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

Primary Purpose

HIV/AIDS

Status
Unknown status
Phase
Phase 4
Locations
Puerto Rico
Study Type
Interventional
Intervention
Emtricitabine and Tenofovir
Sponsored by
Puerto Rico Community Network for Clinical Research on AIDS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring HIV prevention, high risk MSM, sero-discordant couples, PrEP

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Puerto Rico Community Network for Clinical Research on AIDS (PR-CoNCRA)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subjects at risk of HIV

Arm Description

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

Outcomes

Primary Outcome Measures

Retention in care
Retention to follow up clinical visits based on completed and missed visits
Treatment adherence
Determine adherence to study drug based on pill count and died blood spots (DBS)
PrEP knowledge
Measure the level of education of the study subjects in the topic of PrEP using a questionnaire

Secondary Outcome Measures

Study drug safety
Determine safety of study drug based on AE reports related to treatment
Study drug safety
Determine safety of study drug based on safety laboratories monitoring, reported as percentage of participants with abnormal laboratory values
HIV sero-prevalence
Determine the sero-prevalence of the study subjects receiving PrEP based on the number of study subjects diagnosed with HIV during study duration.
Changes in sexual risk behaviors
Measure changes from baseline sexual risk behaviors after initiating use of study drug, specifically frequency of unprotected sexual intercourse according to sexual behaviors questionnaire.

Full Information

First Posted
April 11, 2017
Last Updated
April 4, 2018
Sponsor
Puerto Rico Community Network for Clinical Research on AIDS
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03120494
Brief Title
Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part B
Official Title
Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part B
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Puerto Rico Community Network for Clinical Research on AIDS
Collaborators
Gilead Sciences

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
HIV prevention, high risk MSM, sero-discordant couples, PrEP

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
All subjects will receive same treatment with study drug
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects at risk of HIV
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Emtricitabine and Tenofovir
Other Intervention Name(s)
Truvada
Intervention Description
All subjects will be provided study drug for use daily for one year.
Primary Outcome Measure Information:
Title
Retention in care
Description
Retention to follow up clinical visits based on completed and missed visits
Time Frame
12 months
Title
Treatment adherence
Description
Determine adherence to study drug based on pill count and died blood spots (DBS)
Time Frame
12 months
Title
PrEP knowledge
Description
Measure the level of education of the study subjects in the topic of PrEP using a questionnaire
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Study drug safety
Description
Determine safety of study drug based on AE reports related to treatment
Time Frame
12 months
Title
Study drug safety
Description
Determine safety of study drug based on safety laboratories monitoring, reported as percentage of participants with abnormal laboratory values
Time Frame
12 months
Title
HIV sero-prevalence
Description
Determine the sero-prevalence of the study subjects receiving PrEP based on the number of study subjects diagnosed with HIV during study duration.
Time Frame
12 months
Title
Changes in sexual risk behaviors
Description
Measure changes from baseline sexual risk behaviors after initiating use of study drug, specifically frequency of unprotected sexual intercourse according to sexual behaviors questionnaire.
Time Frame
12 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Trans-gender female will be allowed in the study
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject is a male, female or transgender female age 21 or older Subject provides written informed consent. Subject provides written authorization for use and disclosure of protected health information (PHI). 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 Baseline eCrCl of ≥60 ml/min (calculated using the CKD-EPI formula) Negative Hepatitis B serology No medical contraindications to the use of PrEP Confirmed HIV negative by 5th generation (AB/antigen) HIV test Exclusion Criteria: younger than 21 years of age unable to provide consent 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). 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 Baseline eCrCl <60 ml/min Positive Hepatitis B serology to avoid potential flares upon product discontinuation 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 HIV infected Signs and symptoms of acute HIV infection For sero-discordant couples: upon review of HIV positive partner's chart, evidence of resistance to any of the components of the study drug. Illness or other condition that, in the opinion of the PI, may interfere with study participation at the time of enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivian M Tamayo-Agrait, MD
Organizational Affiliation
PR-CoNCRA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Puerto Rico Community Network for Clinical Research on AIDS (PR-CoNCRA)
City
San Juan
ZIP/Postal Code
00928
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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