Collaborative Research Networks

CBAR provides statistical leadership and expertise to collaborative research networks in HIV and other infectious diseases in the United States and internationally. This includes representing the Statistical and Data Analysis Center (SDAC) and the Data and Operations Center (DOC) for the following research networks:

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections – ACTG (formerly known as the AIDS Clinical Trials Group)

The ACTG is an international cooperative clinical trials group dedicated to research in the treatment of HIV/AIDS, and the treatment and prevention of co-infections and other co-morbidities that affect HIV-infected people, notably tuberculosis and viral hepatitis. The ACTG is primarily funded by the National Institute of Allergy and Infectious Diseases (NIAID), with funding from other NIH Institutes including NCI and NIMH.

Selected Recent Publications

Marc JB, McCarthy C, Wallis CL, Kityo C, Hughes MD, Godfrey C, Shah NS, Parikh UM, Maartens G, Kanyike F, Van Schalkwyk M, Kihumuro RB, Asiimwe P, Tsikhutsu I, Munyanga C, Some FF, Joseph Y, Flowers T, Mohapi L, Samaneka WP, Mponda K, Rassool MS, Pierre S, Woolley E, Manabe YC, Mellors JW, Flexner C, Koenig SP, Mngqibisa R; ACTG A5381–Hakim Study Team. Virological and drug-resistance outcomes for people living with HIV initiating or switching to tenofovir, lamivudine, and dolutegravir in six PEPFAR-supported countries: a prospective cohort study. Lancet HIV. 2025 Dec;12(12):e836-e849. doi: 10.1016/S2352-3018(25)00162-6. PMID: 41314742; PMCID: PMC12751040.

Harrison LJ, Velásquez GE, Kempker RR, Imperial MZ, Nuermberger E, Dorman SE, Ignatius E, Granche J, Phillips PPJ, Furin J, Yang E, Foley C, Chiambah S, Rogers R, Van Grack A, Roa J, Shenje J, Nerette S, Kanyama C, Kyeyune RB, Mendoza-Ticona A, Murtaugh W, Foraida S, Goth M, Vernon A, Dooley KE, Savic RM. ACTG A5409 (RAD-TB): Study protocol for a phase 2 randomized, adaptive, dose-ranging, open-label trial of novel regimens for the treatment of pulmonary tuberculosis. Trials. 2025 August 15;26(1):291. PubMed PMID: 40817073; PubMed Central PMCID: PMC12357366; DOI: 10.1186/s13063-025-08973-w.

Han WM, Solomon SS, Smeaton L, Avihingsanon A, Wagner Cardoso S, Li J, Parvangada A, Sulkowski M, Naggie S, Martin R, Mo H, Maiorova E, Wyles D. Reinfection and Resistance Associated Substitutions Following a Minimal Monitoring Approach for Hepatitis C Virus Treatment in MINMON Trial. Clin Infect Dis. 2025 Jul 18;80(6):1293-1301. doi: 10.1093/cid/ciae627. PMID: 39702964; PMCID: PMC12272843

Marks KM, Kang M, Umbleja T, Cox A, Vigil KJ, Avihingsanon A, Sugandhavesa P, Katsidzira L, Kosgei J, Perazzo H, Price J, Caruso S, Knowles K, Alston-Smith BL, Rathod P, Sherman KE; ACTG 5379 (BEe-HIVe) Study Team. HepB-CpG Vaccine in People With HIV and Prior Nonresponse to HBV Vaccine: The BEe-HIVe Trial End-of-Study Results. JAMA. 2025 Jul 2:e259894. doi: 10.1001/jama.2025.9894. Epub ahead of print. PMID: 40601334; PMCID: PMC12224048. ACTG 5379

Giganti MJ, Chew KW, Moser C, Eron JJ, Pinilla M, Li JZ, Ritz J, Javan AC, Wohl DA, Daar ES, Currier JS, Smith DM, Hughes MD; ACTIV-2/A5401 Study Team. Implementation of a seamless phase 2/3 study design in the setting of an emergent infectious disease pandemic: Lessons learned from the ACTIV-2 platform COVID-19 treatment trial. Contemp Clin Trials. 2025 Jun;153:107887. doi: 10.1016/j.cct.2025.107887. Epub 2025 Mar 25. PMID: 40147543; PMCID: PMC12085286.

