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

NCT03043326 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2019-07-08

No results posted yet for this study

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.

Conditions

  • HIV Prevention

Interventions

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.

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Asociación Civil Impacta Salud y Educación, Peru

    lead OTHER

Principal Investigators

  • Pedro Gonzales, M.D., M.A.S. · Asociación Civil Impacta Salud y Educación, Peru

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-23
Primary Completion
2020-01-31
Completion
2022-01-31
FDA Drug
Yes

Countries

  • Peru

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03043326 on ClinicalTrials.gov