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Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part B

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03120494
Recruitment Status : Unknown
Verified April 2017 by Puerto Rico Community Network for Clinical Research on AIDS.
Recruitment status was:  Enrolling by invitation
First Posted : April 19, 2017
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Puerto Rico Community Network for Clinical Research on AIDS

Brief Summary:
75 subjects at risk for HIV infection (25 high risk MSM and 50 sero-discordant couples) will be recruited. All subjects will receive Truvada for pre-exposure prophylaxis or PrEP, as well as routine medical evaluations during one year. Subjects will be managed according to CDC's guidelines on the management of PrEP as a tool for HIV prevention.

Condition or disease Intervention/treatment Phase
HIV/AIDS Drug: Emtricitabine and Tenofovir Phase 4

Detailed Description:

75 subjects at risk for HIV infection (25 high risk MSM and 50 sero-discordant couples) will be recruited. All subjects will receive Truvada for PrEP, as well as routine medical evaluations during one year. Subjects will be managed according to CDC's guidelines on the management of PrEP as a tool for HIV prevention.

All subjects will have a total of at least 8 study visits during which routine assessment are performed for patients on Truvada for PrEP. Apart from offering routine medical care, a baseline questionnaire that includes socio-demographic variables, PrEP knowledge and acceptability and sexual conducts will be offered. At the 6 months visit, an abbreviated sexual conducts questionnaire will be offered.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All subjects will receive same treatment with study drug
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part B
Actual Study Start Date : November 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Subjects at risk of HIV
25 high risk MSM and 50 negative partners in a sero-discordant couple will be recruited and emtricitabine and tenofovir (Truvada) for PrEP will be provided, per guidelines, for one year
Drug: Emtricitabine and Tenofovir
All subjects will be provided study drug for use daily for one year.
Other Name: Truvada




Primary Outcome Measures :
  1. Retention in care [ Time Frame: 12 months ]
    Retention to follow up clinical visits based on completed and missed visits

  2. Treatment adherence [ Time Frame: 12 months ]
    Determine adherence to study drug based on pill count and died blood spots (DBS)

  3. PrEP knowledge [ Time Frame: 12 months ]
    Measure the level of education of the study subjects in the topic of PrEP using a questionnaire


Secondary Outcome Measures :
  1. Study drug safety [ Time Frame: 12 months ]
    Determine safety of study drug based on AE reports related to treatment

  2. Study drug safety [ Time Frame: 12 months ]
    Determine safety of study drug based on safety laboratories monitoring, reported as percentage of participants with abnormal laboratory values

  3. HIV sero-prevalence [ Time Frame: 12 months ]
    Determine the sero-prevalence of the study subjects receiving PrEP based on the number of study subjects diagnosed with HIV during study duration.

  4. Changes in sexual risk behaviors [ Time Frame: 12 months ]
    Measure changes from baseline sexual risk behaviors after initiating use of study drug, specifically frequency of unprotected sexual intercourse according to sexual behaviors questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Trans-gender female will be allowed in the study
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject is a male, female or transgender female age 21 or older
  2. Subject provides written informed consent.
  3. Subject provides written authorization for use and disclosure of protected health information (PHI).
  4. Subject has one of the following risk factors:

    • male, female or transgender female or female sexual partner of an HIV-infected individual, ideally who is not virologically suppressed
    • high risk MSM as defined by: having unprotected sexual intercourse with at least two male partner in the last 6 months, or
    • diagnosed with an STI in the past 6 months
  5. Baseline eCrCl of ≥60 ml/min (calculated using the CKD-EPI formula)
  6. Negative Hepatitis B serology
  7. No medical contraindications to the use of PrEP
  8. Confirmed HIV negative by 5th generation (AB/antigen) HIV test

Exclusion Criteria:

  1. younger than 21 years of age
  2. unable to provide consent
  3. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice).
  4. Positive pregnancy test: Women of childbearing potential must have a negative serum or urine pregnancy test within 1 week prior to study entry. Pregnancy testing will also be performed in enrolled female participants prior to any study procedures being performed
  5. Baseline eCrCl <60 ml/min
  6. Positive Hepatitis B serology to avoid potential flares upon product discontinuation
  7. Any medical contraindication to the use of PrEP or any other conditions deemed by the study investigator to exclude the subject's participation in the study
  8. HIV infected
  9. Signs and symptoms of acute HIV infection
  10. For sero-discordant couples: upon review of HIV positive partner's chart, evidence of resistance to any of the components of the study drug.
  11. Illness or other condition that, in the opinion of the PI, may interfere with study participation at the time of enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120494


Locations
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Puerto Rico
Puerto Rico Community Network for Clinical Research on AIDS (PR-CoNCRA)
San Juan, Puerto Rico, 00928
Sponsors and Collaborators
Puerto Rico Community Network for Clinical Research on AIDS
Gilead Sciences
Investigators
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Principal Investigator: Vivian M Tamayo-Agrait, MD PR-CoNCRA
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Responsible Party: Puerto Rico Community Network for Clinical Research on AIDS
ClinicalTrials.gov Identifier: NCT03120494    
Other Study ID Numbers: Puerto Rico PrEP study- Part B
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Puerto Rico Community Network for Clinical Research on AIDS:
HIV prevention, high risk MSM, sero-discordant couples, PrEP
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Emtricitabine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents