HIV/AIDSNCT04329442
Accelerated PrEP Access for Black MSM and TW
A study testing Emtricitabine / Tenofovir Disoproxil Oral Tablet in people with HIV/AIDS, run by University of Chicago.
Trial summary
The investigators will pilot-test an accelerated PrEP initiation approach among young high-risk Black/African American (B/AA) men who have sex with men (MSM) and transgender women (YMSM/TW) at the point of care in community contexts. Read more about this study
- Who is it for?
- Ages 18 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Emtricitabine / Tenofovir Disoproxil Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 31 Jul 2021
- 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 18 to 24 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ages 18-24;
- assigned male at birth, identify as a man (cisgender), transgender woman, or gender non-conforming or genderqueer;
- identifying as Black, African American, or multiracial with at least one parent identifying as Black or African American;
- not currently taking PrEP or attending a visit to initiate PrEP;
- self-report being HIV-negative;
- reporting one of the following HIV risks in the last 6 months (Hosek, Rudy et al. 2015, Hosek, Rudy et al. 2017): a. condomless anal intercourse with an HIV-infected male partner or a male partner of unknown HIV status; b. anal intercourse with 3 or more male sex partners; c. exchange of money, gifts, shelter, or drugs for anal sex with a male partner; d. sex with a male partner and has had a sexually transmitted infection; e. sexual partner of an HIV-infected male with whom condoms were not consistently used; f. anal intercourse where the condom broke or slipped off
Who cannot join
- We are excluding those individuals who were assigned female at birth (female birth certificate) and/or cis-gender women (those assigned female at birth and identify as women) from the all phases of this study as this study is intended to explore the HIV prevention behaviors of B/AA young men who have sex with men and young transgender women (assigned male at birth) as these two groups represent the highest risk groups for HIV infection in the US, yet only a small percentage are aware or currently use PrEP for HIV prevention.
About this study
Official title: Point of Care PrEP Delivery for Young Black/African American Men Who Have Sex With Men and Young Transgender Women at High Risk for HIV Infection
The investigators will pilot-test an accelerated PrEP initiation approach among young high-risk Black/African American (B/AA) men who have sex with men (MSM) and transgender women (YMSM/TW) at the point of care in community contexts.
Read the detailed description
The study team will provide a free 30-day supply of HIV pre-exposure prophylaxis (PrEP) to young Black MSM and TW identified as PrEP-eligible and interested in taking PrEP to reduce their risk of HIV acquisition. This intervention is intended to assist youth at high risk for HIV acquisition in successfully initiating PrEP use.
- Conditions
- HIV/AIDS
- Being tested
- Emtricitabine / Tenofovir Disoproxil Oral Tablet
- Keywords
- PrEP, HIV Prevention, Young Men Who Have Sex with Men, Young Transgender Women
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emtricitabine / Tenofovir Disoproxil Oral TabletDrug
Also called Truvada
30 day supply of 200mg tablets
| Study group | Role | What they receive |
|---|---|---|
| PrEP Received | Experimental | Participants will be provided with a free 30-day supply of PrEP. Receives: Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention to Continue PrEP
Intention to continue use of PrEP will be assessed via survey questions related to a respondent having made a follow-up appointment to continue taking PrEP, attended an appointment to continue taking PrEP, having filled a prescription for PrEP, and reporting an interest in continuing PrEP after current supply is complete.
Measured: Post Intervention (1 month after receiving intervention)
Intention to Continue PrEP
Intention to continue use of PrEP will be assessed via survey questions related to a respondent having made a follow-up appointment to continue taking PrEP, attended an appointment to continue taking PrEP, having filled a prescription for PrEP, and reporting an interest in continuing PrEP after current supply is complete.
Measured: Post Intervention (4 months after receiving intervention)
PrEP Adherence
PrEP adherence will be assessed via self-report of how many pills from the initial intervention remain and a self-assessment of success at remembering to take PrEP daily.
Measured: Post Intervention (1 month after receiving intervention)
PrEP Adherence
PrEP adherence will be assessed via self-report of how many pills from the initial intervention remain and a self-assessment of success at remembering to take PrEP daily.
Measured: Post Intervention (4 months after receiving intervention)
Secondary outcomes (2)
PrEP Adherence Self-Efficacy
PrEP adherence self-efficacy will be assessed via a 9-question scale focused on respondents' belief that they could continue to take PrEP when experiencing barriers to adherence. Each item is scored on a 0-10 scale, where 0 means "cannot do at all" and 10 means "completely certainly can do." This scale has been adapted from the Adherence Self-Efficacy Scale (Johnson et al., 2007).
