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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
United States1 site
Columbia University School of Nursing
New York, New York, 10032
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.
- Conditions
- Human Immunodeficiency Virus
- 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 group | Role | What they receive |
|---|---|---|
| PrEP Romania | Experimental | Participants will receive PrEP (as part of their standard of care), motivational counseling, and PrEP adherence support. Receives: Behavioral: SPARK; Behavioral: HealthMpowerment |
| Control | Active comparator | Participants 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.
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)
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
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.
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.
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
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
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
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
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
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
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
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
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
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
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.
- First posted12 Apr 2022
- Study start1 Oct 2021
- Primary completion30 Sep 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Corina Lelutiu-Weinberger, Columbia University
- Investigators
- Corina Lelutiu-Weinberger, PhD, Principal investigator, Columbia University
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing for Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries With Low Access to Biomedical Prevention
- ClinicalTrials.gov ID
- NCT05323123
- Acronym / sponsor ID
- AAAU1673
- Conditions
- Human Immunodeficiency Virus
- Keywords
- pre-exposure prophylaxis, gay and bisexual men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Yale University, Fogarty International Center of the National Institute of Health
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Posted 27 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PrEP Romania | Experimental | Behavioral: SPARK, Behavioral: HealthMpowermentParticipants will receive PrEP (as part of their standard of care), motivational counseling, and PrEP adherence support. |
| Control | Active comparator | Behavioral: PrEP EducationParticipants will receive PrEP (as part of their standard of care) and PrEP education during medical visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- those not meeting eligibility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPARKAlso: Sexual Health CounselingSPARK is delivered in a clinic setting by a counselor using motivational interviewing techniques (e.g., open-ended questions, affirmations). | Behavioural | PrEP Romania |
| HealthMpowermentPrEP adherence support app that utilizes engaging social networking and game-based elements, with an in-app portal for individualized live adherence counseling. | Behavioural | PrEP Romania |
| PrEP EducationEducational information about PrEP provided by physician during medical visits. | Behavioural | Control |
Primary outcome
PrEP Adherence Via Biological Measures (Binary)
Time frame: 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).
14 secondary outcomes
PrEP Adherence Via Biological Measures (Continuous)
Time frame: Measured at 3 months post-baseline and 6 months post-baseline
PrEP Adherence Via Self-report Measures (Binary)
Time frame: Measured at 3 months post-baseline and 6 months post-baseline.
PrEP Adherence Via Self-report Measures (Continuous)
Time frame: Measured at 3 months post-baseline and 6 months post-baseline.
PrEP Motivation
Time frame: Measured at baseline, 3 months post-baseline, and 6 months post-baseline
PrEP Knowledge
Time frame: Measured at baseline, 3 months post-baseline, and 6 months post-baseline
PrEP Attitudes and Beliefs - Positive Statements Subscore
Time frame: Measured at baseline, 3 months post-baseline, and 6 months post-baseline
PrEP Attitudes and Beliefs - Negative Statements Subscore
Time frame: Measured at baseline, 3 months post-baseline, and 6 months post-baseline
PrEP Barriers
Time frame: Measured at baseline, 3 months post-baseline, and 6 months post-baseline
PrEP Facilitators
Time frame: Measured at baseline, 3 months post-baseline, and 6 months post-baseline
PrEP Stigma - Score on PrEP Stigma Scale-Shortened Version
Time frame: Measured at baseline, 3 months post-baseline, and 6 months post-baseline
Depression Symptomology - Score on Patient Health Questionnaire-9 Item (PHQ-9)
Time frame: Measured at baseline, 3 months post-baseline, and 6 months post-baseline
Anxiety Symptomology - Score on Generalized Anxiety Disorder 7-item(GAD-7)
Time frame: Measured at baseline, 3 months post-baseline, and 6 months post-baseline
HIV Risk - Number of Condomless Anal Sex (CAS) Acts
Time frame: Baseline and 6 months post-baseline
Sexually Transmitted Infection (STI) Diagnoses
Time frame: Baseline and 6 months post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38987812Lelutiu-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corina Lelutiu-Weinberger, PhD principal investigator
Columbia University
3 sites in 2 countries: see every site and its status.
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.