NCT03043326

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

Status unknown Last updated 8 July 2019

What this trial tests

trial testing Tenofovir Disoproxil Fumarate and Emtricitabine in HIV Prevention in 1,000 participants. Status unknown.

Timeline

23 January 2017

Primary endpoint
31 January 2020

31 January 2022

Quick facts

Lead sponsor	Asociación Civil Impacta Salud y Educación, Peru
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	1,000
Start date	23 January 2017
Primary completion	31 January 2020
Estimated completion	31 January 2022
Sites	5 locations across Peru

Drugs / interventions tested

• Tenofovir Disoproxil Fumarate and Emtricitabine — full drug profile →

Conditions studied

• HIV Prevention — all drugs for HIV Prevention →

Sponsor

Asociación Civil Impacta Salud y Educación, Peru — full company profile →

Who can join

18 and older, male only, with HIV Prevention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.