Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries

Not Applicable

Completed

Conditions: Human Immunodeficiency Virus

Interventions: Drug: Pre-Exposure Prophylaxis (PrEP)
Behavioral: SPARK
Behavioral: HealthMpowerment

Registration Number: NCT05323123

Lead Sponsor: Columbia University

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 in PrEP adherence (self-reported and biomarker verified) between arms will be examined 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 & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

• those not meeting eligibility

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PrEP Romania	Pre-Exposure Prophylaxis (PrEP)	Participants will receive PrEP, motivational counseling, and adherence support
PrEP Romania	SPARK	Participants will receive PrEP, motivational counseling, and adherence support
PrEP Romania	HealthMpowerment	Participants will receive PrEP, motivational counseling, and adherence support
Control	Pre-Exposure Prophylaxis (PrEP)	Participants will receive PrEP during a medical visit.
Control	SPARK	Participants will receive PrEP during a medical visit.

Primary Outcome Measures

Name	Time	Method
PrEP Adherence Via Biological Measures (Binary)	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).

Secondary Outcome Measures

Name	Time	Method
PrEP Adherence Via Biological Measures (Continuous)	Measured at 3 months post-baseline and 6 months post-baseline	A continuous measure of blood plasma concentration of tenofovir diphosphate (TFVdp) from PrEP medication determined using via dried blood spot (DBS) analysis. A higher measure of fmol TFVdp demonstrates greater PrEP adherence (i.e., a better outcome).
PrEP Adherence Via Self-report Measures (Binary)	Measured at 3 months post-baseline and 6 months post-baseline.	A binary measure of PrEP adherence obtained from participant self-report data. Each week, participants mark the days over the past week on which they took or missed their PrEP dose. Each participant's weekly survey results are averaged to determine their mean number of PrEP doses taken per week over the past 3 months. The binary version of this outcome is defined as: 0-3 doses per week, on average, vs. ≥4 doses per week, on average, with ≥4 doses representing a sufficient level of PrEP adherence to be protected against HIV transmission (i.e., a better outcome).
PrEP Adherence Via Self-report Measures (Continuous)	Measured at 3 months post-baseline and 6 months post-baseline.	A continuous measure of PrEP adherence obtained from participant self-report data. Each week, participants mark the days over the past week on which they took or missed their PrEP dose. Each participant's weekly survey results are averaged to determine their mean number of PrEP doses taken per week over the past 3 months, with higher numbers indicating greater PrEP adherence (i.e., a better outcome).
PrEP Motivation	Measured at baseline, 3 months post-baseline, and 6 months post-baseline	PrEP motivation is assessed through participants responses to a single question ("If you are using/were to use PrEP, how motivated are you/would you be to take the pill every day?") with responses scored from 1 to 7 (1=not at all motivated 7=extremely motivated). Higher scores indicate greater PrEP motivation (i.e., a better outcome).
PrEP Knowledge	Measured at baseline, 3 months post-baseline, and 6 months post-baseline	PrEP knowledge is measured through 3 multiple choice questions about PrEP efficacy (e.g., "If taken as indicated by the provider, how effective is PrEP at preventing HIV infection?") where responses are scored as 0 (incorrect or unsure) or 1 (correct). Participants responding correctly to all 3 questions are assigned a total score of 1 (higher PrEP knowledge (i.e., a better outcome)), whereas all others are assigned a total score of 0.
PrEP Attitudes and Beliefs - Positive Statements Subscore	Measured at baseline, 3 months post-baseline, and 6 months post-baseline	Pro-PrEP attitudes and beliefs are measured via a 3-item scale scale consisting of statements describing favorable opinions about PrEP (e.g., "A daily pill would be a good way to protect myself against HIV"). Respondents mark their level of agreement with each item on a scale from 1 (totally disagree) to 5 (totally agree). The 3 individual item scores are summed to obtain an overall score from 5-15, where higher overall scores indicate greater positive attitudes/beliefs about PrEP (i.e., a better outcome).
