Program Affiliation Cont...: HPTN 083 - Bronx Prevention Center

HPTN 083 recruited HIV-uninfected men who have sex with men and transgender women at risk for acquiring HIV infection to evaluate the efficacy of the long-acting injectable agent, cabotegravir (CAB LA), for PrEP and demonstrated the superiority of cabotegravir for HIV prevention in these populations.

Closed to enrollment, in active study follow-up

Web Links:
https://clinicaltrials.gov/ct2/show/NCT02720094 https://www.hptn.org/research/studies/hptn083 https://giveprepashot.org/

A randomized, double-blind, placebo-controlled Phase 3 efficacy study of an Ad26.RSV.preF-based vaccine in the prevention of lower respiratory tract disease caused by RSV in adults aged 60 years and older.

HPTN 091 is a study assessing the feasibility, acceptability, preliminary impact of a multi-component strategy that provides HIV prevention services, gender-affirming hormone therapy, and Peer Health Navigation to improve pre-exposure prophylaxis (PrEP) uptake and adherence.

Web Links:
https://www.hptn.org/research/studies/hptn091

A Study of SARS CoV-2 Infection and Potential Transmission in Individuals Immunized With Moderna COVID-19 Vaccine

Study to assess SARS CoV-2 infection, viral shedding, and subsequent potential transmission in university students immunized with Moderna COVID-19 Vaccine

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04811664

https://www.coronaviruspreventionnetwork.org/moderna-vaccine-university-study/

SARS- COV-2 Prevalence Study – to assess the prevalence of active and recovered COVID infections in the Harlem community Open to enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04658121 https://www.compassstudy.org/

Open to enrollment Characterizing SARS-CoV-2-specific immunity in convalescent individuals   Report Links: https://clinicaltrials.gov/ct2/show/NCT04403880 https://www.hvtn.org/content/dam/hvtn/MEDIAROOM/study-fact-sheet_HVTN405-HPTN1901_v2.pdf

HIV Vaccine Trials Network Open to enrollment Study of Heterologous Vaccine Regimen to prevent HIV-1 Infection among Cis-gender Men and Transgender Individuals who have Sex with Cis-gender Men and/or Transgender Individuals

Web Links:
https://clinicaltrials.gov/ct2/show/NCT03964415
https://www.hvtn.org/en/community/community-compass/vol19-issue2/mosaico.html
https://www.avac.org/trial/hpx-3002-hvtn-706-mosaico

Closed to enrollment and study follow-up A Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies administered via intravenous infusion in healthy, HIV-uninfected adults Web Links: https://www.clinicaltrials.gov/ct2/show/NCT03928821 https://www.hptn.org/research/studies/130_089 https://www.hptn.org/sites/default/files/inline-files/HVTN130-HPTN089_v1.0_loa1_FINAL.pdf

Closed to enrollment and study follow-up Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2 More information: https://clinicaltrials.gov/ct2/show/NCT04452318 https://clinicalresearch.itmat.upenn.edu/clinicaltrial/6567/covid-covid19-healthy-volunteers-covpn-3502-regeneron/

Closed to enrollment and study follow-up

Study to Assess the Efficacy and Safety of Ad26.COV2.S (the Johnson & Johnson COVID vaccine) for the Prevention of SARS-COV-2 mediated COVID-19 in Adults Aged 18 Years and Older

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04505722

https://clinicalresearch.itmat.upenn.edu/clinicaltrial/6568/covid19-covid-vaccine-covpn-3003-janssen/

The STAR Study is a five-year study that tested the effectiveness of respondent-driven sampling to seek and recruit substance-using Black men who have sex with men (MSM) at high risk for HIV. The study assessed the feasibility and cost-effectiveness of two linkage and retention strategies to develop innovative approaches to engage highest-risk, hard-to-reach individuals for HIV services and retain them in treatment. (funded by NIH) Report Links: Franks, et. al. 2018. Multiple strategies to identify HIV-positive black men who have sex with men and transgender women in New York City: A cross-sectional analysis of recruitment results. Journal of the International AIDS Society. Grant, et. al. 2018. Daily and nondaily oral preexposure prophylaxis in men and transgender women who have sex with men: The Human Immunodeficiency Virus Prevention Trials Network 067/ADAPT Study. Clinical Infectious Diseases.   Web Links: https://clinicaltrials.gov/ct2/show/NCT01790360

HPTN 083 recruited HIV-uninfected men who have sex with men and transgender women at risk for acquiring HIV infection to evaluate the efficacy of the long-acting injectable agent, cabotegravir (CAB LA), for PrEP in HIV-uninfected men and transgender women who have sex with men.

