<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02183909</url>
  </required_header>
  <id_info>
    <org_study_id>EI12-EBACA-003</org_study_id>
    <nct_id>NCT02183909</nct_id>
  </id_info>
  <brief_title>Connecting Resources for Urban Sexual Health</brief_title>
  <acronym>CRUSH</acronym>
  <official_title>Connecting Resources for Urban Sexual Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal of the CRUSH project is to enhance and extend a response to the local&#xD;
      HIV/AIDS epidemic in Alameda County with a set of innovative, evidence-based interventions&#xD;
      across the continuum of HIV prevention and care, targeting individuals and communities most&#xD;
      vulnerable to HIV. The East Bay AIDS Center, in partnership with the University of California&#xD;
      San Francisco's Center for AIDS Prevention Studies, the Gladstone Institutes, and several key&#xD;
      community-based organizations, are engaging in a participatory partnership to enhance and&#xD;
      implement HIV services which target the East Bay's highest risk population- young men who&#xD;
      have sex with men (Y/MSM). Specifically, the CRUSH Project is designed to evaluate a&#xD;
      combination of program approaches to address the sexual health care needs of young gay men of&#xD;
      color and their sexual partners by enhancing the current program activities of the Downtown&#xD;
      Youth Clinic (DYC).&#xD;
&#xD;
      We hypothesize that we can reduce the impact of HIV among Y/MSM by expanding the current DYC&#xD;
      services structure in two ways. We intend to expand HIV testing, and linkage to and retention&#xD;
      in care for youth who test HIV positive, providing them with intensive risk-reduction&#xD;
      counseling and antiretroviral treatment, and thereby ultimately reducing the risk of further&#xD;
      HIV transmission. And we intend for the first time to offer a comprehensive combination&#xD;
      package of preventive services to HIV-negative youth, including routine accesses to HIV/STI&#xD;
      screening and treatment, and access to HIV pre-exposure prophylaxis (PrEP).&#xD;
&#xD;
      The CRUSH Project will also have a substudy that will enroll HIV-negative participants who&#xD;
      are eligible to receive PEP. The substudy will evaluate the tolerability and acceptability of&#xD;
      a 28 day course of Stribild® given as post-exposure prophylaxis (PEP) to prevent sexual&#xD;
      acquisition of HIV-1 in Y/MSM of color.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The CRUSH Project (Connecting Resources for Urban Sexual Health) is a demonstration project&#xD;
      at Alta Bates Summit Medical Center's East Bay AIDS Center (EBAC) and Downtown Youth Clinic&#xD;
      (DYC) offering interventions aimed at reducing HIV-1 incidence among young MSM of color in&#xD;
      the East Bay region. CRUSH has two major components:&#xD;
&#xD;
        1. Providing enhanced testing and linkage to care (TLC+) for HIV positives, aimed at&#xD;
           increasing the proportion of HIV positive Y/MSM who are in care, virologically&#xD;
           suppressed, and receiving intensive risk reduction counseling.&#xD;
&#xD;
        2. Providing comprehensive sexual health services to high risk HIV-negatives, including but&#xD;
           not limited to the provision of PrEP and PEP when clinically appropriate.&#xD;
&#xD;
      In addition, the CRUSH Project will offer a substudy of CRUSH, and will enroll HIV negative&#xD;
      CRUSH participants who are eligible to receive PEP. Stribild® is a single-tablet, four-drug,&#xD;
      once-daily complete regimen that is FDA-approved for the treatment of HIV-1 infection in&#xD;
      treatment-naïve HIV-infected adults with estimated glomerular filtration rate&#xD;
      ≥70ml/min/1.73m2. Because of limited data, no antiretroviral drug or combination of drugs has&#xD;
      been approved for PEP. Current PEP guidelines generally call for using a 28-day course of a&#xD;
      3-drug regimen that has been approved for the treatment of HIV-1 infection&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2013</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of young men who have sex with men (YMSM) of color who test positive for HIV at partner agencies and the proportion of positive and negative YMSM who are tested for HIV and linked to care on a quarterly and annual basis.</measure>
    <time_frame>1 year</time_frame>
    <description>Expanding the investigators currently successful HIV testing strategy-collaborations and systems of referral of new cases of HIV from existing partners-so that referrals are also received for high risk negatives to receive sexual health services. Implementing two new strategies: social network testing and a youth outreach corps working with partner agencies; it is hypothesized that social network testing will increase the proportion of positive test results.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The proportion of HIV-positive enrolled YMSM who are retained, on therapy, and who have achieved viral suppression within one year of entering care.</measure>
    <time_frame>1 year</time_frame>
    <description>Optimizing current HIV care and treatment services at DYC by adding three new components: a patient peer mentoring component, a linkage and retention specialist, and psychosocial support for program staff.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The proportion of HIV-uninfected YMSM participants who are retained, receive sexually transmitted infection (STI) testing, and receive non-occupational post-exposure-prophylaxis (nPEP) and/or PrEP.</measure>
    <time_frame>1 year</time_frame>
    <description>Integrating sexual health services for HIV-uninfected young MSM of color into an HIV care setting, including PrEP, warm-hand offs for high risk negatives, nPEP, risk reduction counseling, frequent HIV and STI testing, and youth-focused programming.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Substudy Primary Outcome: To evaluate the tolerability and acceptability of a 28 day course of Stribild® given as post-exposure prophylaxis (PEP) to prevent sexual acquisition of HIV-1.</measure>
    <time_frame>1 year</time_frame>
    <description>Regimen completion at 28 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Substudy Secondary Outcome: To assess the renal safety of Stribild® PEP.</measure>
    <time_frame>1 year</time_frame>
    <description>Change from baseline in serum creatinine and eGFR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Substudy Secondary Outcome: To assess the renal safety of Stribild® PEP.</measure>
    <time_frame>1 year</time_frame>
    <description>Markers of proximal tubulopathy (glycosuria, proteinuria &gt; 1+).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Substudy Secondary Outcome: To document any HIV-1 seroconversions occurring while on Stribild® PEP.</measure>
    <time_frame>1 year</time_frame>
    <description>HIV-1 seroconversion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Substudy Secondary Outcome: To document the side effect profile of Stribild® given as PEP</measure>
    <time_frame>1 year</time_frame>
    <description>Frequency of adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Substudy Secondary Outcome: To assess adherence to Stribild® PEP.</measure>
    <time_frame>1 year</time_frame>
    <description>Self-reported adherence and reasons for non-adherence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Substudy Secondary Outcome: To assess adherence to Stribild® PEP.</measure>
    <time_frame>1 year</time_frame>
    <description>Changes from baseline in quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Substudy Secondary Outcome: To assess adherence to Stribild® PEP.</measure>
    <time_frame>1 year</time_frame>
    <description>Early cessation of regimen.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">380</enrollment>
  <condition>HIV</condition>
  <condition>Sexually Transmitted Infections</condition>
  <arm_group>
    <arm_group_label>Study intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Testing and linkage to care for Y/MSM</intervention_name>
    <description>Implementation of strategies to enhance testing and linkage to care of Y/MSM, including social network testing and a youth outreach corps working with existing and new community partner agencies.</description>
    <arm_group_label>Study intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Engagement and retention for HIV-positive Y/MSM in care</intervention_name>
    <description>Optimizing current HIV care and treatment services at DYC by implementing a patient peer mentoring component, a linkage and retention specialist, and psychosocial support for program staff.</description>
    <arm_group_label>Study intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Engagement and retention for HIV-negative Y/MSM in sexual health services</intervention_name>
    <description>Offering a highly effective combination HIV prevention strategy, including PrEP; warm-hand offs for high-risk negatives, nPEP; risk reduction counseling; frequent HIV and STI testing, including testing a highly sensitive method of detecting early HIV infection; and youth-focused programming.</description>
    <arm_group_label>Study intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Stribild PEP Substudy</intervention_name>
    <description>A substudy of 28 days of once-daily Stribild® initiated within 72 hours of a high risk sexual exposure for HIV post-exposure prophylaxis (PEP).</description>
    <arm_group_label>Study intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men between the ages of 18-29 who are ever sexually active with men;&#xD;
&#xD;
          -  Transgender females (M2F) between the ages of 18-29 who are sexually active with men;&#xD;
             Transgender males (F2M) between the ages of 18-29 who are sexually active with men;&#xD;
             and&#xD;
&#xD;
          -  Any HIV-negative person aged 18-29, male or female, who has at least one known HIV&#xD;
             positive (i.e. serodiscordant) sexual partner.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None.&#xD;
&#xD;
        For the PEP substudy the inclusion criterion is at least one episode in the 72 hours prior&#xD;
        to presentation of unprotected receptive anal intercourse with a partner known or suspected&#xD;
        to be HIV positive and the following are the substudy exclusion criteria:&#xD;
&#xD;
          -  Known kidney disease&#xD;
&#xD;
          -  Dipstick proteinuria &gt;1+&#xD;
&#xD;
          -  eGFR &lt; 70 ml/min/1.73m2&#xD;
&#xD;
          -  Known metabolic bone disease&#xD;
&#xD;
          -  Signs or symptoms of acute HIV infection&#xD;
&#xD;
          -  Concomitant use of nephrotoxic drug or medication contraindicated with Stribild®&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeff Burack, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>East Bay AIDS Center (EBAC)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert Grant, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gladstone Institutes</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Janet Myers, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCSF Center for AIDS Prevention</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Downtown Youth Clinic</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.altabatessummit.org/clinical/aids_scvs.html</url>
    <description>East Bay AIDS Center Website</description>
  </link>
  <reference>
    <citation>Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.</citation>
    <PMID>21091279</PMID>
  </reference>
  <reference>
    <citation>Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, Tappero JW, Bukusi EA, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kakia A, Odoyo J, Mucunguzi A, Nakku-Joloba E, Twesigye R, Ngure K, Apaka C, Tamooh H, Gabona F, Mujugira A, Panteleeff D, Thomas KK, Kidoguchi L, Krows M, Revall J, Morrison S, Haugen H, Emmanuel-Ogier M, Ondrejcek L, Coombs RW, Frenkel L, Hendrix C, Bumpus NN, Bangsberg D, Haberer JE, Stevens WS, Lingappa JR, Celum C; Partners PrEP Study Team. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012 Aug 2;367(5):399-410. doi: 10.1056/NEJMoa1108524. Epub 2012 Jul 11.</citation>
    <PMID>22784037</PMID>
  </reference>
  <reference>
    <citation>Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, Henderson FL, Pathak SR, Soud FA, Chillag KL, Mutanhaurwa R, Chirwa LI, Kasonde M, Abebe D, Buliva E, Gvetadze RJ, Johnson S, Sukalac T, Thomas VT, Hart C, Johnson JA, Malotte CK, Hendrix CW, Brooks JT; TDF2 Study Group. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012 Aug 2;367(5):423-34. doi: 10.1056/NEJMoa1110711. Epub 2012 Jul 11.</citation>
    <PMID>22784038</PMID>
  </reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>May 6, 2014</study_first_submitted>
  <study_first_submitted_qc>July 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>November 17, 2017</last_update_submitted>
  <last_update_submitted_qc>November 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sexually Transmitted Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>January 4, 2023</submitted>
    <returned>January 30, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02183909
org study id: EI12-EBACA-003
nct id: NCT02183909
lead sponsor: 
has dmc: No
The overall goal of the CRUSH project is to enhance and extend a response to the local
      HIV/AIDS epidemic in Alameda County with a set of innovative, evidence-based interventions
      across the continuum of HIV prevention and care, targeting individuals and communities most
      vulnerable to HIV. The East Bay AIDS Center, in partnership with the University of California
      San Francisco's Center for AIDS Prevention Studies, the Gladstone Institutes, and several key
      community-based organizations, are engaging in a participatory partnership to enhance and
      implement HIV services which target the East Bay's highest risk population- young men who
      have sex with men (Y/MSM). Specifically, the CRUSH Project is designed to evaluate a
      combination of program approaches to address the sexual health care needs of young gay men of
      color and their sexual partners by enhancing the current program activities of the Downtown
      Youth Clinic (DYC).