Torres TS, Saha PT, Smeaton L, Wimbish C, Kliemann DA, Avihingsanon A, Kityo C, Bennet JA, Van Schalkwyk M, Linas B, Nunes EP, Robbins GK, Wyles D, Naggie S, Sulkowski M, Cardoso SW, Solomon S. Impact of a minimal monitoring HCV treatment approach on Health-Related Quality of Life. Qual Life Res. 2025 Jun;34(6):1683-1694. doi: 10.1007/s11136-025-03922-1. Epub 2025 Feb 28. PMID: 40019678; PMCID: PMC12413691.

Zheng Y, Currier JS, Hughes MD. Precision medicine evaluation of heterogeneity of treatment effect for a time-to-event outcome with application in a trial of Initial treatment for people living with HIV. Clin Trials. 2025 May 22:17407745251338558. doi: 10.1177/17407745251338558. Epub ahead of print. PMID: 40400339; PMCID: PMC12353116.

Kolossváry M, Schnittman SR, Zanni MV, Fitch KV, Fichtenbaum CJ, Aberg JA, Bloomfield GS, Malvestutto CD, Currier J, Diggs MR, deFilippi C, Eckard AR, Curran A, Centinbas M, Sadreyev R, Foldyna B, Mayrhofer T, Karady J, Taron J, McCallum S, Lu MT, Ribaudo HJ, Douglas PS, Grinspoon SK. Pitavastatin, Procollagen Pathways, and Plaque Stabilization in Patients With HIV: A Secondary Analysis of the REPRIEVE Randomized Clinical Trial. JAMA Cardiol. 2025 Mar 1;10(3):254-264. doi: 10.1001/jamacardio.2024.4115. PMID: 39661372; PMCID: PMC11771813.

International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network

The IMPAACT Network is an international cooperative clinical trial groups dedicated to research in the treatment of children and adolescents with HIV/AIDS, its complications, and other infectious diseases that affect HIV-infected people, notably tuberculosis.  It also has a major focus on research to prevent mother-to-child transmission of HIV. IMPAACT is primarily funded by the NIAID and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Selected Recent Publications

Kendall MA, Hughes MD, Kim S, Aaron LA, Naini L, Suryavanshi N, Shah NS, Rouzier V, Hafkin J, Sise T, Beck J, Heckman BE, Haberer JE, Harrington M, Scarsi KK, Hesseling AC, Swindells S, Churchyard GJ, Gupta A. Protecting households on exposure to newly diagnosed index multidrug-resistant tuberculosis patients: Study protocol for the PHOENIx phase 3 clinical trial. Contemp Clin Trials. 2025 Nov;158:108084. doi: 10.1016/j.cct.2025.108084. Epub 2025 Sep 22. PMID: 40992540; PMCID: PMC12709595.

Persaud D, Coletti A, Nelson BS, Jao J, Capparelli EV, Costello D, Tierney C, Kekitiinwa AR, Nematadzira T, Njau BN, Moye J, Jean-Philippe P, Korutaro V, Nalugo A, Mbengeranwa T, Chidemo T, Mmbaga BT, Sakasaka PA, Cotton M, Jennings C, Hoffmann C, Hovind L, Bryson Y, Chadwick EG; IMPAACT P1115 Study Team. ART-free HIV-1 remission in children with in-utero HIV-1 after very early ART (IMPAACT P1115): a multicentre, open-label, phase 1/2 proof-of-concept study. Lancet HIV. 2025 Nov;12(11):e743-e752. doi: 10.1016/S2352-3018(25)00189-4. Epub 2025 Sep 25. PMID: 41015049.