Closed to enrollment, in active study follow-up

Web Links:
https://clinicaltrials.gov/ct2/show/NCT02720094
https://www.hptn.org/research/studies/hptn083
https://giveprepashot.org/

A vanguard study of health service delivery in a mobile health delivery unit to link persons who inject opiates to integrated care and prevention for addiction, HIV, hepatitis, STIs and primary care

Soon to begin enrollment

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04804072 https://www.hptn.org/research/studies/190

This randomized, double-blind, placebo-controlled multicenter s investigates the AstraZeneca (AZD1222) vaccine to prevent COVID-19

Closed to enrollment, follow up ongoing

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04516746

The SARS-COV-2 prevalence study is to assess the prevalence of active and recovered COVID infections in the Bronx community Open to enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04658121 https://www.compassstudy.org/

A randomized, active-controlled, double-blind clinical study to investigate the safety and efficacy of oral Islatravir, a once-monthly pill as preexposure prophylaxis (PrEP) in cisgender women at high risk for HIV-1 infection Soon to begin enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04644029

A randomized, placebo-controlled efficacy trial of EVO100 vaginal gel for the prevention of Chlamydia trachomatis and Neisseria gonorrhoeae infection in sexually active young women who have recently had Chlamydia or gonorrhea infection Soon to begin enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04553068

Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID). This multicenter study aims to rapidly identify safe and effective treatments for COVID-19. Ambulatory adults who have recently been diagnosed with mild to moderate COVID-19 may be eligible to receive one of several different treatments that are being studied concurrently in this double-blind, placebo-controlled trial.

Soon to begin enrollment

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04885530

The purpose of this study is to understand if a smartphone app, SmartPrEP, will help promote HIV self testing and PrEP adherence among cisgender and transgender women over a twelve-month period. We will help you to download the app on your phone and provide you with HIV self-test kits and PrEP (if not already taking PrEP) in order to understand if the SmartPrEP app helps you remember to take your medication on schedule and increases your HIV self-testing patterns. You may also take part in interviews and focus groups as part of the study and we will be interested in having you provide your views on the features and usability of the app. The Making PrEP Smart study is active and is enrolling participants. Web Links: https://clinicaltrials.gov/ct2/show/NCT05111119 https://recruit.cumc.columbia.edu/studyinfopage/2254

HPTN 083 recruited HIV-uninfected men who have sex with men and transgender women at risk for acquiring HIV infection to evaluate the efficacy of the long-acting injectable agent, cabotegravir (CAB LA), for PrEP and demonstrated the superiority of cabotegravir for HIV prevention in these populations.

Closed to enrollment, in active study follow-up

Web Links:
https://clinicaltrials.gov/ct2/show/NCT02720094 https://www.hptn.org/research/studies/hptn083 https://giveprepashot.org/

A randomized, double-blind, placebo-controlled Phase 3 efficacy study of an Ad26.RSV.preF-based vaccine in the prevention of lower respiratory tract disease caused by RSV in adults aged 60 years and older.

HPTN 091 is a study assessing the feasibility, acceptability, preliminary impact of a multi-component strategy that provides HIV prevention services, gender-affirming hormone therapy, and Peer Health Navigation to improve pre-exposure prophylaxis (PrEP) uptake and adherence.

Web Links:
https://www.hptn.org/research/studies/hptn091

A Study of SARS CoV-2 Infection and Potential Transmission in Individuals Immunized With Moderna COVID-19 Vaccine

Study to assess SARS CoV-2 infection, viral shedding, and subsequent potential transmission in university students immunized with Moderna COVID-19 Vaccine

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04811664

https://www.coronaviruspreventionnetwork.org/moderna-vaccine-university-study/

SARS- COV-2 Prevalence Study – to assess the prevalence of active and recovered COVID infections in the Harlem community Open to enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04658121 https://www.compassstudy.org/