      We hypothesize that we can reduce the impact of HIV among Y/MSM by expanding the current DYC
      services structure in two ways. We intend to expand HIV testing, and linkage to and retention
      in care for youth who test HIV positive, providing them with intensive risk-reduction
      counseling and antiretroviral treatment, and thereby ultimately reducing the risk of further
      HIV transmission. And we intend for the first time to offer a comprehensive combination
      package of preventive services to HIV-negative youth, including routine accesses to HIV/STI
      screening and treatment, and access to HIV pre-exposure prophylaxis (PrEP).

      The CRUSH Project will also have a substudy that will enroll HIV-negative participants who
      are eligible to receive PEP. The substudy will evaluate the tolerability and acceptability of
      a 28 day course of Stribild® given as post-exposure prophylaxis (PEP) to prevent sexual
      acquisition of HIV-1 in Y/MSM of color.
The CRUSH Project (Connecting Resources for Urban Sexual Health) is a demonstration project
      at Alta Bates Summit Medical Center's East Bay AIDS Center (EBAC) and Downtown Youth Clinic
      (DYC) offering interventions aimed at reducing HIV-1 incidence among young MSM of color in
      the East Bay region. CRUSH has two major components:

        1. Providing enhanced testing and linkage to care (TLC+) for HIV positives, aimed at
           increasing the proportion of HIV positive Y/MSM who are in care, virologically
           suppressed, and receiving intensive risk reduction counseling.

        2. Providing comprehensive sexual health services to high risk HIV-negatives, including but
           not limited to the provision of PrEP and PEP when clinically appropriate.

      In addition, the CRUSH Project will offer a substudy of CRUSH, and will enroll HIV negative
      CRUSH participants who are eligible to receive PEP. Stribild® is a single-tablet, four-drug,
      once-daily complete regimen that is FDA-approved for the treatment of HIV-1 infection in
      treatment-naïve HIV-infected adults with estimated glomerular filtration rate
      ≥70ml/min/1.73m2. Because of limited data, no antiretroviral drug or combination of drugs has
      been approved for PEP. Current PEP guidelines generally call for using a 28-day course of a
      3-drug regimen that has been approved for the treatment of HIV-1 infection
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: The proportion of young men who have sex with men (YMSM) of color who test positive for HIV at partner agencies and the proportion of positive and negative YMSM who are tested for HIV and linked to care on a quarterly and annual basis.
time frame: 1 year
description: Expanding the investigators currently successful HIV testing strategy-collaborations and systems of referral of new cases of HIV from existing partners-so that referrals are also received for high risk negatives to receive sexual health services. Implementing two new strategies: social network testing and a youth outreach corps working with partner agencies; it is hypothesized that social network testing will increase the proportion of positive test results.
measure: The proportion of HIV-positive enrolled YMSM who are retained, on therapy, and who have achieved viral suppression within one year of entering care.
time frame: 1 year
description: Optimizing current HIV care and treatment services at DYC by adding three new components: a patient peer mentoring component, a linkage and retention specialist, and psychosocial support for program staff.
measure: The proportion of HIV-uninfected YMSM participants who are retained, receive sexually transmitted infection (STI) testing, and receive non-occupational post-exposure-prophylaxis (nPEP) and/or PrEP.
time frame: 1 year
description: Integrating sexual health services for HIV-uninfected young MSM of color into an HIV care setting, including PrEP, warm-hand offs for high risk negatives, nPEP, risk reduction counseling, frequent HIV and STI testing, and youth-focused programming.
measure: Substudy Primary Outcome: To evaluate the tolerability and acceptability of a 28 day course of Stribild® given as post-exposure prophylaxis (PEP) to prevent sexual acquisition of HIV-1.
time frame: 1 year
description: Regimen completion at 28 days.
measure: Substudy Secondary Outcome: To assess the renal safety of Stribild® PEP.
time frame: 1 year
description: Change from baseline in serum creatinine and eGFR.
