Protocol Operations Core – Science & Research
| Protocol Number | Description | Protocol Status | Research Area |
|---|---|---|---|
| HPTN 112 (39057)  | Improving HIV prevention among heterosexual men seeking STI services in Malawi: examining the benefits, acceptability, and associated costs of a systems-navigator-delivered integrated prevention package | Enrolling | Integrated Strategy |
| HPTN 111 (39062)  | Feasibility and Acceptability of a Barbershop Based HIV Prevention Initiative Among Heterosexual Men in Kalangala Islands, Uganda: A Cluster Randomized Trial | Closed to Accrual | Integrated Strategy |
| HVTN 143/HPTN 109 (39015) | A phase 1- clinical trial to evaluate the safety, tolerability, pharmacokinetics and tolerability of combinations of monoclonal antibodies VRC01.23LS, PGT121.414.LS, and PGDM1400LS administered via intravenous infusion in adults without HIV | Withdrawn | Antibody Mediated Prevention |
| A5416/HVTN 806/HPTN 108 (39006) | A Phase I, Randomized, Placebo-Controlled Study of the Safety, Antiviral & Immunomodulatory Activity of Broadly Neutralizing Antibodies 3BNC117-LS-J and 10-1074-LS-J in Combination in ART-treated Adults in sub-Saharan Africa Living with HIV during a Monitored Analytical Treatment Interruption | Enrolling | Antibody Mediated Prevention |
| DMID 19-0004/HPTN 107 | A Phase II randomized, observer-blind, placebo-controlled study, to assess efficacy of meningococcal Group B vaccine rMenB+OMV NZ (Bexsero) in preventing gonococcal infection. | Enrolling | |
| HPTN 106 (39002)  | A Phase 2 Crossover Study of On Demand PrEP Formulations Comparing Rectal and Oral TFV-Based PrEP Evaluating Extended Safety, Acceptability, and PK/PD | Pending | |
| HVTN 140/HPTN 101 (154188) | A phase 1 dose-escalation clinical trial to evaluate the safety, tolerability, and pharmacokinetics of PGDM1400LS alone and in combination with VRC07-523LS and PGT121.414.LS in healthy, HIV-uninfected adult participants | Closed to Follow Up | Antibody Mediated Prevention |
| CoVPN 5002 (38749) | SARS-CoV-2 Prevalence Survey | Closed to Follow Up | COVID-19 |
| HPTN 083-02 (38645) | Factors Influencing Adherence to Injectable PrEP and Retention in an Injectable PrEP Research Study | Closed to Follow Up | PrEP |
| HPTN 096 (38561)  | Getting to Zero Among Black MSM in the American South: Testing the Efficacy of an Integrated Intervention Strategy | Enrolling | Integrated Strategy |
| HVTN 804/HPTN 095 (38632) | Antiretroviral analytical treatment interruption (ATI) to assess immunologic and virologic responses in participants who received VRC01 or placebo and became HIV-infected during HVTN 704/HPTN 085 | Closed to Accrual | Other |
| HPTN 094 (38715) | INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit to Link Persons who Inject Drugs to Integrated Care and Prevention for Addiction, HIV, HCV and Primary Care. | Closed to Accrual | Integrated Strategy |
| HVTN 805/HPTN 093 (38691) | Antiretroviral analytical treatment interruption (ATI) to assess immunologic and virologic responses in participants who initiated ART in early HIV infection after having received VRC01 or placebo in HVTN 703/HPTN 081 | Closed to Follow Up | Other |
| HPTN 084-01 (38655)  | Ancillary Study: Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (LA CAB) for the Prevention of HIV among Adolescents | Closed to Follow Up | PrEP |
| HPTN 083-01 (38654)  | Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV among Adolescent Males – A sub-study of HPTN 083 | Closed to Follow Up | PrEP |
| HVTN 136/HPTN 092 (38634) | A phase 1 dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of the monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS via intravenous infusion or via subcutaneous injections in healthy, HIV-uninfected adult participants. | Closed to Follow Up | Antibody Mediated Prevention |
| HPTN 091 (38695)  | Integrating HIV Prevention, Gender-Affirmative Medical Care, and Peer Health Navigation to Prevent HIV Acquisition and HIV Transmission for Transgender Women in the Americas: A Vanguard Feasibility and Acceptability Study | Closed to Accrual | Integrated Strategy |
| HVTN 130/HPTN 089 (38531) | A phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS administered via intravenous infusion in healthy, HIV-uninfected adult participants | Concluded | Antibody Mediated Prevention |