Open to enrollment Characterizing SARS-CoV-2-specific immunity in convalescent individuals   Report Links: https://clinicaltrials.gov/ct2/show/NCT04403880 https://www.hvtn.org/content/dam/hvtn/MEDIAROOM/study-fact-sheet_HVTN405-HPTN1901_v2.pdf

HIV Vaccine Trials Network Open to enrollment Study of Heterologous Vaccine Regimen to prevent HIV-1 Infection among Cis-gender Men and Transgender Individuals who have Sex with Cis-gender Men and/or Transgender Individuals

Web Links:
https://clinicaltrials.gov/ct2/show/NCT03964415
https://www.hvtn.org/en/community/community-compass/vol19-issue2/mosaico.html
https://www.avac.org/trial/hpx-3002-hvtn-706-mosaico

Closed to enrollment and study follow-up A Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies administered via intravenous infusion in healthy, HIV-uninfected adults Web Links: https://www.clinicaltrials.gov/ct2/show/NCT03928821 https://www.hptn.org/research/studies/130_089 https://www.hptn.org/sites/default/files/inline-files/HVTN130-HPTN089_v1.0_loa1_FINAL.pdf

Closed to enrollment and study follow-up Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2 More information: https://clinicaltrials.gov/ct2/show/NCT04452318 https://clinicalresearch.itmat.upenn.edu/clinicaltrial/6567/covid-covid19-healthy-volunteers-covpn-3502-regeneron/

Closed to enrollment and study follow-up

Study to Assess the Efficacy and Safety of Ad26.COV2.S (the Johnson & Johnson COVID vaccine) for the Prevention of SARS-COV-2 mediated COVID-19 in Adults Aged 18 Years and Older

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04505722

https://clinicalresearch.itmat.upenn.edu/clinicaltrial/6568/covid19-covid-vaccine-covpn-3003-janssen/

The STAR Study is a five-year study that tested the effectiveness of respondent-driven sampling to seek and recruit substance-using Black men who have sex with men (MSM) at high risk for HIV. The study assessed the feasibility and cost-effectiveness of two linkage and retention strategies to develop innovative approaches to engage highest-risk, hard-to-reach individuals for HIV services and retain them in treatment. (funded by NIH) Report Links: Franks, et. al. 2018. Multiple strategies to identify HIV-positive black men who have sex with men and transgender women in New York City: A cross-sectional analysis of recruitment results. Journal of the International AIDS Society. Grant, et. al. 2018. Daily and nondaily oral preexposure prophylaxis in men and transgender women who have sex with men: The Human Immunodeficiency Virus Prevention Trials Network 067/ADAPT Study. Clinical Infectious Diseases.   Web Links: https://clinicaltrials.gov/ct2/show/NCT01790360

HPTN 083 recruited HIV-uninfected men who have sex with men and transgender women at risk for acquiring HIV infection to evaluate the efficacy of the long-acting injectable agent, cabotegravir (CAB LA), for PrEP in HIV-uninfected men and transgender women who have sex with men.

Closed to enrollment, in active study follow-up

Web Links:
https://clinicaltrials.gov/ct2/show/NCT02720094
https://www.hptn.org/research/studies/hptn083
https://giveprepashot.org/

A vanguard study of health service delivery in a mobile health delivery unit to link persons who inject opiates to integrated care and prevention for addiction, HIV, hepatitis, STIs and primary care

Soon to begin enrollment

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04804072 https://www.hptn.org/research/studies/190

This randomized, double-blind, placebo-controlled multicenter s investigates the AstraZeneca (AZD1222) vaccine to prevent COVID-19

Closed to enrollment, follow up ongoing

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04516746

The SARS-COV-2 prevalence study is to assess the prevalence of active and recovered COVID infections in the Bronx community Open to enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04658121 https://www.compassstudy.org/

A randomized, active-controlled, double-blind clinical study to investigate the safety and efficacy of oral Islatravir, a once-monthly pill as preexposure prophylaxis (PrEP) in cisgender women at high risk for HIV-1 infection Soon to begin enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04644029

A randomized, placebo-controlled efficacy trial of EVO100 vaginal gel for the prevention of Chlamydia trachomatis and Neisseria gonorrhoeae infection in sexually active young women who have recently had Chlamydia or gonorrhea infection Soon to begin enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04553068

Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID). This multicenter study aims to rapidly identify safe and effective treatments for COVID-19. Ambulatory adults who have recently been diagnosed with mild to moderate COVID-19 may be eligible to receive one of several different treatments that are being studied concurrently in this double-blind, placebo-controlled trial.