Mbengeranwa TG, Ziemba L, Brummel SS, Johnston B, Cassim H, Theron G, Ngqawana Z, Wabwire D, McCarthy K, Shepherd J, Lockman S, Chinula L, Stranix-Chibanda L; IMPAACT 2010/VESTED study team and investigators. Bone Mineral Content, Growth, and Renal Health of Infants With Perinatal Exposure to Maternal Dolutegravir Versus Efavirenz and Tenofovir Disoproxil Fumarate Versus Tenofovir Alafenamide: The Randomized IMPAACT 2010 (VESTED) Trial. J Acquir Immune Defic Syndr. 2025 Jun 1;99(2):211-219. doi: 10.1097/QAI.0000000000003656. PMID: 40001275: PMCID: PMC12455726

Rabie H, Yin DE, Ward S, Rani Y, Ziemba L, Brooks KM, Cressey TR, Masheto GR, Cassim H, Deville JG, Ponatshego PL, Patel F, Aurpibul L, Barnabas SL, Mustich I, Coletti A, Heckman B, Krotje C, Townley E, Moye J, Majji S, Acosta EP, Ryan K, Chandasana H, Brothers CH, Buchanan AM, Flynn PM; IMPAACT 2019 Study Team. Efficacy, Safety and Tolerability of Dispersible and Immediate Release Abacavir/Dolutegravir/Lamivudine Tablets in Children With HIV: IMPAACT 2019 Week 48 Results. Pediatr Infect Dis J. 2025 May 29;44(8):777-784. doi: 10.1097/INF.0000000000004859. PMID: 40440679; PMCID: PMC12221218.

Hughes JA, Pinilla M, Brooks KM, Eke AC, Stek A, Best BM, Mirochnick M, Browning R, Wiesner L, George K, Knowles K, De Koker P, Ngocho JS, Fairlie L, Chakhtoura N, Hesseling AC, Decloedt E, Shapiro DE, van Schalkwyk M; IMPAACT P1026s Protocol Team. Pharmacokinetics and Safety of Levofloxacin for Treatment of Rifampicin-Resistant Tuberculosis During Pregnancy and the Postpartum Period: Results from IMPAACT P1026s. Clin Pharmacokinet. 2025 Apr;64(4):619-630. doi: 10.1007/s40262-025-01498-0. Epub 2025 Mar 28. PMID: 40155501; PMCID: PMC12041113

Moore CB, Baltrusaitis K, Best BM, Moye JH, Townley E, Violari A, Heckman B, Buisson S, Van Solingen-Ristea RM, Capparelli EV, Marzinke MA, Lowenthal ED, Ward S, Krotje C, Milligan R, Agwu AL, Huang J, Cheung SYA, McCoig C, Yin DE, Roberts G, Crauwels H, Van Eygen V, Zabih S, Masheto G, Ounchanum P, Aurpibul L, Korutaro V, Gaur AH; IMPAACT 2017 Collaborators for the IMPAACT 2017 Team. Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study. Lancet HIV. 2025 Mar;12(3):e191-e200. doi: 10.1016/S2352-3018(24)00344-8. PMID: 40049924; PMCID: PMC12087306

Barr EA, Baltrusaitis K, Kennard BD, Emslie GJ, Krotje C, Knowles K, Buisson S, Bergam L, Deville JG, Gillespie SL, Shikora M, Townley E, Shapiro DE, Brown LK. Participant acceptability and clinician satisfaction of cognitive behavioural therapy and medication management algorithm compared with enhanced standard care for treatment of depression among youth with HIV. J Child Adolesc Ment Health. 2024 Nov 17:1-16. doi: 10.2989/17280583.2024.2387632. Epub ahead of print. PMID: 39550758;PMCID: PMC12439113.