| HVTN 127/HPTN 087 (38458) | A multicenter, randomized, partially blinded phase 1 clinical trial to evaluate the safety and serum concentrations of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple doses and routes to healthy, HIV-uninfected adults. | Concluded | Antibody Mediated Prevention |
| HPTN 084 (38070)  | A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women. | Closed to Accrual | PrEP |
| HVTN 704/HPTN 085 (30095)  | A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection among men and transgender persons who have sex with men. | Concluded | Antibody Mediated Prevention |
| HPTN 083 (20725)  | A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), for Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women who have Sex with Men | Closed to Accrual | PrEP |
| HPTN 082 (12068)  | Evaluation of Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study | Concluded | PrEP |
| HVTN 703/HPTN 081 (12045)  | A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection in women in sub-Saharan Africa. | Concluded | Antibody Mediated Prevention |
| HPTN 078 (11995) | Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected Men Who Have Sex with Men (MSM) in the United States | Concluded | Integrated Strategy |
| HPTN 077 (11964) | A Phase IIa Safety, Tolerability and Acceptability Study of an Investigational Injectable HIV Integrase Inhibitor, GSK1265744, for PrEP in HIV Uninfected Men and Women | Concluded | PrEP |
| HPTN 076 (11944) | Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278 LA, for Pre Exposure Prophylaxis (PrEP) | Concluded | PrEP |
| HPTN 075 (11943) | Feasibility of HIV Prevention Cohort Studies Among MSM in Sub-Saharan Africa | Concluded | Behavioral |
| HPTN 074 (11917) | Integrated Treatment and Prevention for People Who Inject Drugs: A Vanguard study for a Network-based Randomized HIV Prevention Trial Comparing an Integrated Intervention Including Supported Antiretroviral Therapy to the Standard of Care | Concluded | Treatment as Prevention |
| HPTN 071 (11865)  | Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART): A cluster-randomized trial of the impact of a combination prevention package on population-level HIV incidence in Zambia and South Africa | Archived | Treatment as Prevention |
| HPTN 073 (11894) | Pre-Exposure Prophylaxis (PrEP) Initiation and Adherence among Black Men who have Sex with Men (BMSM) in Three U.S. Cities | Concluded | PrEP |
| HPTN 069 (11789) | A Phase II Randomized, Double-Blind, Study of the Safety and Tolerability of Maraviroc (MVC), Maraviroc + Emtricitabine (MVC+FTC), Maraviroc + Tenofovir disoproxil fumarate (MVC+TDF), or Tenofovir disoproxil fumarate + Emtricitabine (TDF+FTC) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV Transmission in At-Risk Men Who Have Sex with Men and in At-Risk Women | Concluded | PrEP |
| HPTN 068 (11710) | Effects of cash transfer for the prevention of HIV in young South African women | Concluded | Structural |
| HPTN 067 (10852) | A Phase II, Randomized, Open-Label, Pharmacokinetic and Behavioral Study of the Use of Intermittent Oral Emtricitabine/Tenofovir Disoproxil Fumarate Pre-Exposure Prophylaxis (PrEP) | Concluded | PrEP |
| HPTN 066 (10851) | Dose-Proportionality and Intra-Individual Variability of Intracellular Tenofovir Diphosphate and Emtricitabine Triphosphate in Healthy Volunteers | Concluded | Antiretroviral Therapy |
HPTN 065 (11685) | TLC-Plus: A Study to Evaluate the Feasibility of an Enhanced Test, Link to Care, Plus Treat Approach for HIV Prevention in the United States | Concluded | Integrated Strategy |
| HPTN 064 (10705) | The Women’s HIV SeroIncidence Study | Concluded | Behavioral |
| HPTN 063 (10668) | Preparing for international prevention trials involving HIV-infected individuals in care settings | Concluded | Behavioral |
| HPTN 062 (10667) | Feasibility and Acceptability Study of an Individual-Level Behavioral Intervention for Individuals with Acute and Early HIV-Infection | Concluded | Behavioral |
| HPTN 061 (10666) | Feasibility of a community-level, multi-component intervention for Black MSM in preparation for a Phase IIB community-level randomized trial to test the efficacy of the intervention in reducing HIV incidence among Black MSM | Concluded | Behavioral |
| HPTN 039-01 (10067) | Ancillary Study: Prospective Cohort Study of HPTN 039 Seroconverters: The Effect of HSV-2 Suppression on HIV-1 Viral Set Point | Concluded | STD Control |
| HPTN 059 (10145) | Phase II Expanded Safety and Acceptability Study of the Vaginal Microbicide 1% Tenofovir Gel | Concluded | Microbicides |
