HIVLSPYNCT03805451
Life Steps for PrEP for Youth
A study testing Life Steps for PrEP for Youth in people with HIV and Pre-exposure Prophylaxis, run by Fenway Community Health at 3 sites in United States.
Trial summary
This is a formative study, designed to provide information required to tailor Life-Steps for Pre-Exposure Prophylaxis (PrEP), an evidence-based cognitive behavioral adherence intervention, to enhance PrEP uptake and adherence in high risk young men who have sex with men (YMSM) and young transgender women who have sex… Read more about this study
- Who is it for?
- Ages 16 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Pre-exposure Prophylaxis, Medication Adherence
- What is being tested?
- Life Steps for PrEP for Youth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Sep 2019to 15 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 24 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age 16-24
- HIV-uninfected by self-report
- Assigned male sex at birth
- self-identify as a man who has sex with men or a trans woman who has sex with men
- able to understand English
- Self-reported HIV risk is defined as meeting at least one of the following criteria:
Show all 12Show fewer
- At least one episode of unprotected anal intercourse with an HIV-positive partner with a penis or a partner with a penis of unknown HIV status during the last 6 months;
- Anal intercourse with 3 or more partners with a penis during the last 6 months;
- Exchange of money, gifts, shelter or drugs for anal sex with a partner with a penis during the last 6 months;
- Sex with a partner with a penis and has had an STI(sexually transmitted infection) during the last 6 months;
- Sexual partner of an HIV-positive person with a penis with whom condoms were not consistently used in the last 6 months; or
- At least one episode of anal intercourse where the condom broke or slipped off during the last 6 months
Who cannot join
- Currently enrolled in another PrEP adherence study*
- Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine product.*
- Enrollment in earlier phase of Life Steps for PrEP for Youth*
- Unable to give informed consent/assent due to severe mental or physical illness/substance intoxication at baseline visit
- Has severe cognitive limitation that would limit their ability to comprehend the informed consent or assent
- Presence of an active (i.e. untreated) and interfering psychiatric disorder (e.g., bipolar disorder, schizophrenia, substance abuse)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
PRISM Health
Atlanta, Georgia, 30322
Fenway Health
Boston, Massachusetts, 02215
Core Center
Chicago, Illinois, 60612
About this study
This is a formative study, designed to provide information required to tailor Life-Steps for Pre-Exposure Prophylaxis (PrEP), an evidence-based cognitive behavioral adherence intervention, to enhance PrEP uptake and adherence in high risk young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM).
Life-Steps for Pre-exposure prophylaxis (PrEP) is a manualized modular adherence intervention based on principles of cognitive-behavioral therapy (CBT), that allows for recipients of the intervention to focus on the greatest challenges that they perceive in maintaining optimal adherence to PrEP.
Read the detailed description
Aim 1:
To adapt Life-Steps for Pre-Exposure Prophylaxis (PrEP) to be culturally relevant and appropriate for at-risk young men who have sex with men (YMSM) and transgender women who have sex with men (TWSM). The investigators will conduct in-depth qualitative interviews with up to 20 HIV-uninfected, at risk YMSM/TWSM at Fenway Health, an Adolescent Trials Network (ATN) clinical center. The investigators will also conduct in-depth, individual qualitative interviews with up to 10 key informants, including PrEP providers and staff at community-based organizations that work with YMSM/TWSM. Through these interviews, perceived facilitators and barriers to initiating and adhering to PrEP will be identified, and potential strategies to optimize adherence to PrEP for YMSM/TWSM. The investigators will explore youth perspectives on the use of nurses to deliver health messages and weekly text messages. YMSM/TWSM will be recruited at various points in the PrEP continuum of care, including those have opted not to initiate PrEP despite recommendations from clinicians, those who are using PrEP who report high levels of adherence and those who report adherence challenges through clinician referrals and direct recruitment in clinic waiting areas. Interviews will last approximately 60 minutes and will be digitally-recorded. Recordings will be transcribed and analyzed rapidly to inform the design of the youth-tailored Life-Steps for PrEP for YMSM/TWSM that we will test in Aim 2.
Aim 2:
To conduct a 2-arm pilot randomized control trial (RCT) to assess feasibility and acceptability of the Life-Steps for PrEP for youth intervention and preliminary efficacy of the intervention to improve PrEP adherence and retention in PrEP care compared to the standard of PrEP care at three different clinical sites. Investigators will enroll 50 YMSM/TWSM in the RCT (randomized 1:1 to the 2 arms) across the 3 sites. The primary efficacy outcomes will be PrEP adherence-as measured by dried blood spot testing -and retention in PrEP care-as measured by attendance at quarterly clinic appointments-at 3 and 6 months post baseline. Secondary outcomes include changes in sexual behaviors, retention in prevention services, and acceptability of the interventions which will be assessed at each major visit. Investigators will also conduct a brief, 15-minute semi-structured exit interview with participants in the Life-Steps for PrEP for youth intervention arm to provide an opportunity for more in-depth (open-ended) feedback on intervention satisfaction and acceptability. These data will be used to finalize the intervention manual to enhance participant acceptability.
