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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03043326 |
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Date of registration:
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30/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Demonstration Project on the Feasibility to Implement PrEP in MSM and TG Women
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Scientific title:
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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 |
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Date of first enrolment:
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January 23, 2017 |
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Target sample size:
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1000 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03043326 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Peru
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Contacts
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Name:
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Pedro Gonzales, M.D., M.A.S. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Asociación Civil Impacta Salud y Educación, Peru |
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Name:
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Pedro A Gonzales, M.D., M.A.S. |
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Address:
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Telephone:
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(51) 989585073 |
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Email:
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pgonzales@impactaperu.org |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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HIV Prevention
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Intervention(s)
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Drug: Tenofovir Disoproxil Fumarate and Emtricitabine
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Describing the changes over time in risky sexual behavior among study participants.
[Time Frame: through study completion, an average of 4 years]
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Secondary ID(s)
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PrEP Peru
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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