Soon to begin enrollment

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04885530

The purpose of this study is to understand if a smartphone app, SmartPrEP, will help promote HIV self testing and PrEP adherence among cisgender and transgender women over a twelve-month period. We will help you to download the app on your phone and provide you with HIV self-test kits and PrEP (if not already taking PrEP) in order to understand if the SmartPrEP app helps you remember to take your medication on schedule and increases your HIV self-testing patterns. You may also take part in interviews and focus groups as part of the study and we will be interested in having you provide your views on the features and usability of the app. The Making PrEP Smart study is active and is enrolling participants. Web Links: https://clinicaltrials.gov/ct2/show/NCT05111119 https://recruit.cumc.columbia.edu/studyinfopage/2254

HPTN 083 recruited HIV-uninfected men who have sex with men and transgender women at risk for acquiring HIV infection to evaluate the efficacy of the long-acting injectable agent, cabotegravir (CAB LA), for PrEP and demonstrated the superiority of cabotegravir for HIV prevention in these populations.

Closed to enrollment, in active study follow-up

Web Links:
https://clinicaltrials.gov/ct2/show/NCT02720094 https://www.hptn.org/research/studies/hptn083 https://giveprepashot.org/

A randomized, double-blind, placebo-controlled Phase 3 efficacy study of an Ad26.RSV.preF-based vaccine in the prevention of lower respiratory tract disease caused by RSV in adults aged 60 years and older.

HPTN 091 is a study assessing the feasibility, acceptability, preliminary impact of a multi-component strategy that provides HIV prevention services, gender-affirming hormone therapy, and Peer Health Navigation to improve pre-exposure prophylaxis (PrEP) uptake and adherence.

Web Links:
https://www.hptn.org/research/studies/hptn091

A Study of SARS CoV-2 Infection and Potential Transmission in Individuals Immunized With Moderna COVID-19 Vaccine

Study to assess SARS CoV-2 infection, viral shedding, and subsequent potential transmission in university students immunized with Moderna COVID-19 Vaccine

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04811664

https://www.coronaviruspreventionnetwork.org/moderna-vaccine-university-study/

SARS- COV-2 Prevalence Study – to assess the prevalence of active and recovered COVID infections in the Harlem community Open to enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04658121 https://www.compassstudy.org/

Open to enrollment Characterizing SARS-CoV-2-specific immunity in convalescent individuals   Report Links: https://clinicaltrials.gov/ct2/show/NCT04403880 https://www.hvtn.org/content/dam/hvtn/MEDIAROOM/study-fact-sheet_HVTN405-HPTN1901_v2.pdf

HIV Vaccine Trials Network Open to enrollment Study of Heterologous Vaccine Regimen to prevent HIV-1 Infection among Cis-gender Men and Transgender Individuals who have Sex with Cis-gender Men and/or Transgender Individuals

Web Links:
https://clinicaltrials.gov/ct2/show/NCT03964415
https://www.hvtn.org/en/community/community-compass/vol19-issue2/mosaico.html
https://www.avac.org/trial/hpx-3002-hvtn-706-mosaico

Closed to enrollment and study follow-up A Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies administered via intravenous infusion in healthy, HIV-uninfected adults Web Links: https://www.clinicaltrials.gov/ct2/show/NCT03928821 https://www.hptn.org/research/studies/130_089 https://www.hptn.org/sites/default/files/inline-files/HVTN130-HPTN089_v1.0_loa1_FINAL.pdf

Closed to enrollment and study follow-up Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2 More information: https://clinicaltrials.gov/ct2/show/NCT04452318 https://clinicalresearch.itmat.upenn.edu/clinicaltrial/6567/covid-covid19-healthy-volunteers-covpn-3502-regeneron/

Closed to enrollment and study follow-up

Study to Assess the Efficacy and Safety of Ad26.COV2.S (the Johnson & Johnson COVID vaccine) for the Prevention of SARS-COV-2 mediated COVID-19 in Adults Aged 18 Years and Older

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04505722

https://clinicalresearch.itmat.upenn.edu/clinicaltrial/6568/covid19-covid-vaccine-covpn-3003-janssen/

