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

NCT03120494 | Unknown Phase 4

• 1 other identifier: Puerto Rico PrEP study- Part B
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

HIV prevention, high risk MSM, sero-discordant couples, PrEP

Outcome Measures

Primary Outcomes (3)

• Retention in care

  Retention to follow up clinical visits based on completed and missed visits

  12 months

• Treatment adherence

  Determine adherence to study drug based on pill count and died blood spots (DBS)

  12 months

• PrEP knowledge

  Measure the level of education of the study subjects in the topic of PrEP using a questionnaire

  12 months

Secondary Outcomes (4)

• Study drug safety

  12 months

• Study drug safety

  12 months

• HIV sero-prevalence

  12 months

• Changes in sexual risk behaviors

  12 months

Study Arms (1)

Subjects at risk of HIV

EXPERIMENTAL

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

Interventions

Emtricitabine and Tenofovir DRUG

All subjects will be provided study drug for use daily for one year.

Also known as: Truvada

Subjects at risk of HIV

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Trans-gender female will be allowed in the study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Puerto Rico Community Network for Clinical Research on AIDS: lead
• Gilead Sciences: collaborator

Study Sites (1)

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

San Juan, PR, 00928, Puerto Rico

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Emtricitabine; Tenofovir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Vivian M Tamayo-Agrait, MD

  PR-CoNCRA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects will receive same treatment with study drug

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 19, 2017
• Study Start: November 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: November 1, 2019
• Last Updated: April 5, 2018

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1)