Skip to content

Project Jumpstart for Improving PrEP Care of Continuum Outcomes

Unified Approach to Address PrEP Care Cascade

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04201327
Enrollment
175
Registered
2019-12-17
Start date
2020-01-01
Completion date
2021-02-28
Last updated
2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Brief 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.

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.

Interventions

BEHAVIORALProject Jumpstart

PrEP focused intervention to improve PrEP related health outcomes

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Connecticut
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

The investigator and the assessment staff are blind to the assignment of participants throughout the data collection phase of the study.

Intervention model description

4 arm randomized controlled trial

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Living with HIV

Design outcomes

Primary

MeasureTime frameDescription
PrEP Linkage6 monthsNumber of participants who attend PrEP care appointment. Documentation will be provided from clinic.
PrEP Uptake6 monthsNumber of participants who receive PrEP prescription from provider. Documentation will be provided from clinic.
PrEP Adherence6 monthsNumber of participants who adhere to PrEP medications. Documentation will be provided through self report and urine tests (UrSure).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026