The STAR Study is a five-year study that tested the effectiveness of respondent-driven sampling to seek and recruit substance-using Black men who have sex with men (MSM) at high risk for HIV. The study assessed the feasibility and cost-effectiveness of two linkage and retention strategies to develop innovative approaches to engage highest-risk, hard-to-reach individuals for HIV services and retain them in treatment. (funded by NIH) Report Links: Franks, et. al. 2018. Multiple strategies to identify HIV-positive black men who have sex with men and transgender women in New York City: A cross-sectional analysis of recruitment results. Journal of the International AIDS Society. Grant, et. al. 2018. Daily and nondaily oral preexposure prophylaxis in men and transgender women who have sex with men: The Human Immunodeficiency Virus Prevention Trials Network 067/ADAPT Study. Clinical Infectious Diseases.   Web Links: https://clinicaltrials.gov/ct2/show/NCT01790360

HPTN 083 recruited HIV-uninfected men who have sex with men and transgender women at risk for acquiring HIV infection to evaluate the efficacy of the long-acting injectable agent, cabotegravir (CAB LA), for PrEP in HIV-uninfected men and transgender women who have sex with men.

Closed to enrollment, in active study follow-up

Web Links:
https://clinicaltrials.gov/ct2/show/NCT02720094
https://www.hptn.org/research/studies/hptn083
https://giveprepashot.org/

A vanguard study of health service delivery in a mobile health delivery unit to link persons who inject opiates to integrated care and prevention for addiction, HIV, hepatitis, STIs and primary care

Soon to begin enrollment

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04804072 https://www.hptn.org/research/studies/190

This randomized, double-blind, placebo-controlled multicenter s investigates the AstraZeneca (AZD1222) vaccine to prevent COVID-19

Closed to enrollment, follow up ongoing

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04516746

The SARS-COV-2 prevalence study is to assess the prevalence of active and recovered COVID infections in the Bronx community Open to enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04658121 https://www.compassstudy.org/

A randomized, active-controlled, double-blind clinical study to investigate the safety and efficacy of oral Islatravir, a once-monthly pill as preexposure prophylaxis (PrEP) in cisgender women at high risk for HIV-1 infection Soon to begin enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04644029

A randomized, placebo-controlled efficacy trial of EVO100 vaginal gel for the prevention of Chlamydia trachomatis and Neisseria gonorrhoeae infection in sexually active young women who have recently had Chlamydia or gonorrhea infection Soon to begin enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04553068

Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID). This multicenter study aims to rapidly identify safe and effective treatments for COVID-19. Ambulatory adults who have recently been diagnosed with mild to moderate COVID-19 may be eligible to receive one of several different treatments that are being studied concurrently in this double-blind, placebo-controlled trial.

Soon to begin enrollment

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04885530

The purpose of this study is to understand if a smartphone app, SmartPrEP, will help promote HIV self testing and PrEP adherence among cisgender and transgender women over a twelve-month period. We will help you to download the app on your phone and provide you with HIV self-test kits and PrEP (if not already taking PrEP) in order to understand if the SmartPrEP app helps you remember to take your medication on schedule and increases your HIV self-testing patterns. You may also take part in interviews and focus groups as part of the study and we will be interested in having you provide your views on the features and usability of the app. The Making PrEP Smart study is active and is enrolling participants. Web Links: https://clinicaltrials.gov/ct2/show/NCT05111119 https://recruit.cumc.columbia.edu/studyinfopage/2254

HPTN 083 recruited HIV-uninfected men who have sex with men and transgender women at risk for acquiring HIV infection to evaluate the efficacy of the long-acting injectable agent, cabotegravir (CAB LA), for PrEP and demonstrated the superiority of cabotegravir for HIV prevention in these populations.

Closed to enrollment, in active study follow-up

Web Links:
https://clinicaltrials.gov/ct2/show/NCT02720094 https://www.hptn.org/research/studies/hptn083 https://giveprepashot.org/

A randomized, double-blind, placebo-controlled Phase 3 efficacy study of an Ad26.RSV.preF-based vaccine in the prevention of lower respiratory tract disease caused by RSV in adults aged 60 years and older.

HPTN 091 is a study assessing the feasibility, acceptability, preliminary impact of a multi-component strategy that provides HIV prevention services, gender-affirming hormone therapy, and Peer Health Navigation to improve pre-exposure prophylaxis (PrEP) uptake and adherence.

