Implementation of PrEP to HIV in Brazilian Transgender Women (PrEParadas)

Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV in Brazilian Transgender Women

Subjects preliminarily eligible who choose to receive PrEP will be included after obtaining the informed consent and confirmation of eligibility within 45 days after the screening visit.

Once included, participants will be examined in a follow-up visit performed four weeks later and evaluated for evidence of seroconversion to HIV, medication compliance and clinical toxicity. The second follow-up visit will occur at 12th week and every 12 weeks successively (quarterly). Quarterly visits include HIV testing, serum creatinine and counseling on medication compliance and risk reduction.

The study has a total of 6 visits plus 2 extra visits for those participants enrolled in the PK study. In all visits will be assessed the risks, HIV testing will be performed, monitoring of renal function and dispensing of the drug Truvada [emtricitabine 1 tablet (FTC) / tenofovir (TDF) (200/300 mg) once a day orally for 12 months].

Participants who have completed 48 weeks of follow-up or prematurely discontinue a PrEP will be encouraged to return for a follow-up visit after discontinuation of medication for monitoring of the status and evaluation of HIV as the resolution of side effects.

Study Overview

• Status: Unknown
• Conditions: HIV, Prevention
• Intervention / Treatment: Drug: emtricitabine / tenofovir 200/300 mg

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Beatriz Grinsztejn, MD; Phone Number: +55 21 22707064; Email: gbeatriz@ini.fiocruz.br
• Study Contact Backup: Name: Emilia Jalil, MD; Phone Number: +55 21 22707064; Email: emilia.jalil@ini.fiocruz.br

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 21040360
    • Recruiting
    • Instituto Nacional de Infectologia Evandro Chagas (INI) - FIOCRUZ
    • Contact: Beatriz Grinsztejn, PhD; Phone Number: 552122707064; Email: gbeatriz@ini.fiocruz.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Male (at birth) AND transgender women identity;
• Willing and able to provide informed consent in writing;
• Age = or > 18 years;
• Not infected by HIV-1, in accordance with the flowchart of testing from Brazilian Ministry of Health;
• Evidence risk for acquiring HIV-1, including any of the following:
• Anal or vaginal sex without a condom with two or more men or transgender women in the last 12 months, or
• 2 or more episodes of anal sex with at least one HIV+ sexual partner HIV + in the last 12 months, or
• Sex with a man or trans woman and diagnosis or report of any of the following STDs in the last 12 months: syphilis, rectal gonorrhea or chlamydial infection in the rectum.;
• Report of exchanging sex for money, presents, shelter or drugs.
• Able to provide a residential address or contact phone itself, or two personal contacts who would know about his whereabouts during the study period demonstrative;
• Adequate renal function: Creatinine clearance > or = 60 ml / min, estimated by the formula modification of diet in renal disease (MDRD, from English 'Modification of Diet in Renal Disease') within 45 days of enrollment;
• urine Tape with negative result or showing only traces of protein within 45 days prior to enrollment;

Exclusion Criteria:

• Signs or symptoms of acute HIV infection,which is confirmed by laboratory examination in subsequent samples;
• Active and severe infections previously diagnosed, including active tuberculosis or osteomyelitis and all infections requiring parenteral antibiotics (except STD that require intramuscular injections of antibiotics);
• clinically significant active medical problems, including heart disease poorly controlled (eg, symptoms ischemia, congestive heart failure) previously diagnosed malignancy, or which will require additional treatment;
• Patients with positive tests for antigens of hepatitis B surface (HBsAg);
• History of pathological bone fractures unrelated to trauma;
• Patients using any of the following: ARV, including nucleoside inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors and antiretroviral agents under study, treatment with interferon (alpha, beta, or gamma) or interleukin (e.g. ,IL-2), with potential significant nephrotoxic agents, other agents which may inhibit or compete for renal elimination via active tubular secretion (eg probenecid) and / or other agents under study;
• Participation in a clinical trial using concomitant agents under investigation, including placebo-controlled trials using such agents;
• Patients who have any condition at the time of inclusion in the study, according to the opinion of the investigator, may prevent the provision of informed consent, make study participation unsafe, complicate data interpretation, or interfere anyway with the achievement of project objectives.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: emtricitabine / tenofovir 200/300 mg; emtricitabine / tenofovir 200/300 mg Fixed dose combination of emtricitabine / tenofovir 200/300 mg once daily orally during one year.	Drug: emtricitabine / tenofovir 200/300 mg; Fixed dose combination of emtricitabine / tenofovir 200/300 mg once daily orally during one year; Other Names: Truvada

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance to study treatment	Number of volunteers who keep the study treatment during 24 months Correlation of socio-demographic factors of acceptance and refusal Duration of PrEP Side effects and toxicities, including elevations of creatinine Adherence to PrEP: number of tablets per day, patterns of adherence Number of male sexual partners, by serostatus and condom use, and episodes of anal sex by partner serostatus, the interviewee practices and condom use.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV seroconversions rate	Number of patients who become HIV-infected	2 years
Maximum Plasma Concentration [Cmax] of FTC / TDF	Compare FTC/TDF Cmax between volunteers using or not hormones	2 years
Area Under the Curve [AUC] of FTC / TDF	Compare FTC/TDF AUC between volunteers using or not hormones	2 years

Collaborators and Investigators

• Sponsor: Oswaldo Cruz Foundation

Publications and helpful links

General Publications

• Jalil EM, Torres TS, Luz PM, Monteiro L, Moreira RI, de Castro CRV, Leite IDC, Cunha M, de Cassia Elias Estrela R, Ramos M, Hoagland B, Wagner Cardoso S, Anderson P, Veloso VG, Wilson E, Grinsztejn B; PrEParadas Study Team. Low PrEP adherence despite high retention among transgender women in Brazil: the PrEParadas study. J Int AIDS Soc. 2022 Mar;25(3):e25896. doi: 10.1002/jia2.25896.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2017
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: July 14, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir; Emtricitabine
• Other Study ID Numbers: PrEParadas

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No