PrEP Attitudes and Beliefs - Negative Statements Subscore	Measured at baseline, 3 months post-baseline, and 6 months post-baseline	Negative PrEP attitudes and beliefs are measured via a 7-item scale scale consisting of statements describing negative opinions about PrEP (e.g., " I would be very embarrassed to take HIV medication if I didn't have HIV"). Respondents mark their level of agreement with each item on a scale from 1 (totally disagree) to 5 (totally agree). The 7 individual item scores are summed to obtain an overall score from 7-35, where higher overall scores indicate greater negative attitudes/beliefs about PrEP (i.e., a worse outcome).
PrEP Barriers	Measured at baseline, 3 months post-baseline, and 6 months post-baseline	Barriers to taking PrEP are measured via an 11-item scale scale consisting of statements describing potential barriers to taking PrEP (e.g., "the fact that you have to take a pill every day"). Respondents mark the degree to which each item is important to them on a scale from 1 (not important at all) to 5 (extremely important). The 11 individual item scores are summed to obtain an overall score from 11-55, where higher overall scores indicate more barriers to taking PrEP (i.e., a worse outcome).
PrEP Facilitators	Measured at baseline, 3 months post-baseline, and 6 months post-baseline	Facilitators for taking PrEP are measured via an 8-item scale scale consisting of statements describing potential facilitators for taking PrEP (e.g., "the fact that I don't have to pay for PrEP"). Respondents mark the degree to which each item is important to them on a scale from 1 (not important at all) to 5 (extremely important). The 8 individual item scores are summed to obtain an overall score from 8-40, where higher overall scores indicate more facilitators for taking PrEP (i.e., a better outcome).
PrEP Stigma - Score on PrEP Stigma Scale-Shortened Version	Measured at baseline, 3 months post-baseline, and 6 months post-baseline	The PrEP Stigma Scale-Shortened Version is an 11 item scale measuring anticipated and/or perceived stigma related to PrEP use. Participants state their level of agreement (1=strongly disagree, 5=strongly agree) to statements about PrEP-related stigma (e.g., "My friends would think less of me if they found out I was using PrEP"). Item scores are summed to obtain an overall score from 11 to 55, with higher total scores indicate increased stigma (i.e., a worse outcome).
Depression Symptomology - Score on Patient Health Questionnaire-9 Item (PHQ-9)	Measured at baseline, 3 months post-baseline, and 6 months post-baseline	The Patient Health Questionnaire-9 item (PHQ-9) measures severity of depression symptoms in the last 2 weeks, with respondents quantifying the frequency (0=not at all, 3=nearly every day) of their depression symptoms (e.g., Little interest or pleasure in doing things). Item scores are summed to obtain an overall score from 0-27 with higher overall scores indicate increased depression symptoms (i.e., a worse outcome).
Anxiety Symptomology - Score on Generalized Anxiety Disorder 7-item(GAD-7)	Measured at baseline, 3 months post-baseline, and 6 months post-baseline	The Generalized Anxiety Disorder 7-item(GAD-7) measures severity of anxiety symptoms in the last 2 weeks, with respondents quantifying the frequency (0=not at all, 3=nearly every day) of their anxiety symptoms (e.g., Feeling nervous, anxious or on edge). Item scores are summed to obtain an overall score from 0-21 with higher overall scores indicate increased anxiety symptoms (i.e., a worse outcome).
HIV Risk - Number of Condomless Anal Sex (CAS) Acts	Baseline and 6 months post-baseline	HIV risk, measured by number of condomless anal sex (CAS) acts with an HIV-positive or status-unknown male partner over the past 6 months is self-reported by participants. A higher number of CAS acts represents greater HIV risk (i.e., a worse outcome).
Sexually Transmitted Infection (STI) Diagnoses	Baseline and 6 months post-baseline	Participants were asked whether they had been diagnosed with any bacterial sexually transmitted infections (STIs) over the past 6 months. This self-reported measure was coded in a binary manner as either yes (i.e., a worse outcome) or no.

Trial Locations

Locations (2): Columbia University School of Nursing
🇺🇸
New York, New York, United States
Romanian Association Against AIDS
🇷🇴
Cluj-Napoca, Romania
Columbia University School of Nursing
🇺🇸New York, New York, United States