Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries

Human Immunodeficiency Virus Clinical Trial

Official title:

Preparing for Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries With Low Access to Biomedical Prevention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05323123
• Other study ID #: AAAU1673
• Secondary ID: 5R33TW011752
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: November 30, 2024

Study information

• Verified date: June 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 145
• Est. completion date: November 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

Behavioral:
• PrEP Romania
Enrolled participants will receive PrEP education and adherence counseling from trained counselors, and have a medical evaluation from a physician, who will prescribe PrEP.

Locations

Country	Name	City	State
Romania	Romanian Association Against AIDS	Bucharest
Romania	Romanian Association Against AIDS	Cluj-Napoca
United States	Columbia University School of Nursing	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Fogarty International Center of the National Institute of Health, Yale University

Countries where clinical trial is conducted

United States,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PrEP Adherence via biological measures	Blood plasma concentration (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	Baseline and 6 months
Secondary	PrEP adherence via self-report measures	PrEP adherence measured via self-report,, both a continuous (average number of PrEP doses taken per week when data were reported, from 0 to 7) and binary variable (0-3 doses per week, on average vs. =4 doses per week, on average)	Baseline and 6 months
Secondary	PrEP Persistence	Yes vs. no (continuing vs. stopping without restarting PrEP for the 6-month study period, measured dichotomously).	Baseline and 6 months
Secondary	PrEP stigma	Reports of anticipated and/or experienced stigma related to PrEP use; higher scores indicate increased stigma	Baseline and 6 months
Secondary	Depression	Patient Health Questionnaire; minimum value is 0 and maximum value is 27; higher scores indicate increased depression	Baseline and 6 months
Secondary	Anxiety	Generalized Anxiety Disorder; minimum value is 0 and maximum value is 21; higher scores indicate increased anxiety	Baseline and 6 months
Secondary	HIV risk	number of acts of condomless anal sex with an HIV-positive or status-unknown male partner over the past six months	Baseline and 6 months
Secondary	Percentage of participants using app (App feasibility)	feasibility defined as at least 50% of individuals used the app on average >2x/week over the 3-month intervention period.	Baseline and 6 months
Secondary	Score of app usability rating (App acceptability)	The System Usability Scale (SUS) is a validated 10-item scale that provides a global measure of system usability. The minimum value is 0 and the maximum value is 100, with higher scores indicating better usability. A score > 68 indicates app usability (or acceptability).	Baseline and 6 months