Pediatric HIV/AIDS Cohort Study (PHACS)

Between 2005-2025, the Pediatric HIV/AIDS Cohort Study (PHACS) network conducted longitudinal cohort studies investigating the long-term effects of HIV and antiretroviral (ARV) medications in infants, children, adolescents, and young adults (YA) living with perinatal HIV (PHIV) or born HIV-negative to mothers living with HIV. Six different studies were conducted (SMARTT, AMP, AMP Up, AMP Up Lite, TERBO BRAIN, and ASTRO) at 21 clinical sites across the U.S., and enrolled over 10,000 participants followed for a median of 7 years.  Starting in 2025, the PHACS network transitioned to a single study called PHACS RISE (Research on Immune aging, Supporting reproductive health, and perinatal acquisition: Elucidating relationships in HIV) which focuses on biological aging and reproductive health in adult men and women with HIV, with a particular focus on those with perinatally acquired HIV.  It is primarily funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), with co-funding from NIDCR, NIAID, and NHLBI.  ​

See the PHACS network website for more detail:  www.phacsstudy.org

Selected Recent Publications

Khetan P, Patel K, Yu W, Szewczyk J, Dhummakupt A, Burchett S, Van Dyke RB, Persaud D. Dynamics of intact and defective HIV-1 proviruses during decades of suppressive antiretroviral treatment in young adults with perinatal HIV-1. J Infect Dis. 2026 Jan 30:jiag045. Epub ahead of print. https://pubmed.ncbi.nlm.nih.gov/41616083/

Serghides L, Lee J, JacobsonDL, Geffner ME, DiMeglio LA, McFarland EJ, Powis KM, WilliamsPL, Jao J: Pediatric HIV/AIDS Study. Is perinatal exposure to HIV and protease inhibitors associated with timing of pubertal onset?  AIDS 2025; https://pubmed.ncbi.nlm.nih.gov/41259113/

Williams PL, Boahene M, Mash L, Chadwick EG, Huo Y, Spector SA, Oetting J, Garvie P, Smith R. Maternal use of integrase strand transfer inhibitors during pregnancy and infant neurodevelopment.  JAMA Netw Open 2025; Nov 3;8(11):e2545652.  https://pubmed.ncbi.nlm.nih.gov/41296482/

Patel K, Jaramillo-Underwood A, Karalius B, Yao TJ, Van Dyke RB, Mirza A, Jao J, Agwu AL, for the Pediatric HIV/AIDS Cohort Study (PHACS). Integrase strand transfer inhibitors for treatment-experienced young adults with perinatal HIV in the US: immunologic, virologic, and anthropometric outcomes. Clin Infect Dis. 2025;  https://pubmed.ncbi.nlm.nih.gov/41123331/

Tassiopoulos K, Huo Y, Kacanek D, Malee K, Nichols S, Mellins CA, Kohlhoff S, Van Dyke RB; Pediatric HIV/AIDS Cohort Study. Association of Perceived Social Support with Viral Suppression Among Young Adults with Perinatally-Acquired HIV in the US-based Pediatric HIV/AIDS Cohort Study (PHACS). Clin Epidemiol. 2023 May 9;15:601-611. https://pubmed.ncbi.nlm.nih.gov/37193342/

Yao TJ, Zhang Z, Malee K, Smith R, Rice M, Redmond SM, Williams PL for the Pediatric HIV/AIDS Cohort Study (PHACS). Prenatal Antiretroviral Exposure and Concomitant Neurodevelopmental problems among 5-year-old children who are HIV-exposed and uninfected. J Acquired Immune Defic Synd 2025,  Oct 1;100(2):131-136.  https://pubmed.ncbi.nlm.nih.gov/40553012/

Other research projects include:

The Biostatistical Core for the Harvard University Center for AIDS Research (CFAR)

The Botswana Harvard AIDS Institute Partnership (BHP)

Data Coordinating Center for the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE)

Completed research project:

CBAR provided statistical expertise for the design, analysis, and interpretation of results of studies undertaken by the NIAID Influenza Research Collaboration (IRC). The IRC was a collaboration of centers that conducted studies (including clinical trials) to advance knowledge concerning the treatment and prevention of influenza infections. The IRC was set up by NIAID to provide a rapid mechanism for evaluating interventions for the treatment and prevention of influenza, motivated initially by the possibility of an H1N1 influenza epidemic.