measure: Substudy Secondary Outcome: To assess the renal safety of Stribild® PEP.
time frame: 1 year
description: Markers of proximal tubulopathy (glycosuria, proteinuria > 1+).
measure: Substudy Secondary Outcome: To document any HIV-1 seroconversions occurring while on Stribild® PEP.
time frame: 1 year
description: HIV-1 seroconversion.
measure: Substudy Secondary Outcome: To document the side effect profile of Stribild® given as PEP
time frame: 1 year
description: Frequency of adverse events.
measure: Substudy Secondary Outcome: To assess adherence to Stribild® PEP.
time frame: 1 year
description: Self-reported adherence and reasons for non-adherence.
measure: Substudy Secondary Outcome: To assess adherence to Stribild® PEP.
time frame: 1 year
description: Changes from baseline in quality of life.
measure: Substudy Secondary Outcome: To assess adherence to Stribild® PEP.
time frame: 1 year
description: Early cessation of regimen.
arm group label: Study intervention
arm group type: Experimental
intervention type: Other
intervention name: Testing and linkage to care for Y/MSM
description: Implementation of strategies to enhance testing and linkage to care of Y/MSM, including social network testing and a youth outreach corps working with existing and new community partner agencies.
arm group label: Study intervention
intervention type: Behavioral
intervention name: Engagement and retention for HIV-positive Y/MSM in care
description: Optimizing current HIV care and treatment services at DYC by implementing a patient peer mentoring component, a linkage and retention specialist, and psychosocial support for program staff.
arm group label: Study intervention
intervention type: Other
intervention name: Engagement and retention for HIV-negative Y/MSM in sexual health services
description: Offering a highly effective combination HIV prevention strategy, including PrEP; warm-hand offs for high-risk negatives, nPEP; risk reduction counseling; frequent HIV and STI testing, including testing a highly sensitive method of detecting early HIV infection; and youth-focused programming.
arm group label: Study intervention
intervention type: Drug
intervention name: Stribild PEP Substudy
description: A substudy of 28 days of once-daily Stribild® initiated within 72 hours of a high risk sexual exposure for HIV post-exposure prophylaxis (PEP).
arm group label: Study intervention
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 29 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeff Burack, MD
role: Principal Investigator
affiliation: East Bay AIDS Center (EBAC)
last name: Robert Grant, MD, MPH
role: Principal Investigator
affiliation: Gladstone Institutes
last name: Janet Myers, PhD
role: Principal Investigator
affiliation: UCSF Center for AIDS Prevention
facility: 
country: United States
url: http://www.altabatessummit.org/clinical/aids_scvs.html
description: East Bay AIDS Center Website
citation: Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.
PMID: 21091279
citation: Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, Tappero JW, Bukusi EA, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kakia A, Odoyo J, Mucunguzi A, Nakku-Joloba E, Twesigye R, Ngure K, Apaka C, Tamooh H, Gabona F, Mujugira A, Panteleeff D, Thomas KK, Kidoguchi L, Krows M, Revall J, Morrison S, Haugen H, Emmanuel-Ogier M, Ondrejcek L, Coombs RW, Frenkel L, Hendrix C, Bumpus NN, Bangsberg D, Haberer JE, Stevens WS, Lingappa JR, Celum C; Partners PrEP Study Team. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012 Aug 2;367(5):399-410. doi: 10.1056/NEJMoa1108524. Epub 2012 Jul 11.
PMID: 22784037
citation: Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, Henderson FL, Pathak SR, Soud FA, Chillag KL, Mutanhaurwa R, Chirwa LI, Kasonde M, Abebe D, Buliva E, Gvetadze RJ, Johnson S, Sukalac T, Thomas VT, Hart C, Johnson JA, Malotte CK, Hendrix CW, Brooks JT; TDF2 Study Group. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012 Aug 2;367(5):423-34. doi: 10.1056/NEJMoa1110711. Epub 2012 Jul 11.
PMID: 22784038
responsible party type: Sponsor
mesh term: Sexually Transmitted Diseases
mesh term: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
submitted: January 4, 2023
returned: January 30, 2023