- Conditions
- HIV, Pre-exposure Prophylaxis, Medication Adherence
- Being tested
- Life Steps for PrEP for Youth
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life Steps for PrEP for YouthBehavioural
Life-Steps is a modular adherence intervention based on principles of cognitive-behavioral therapy (CBT), that allows for recipients of the intervention to focus on the greatest challenges that they perceive in maintaining optimal adherence to pre-exposure prophylaxis.
| Study group | Role | What they receive |
|---|---|---|
| Life Steps for PrEP for Youth | Experimental | Life Steps for PrEP for Youth was derived from our prior PrEP work supported by the National Institute of Mental Health and will be tailored for YMSM/TWSM based on the findings from 20 qualitative interviews with YMSM and TWSM and 10 qualitative interviews with key informants. It will likely consist of four weekly sessions at the time of PrEP initiation and two booster sessions, which occur two and three months after PrEP initiation. Overall, the core components of the intervention will focus on medication adherence, sexual behavior, and problem solving barriers to adherence, using motivational interviewing when needed. Receives: Behavioral: Life Steps for PrEP for Youth |
| Standard of Care | No intervention | After being prescribed PrEP, participants will receive standard-of-care adherence support for PrEP. They will have blood collected for medication adherence measures and will complete computer assisted behavioral surveys during study visits. Participants in this arm will also be followed for 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-Exposure Prophylaxis (PrEP) Adherence at 3 months post PrEP initiation
Measured by dried blood spot (DBS) testing of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP)
Measured: Blood sample collected at 3 month visit post baseline
Pre-Exposure Prophylaxis (PrEP) Adherence at 6 months post PrEP initiation
Measured by dried blood spot (DBS) testing of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP)
Measured: blood sample collected at 6 month visit post baseline
Secondary outcomes (3)
Retention in Pre-Exposure Prophylaxis (PrEP) care and prevention services
Attendance at quarterly clinic appointments obtained through medical record abstraction
Measured: Records will be abstracted at the end of the study period for each participant to determine if they attended a clinic appointment at 3 and 6 months post baseline
LifeSteps for PrEP for Youth Intervention Acceptability
To measure acceptability, participants will be asked to self-report the degree to which they find the intervention appropriate and useful using Likert-type agreement scales.
Measured: Measured at each study visit (3 and 6 months post baseline)
LifeSteps for PrEP for Youth Intervention Satisfaction
Satisfaction will be measured with the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item, easily scored and administered measurement designed to measure client satisfaction with services.
The CSQ-8 has been extensively studied, and while it is not necessarily a measure of a client's perceptions of gain from treatment, or outcome, it does elicit the client's perspective on the value of services received. The CSQ-8 seems to operate about the same across all ethnic groups.
The CSQ-8 is scored by summing the item scores to produce a range of 8 to 32, with high scores indicating greater satisfaction.
Larsen, D.L., Attkisson, C.C., Hargreaves, W.A., and Nguyen, T.D. (1979). Assessment of client/patient satisfaction: Development of a general scale, Evaluation and Program Planning, 2, 197-207. Instrument reproduced with permission of C. Clifford Attkisson. Attkisson, C. C., \& Greenfield, T. K. (1994). Client Satisfaction Questionnaire-8 and Service Satisfaction Scale-30.
Measured: Measured at each study visit (3 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 posted15 Jan 2019
- Study start27 Sep 2019
- Primary completion31 May 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenway Community Health
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, University of North Carolina, Emory University, Brown University, Cook County Hospital
- Responsible party
- Principal investigator, Kenneth H. Mayer, MD, Fenway Community Health
- Investigators
- Ken A Mayer, MD, Principal investigator, The Fenway InstituteChristina Psaros, Ph.D., Principal investigator, Harvard Medical School and Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805451
- Sponsor's protocol ID
- ATN 158
- Acronym
- LSPY
- Status last verified
- Mar 2023
- First submitted
- 8 May 2018
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life Steps for PrEP for Youth
- ClinicalTrials.gov ID
- NCT03805451
- Acronym / sponsor ID
- LSPY / ATN 158
- Conditions
- HIV, Pre-exposure Prophylaxis, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Fenway Community HealthUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, University of North Carolina, Emory University, Brown University, Cook County Hospital
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a formative study, designed to provide information required to tailor Life-Steps for Pre-Exposure Prophylaxis (PrEP), an evidence-based cognitive behavioral adherence intervention, to enhance PrEP uptake and adherence in high risk young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM).
Life-Steps for Pre-exposure prophylaxis (PrEP) is a manualized modular adherence intervention based on principles of cognitive-behavioral therapy (CBT), that allows for recipients of the intervention to focus on the greatest challenges that they perceive in maintaining optimal adherence to PrEP.