| HPTN 058 (10144) | A Phase III randomized controlled trial to evaluate the efficacy of drug treatment in prevention of HIV infection and death among opiate dependent injectors | Concluded | Substance Use |
| HPTN 057 (10143) | A Phase I Open Label Trial of the Safety and Pharmacokinetics of Tenofovir Disoproxil Fumarate in HIV-1 Infected Pregnant Women and their Infants | Concluded | Perinatal |
HPTN 056 | Characterization of Baseline Mucosal Indices of Injury and Inflammation in Men for Use in Rectal Microbicide Trials | Concluded | Microbicides |
| HPTN 055 | HIV Prevention Preparedness Study | Concluded | Microbicides |
HPTN 052 (10068) | A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples | Concluded | Treatment as Prevention |
| HPTN 043 | A Phase III Randomized Controlled Trial of Community Mobilization, Mobile Testing, Same-Day Results, and Post-Test Support for HIV in Sub-Saharan Africa and Thailand | Concluded | Structural |
| HPTN 037 (10125) | A Phase III Randomized Study to Evaluate the Efficacy of a Network-oriented Peer Educator Intervention for the Prevention of HIV Transmission Among Injection Drug Users And Their Network Members | Concluded | Substance Use |
| HPTN 046 (10142) | Phase III Trial to Determine the Efficacy and Safety of an Extended Regimen of Nevirapine in Infants Born to HIV Infected Women to Prevent Vertical HIV Transmission During Breastfeeding | Concluded | Perinatal |
| HPTN 049 | Phase I Safety and Acceptability Study of the Vaginal Microbicide 6% Cellulose Sulfate Gel Among HIV-Infected Women | Concluded | Microbicides |
| HPTN 039 (10066) | A Phase III, randomized, double-blind, placebo-controlled trial of acyclovir for the reduction of HIV acquisition among high risk HSV-2 seropositive, HIV-seronegative individuals | Concluded | STD Control |
| HPTN 035 (10065) | Phase II/IIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO2000/5 Gel (P) for the Prevention of HIV Infection in Women | Concluded | Microbicides |
| HPTN 033 | HIV Prevention Preparedness Study | Concluded | Substance Use |
HPTN 050 | Phase I Safety and Acceptability Study of the Vaginal Microbicide Agent PMPA Gel | Concluded | Microbicides |
| HPTN 036 | HIV Prevalence, Incidence, and HSV-2 Prevalence Among High-Risk MSM in Perú | Concluded | STD Control |
| HPTN 034 (10199) | HIV Incidence and Participant Retention Protocol, Pune, India | Concluded | Other |
| HPTN 047 | A Phase I Safety and Acceptability Study of the Investigational Vaginal Microbicide PRO 2000/5 Gel (P) | Concluded | Microbicides |
| HPTN 032 | Male Tolerance Study of BufferGel and PRO 2000/5 Gel (P) | Concluded | Microbicides |
| HPTN 027 (10141) | A Phase I Study to Evaluate the Safety and Immunogenicity of ALVAC-HIV vCP1521 in Infants Born to HIV-1 Infected Women in Uganda | Concluded | Perinatal |
| HIVNET 016A | Condom Promotion and Counseling Study | Concluded | Microbicides |
HIVNET 015 | EXPLORE: A Randomized Clinical Trial of the Efficacy of a Behavioral Intervention to Prevent Acquisition of HIV among Men who have Sex with Men (MSM) | Concluded | Behavioral |
| HIVNET 024 | Phase III Trial of Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission | Concluded | Perinatal |
HIVNET 012 | A Phase IIB Trial to Determine the Efficacy of Oral AZT and the Efficacy of Oral Nevirapine for the Prevention of Vertical Transmission of HIV-1 Infection in Pregnant Ugandan Women and Their Neonates | Concluded | Perinatal |
Paul Richardson graduated from Manchester Polytechnic in England and is a registered multidisciplinary Biomedical Scientist with the Health Care Professions Council (UK). Paul later received his Fellowship of the Institute of Biomedical Sciences (London) in 1991 followed by a Master of Science in Biomedical Science from the Manchester Metropolitan University in 1999. His experience includes working in multiple hospital clinical laboratories, instrument sales and technical support. He is currently a Senior International QA/QC Coordinator for the HPTN Laboratory Center at Johns Hopkins University in Baltimore and has been involved in HPTN studies since 2005
Amber Moser graduated from Stevenson University with a Medical Laboratory Scientist degree and is American Society of Clinical Pathology MLS (ASCP) certified. Prior to working at the Johns Hopkins Hospital and University School of Medicine she worked at Sinai Hospital in the core laboratory and at Northwest Hospital as the team leader of the laboratory.