Selected Recent Publications

Beigel JH, Aga E, Elie-Turenne MC, Cho J, Tebas P, Clark CL, Metcalf JP, Ozment C, Raviprakash K, Beeler J, Holley HP Jr, Warner S, Chorley C, Lane HC, Hughes MD, Davey RT Jr. Anti-influenza immune plasma for the treatment of patients with severe influenza A: a randomised, double-blind, phase 3 trial. Lancet Respir Med. 2019 Nov;7(11):941-950. doi: 10.1016/S2213-2600(19)30199-7. Epub 2019 Sep 30. PubMed PMID: 31582360; PubMed Central PMCID: PMC6941345. https://pmc.ncbi.nlm.nih.gov/articles/PMC6941345/

Beigel JH, Manosuthi W, Beeler J, Bao Y, Hoppers M, Ruxrungtham K, Beasley RL, Ison M, Avihingsanon A, Losso MH, Langlois N, Hoopes J, Lane HC, Holley HP, Myers CA, Hughes MD, Davey RT. Effect of Oral Oseltamivir on Virological Outcomes in Low-risk Adults With Influenza: A Randomized Clinical Trial. Clin Infect Dis. 2020 May 23;70(11):2317-2324. doi: 10.1093/cid/ciz634. PMID: 31541242; PMCID: PMC7245154. https://pubmed.ncbi.nlm.nih.gov/31541242/

Beigel JH, Tebas P, Elie-Turenne MC, Bajwa E, Bell TE, Cairns CB, Shoham S, Deville JG, Feucht E, Feinberg J, Luke T, Raviprakash K, Danko J, O’Neil D, Metcalf JA, King K, Burgess TH, Aga E, Lane HC, Hughes MD, Davey RT; IRC002 Study Team. Immune plasma for the treatment of severe influenza: an open-label, multicentre, phase 2 randomised study. Lancet Respir Med. 2017 Jun;5(6):500-511. doi: 10.1016/S2213-2600(17)30174-1. Epub 2017 May 15. Erratum in: Lancet Respir Med. 2017 Jul;5(7):e26. doi: 10.1016/S2213-2600(17)30225-4. PMID: 28522352; PMCID: PMC5828518. https://pubmed.ncbi.nlm.nih.gov/28522352/

Beigel JH, Bao Y, Beeler J, Manosuthi W, Slandzicki A, Dar SM, Panuto J, Beasley RL, Perez-Patrigeon S, Suwanpimolkul G, Losso MH, McClure N, Bozzolo DR, Myers C, Holley HP Jr, Hoopes J, Lane HC, Hughes MD, Davey RT; IRC003 Study Team. Oseltamivir, amantadine, and ribavirin combination antiviral therapy versus oseltamivir monotherapy for the treatment of influenza: a multicentre, double-blind, randomised phase 2 trial. Lancet Infect Dis. 2017 Dec;17(12):1255-1265. doi: 10.1016/S1473-3099(17)30476-0. Epub 2017 Sep 22. PMID: 28958678; PMCID: PMC5777222. https://pubmed.ncbi.nlm.nih.gov/28958678/

Beigel JH, Aga E, Elie-Turenne MC, Cho J, Tebas P, Clark CL, Metcalf JP, Ozment C, Raviprakash K, Beeler J, Holley HP Jr, Warner S, Chorley C, Lane HC, Hughes MD, Davey RT Jr; IRC005 Study Team. Anti-influenza immune plasma for the treatment of patients with severe influenza A: a randomised, double-blind, phase 3 trial. Lancet Respir Med. 2019 Nov;7(11):941-950. doi: 10.1016/S2213-2600(19)30199-7. Epub 2019 Sep 30. PMID: 31582360; PMCID: PMC6941345. https://pubmed.ncbi.nlm.nih.gov/31582360/