HIV InfectionsNCT04201327
Project Jumpstart for Improving PrEP Care of Continuum Outcomes
A study testing Project Jumpstart in people with HIV Infections, run by University of Connecticut at 1 site in United States.
Trial summary
Stigma related to PrEP interest and uptake, and medication cognitions related to PrEP adherence and persistence remain strong barriers to improving PrEP use. To address these areas, the investigators are proposing to develop an intervention grounded in two novel cognitive/behavioral theories: the HIV Stigma Framework… 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
- HIV Infections
- What is being tested?
- Project Jumpstart
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 28 Feb 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Prior sex with a man, identify as Black, and HIV negative status.
Who cannot join
- Living with HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unified Approach to Address PrEP Care Cascade
Stigma related to PrEP interest and uptake, and medication cognitions related to PrEP adherence and persistence remain strong barriers to improving PrEP use. To address these areas, the investigators are proposing to develop an intervention grounded in two novel cognitive/behavioral theories: the HIV Stigma Framework and the Medication Necessity-Concerns Framework. Advances in biomedical HIV prevention, such as the availability of PrEP, will only impact the HIV epidemic if concurrent efforts are made to address the social and behavioral challenges that are associated with achieving sufficient coverage of PrEP among individuals at elevated risk for HIV.
Read the detailed description
Biomedical HIV prevention tools are very promising, but are not sufficiently reaching those in greatest need. BMSM have experienced elevated rates of HIV incidence and prevalence since the beginning of the US epidemic, and the CDC estimates that half of BMSM will be diagnosed with HIV in their lifetime. Although Pre-Exposure Prophylaxis (PrEP) is highly effective for preventing HIV, there is urgent need to improve efforts to deliver PrEP, in particular, for BMSM at-risk for HIV. Current strategies to increase PrEP interest, uptake, and adherence are not adequate and there are formidable barriers (e.g., stigma surrounding PrEP use, and adherence and retention concerns) to sufficient coverage of PrEP that must be addressed. Without considerable and targeted change to our current approach to PrEP delivery, public health initiatives will fail to adequately provide PrEP to those in greatest need. In our PrEP focused preliminary studies with BMSM, the investigators have identified two primary areas in need of critical focus and intervention - (1) stigma related to PrEP use, and (2) medication cognitions such as the perceived costs and benefits of taking PrEP, both of which can impede PrEP interest, uptake, and adherence. To address these areas the investigators have developed an intervention grounded in two novel cognitive/behavioral theories: the HIV Stigma Framework and the Medication Necessity-Concerns Framework. Our study includes: Conducting a pilot test that compares our (a) PrEP information only control (n=25), (b) PrEP counseling (n=50), (c) PrEP counseling with text messages (n=50), and (d) PrEP enhancement counseling with text messaging and on-demand counseling (n=50). Advances in biomedical HIV prevention, such as the availability of PrEP, will only impact the HIV epidemic if concurrent efforts are made to address the social and behavioral challenges that are associated with achieving sufficient coverage of PrEP among individuals at elevated risk for HIV. Low-resource burden, easily implemented, and effective social/behavioral interventions are urgently needed if the full benefits of PrEP are to be realized. If effective and disseminated, this intervention would meet current prevention needs and its potential impact on HIV infections averted could be substantial.
- Conditions
- HIV Infections
- Being tested
- Project Jumpstart
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project JumpstartBehavioural
PrEP focused intervention to improve PrEP related health outcomes
| Study group | Role | What they receive |
|---|---|---|
| PrEP information only arm | Active comparator | Information to for accessing HIV prevention tools will be provided to participants. Receives: Behavioral: Project Jumpstart |
| PrEP counseling arm | Experimental | Stigma focused counseling (one-session) aimed at addressing barriers to health care access will be provided. Receives: Behavioral: Project Jumpstart |
| PrEP counseling plus text messaging arm | Experimental | Stigma focused counseling (one-session) and interactive text messaging aimed at addressing barriers to health care access will be provided. Receives: Behavioral: Project Jumpstart |
| PrEP counseling plus text messaging and on demand counseling | Experimental | Ongoing stigma focused counseling and interactive text messaging aimed at addressing barriers to health care access will be provided. Receives: Behavioral: Project Jumpstart |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Linkage
Number of participants who attend PrEP care appointment. Documentation will be provided from clinic.
Measured: 6 months
PrEP Uptake
Number of participants who receive PrEP prescription from provider. Documentation will be provided from clinic.
Measured: 6 months
PrEP Adherence
Number of participants who adhere to PrEP medications. Documentation will be provided through self report and urine tests (UrSure).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start1 Jan 2020
- Primary completion30 Dec 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Model description
- 4 arm randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Lisa Eaton, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201327
- Sponsor's protocol ID
- H17-335
- Other IDs
- R34MH115798
- Status last verified
- Mar 2021
- First submitted
- 25 Nov 2019
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eaton LA, Layland EK, Driver R, Kalichman SC, Kalichman MO, Watson RJ, Kalinowski J, Chandler CJ, Earnshaw VA. Novel Latent Profile Analysis of a Test of Concept, Stigma Intervention to Increase PrEP Uptake Among Black Sexual Minority Men. J Acquir Immune Defic Syndr. 2023 Sep 1;94(1):1-9. doi: 10.1097/QAI.0000000000003223.
