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CompletedNCT04201327Updated Mar 30, 2021

Project Jumpstart for Improving PrEP Care of Continuum Outcomes

An interventional study of Project Jumpstart in HIV Infections, sponsored by University of Connecticut. Completed at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-30.

Sponsored by University of Connecticut · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
175
Allocation
Randomized
Ages
18 Years and older
Sex
Male
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Study 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 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.

02

Conditions studied

  • HIV Infections

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03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 175 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

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Lead sponsor

University of Connecticut is the lead sponsor of 133 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Prior sex with a man, identify as Black, and HIV negative status.

Exclusion criteria

Exclusion Criteria:

  • Living with HIV
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
175 participants (actual)

Study arms

  • Active comparator
    PrEP information only arm

    Information to for accessing HIV prevention tools will be provided to participants.

    Behavioral: Project Jumpstart

  • Experimental
    PrEP counseling arm

    Stigma focused counseling (one-session) aimed at addressing barriers to health care access will be provided.

    Behavioral: Project Jumpstart

  • Experimental
    PrEP counseling plus text messaging arm

    Stigma focused counseling (one-session) and interactive text messaging aimed at addressing barriers to health care access will be provided.

    Behavioral: Project Jumpstart

  • Experimental
    PrEP counseling plus text messaging and on demand counseling

    Ongoing stigma focused counseling and interactive text messaging aimed at addressing barriers to health care access will be provided.

    Behavioral: Project Jumpstart

Interventions

  • BehavioralProject Jumpstart

    PrEP focused intervention to improve PrEP related health outcomes

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What researchers measure

Primary outcomes

  1. PrEP Linkage

    Number of participants who attend PrEP care appointment. Documentation will be provided from clinic.

    Time frame: 6 months

  2. PrEP Uptake

    Number of participants who receive PrEP prescription from provider. Documentation will be provided from clinic.

    Time frame: 6 months

  3. PrEP Adherence

    Number of participants who adhere to PrEP medications. Documentation will be provided through self report and urine tests (UrSure).

    Time frame: 6 months

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Study locations

1 site
  • SHARE Project
    Atlanta, Georgia 30308, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04201327
Lead sponsor
University of Connecticut
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Lisa Eaton (Professor, University of Connecticut) — Principal investigator
First posted
Dec 17, 2019
Start date
Jan 1, 2020
Primary completion
Dec 30, 2020
Completion
Feb 28, 2021
Last update
Mar 30, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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