Web Links:
https://www.hptn.org/research/studies/hptn091

A Study of SARS CoV-2 Infection and Potential Transmission in Individuals Immunized With Moderna COVID-19 Vaccine

Study to assess SARS CoV-2 infection, viral shedding, and subsequent potential transmission in university students immunized with Moderna COVID-19 Vaccine

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04811664

https://www.coronaviruspreventionnetwork.org/moderna-vaccine-university-study/

SARS- COV-2 Prevalence Study – to assess the prevalence of active and recovered COVID infections in the Harlem community Open to enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04658121 https://www.compassstudy.org/

Open to enrollment Characterizing SARS-CoV-2-specific immunity in convalescent individuals   Report Links: https://clinicaltrials.gov/ct2/show/NCT04403880 https://www.hvtn.org/content/dam/hvtn/MEDIAROOM/study-fact-sheet_HVTN405-HPTN1901_v2.pdf

HIV Vaccine Trials Network Open to enrollment Study of Heterologous Vaccine Regimen to prevent HIV-1 Infection among Cis-gender Men and Transgender Individuals who have Sex with Cis-gender Men and/or Transgender Individuals

Web Links:
https://clinicaltrials.gov/ct2/show/NCT03964415
https://www.hvtn.org/en/community/community-compass/vol19-issue2/mosaico.html
https://www.avac.org/trial/hpx-3002-hvtn-706-mosaico

Closed to enrollment and study follow-up A Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies administered via intravenous infusion in healthy, HIV-uninfected adults Web Links: https://www.clinicaltrials.gov/ct2/show/NCT03928821 https://www.hptn.org/research/studies/130_089 https://www.hptn.org/sites/default/files/inline-files/HVTN130-HPTN089_v1.0_loa1_FINAL.pdf

Closed to enrollment and study follow-up Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2 More information: https://clinicaltrials.gov/ct2/show/NCT04452318 https://clinicalresearch.itmat.upenn.edu/clinicaltrial/6567/covid-covid19-healthy-volunteers-covpn-3502-regeneron/

Closed to enrollment and study follow-up

Study to Assess the Efficacy and Safety of Ad26.COV2.S (the Johnson & Johnson COVID vaccine) for the Prevention of SARS-COV-2 mediated COVID-19 in Adults Aged 18 Years and Older

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04505722

https://clinicalresearch.itmat.upenn.edu/clinicaltrial/6568/covid19-covid-vaccine-covpn-3003-janssen/

The STAR Study is a five-year study that tested the effectiveness of respondent-driven sampling to seek and recruit substance-using Black men who have sex with men (MSM) at high risk for HIV. The study assessed the feasibility and cost-effectiveness of two linkage and retention strategies to develop innovative approaches to engage highest-risk, hard-to-reach individuals for HIV services and retain them in treatment. (funded by NIH) Report Links: Franks, et. al. 2018. Multiple strategies to identify HIV-positive black men who have sex with men and transgender women in New York City: A cross-sectional analysis of recruitment results. Journal of the International AIDS Society. Grant, et. al. 2018. Daily and nondaily oral preexposure prophylaxis in men and transgender women who have sex with men: The Human Immunodeficiency Virus Prevention Trials Network 067/ADAPT Study. Clinical Infectious Diseases.   Web Links: https://clinicaltrials.gov/ct2/show/NCT01790360

HPTN 083 recruited HIV-uninfected men who have sex with men and transgender women at risk for acquiring HIV infection to evaluate the efficacy of the long-acting injectable agent, cabotegravir (CAB LA), for PrEP in HIV-uninfected men and transgender women who have sex with men.