PubMed 37195906
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unified Approach to Address PrEP Care Cascade
- ClinicalTrials.gov ID
- NCT04201327
- Acronym / sponsor ID
- H17-335
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 17 Dec 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.
Stigma related to PrEP interest and uptake, and medication cognitions related to PrEP adherence and persistence remain strong barriers to improving PrEP use. To address these areas, the investigators are proposing to develop an intervention grounded in two novel cognitive/behavioral theories: the HIV Stigma Framework and the Medication Necessity-Concerns Framework. Advances in biomedical HIV prevention, such as the availability of PrEP, will only impact the HIV epidemic if concurrent efforts are made to address the social and behavioral challenges that are associated with achieving sufficient coverage of PrEP among individuals at elevated risk for HIV.
Detailed description
Biomedical HIV prevention tools are very promising, but are not sufficiently reaching those in greatest need. BMSM have experienced elevated rates of HIV incidence and prevalence since the beginning of the US epidemic, and the CDC estimates that half of BMSM will be diagnosed with HIV in their lifetime. Although Pre-Exposure Prophylaxis (PrEP) is highly effective for preventing HIV, there is urgent need to improve efforts to deliver PrEP, in particular, for BMSM at-risk for HIV. Current strategies to increase PrEP interest, uptake, and adherence are not adequate and there are formidable barriers (e.g., stigma surrounding PrEP use, and adherence and retention concerns) to sufficient coverage of PrEP that must be addressed. Without considerable and targeted change to our current approach to PrEP delivery, public health initiatives will fail to adequately provide PrEP to those in greatest need. In our PrEP focused preliminary studies with BMSM, the investigators have identified two primary areas in need of critical focus and intervention - (1) stigma related to PrEP use, and (2) medication cognitions such as the perceived costs and benefits of taking PrEP, both of which can impede PrEP interest, uptake, and adherence. To address these areas the investigators have developed an intervention grounded in two novel cognitive/behavioral theories: the HIV Stigma Framework and the Medication Necessity-Concerns Framework. Our study includes: Conducting a pilot test that compares our (a) PrEP information only control (n=25), (b) PrEP counseling (n=50), (c) PrEP counseling with text messages (n=50), and (d) PrEP enhancement counseling with text messaging and on-demand counseling (n=50). Advances in biomedical HIV prevention, such as the availability of PrEP, will only impact the HIV epidemic if concurrent efforts are made to address the social and behavioral challenges that are associated with achieving sufficient coverage of PrEP among individuals at elevated risk for HIV. Low-resource burden, easily implemented, and effective social/behavioral interventions are urgently needed if the full benefits of PrEP are to be realized. If effective and disseminated, this intervention would meet current prevention needs and its potential impact on HIV infections averted could be substantial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 4 arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| PrEP information only arm | Active comparator | Behavioral: Project JumpstartInformation to for accessing HIV prevention tools will be provided to participants. |
| PrEP counseling arm | Experimental | Behavioral: Project JumpstartStigma focused counseling (one-session) aimed at addressing barriers to health care access will be provided. |
| PrEP counseling plus text messaging arm | Experimental | Behavioral: Project JumpstartStigma focused counseling (one-session) and interactive text messaging aimed at addressing barriers to health care access will be provided. |
| PrEP counseling plus text messaging and on demand counseling | Experimental | Behavioral: Project JumpstartOngoing stigma focused counseling and interactive text messaging aimed at addressing barriers to health care access will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Prior sex with a man, identify as Black, and HIV negative status.
Key exclusion criteria (1 listed)
- Living with HIV
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 |
|---|---|---|
| Project JumpstartPrEP focused intervention to improve PrEP related health outcomes | Behavioural | PrEP counseling arm, PrEP counseling plus text messaging and on demand counseling, PrEP counseling plus text messaging arm, PrEP information only arm |
Primary outcome
PrEP Linkage
Time frame: 6 months
Number of participants who attend PrEP care appointment. Documentation will be provided from clinic.
PrEP Uptake
Time frame: 6 months
Number of participants who receive PrEP prescription from provider. Documentation will be provided from clinic.
PrEP Adherence
Time frame: 6 months
Number of participants who adhere to PrEP medications. Documentation will be provided through self report and urine tests (UrSure).
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 30 Mar 2021.
- Derived from this study: PubMed 37195906Eaton LA, Layland EK, Driver R, Kalichman SC, Kalichman MO, Watson RJ, Kalinowski J, Chandler CJ, Earnshaw VA. Novel Latent Profile Analysis of a Test of Concept, Stigma Intervention to Increase PrEP Uptake Among Black Sexual Minority Men. J Acquir Immune Defic Syndr. 2023 Sep 1;94(1):1-9. doi: 10.1097/QAI.0000000000003223.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Jumpstart in people with HIV Infections, run by University of Connecticut at 1 site 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 1 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 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
PrEP Linkage (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT04201327, 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 30 Mar 2021.