HPTN 091: Integrating HIV Prevention, Gender-Affirmative Medical Care, and Peer Health Navigation for Transgender Women in the Americas: A Vanguard Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 304
- 试验地点
- 5
- 主要终点
- PrEP Uptake
研究概览
简要总结
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.
详细描述
entered elsewhere
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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:
- •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.
- •Anal or vaginal sex in exchange for money, food, shelter, or other goods or favors in the previous 3 months.
- •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:
- •Calculated creatinine clearance ≥ 60 mL/minute using the Cockcroft-Gault equation.
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 times the upper limit of normal (ULN.)
- •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.
排除标准
- •Any reactive or positive HIV test result at Screening or Enrollment, even if HIV infection is not confirmed.
- •Plans to move away from the site area within the next 18 months.
- •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).
- •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).
- •History of deep vein thrombosis, pulmonary embolism, and/or clotting disorder.
- •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.
- •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.
研究组 & 干预措施
Immediate Intervention Arm
PrEP (pre-exposure prophylaxis) provision, STI screening and treatment, GAHT (gender-affirming hormonal therapy), peer-health management using strengths-based management. PrEP provision includes using one daily tablet of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25mg, FTC/TAF) or one daily tablet of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) in the US, and one daily tablet of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) in Brazil.
干预措施: Immediate Intervention Arm (Drug)
Deferred Intervention Arm
0-6 months PrEP (pre-exposure prophylaxis) provision and STI screening and treatment. From months 6-18, GAHT (gender-affirming hormonal therapy) and peer-health management using strengths-based management. PrEP provision includes one daily tablet of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25mg, FTC/TAF) or one daily tablet of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) in the US, and one daily table of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) in Brazil.
干预措施: Deferred Intervention Arm (Drug)
结局指标
主要结局
PrEP Uptake
时间窗: Week 26
Comparison of PrEP uptake between study arms at the end of Week 26. PrEP uptake is defined as whether the participant initiated PrEP at the study clinic..
PrEP Adherence
时间窗: Week 26
The proportion of TGW determined to be adherent at the Week 26 visit was compared by study arm. PrEP adherence was defined as having a detectable concentration of PrEP (Truvada or Descovy) in DBS sample.
Acceptability and Feasibility of Co-located Services
时间窗: 0-18 months
Percentage of participants who report desire for co-located services at the end of the study
Participant Retention at Weeks 26, 52 and 78
时间窗: Weeks 26, 52, 78
Participant retention at weeks 26, 52 and 78 by study arm. Retention defined as the number of participants who completed the visit divided by the number of participants who are expected or have completed the visit.
Acceptability and Feasibility of Peer Health Navigation
时间窗: 0-18 months
Number of each type of peer health navigation encounter.
PrEP Persistent
时间窗: 0-18 months
PrEP persistent is defined as the proportion of study visits where a participant demonstrates high adherence to PrEP among those who initiated PrEP at the study clinic. High adherence at a visit is based on drug concentrations in dried blood spots (DBS): Truvada (TDF/FTC): TFV-DP ≥ 900 fmol/punch Descovy (TAF/FTC): TFV-DP ≥ 950 fmol/punch PrEP persistent reflects sustained high PrEP adherence across multiple visits over time, rather than high PrEP adherence at a single point.
次要结局
- Examining Changes in Sexual Risk-taking Behavior(0-18 months)
- Prevalence of STI Infection (GC, CT, Syphilis) at Baseline(0 months)
- Estimate Prevalence of Baseline Laboratory Values.(0 months)
- Gender-Affirming Hormone Therapy by Visit(0-18 months)
- Annual Incidence of HIV Infections(0-18 months)
- Incidence of STI Infection (GC, CT, Syphilis)(0-18 months)
- Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Uptake(0-18 months)
- Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Associated With PrEP Adherence Across Study Visits.(0-18 months)
- Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Persistence(0-18 months)
- Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to Interest in Future HIV Research(0-18 months)