Closed to enrollment, in active study follow-up

Web Links:
https://clinicaltrials.gov/ct2/show/NCT02720094
https://www.hptn.org/research/studies/hptn083
https://giveprepashot.org/

A vanguard study of health service delivery in a mobile health delivery unit to link persons who inject opiates to integrated care and prevention for addiction, HIV, hepatitis, STIs and primary care

Soon to begin enrollment

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04804072 https://www.hptn.org/research/studies/190

This randomized, double-blind, placebo-controlled multicenter s investigates the AstraZeneca (AZD1222) vaccine to prevent COVID-19

Closed to enrollment, follow up ongoing

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04516746

The SARS-COV-2 prevalence study is to assess the prevalence of active and recovered COVID infections in the Bronx community Open to enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04658121 https://www.compassstudy.org/

A randomized, active-controlled, double-blind clinical study to investigate the safety and efficacy of oral Islatravir, a once-monthly pill as preexposure prophylaxis (PrEP) in cisgender women at high risk for HIV-1 infection Soon to begin enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04644029

A randomized, placebo-controlled efficacy trial of EVO100 vaginal gel for the prevention of Chlamydia trachomatis and Neisseria gonorrhoeae infection in sexually active young women who have recently had Chlamydia or gonorrhea infection Soon to begin enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04553068

Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID). This multicenter study aims to rapidly identify safe and effective treatments for COVID-19. Ambulatory adults who have recently been diagnosed with mild to moderate COVID-19 may be eligible to receive one of several different treatments that are being studied concurrently in this double-blind, placebo-controlled trial.

Soon to begin enrollment

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04885530

The purpose of this study is to understand if a smartphone app, SmartPrEP, will help promote HIV self testing and PrEP adherence among cisgender and transgender women over a twelve-month period. We will help you to download the app on your phone and provide you with HIV self-test kits and PrEP (if not already taking PrEP) in order to understand if the SmartPrEP app helps you remember to take your medication on schedule and increases your HIV self-testing patterns. You may also take part in interviews and focus groups as part of the study and we will be interested in having you provide your views on the features and usability of the app. The Making PrEP Smart study is active and is enrolling participants. Web Links: https://clinicaltrials.gov/ct2/show/NCT05111119 https://recruit.cumc.columbia.edu/studyinfopage/2254

HPTN 083 recruited HIV-uninfected men who have sex with men and transgender women at risk for acquiring HIV infection to evaluate the efficacy of the long-acting injectable agent, cabotegravir (CAB LA), for PrEP and demonstrated the superiority of cabotegravir for HIV prevention in these populations.

Closed to enrollment, in active study follow-up

Web Links:
https://clinicaltrials.gov/ct2/show/NCT02720094 https://www.hptn.org/research/studies/hptn083 https://giveprepashot.org/

A randomized, double-blind, placebo-controlled Phase 3 efficacy study of an Ad26.RSV.preF-based vaccine in the prevention of lower respiratory tract disease caused by RSV in adults aged 60 years and older.

HPTN 091 is a study assessing the feasibility, acceptability, preliminary impact of a multi-component strategy that provides HIV prevention services, gender-affirming hormone therapy, and Peer Health Navigation to improve pre-exposure prophylaxis (PrEP) uptake and adherence.

Web Links:
https://www.hptn.org/research/studies/hptn091

A Study of SARS CoV-2 Infection and Potential Transmission in Individuals Immunized With Moderna COVID-19 Vaccine

Study to assess SARS CoV-2 infection, viral shedding, and subsequent potential transmission in university students immunized with Moderna COVID-19 Vaccine

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04811664

https://www.coronaviruspreventionnetwork.org/moderna-vaccine-university-study/

SARS- COV-2 Prevalence Study – to assess the prevalence of active and recovered COVID infections in the Harlem community Open to enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04658121 https://www.compassstudy.org/

Open to enrollment Characterizing SARS-CoV-2-specific immunity in convalescent individuals   Report Links: https://clinicaltrials.gov/ct2/show/NCT04403880 https://www.hvtn.org/content/dam/hvtn/MEDIAROOM/study-fact-sheet_HVTN405-HPTN1901_v2.pdf

HIV Vaccine Trials Network Open to enrollment Study of Heterologous Vaccine Regimen to prevent HIV-1 Infection among Cis-gender Men and Transgender Individuals who have Sex with Cis-gender Men and/or Transgender Individuals

Web Links:
https://clinicaltrials.gov/ct2/show/NCT03964415
https://www.hvtn.org/en/community/community-compass/vol19-issue2/mosaico.html
https://www.avac.org/trial/hpx-3002-hvtn-706-mosaico

Closed to enrollment and study follow-up A Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies administered via intravenous infusion in healthy, HIV-uninfected adults Web Links: https://www.clinicaltrials.gov/ct2/show/NCT03928821 https://www.hptn.org/research/studies/130_089 https://www.hptn.org/sites/default/files/inline-files/HVTN130-HPTN089_v1.0_loa1_FINAL.pdf

