Clinical trial NCT05323123: Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries
Official title: Preparing for Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries with Low Access to Biomedical Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: pre-exposure prophylaxis
gay and bisexual men
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Yale University
name: Fogarty International Center of the National Institute of Health
First posted: 2022-04-12
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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 across arms will be examined for PrEP uptake, adherence, persistence (self-reported and biomarker verified) at 3- and 6-months post-PrEP initiation.

Aim 4 (R33). In months 31-36, individual and institutional barriers and facilitators of implementing PrEP Romania will be identified by examining Aim 3 feasibility and acceptability data, and via provider, clinic director, and GBM interviews to inform a future hybrid effectiveness-implementation trial.

Eligibility criteria: 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.

Exclusion Criteria:

• those not meeting eligibility

Primary outcomes:
measure: PrEP Adherence via biological measures
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: PrEP adherence via self-report measures
timeFrame: Baseline and 6 months
measure: PrEP Persistence
timeFrame: Baseline and 6 months
measure: PrEP stigma
timeFrame: Baseline and 6 months
measure: Depression
timeFrame: Baseline and 6 months
measure: Anxiety
timeFrame: Baseline and 6 months
measure: HIV risk
timeFrame: Baseline and 6 months
measure: Percentage of participants using app (App feasibility)
timeFrame: Baseline and 6 months
measure: Score of app usability rating (App acceptability)
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University School of Nursing
state: New York
city: Bucharest
country: Romania
facility: Romanian Association Against AIDS
city: Cluj-Napoca
country: Romania
facility: Romanian Association Against AIDS
Study officials:
affiliation: Columbia University
name: Corina Lelutiu-Weinberger, PhD
role: PRINCIPAL_INVESTIGATOR
References: