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Trial record 47 of 1402 for:    Peru

Demonstration Project on the Feasibility to Implement PrEP in MSM and TG Women

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ClinicalTrials.gov Identifier: NCT03043326
Recruitment Status : Recruiting
First Posted : February 6, 2017
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Asociación Civil Impacta Salud y Educación, Peru

Brief Summary:

The purpose of the study is to evaluating the acceptability, use and adherence of a pre-exposure prophylaxis (PrEP) program using the co-formulation tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg (TDF/FTC) administered daily by mouth, at four health facilities and one community-based organization providing health care services for MSM and transgender women.

This is an Observational, longitudinal, multicenter, open-label study to evaluate the acceptability, use and adherence to TDF/FTC-based PrEP in volunteer men who have sex with men and transgender women at substantial high risk of acquiring HIV, who were prescribed for PrEP , following the clinical guidelines to prevent HIV infection of the U.S. Centers for Disease Control and Prevention (2014) and the World Health Organization (2015).

Follow-up: Participants will be followed for 96 weeks (approximately two years) after the start of prophylactic treatment.

Implementation Target Population: Adults (≥18 years of age), without HIV infection diagnosis, and who were prescribed with PrEP and have a substantial risk of acquiring HIV infection according to the international guidelines for HIV prevention.

Sample Size: 1,000 participants

Implementation Sites:

  1. Asociación Civil Impacta Salud y Educación, Barranco study site
  2. Asociación Civil Impacta Salud y Educación, San Miguel study site
  3. Asociación Civil Selva Amazónica, ACSA study site
  4. Asociación Vía Libre, Vía Libre study site
  5. Espacio Común, Epicentro study site

Primary Objectives:

  1. Describing the acceptability and its socio-demographic and sexual behavior correlates for the use of PrEP.
  2. Evaluate the persistence of the use of PrEP and its correlates with risk behaviors
  3. Evaluating the adherence to the PrEP using self-reporting and pill counts

Secondary Objectives:

  1. Describing the changes over time in risky sexual behavior among study participants.
  2. Describing the number of participants who acquire HIV infection.
  3. Evaluate the deviation of the indication of use of PrEP through self- reporting of its sale or sharing with third parties.

Condition or disease Intervention/treatment
HIV Prevention Drug: Tenofovir Disoproxil Fumarate and Emtricitabine

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Demonstration Project on the Feasibility to Implement a Pre-Exposure Oral Prophylaxis Program in Men Who Have Sex With Other Men and Transgender Women at Risk of Acquiring HIV
Actual Study Start Date : January 23, 2017
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2022



Intervention Details:
  • Drug: Tenofovir Disoproxil Fumarate and Emtricitabine
    This is an observational study. Pre-exposure Prophylaxis with TDF/3TC will be distributed to all participants elegible to receive PrEP.
    Other Name: TRUVADA tablets


Primary Outcome Measures :
  1. Acceptability, use and adherence of a pre-exposure prophylaxis (PrEP) program using the co-formulation tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg (TDF/FTC) administered daily by mouth, [ Time Frame: through study completion, an average of 4 years ]
    At all study visits, a Computer Assisted Self Interview will be performed and get information about acceptability, self reported adherence. Pharmacist at each site will get information counting pills to measure adherence.


Secondary Outcome Measures :
  1. Evaluating the deviation of the indication of use of PrEP through self-reporting of its sale or sharing with third parties. [ Time Frame: through study completion, an average of 4 years ]
    Information will be captured at each visit, using CASI

  2. Describing the changes over time in risky sexual behavior among study participants. [ Time Frame: through study completion, an average of 4 years ]
    At all study visits, the Computer Assisted Self Interview will be performed and information regarding the risk behavior will be obtained.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This PrEP research project will be implemented in volunteer MSM and transgender women without diagnosis of HIV infection and at risk of acquiring HIV because of their sexual behavior and prior to this observational study enrollment, be prescribed with PrEP by their primary care providers according the clinic guidelines of the U.S. CDC (2014) and the WHO ( 2015)
Criteria

Inclusion Criteria:

  • Be prescribed with PrEP
  • Male biological sex;
  • Age ≥18 years;
  • Willing and able to provide written informed consent;

Exclusion Criteria:

  • Signs or symptoms of acute retroviral syndrome;
  • Upon enrollment, having a condition that, based on the opinion of the investigator or designee, prevents the participant from providing informed consent; makes participation in the project unsafe; complicates the interpretation of results; or somehow interferes with the achievement of project objectives

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): NCT03043326


Contacts
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Contact: Pedro A Gonzales, M.D., M.A.S. (51) 989585073 pgonzales@impactaperu.org
Contact: Carla J Porcile, R.N. (51-1) 5621600 ext 644 cporcile@impactaperu.org

Locations
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Peru
Asociacion Civil Selva amazonica Recruiting
Iquitos, Maynas, Peru, 16000
Contact: Juan Hinojosa    (51) 965621860    jhinojosa@acsaperu.org   
Asociacion Via Libre Recruiting
Lima, Peru, Lima 01
Contact: Robinson Cabello, M.D.    (51) 993505140    rcabello@vialibre.org.pe   
Asociacion Civil Impacta Salud y Educacion- Barranco CRS Recruiting
Lima, Peru, Lima 04
Contact: Javier VAlencia, M.D.    (51) 2067800    jvalencia@impactaperu.org   
Epicentro Recruiting
Lima, Peru, Lima 04
Contact: Hugo Sanchez    (51) 997912324    hsanchez@epicentro.org.pe   
Asociación Civil Impacta Salud y Educación-San Miguel CRS Recruiting
Lima, Peru, Lima 32
Contact: Pedro Gonzales, M.D.,M.A.S.    (51) 989585073    pgonzales@impactaperu.org   
Principal Investigator: Pedro Gonzales, M.D., M.A.S.         
Sponsors and Collaborators
Asociación Civil Impacta Salud y Educación, Peru
Gilead Sciences
Investigators
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Study Chair: Pedro Gonzales, M.D., M.A.S. Asociación Civil Impacta Salud y Educación, Peru

Additional Information:
Publications of Results:
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Responsible Party: Asociación Civil Impacta Salud y Educación, Peru
ClinicalTrials.gov Identifier: NCT03043326     History of Changes
Other Study ID Numbers: PrEP Peru
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Asociación Civil Impacta Salud y Educación, Peru:
Pre-exposure Prophylaxis
MSM and transgender women
Additional relevant MeSH terms:
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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