Closed to enrollment and study follow-up Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2 More information: https://clinicaltrials.gov/ct2/show/NCT04452318 https://clinicalresearch.itmat.upenn.edu/clinicaltrial/6567/covid-covid19-healthy-volunteers-covpn-3502-regeneron/

Closed to enrollment and study follow-up

Study to Assess the Efficacy and Safety of Ad26.COV2.S (the Johnson & Johnson COVID vaccine) for the Prevention of SARS-COV-2 mediated COVID-19 in Adults Aged 18 Years and Older

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04505722

https://clinicalresearch.itmat.upenn.edu/clinicaltrial/6568/covid19-covid-vaccine-covpn-3003-janssen/

The STAR Study is a five-year study that tested the effectiveness of respondent-driven sampling to seek and recruit substance-using Black men who have sex with men (MSM) at high risk for HIV. The study assessed the feasibility and cost-effectiveness of two linkage and retention strategies to develop innovative approaches to engage highest-risk, hard-to-reach individuals for HIV services and retain them in treatment. (funded by NIH) Report Links: Franks, et. al. 2018. Multiple strategies to identify HIV-positive black men who have sex with men and transgender women in New York City: A cross-sectional analysis of recruitment results. Journal of the International AIDS Society. Grant, et. al. 2018. Daily and nondaily oral preexposure prophylaxis in men and transgender women who have sex with men: The Human Immunodeficiency Virus Prevention Trials Network 067/ADAPT Study. Clinical Infectious Diseases.   Web Links: https://clinicaltrials.gov/ct2/show/NCT01790360

HPTN 083 recruited HIV-uninfected men who have sex with men and transgender women at risk for acquiring HIV infection to evaluate the efficacy of the long-acting injectable agent, cabotegravir (CAB LA), for PrEP in HIV-uninfected men and transgender women who have sex with men.

Closed to enrollment, in active study follow-up

Web Links:
https://clinicaltrials.gov/ct2/show/NCT02720094
https://www.hptn.org/research/studies/hptn083
https://giveprepashot.org/

A vanguard study of health service delivery in a mobile health delivery unit to link persons who inject opiates to integrated care and prevention for addiction, HIV, hepatitis, STIs and primary care

Soon to begin enrollment

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04804072 https://www.hptn.org/research/studies/190

This randomized, double-blind, placebo-controlled multicenter s investigates the AstraZeneca (AZD1222) vaccine to prevent COVID-19

Closed to enrollment, follow up ongoing

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04516746

The SARS-COV-2 prevalence study is to assess the prevalence of active and recovered COVID infections in the Bronx community Open to enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04658121 https://www.compassstudy.org/

A randomized, active-controlled, double-blind clinical study to investigate the safety and efficacy of oral Islatravir, a once-monthly pill as preexposure prophylaxis (PrEP) in cisgender women at high risk for HIV-1 infection Soon to begin enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04644029

A randomized, placebo-controlled efficacy trial of EVO100 vaginal gel for the prevention of Chlamydia trachomatis and Neisseria gonorrhoeae infection in sexually active young women who have recently had Chlamydia or gonorrhea infection Soon to begin enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04553068

Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID). This multicenter study aims to rapidly identify safe and effective treatments for COVID-19. Ambulatory adults who have recently been diagnosed with mild to moderate COVID-19 may be eligible to receive one of several different treatments that are being studied concurrently in this double-blind, placebo-controlled trial.

Soon to begin enrollment

Web Links:
https://clinicaltrials.gov/ct2/show/NCT04885530

The purpose of this study is to understand if a smartphone app, SmartPrEP, will help promote HIV self testing and PrEP adherence among cisgender and transgender women over a twelve-month period. We will help you to download the app on your phone and provide you with HIV self-test kits and PrEP (if not already taking PrEP) in order to understand if the SmartPrEP app helps you remember to take your medication on schedule and increases your HIV self-testing patterns. You may also take part in interviews and focus groups as part of the study and we will be interested in having you provide your views on the features and usability of the app. The Making PrEP Smart study is active and is enrolling participants. Web Links: https://clinicaltrials.gov/ct2/show/NCT05111119 https://recruit.cumc.columbia.edu/studyinfopage/2254