Measured: Post Intervention (1 month after receiving intervention)
PrEP Adherence Self-Efficacy
PrEP adherence self-efficacy will be assessed via a 9-question scale focused on respondents' belief that they could continue to take PrEP when experiencing barriers to adherence. Each item is scored on a 0-10 scale, where 0 means "cannot do at all" and 10 means "completely certainly can do." This scale has been adapted from the Adherence Self-Efficacy Scale (Johnson et al., 2007).
Measured: Post Intervention (4 months after receiving intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Apr 2020 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Why it stopped: COVID-19 caused substantial barriers to recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- A single-arm longitudinal pre/post study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Planned Parenthood Great Plains
- Responsible party
- Sponsor
- Investigators
- Darnell N Motley, PhD, Study director, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329442
- Sponsor's protocol ID
- IRB19-1154
- Status last verified
- May 2022
- First submitted
- 26 Mar 2020
- Last updated
- 19 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care PrEP Delivery for Young Black/African American Men Who Have Sex With Men and Young Transgender Women at High Risk for HIV Infection
- ClinicalTrials.gov ID
- NCT04329442
- Acronym / sponsor ID
- IRB19-1154
- Conditions
- HIV/AIDS
- Keywords
- PrEP, HIV Prevention, Young Men Who Have Sex with Men, Young Transgender Women
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 caused substantial barriers to recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Planned Parenthood Great Plains
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 1 Apr 2020 (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.
The investigators will pilot-test an accelerated PrEP initiation approach among young high-risk Black/African American (B/AA) men who have sex with men (MSM) and transgender women (YMSM/TW) at the point of care in community contexts.
Detailed description
The study team will provide a free 30-day supply of HIV pre-exposure prophylaxis (PrEP) to young Black MSM and TW identified as PrEP-eligible and interested in taking PrEP to reduce their risk of HIV acquisition. This intervention is intended to assist youth at high risk for HIV acquisition in successfully initiating PrEP use.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm longitudinal pre/post study
| Arm | Type | Receives |
|---|---|---|
| PrEP Received | Experimental | Drug: Emtricitabine / Tenofovir Disoproxil Oral TabletParticipants will be provided with a free 30-day supply of PrEP. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- ages 18-24;
- assigned male at birth, identify as a man (cisgender), transgender woman, or gender non-conforming or genderqueer;
- identifying as Black, African American, or multiracial with at least one parent identifying as Black or African American;
- not currently taking PrEP or attending a visit to initiate PrEP;
- self-report being HIV-negative;
Key exclusion criteria (1 listed)
- We are excluding those individuals who were assigned female at birth (female birth certificate) and/or cis-gender women (those assigned female at birth and identify as women) from the all phases of this study as this study is intended to explore the HIV prevention behaviors of B/AA young men who have sex with men and young transgender women (assigned male at birth) as these two groups represent the highest risk groups for HIV infection in the US, yet only a small percentage are aware or currently use PrEP for HIV prevention.
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 |
|---|---|---|
| Emtricitabine / Tenofovir Disoproxil Oral TabletAlso: Truvada30 day supply of 200mg tablets | Drug | PrEP Received |
Primary outcome
Intention to Continue PrEP
Time frame: Post Intervention (1 month after receiving intervention)
Intention to continue use of PrEP will be assessed via survey questions related to a respondent having made a follow-up appointment to continue taking PrEP, attended an appointment to continue taking PrEP, having filled a prescription for PrEP, and reporting an interest in continuing PrEP after current supply is complete.
Intention to Continue PrEP
Time frame: Post Intervention (4 months after receiving intervention)
Intention to continue use of PrEP will be assessed via survey questions related to a respondent having made a follow-up appointment to continue taking PrEP, attended an appointment to continue taking PrEP, having filled a prescription for PrEP, and reporting an interest in continuing PrEP after current supply is complete.
PrEP Adherence
Time frame: Post Intervention (1 month after receiving intervention)
PrEP adherence will be assessed via self-report of how many pills from the initial intervention remain and a self-assessment of success at remembering to take PrEP daily.
PrEP Adherence
Time frame: Post Intervention (4 months after receiving intervention)
PrEP adherence will be assessed via self-report of how many pills from the initial intervention remain and a self-assessment of success at remembering to take PrEP daily.
2 secondary outcomes
PrEP Adherence Self-Efficacy
Time frame: Post Intervention (1 month after receiving intervention)
PrEP Adherence Self-Efficacy
Time frame: Post Intervention (4 months after receiving intervention)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
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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.
Darnell N Motley, PhD study director
University of Chicago
Questions about this trial
What is this clinical trial studying?
A study testing Emtricitabine / Tenofovir Disoproxil Oral Tablet in people with HIV/AIDS, run by University of Chicago.
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 6 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: withdrawn, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Intention to Continue PrEP (time frame: Post Intervention (1 month after receiving intervention)). The study lists 4 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 19 May 2022.