Tinia Hill graduated from Harrisburg University of Science and Technology with her Bachelors in Biology. She then went on to University of Maryland, School of Medicine and enrolled in their Department of Medical Research and Technology categorical program. She graduated in 2016 and is ASCP certified in Hematology. Prior to working at Johns Hopkins University School of Medicine, she worked at University of Maryland Medical Center in the HLA lab. She also has worked in other area clinical labs as a generalist.
Danielle Heyl graduated from Ferris State University with a Medical technology degree and is American Society of Clinical Pathology MLS (ASCP) certified. Prior to working at the Johns Hopkins University School of Medicine, she worked at Rex Hospital, KRR Laboratory as well as the Maryland Zoo’s Animal Hospital and AniLab, a full service clinical laboratory, specializing exclusively in veterinary testing.
Anjali Shankar graduated from George Washington University with a BS in Public Health with a concentration in bioinformatics, and from Johns Hopkins University with an MS in Biotechnology. Prior to working to at Johns Hopkins Hospital, she worked as a research assistant at Children’s National and as a scribe at The George Washington University Hospital. Currently, she is a research technologist at the HPTN LC Core Laboratory.
Meagan Peoples graduated from Johns Hopkins University with a double major in Chemistry and Writing Seminars. Prior to working at the Johns Hopkins Hospital and University School of Medicine, she worked as an interfaces engineer at Epic Systems, first in Wisconsin and then later abroad at their Bristol office.
Shahnaz Ahmed graduated from the University of Bombay with a Bachelor’s degree in Microbiology and a postgraduate degree in Medical Technology. She began her laboratory career in Bombay before moving to the USA. In the USA, Shahnaz completed her MLT ASCP certification before working as a generalist at Cleveland Clinic Hospital, Ohio. She then took on the role of Lab Supervisor at Frisco Urgent Care in Texas In 2018, Shahnaz joined Johns Hopkins University, where she currently serves as the International Lab QA/QC Coordinator.
Janet Small has been with Johns Hopkins Medicine since 2015. Prior to working at the Johns Hopkins University School of Medicine, she worked for Johns Hopkins Community Physicians as a Medical Office Assistant, as well as Quest Diagnostics. She worked at Quest Diagnostics for 22 years, starting out in Client Services, where she provided technical information to Doctors and their staff, became a Group Lead, and in 2014 became the Supervisor of the Department. In 2015 Janet started working at JHCP as a Medical Office Assistant, then in 2018 moved to HPTN LC as the Administrative Coordinator.
Yaw Agyei is a graduate of the University of Maryland with a medical technology degree and is American Society of Clinical Pathology MLS (ASCP). He worked at the Johns Hopkins Hospital Core Laboratory following an internship right after Medical Technology school. He stayed there for five years before joining the HIV Prevention Trails Network-Laboratory Center (HPTN- LC). He is a senior laboratory QA/QC coordinator and has spent many years working in different countries in Southern Africa, where his cultural background has helped in building capacity across local labs. In addition to his laboratory training, Yaw holds a Masters in Public Health (MPH) degree.