Detailed description
Aim 1:
To adapt Life-Steps for Pre-Exposure Prophylaxis (PrEP) to be culturally relevant and appropriate for at-risk young men who have sex with men (YMSM) and transgender women who have sex with men (TWSM). The investigators will conduct in-depth qualitative interviews with up to 20 HIV-uninfected, at risk YMSM/TWSM at Fenway Health, an Adolescent Trials Network (ATN) clinical center. The investigators will also conduct in-depth, individual qualitative interviews with up to 10 key informants, including PrEP providers and staff at community-based organizations that work with YMSM/TWSM. Through these interviews, perceived facilitators and barriers to initiating and adhering to PrEP will be identified, and potential strategies to optimize adherence to PrEP for YMSM/TWSM. The investigators will explore youth perspectives on the use of nurses to deliver health messages and weekly text messages. YMSM/TWSM will be recruited at various points in the PrEP continuum of care, including those have opted not to initiate PrEP despite recommendations from clinicians, those who are using PrEP who report high levels of adherence and those who report adherence challenges through clinician referrals and direct recruitment in clinic waiting areas. Interviews will last approximately 60 minutes and will be digitally-recorded. Recordings will be transcribed and analyzed rapidly to inform the design of the youth-tailored Life-Steps for PrEP for YMSM/TWSM that we will test in Aim 2.
Aim 2:
To conduct a 2-arm pilot randomized control trial (RCT) to assess feasibility and acceptability of the Life-Steps for PrEP for youth intervention and preliminary efficacy of the intervention to improve PrEP adherence and retention in PrEP care compared to the standard of PrEP care at three different clinical sites. Investigators will enroll 50 YMSM/TWSM in the RCT (randomized 1:1 to the 2 arms) across the 3 sites. The primary efficacy outcomes will be PrEP adherence-as measured by dried blood spot testing -and retention in PrEP care-as measured by attendance at quarterly clinic appointments-at 3 and 6 months post baseline. Secondary outcomes include changes in sexual behaviors, retention in prevention services, and acceptability of the interventions which will be assessed at each major visit. Investigators will also conduct a brief, 15-minute semi-structured exit interview with participants in the Life-Steps for PrEP for youth intervention arm to provide an opportunity for more in-depth (open-ended) feedback on intervention satisfaction and acceptability. These data will be used to finalize the intervention manual to enhance participant acceptability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Life Steps for PrEP for Youth | Experimental | Behavioral: Life Steps for PrEP for YouthLife Steps for PrEP for Youth was derived from our prior PrEP work supported by the National Institute of Mental Health and will be tailored for YMSM/TWSM based on the findings from 20 qualitative interviews with YMSM and TWSM and 10 qualitative interviews with key informants. It will likely consist of four weekly sessions at the time of PrEP initiation and two booster sessions, which occur two and three months after PrEP initiation. Overall, the core components of the intervention will focus on medication adherence, sexual behavior, and problem solving barriers to adherence, using motivational interviewing when needed. |
| Standard of Care | No intervention | –After being prescribed PrEP, participants will receive standard-of-care adherence support for PrEP. They will have blood collected for medication adherence measures and will complete computer assisted behavioral surveys during study visits. Participants in this arm will also be followed for 6 months. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- age 16-24
- HIV-uninfected by self-report
- Assigned male sex at birth
- self-identify as a man who has sex with men or a trans woman who has sex with men
- able to understand English
Key exclusion criteria (6 listed)
- Currently enrolled in another PrEP adherence study*
- Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine product.*
- Enrollment in earlier phase of Life Steps for PrEP for Youth*
- Unable to give informed consent/assent due to severe mental or physical illness/substance intoxication at baseline visit
- Has severe cognitive limitation that would limit their ability to comprehend the informed consent or assent
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 |
|---|---|---|
| Life Steps for PrEP for YouthLife-Steps is a modular adherence intervention based on principles of cognitive-behavioral therapy (CBT), that allows for recipients of the intervention to focus on the greatest challenges that they perceive in maintaining optimal adherence to pre-exposure prophylaxis. | Behavioural | Life Steps for PrEP for Youth |
Primary outcome
Pre-Exposure Prophylaxis (PrEP) Adherence at 3 months post PrEP initiation
Time frame: Blood sample collected at 3 month visit post baseline
Measured by dried blood spot (DBS) testing of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP)
Pre-Exposure Prophylaxis (PrEP) Adherence at 6 months post PrEP initiation
Time frame: blood sample collected at 6 month visit post baseline
Measured by dried blood spot (DBS) testing of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP)
3 secondary outcomes
Retention in Pre-Exposure Prophylaxis (PrEP) care and prevention services
Time frame: Records will be abstracted at the end of the study period for each participant to determine if they attended a clinic appointment at 3 and 6 months post baseline
LifeSteps for PrEP for Youth Intervention Acceptability
Time frame: Measured at each study visit (3 and 6 months post baseline)
LifeSteps for PrEP for Youth Intervention Satisfaction
Time frame: Measured at each study visit (3 and 6 months post baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- 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.
Ken A Mayer, MD principal investigator
The Fenway Institute
Christina Psaros, Ph.D. principal investigator
Harvard Medical School and Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life Steps for PrEP for Youth in people with HIV and Pre-exposure Prophylaxis, run by Fenway Community Health at 3 sites in United States.
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 12 inclusion and 6 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 22 Mar 2023. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pre-Exposure Prophylaxis (PrEP) Adherence at 3 months post PrEP initiation (time frame: Blood sample collected at 3 month visit post baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2023.