Pre-Exposure Prophylaxis for Transgender Women in the US and South America

HIV Prevention Clinical Trial

Official title:

HPTN 091: Integrating HIV Prevention, Gender-Affirmative Medical Care, and Peer Health Navigation for Transgender Women in the Americas: A Vanguard Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04742491
• Other study ID #: HPTN 091
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: March 26, 2021
• Est. completion date: September 16, 2024

Study information

• Verified date: July 2023
• Source: HIV Prevention Trials Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study to assess the feasibility, acceptability, and preliminary impact of a multi-component strategy to improve pre-exposure prophylaxis (PrEP) uptake and adherence that integrates delivery of biomedical HIV prevention co-located with gender-affirming transgender care (hormonal therapy and medical monitoring) and Peer Health Navigation (PHN) using Strengths-Based Case Management (SBCM) professional supervision.

Multi-site, open-label study with each participant randomized 1:1 to Immediate Intervention vs. 6-month Deferred Intervention Arms. Both arms will be provided PrEP and sexually transmitted infection (STI) screening and treatment. Participants in the Immediate Intervention Arm will receive co-located gender-affirming medical care and PHN using SBCM starting at the Enrollment Visit. Participants in the Deferred Intervention Arm will receive linkage to external gender-affirming medical care and case management services during the deferred period and will transition to the study intervention six months following the Enrollment Visit.

Description:

entered elsewhere

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 307
• Est. completion date: September 16, 2024
• Est. primary completion date: September 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• TGW (assigned male at birth, trans-feminine spectrum - as defined in the SSP Manual - by self-report) who meet all of the following criteria are eligible for inclusion in this study.

• Eighteen years or older at the time of screening.

• Willing and able to provide informed consent for the study.

• Interest in PrEP - as defined in the SSP Manual.

• Non-reactive HIV test results at Screening and Enrollment.

• Available to return for all study visits and within site catchment area, as defined per site's Standard Operating Procedures (SOP).

• At risk for sexually acquiring HIV infection based on self-report of at least one of the following:

1. Any anal or vaginal sex with one or more serodiscordant or HIV-unknown serostatus sexual partners in the previous 3 months, regardless of condom use.

2. Anal or vaginal sex in exchange for money, food, shelter, or other goods or favors in the previous 3 months.

3. History of STI(s) in the past 6 months.

• Willing to undergo all required study procedures.

• General good health, as evidenced by the following laboratory values:

1. Calculated creatinine clearance = 60 mL/minute using the Cockcroft-Gault equation.

2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 times the upper limit of normal (ULN.)

3. HBV surface antigen (HBsAg) negative.

Note: Otherwise eligible participants with laboratory results outside the above-mentioned values, with the exception of those with reactive HIV test, can be re-tested during the screening window. Participants with reactive HIV tests will not be able to rescreen.

Note: Participants who practice receptive vaginal sex cannot be provided Descovy® as it is not approved for this indication.

Exclusion Criteria:

1. Any reactive or positive HIV test result at Screening or Enrollment, even if HIV infection is not confirmed.

2. Plans to move away from the site area within the next 18 months.

3. Co-enrollment in any other research study that may interfere with this study (as provided by self-report or other available documentation). Exceptions may be made after consultation with the Clinical Management Committee (CMC).

4. Current or chronic history of liver disease (e.g., non-alcoholic or alcoholic steatohepatitis) or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome, asymptomatic gallstones, or cholecystectomy).

5. History of deep vein thrombosis, pulmonary embolism, and/or clotting disorder.

6. Active or planned use of medications with significant drug interactions as described in the Package Insert for Truvada® or Descovy®, per clinician's discretion (provided by selfreport or obtained from medical history or medical records). See Section 5.8 for a full list of drug interactions.

7. Any other condition, including but not limited to alcohol or substance abuse and uncontrolled medical condition and/or allergies, that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives would make the patient unsuitable for the study or unable/unwilling to comply with the study requirements.

Related Conditions & MeSH terms

• HIV Prevention

Intervention

Drug:
• Immediate Intervention Arm Truvada in the US
Truvada in the United States
• Deferred Intervention Arm Truvada in the US
Truvada in the United States
• Immediate Intervention Arm Truvada in Brazil
Truvada in Brazil
• Deferred Intervention Arm Truvada in Brazil
Truvada in Brazil
• Immediate Intervention Arm Descovy in the US
Descovy in the United States
• Deferred Intervention Arm Descovy in the US
Descovy in the United States

Locations

Country	Name	City	State
Brazil	Instituto de Pesquisa Clinicaq Evandro Chagas CRS	Manguinhos	RJ
United States	Houston AIDS Research Team CRS	Houston	Texas
United States	Harlem Prevention Center CRS	New York	New York
United States	Penn Prevention CRS	Philadelphia	Pennsylvania
United States	Bridge HIV CRS	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
HIV Prevention Trials Network	Gilead Sciences

Countries where clinical trial is conducted

United States,  Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of hormonal therapy and PrEP	Strengths-based case management to measure amount of PrEP uptake and gender affirming hormonal therapy uptake	0-36 months
Primary	PrEP adherence and persistence	Measure of amount of drug taken via self reported pill count and biological markers via plasma	0-36 months
Secondary	HIV incidence	Measured via 4th generation ELISA	0-36 months
Secondary	STI incidence	GC/chlamydial and syphilis laboratory testing	0-36 months
Secondary	Changes in sexual risk taking behavior	Self report number of partners, serostatus and number/type of acts	0-36 months
Secondary	Measure of baseline lab data for suitability of this population for future PrEP research	Hepatitis B status via antibody, antigen and core antibody testing	0-36 months
Secondary	Measure of baseline lab data for suitability of this population for future PrEP research	Hepatitis C testing via antibody testing	0-36 months
Secondary	Measure of baseline lab data for suitability of this population for future PrEP research	serum creatinine	0-36 months
Secondary	Measure of baseline lab data for suitability of this population for future PrEP research	urine for STI testing	0-36 months
Secondary	Measure of baseline lab data for suitability of this population for future PrEP research	NAAT for rectal and pharyngeal swabs for STI testing	0-36 months
Secondary	psychological factors tied to PreP uptake, adherence, persistence, interest in future HIV research	Self-administered questionnaire; o Depression via PHQ2: Scale 0-6, score 3 or higher is positive	0-36 months
Secondary	behavioral alcohol use factors tied to PreP uptake, adherence, persistence, interest in future HIV research	Self-administered questionnaire; o Alcohol use via AUDIT-C: Scale 0-12 points. Score > 4 is positive	0-36 months
Secondary	behavioral substance use factors tied to PreP uptake, adherence, persistence, interest in future HIV research	Self-administered questionnaire; o Substance use via CAGE-AID: Scale 0-4. Score >2 is positive.	0-36 months
Secondary	PrEP uptake, adherence, persistence and interest in future HIV research	Self-administered questionnaire (no scale)	0-36 months