathias, Lusasi, Abdallah, Chacky, Frank, David, Anna, Thawer, Sumaiyya, Mohamed, Ally, Lazaro, Samwel, Molteni, Fabrizio, Nkayamba, Alex, Van geertruyden, Jean-Pierre, and Lusingu, John P. A.

Abstract

Additional file 2: Appendix S2. Drug dispensing log.

Published
2023
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