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

NCT03043326 | Unknown DMC FDA Drug

• 1 other identifier: PrEP Peru
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 5

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. 1.Asociación Civil Impacta Salud y Educación, Barranco study site
2. 2.Asociación Civil Impacta Salud y Educación, San Miguel study site
3. 3.Asociación Civil Selva Amazónica, ACSA study site
4. 4.Asociación Vía Libre, Vía Libre study site
5. 5.Espacio Común, Epicentro study site
6. 6.Describing the acceptability and its socio-demographic and sexual behavior correlates for the use of PrEP.
7. 7.Evaluate the persistence of the use of PrEP and its correlates with risk behaviors
8. 8.Evaluating the adherence to the PrEP using self-reporting and pill counts
9. 9.Describing the changes over time in risky sexual behavior among study participants.
10. 10.Describing the number of participants who acquire HIV infection.
11. 11.Evaluate the deviation of the indication of use of PrEP through self- reporting of its sale or sharing with third parties.

Conditions

HIV Prevention

Keywords

Pre-exposure Prophylaxis; MSM and transgender women

Outcome Measures

Primary Outcomes (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,

  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.

  through study completion, an average of 4 years

Secondary Outcomes (2)

• Evaluating the deviation of the indication of use of PrEP through self-reporting of its sale or sharing with third parties.

  through study completion, an average of 4 years

• Describing the changes over time in risky sexual behavior among study participants.

  through study completion, an average of 4 years

Interventions

Tenofovir Disoproxil Fumarate and Emtricitabine DRUG

This is an observational study. Pre-exposure Prophylaxis with TDF/3TC will be distributed to all participants elegible to receive PrEP.

Also known as: TRUVADA tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asociación Civil Impacta Salud y Educación, Peru: lead
• Gilead Sciences: collaborator

Study Sites (5)

Asociacion Civil Selva amazonica

Iquitos, Maynas, 16000, Peru

RECRUITING

Asociacion Via Libre

Lima, Lima 01, Peru

RECRUITING

Asociacion Civil Impacta Salud y Educacion- Barranco CRS

Lima, Lima 04, Peru

RECRUITING

Epicentro

Lima, Lima 04, Peru

RECRUITING

Asociación Civil Impacta Salud y Educación-San Miguel CRS

Lima, Lima 32, Peru

RECRUITING

Related Publications (2)

• Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.

  PMID: 21091279 RESULT

• Anderson PL, Glidden DV, Liu A, Buchbinder S, Lama JR, Guanira JV, McMahan V, Bushman LR, Casapia M, Montoya-Herrera O, Veloso VG, Mayer KH, Chariyalertsak S, Schechter M, Bekker LG, Kallas EG, Grant RM; iPrEx Study Team. Emtricitabine-tenofovir concentrations and pre-exposure prophylaxis efficacy in men who have sex with men. Sci Transl Med. 2012 Sep 12;4(151):151ra125. doi: 10.1126/scitranslmed.3004006.

  PMID: 22972843 RESULT

MeSH Terms

Interventions

Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

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

Study Officials

• Pedro Gonzales, M.D., M.A.S.

  Asociación Civil Impacta Salud y Educación, Peru

  STUDY CHAIR

Central Study Contacts

Pedro A Gonzales, M.D., M.A.S.

CONTACT

(51) 989585073; pgonzales@impactaperu.org

Carla J Porcile, R.N.

CONTACT

(51-1) 5621600; cporcile@impactaperu.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 6, 2017
• Study Start: January 23, 2017
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2022
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

PE (5)