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Human Immunodeficiency VirusNCT05323123

Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries

A study testing SPARK, HealthMpowerment and PrEP Education in people with Human Immunodeficiency Virus, run by Columbia University at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Human Immunodeficiency Virus
What is being tested?
SPARK, HealthMpowerment and PrEP Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
3 sitesin 2 countries
Study dates
1 Oct 2021to 30 Nov 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • those not meeting eligibility

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Romania2 sites
  • Romanian Association Against AIDS

    Bucharest

  • Romanian Association Against AIDS

    Cluj-Napoca

Other trials in Romania

United States1 site
  • Columbia University School of Nursing

    New York, New York, 10032

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
SPARK, HealthMpowerment, PrEP Education
Keywords
pre-exposure prophylaxis, gay and bisexual men
Medical subject headings
Acquired Immunodeficiency Syndrome, Homosexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPARKBehavioural

    Also called Sexual Health Counseling

    SPARK is delivered in a clinic setting by a counselor using motivational interviewing techniques (e.g., open-ended questions, affirmations).

  • HealthMpowermentBehavioural

    PrEP adherence support app that utilizes engaging social networking and game-based elements, with an in-app portal for individualized live adherence counseling.

  • PrEP EducationBehavioural

    Educational information about PrEP provided by physician during medical visits.

Study groups in NCT05323123
Study groupRoleWhat they receive
PrEP RomaniaExperimentalParticipants will receive PrEP (as part of their standard of care), motivational counseling, and PrEP adherence support.
Receives: Behavioral: SPARK; Behavioral: HealthMpowerment
ControlActive comparatorParticipants will receive PrEP (as part of their standard of care) and PrEP education during medical visits.
Receives: Behavioral: PrEP Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PrEP Adherence Via Biological Measures (Binary)

    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).

    Measured: Measured at 3 months post-baseline and 6 months post-baseline

Secondary outcomes (14)
  1. PrEP Adherence Via Biological Measures (Continuous)

    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).

    Measured: Measured at 3 months post-baseline and 6 months post-baseline

  2. PrEP Adherence Via Self-report Measures (Binary)

    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).

    Measured: Measured at 3 months post-baseline and 6 months post-baseline.

  3. PrEP Adherence Via Self-report Measures (Continuous)

    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).

    Measured: Measured at 3 months post-baseline and 6 months post-baseline.

  4. PrEP Motivation

    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).

    Measured: Measured at baseline, 3 months post-baseline, and 6 months post-baseline

  5. PrEP Knowledge

    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.

    Measured: Measured at baseline, 3 months post-baseline, and 6 months post-baseline

  6. PrEP Attitudes and Beliefs - Positive Statements Subscore

    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).

    Measured: Measured at baseline, 3 months post-baseline, and 6 months post-baseline

  7. PrEP Attitudes and Beliefs - Negative Statements Subscore

    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).

    Measured: Measured at baseline, 3 months post-baseline, and 6 months post-baseline

  8. PrEP Barriers

    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).

    Measured: Measured at baseline, 3 months post-baseline, and 6 months post-baseline

  9. PrEP Facilitators

    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).

    Measured: Measured at baseline, 3 months post-baseline, and 6 months post-baseline

  10. PrEP Stigma - Score on PrEP Stigma Scale-Shortened Version

    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).

    Measured: Measured at baseline, 3 months post-baseline, and 6 months post-baseline

  11. Depression Symptomology - Score on Patient Health Questionnaire-9 Item (PHQ-9)

    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).

    Measured: Measured at baseline, 3 months post-baseline, and 6 months post-baseline

  12. Anxiety Symptomology - Score on Generalized Anxiety Disorder 7-item(GAD-7)

    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).

    Measured: Measured at baseline, 3 months post-baseline, and 6 months post-baseline

  13. HIV Risk - Number of Condomless Anal Sex (CAS) Acts

    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).

    Measured: Baseline and 6 months post-baseline

  14. Sexually Transmitted Infection (STI) Diagnoses

    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.

    Measured: Baseline and 6 months post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2022
  2. Study start1 Oct 2021
  3. Primary completion30 Sep 2024
  4. Study completion30 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05323123
Sponsor's protocol ID
AAAU1673
Other IDs
5R33TW011752
Status last verified
Oct 2025
First submitted
25 Mar 2022
Last updated
27 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lelutiu-Weinberger C, Filimon ML, Zavodszky AM, Lixandru M, Hanu L, Fierbinteanu C, Patrascu R, Streinu-Cercel A, Luculescu S, Bora M, Filipescu I, Jianu C, Hightow-Weidman LB, Rochelle A, Yi B, Buckner N, Golub SA, van Dyk IS, Burger J, Li F, Pachankis JE. Prepare Romania: study protocol for a randomized controlled trial of an intervention to promote pre-exposure prophylaxis adherence and persistence among gay, bisexual, and other men who have sex with men. Trials. 2024 Jul 10;25(1):470. doi: 10.1186/s13063-024-08313-4.

    PubMed 38987812

Questions about this trial

What is this clinical trial studying?

A study testing SPARK, HealthMpowerment and PrEP Education in people with Human Immunodeficiency Virus, run by Columbia University at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Romania, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PrEP Adherence Via Biological Measures (Binary) (time frame: Measured at 3 months post-baseline and 6 months post-baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05323123, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.

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