Preparing for Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries With Low Access to Biomedical Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- PrEP Adherence Via Biological Measures (Binary)
研究概览
简要总结
To stem increasing rates of HIV among gay and bisexual men in Central-Eastern Europe, the feasibility, acceptability, and early efficacy of a culturally adapted evidence-based program to introduce pre-exposure prophylaxis (PrEP) into Romania's healthcare practice will be established. PrEP Romania, a hybrid in-person + mHealth PrEP uptake and adherence program, aims to empower gay and bisexual men and their healthcare system to adopt PrEP and support adherence. Findings can inform evidence-based PrEP rollout in other Central-Eastern European countries with similar levels of unpreparedness for biomedical prevention.
详细描述
Despite the effectiveness of pre-exposure prophylaxis (PrEP) in preventing HIV acquisition, PrEP is not currently medically prescribed in Romania, although demand is rapidly growing. Evidence-based knowledge is urgently needed to guide PrEP's effective rollout in Romania. First, Romania has the 2nd highest increasing HIV incidence of 15 Central-Eastern European (CEE) countries, with gay and bisexual men (GBM) being one of the few epidemic-driving groups; however, there is no national HIV programming for GBM. Second, in a large 2019 GBM report, Romania was the 8th of 44 European countries with the largest gap between PrEP use (1%) and demand (70%). Third, Romania displays some of the highest homophobic attitudes in CEE, keeping GBM in hiding and underutilizing healthcare. Consequently, many Romanian GBM obtain PrEP on their own and use it without medical guidance, thereby increasing their HIV and other health risks.
To address the unmet HIV-prevention needs of Romanian GBM, an established US-Romanian team proposes to introduce a culturally-responsive pre-exposure prophylaxis (PrEP) program in Romania. Two US-based tools will be integrated and adapted 1) SPARK, an in-person motivational intervention for uptake of and adherence to PrEP using an empowering sexual health approach; and 2) P3 (Prepared, Protected, emPowered), a PrEP adherence support app that utilizes engaging social networking and game-based elements, with an in-app portal for individualized live adherence counseling. PrEP Romania will be created with the support of a local Partner Consortium of GBM-competent health providers and community members, and be composed of both in-person (adapted SPARK to build initial motivation for PrEP uptake and adherence) and mHealth (adapted P3 to provide ongoing app-based PrEP motivation, education, and adherence support) components.
Aim 1 (R21). In months 2-11, using the ADAPT-ITT Model, SPARK and P3 will be systematically combined and culturally adapted.
Aim 2 (R21). In months 12-20, 20 GBM will be enrolled in a one-arm pilot to test PrEP Romania's feasibility (e.g., medical visit attendance), acceptability (e.g., intervention staff protocol feedback, GBM interviews about counseling, app usability, and PrEP use), and PrEP uptake (e.g., filled prescriptions), adherence (i.e., self-reported, biomarker verified) and persistence (i.e., still on PrEP) at 3 months. R21-R33 Transition Aim. In mos 21-24, PrEP Romania's promise and anticipated R33 plans will be summarized.
Aim 3 (R33). In months 1-4, necessary adjustments will be made to PrEP Romania. In months 5-30, 120 PrEP-eligible GBM in two cities will be randomized to receive either 1) PrEP Romania or 2) a PrEP education condition. Differences in PrEP adherence (self-reported and biomarker verified) between arms will be examined at 3- and 6-months post-PrEP initiation.
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
- •Men will be eligible based on CDC criteria for GBM PrEP candidates, as European guidelines are yet to be formalized:
- •male sex at birth and current male identity;
- •age ≥ 18;
- •≥1 acts of condomless anal sex with an HIV-positive or status-unknown male partner or diagnosis of bacterial sexually transmitted infection in past 6 months;
- •intentions to start a PrEP regimen;
- •confirmed to be HIV-negative upon study testing; and
- •own a mobile device (smartphone, tablet, laptop); this is highly feasible given the high prevalence of smartphone and internet use in Romania, but we will cover phone plans if needed.
排除标准
- •those not meeting eligibility
研究组 & 干预措施
Control
Participants will receive PrEP (as part of their standard of care) and PrEP education during medical visits.
干预措施: PrEP Education (Behavioral)
PrEP Romania
Participants will receive PrEP (as part of their standard of care), motivational counseling, and PrEP adherence support.
干预措施: SPARK (Behavioral)
PrEP Romania
Participants will receive PrEP (as part of their standard of care), motivational counseling, and PrEP adherence support.
干预措施: HealthMpowerment (Behavioral)
结局指标
主要结局
PrEP Adherence Via Biological Measures (Binary)
时间窗: Measured at 3 months post-baseline and 6 months post-baseline
A binary measure of blood plasma concentration of tenofovir diphosphate (TFVdp) from PrEP medication determined using via dried blood spot or DBS analysis. ≥4 doses per week, equivalent to ≥1,000 fmol TFVdp has been shown to be protective against HIV transmission. A measurement of ≥1,000 fmol TFVdp therefore demonstrates sufficient PrEP adherence (i.e., a better outcome).
次要结局
- PrEP Adherence Via Biological Measures (Continuous)(Measured at 3 months post-baseline and 6 months post-baseline)
- PrEP Adherence Via Self-report Measures (Binary)(Measured at 3 months post-baseline and 6 months post-baseline.)
- PrEP Adherence Via Self-report Measures (Continuous)(Measured at 3 months post-baseline and 6 months post-baseline.)
- PrEP Motivation(Measured at baseline, 3 months post-baseline, and 6 months post-baseline)
- PrEP Knowledge(Measured at baseline, 3 months post-baseline, and 6 months post-baseline)
- PrEP Attitudes and Beliefs - Positive Statements Subscore(Measured at baseline, 3 months post-baseline, and 6 months post-baseline)
- PrEP Attitudes and Beliefs - Negative Statements Subscore(Measured at baseline, 3 months post-baseline, and 6 months post-baseline)
- PrEP Barriers(Measured at baseline, 3 months post-baseline, and 6 months post-baseline)
- PrEP Facilitators(Measured at baseline, 3 months post-baseline, and 6 months post-baseline)
- PrEP Stigma - Score on PrEP Stigma Scale-Shortened Version(Measured at baseline, 3 months post-baseline, and 6 months post-baseline)
- Depression Symptomology - Score on Patient Health Questionnaire-9 Item (PHQ-9)(Measured at baseline, 3 months post-baseline, and 6 months post-baseline)
- Anxiety Symptomology - Score on Generalized Anxiety Disorder 7-item(GAD-7)(Measured at baseline, 3 months post-baseline, and 6 months post-baseline)
- HIV Risk - Number of Condomless Anal Sex (CAS) Acts(Baseline and 6 months post-baseline)
- Sexually Transmitted Infection (STI) Diagnoses(Baseline and 6 months post-baseline)
研究者
Corina Lelutiu-Weinberger
Associate Professor of Health Sciences Research (in Nursing)
Columbia University