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
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
- Asociación Civil Impacta Salud y Educación, Barranco study site
- Asociación Civil Impacta Salud y Educación, San Miguel study site
- Asociación Civil Selva Amazónica, ACSA study site
- Asociación Vía Libre, Vía Libre study site
- Espacio Común, Epicentro study site
- Describing the acceptability and its socio-demographic and sexual behavior correlates for the use of PrEP.
- Evaluate the persistence of the use of PrEP and its correlates with risk behaviors
- Evaluating the adherence to the PrEP using self-reporting and pill counts
- Describing the changes over time in risky sexual behavior among study participants.
- Describing the number of participants who acquire HIV infection.
- 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
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|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|
- 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
- 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.
- 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
- 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.
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
|Contact: Pedro A Gonzales, M.D., M.A.S.||(51) email@example.com|
|Contact: Carla J Porcile, R.N.||(51-1) 5621600 ext firstname.lastname@example.org|
|Asociacion Civil Selva amazonica||Recruiting|
|Iquitos, Maynas, Peru, 16000|
|Contact: Juan Hinojosa (51) 965621860 email@example.com|
|Asociacion Via Libre||Recruiting|
|Lima, Peru, Lima 01|
|Contact: Robinson Cabello, M.D. (51) 993505140 firstname.lastname@example.org|
|Asociacion Civil Impacta Salud y Educacion- Barranco CRS||Recruiting|
|Lima, Peru, Lima 04|
|Contact: Javier VAlencia, M.D. (51) 2067800 email@example.com|
|Lima, Peru, Lima 04|
|Contact: Hugo Sanchez (51) 997912324 firstname.lastname@example.org|
|Asociación Civil Impacta Salud y Educación-San Miguel CRS||Recruiting|
|Lima, Peru, Lima 32|
|Contact: Pedro Gonzales, M.D.,M.A.S. (51) 989585073 email@example.com|
|Principal Investigator: Pedro Gonzales, M.D., M.A.S.|
|Study Chair:||Pedro Gonzales, M.D., M.A.S.||Asociación Civil Impacta Salud y Educación, Peru|