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Project Jumpstart for Improving PrEP Care of Continuum Outcomes

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project Jumpstart
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Living with HIV

Sites / Locations

  • SHARE Project

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

PrEP information only arm

PrEP counseling arm

PrEP counseling plus text messaging arm

PrEP counseling plus text messaging and on demand counseling

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

PrEP Linkage
Number of participants who attend PrEP care appointment. Documentation will be provided from clinic.
PrEP Uptake
Number of participants who receive PrEP prescription from provider. Documentation will be provided from clinic.
PrEP Adherence
Number of participants who adhere to PrEP medications. Documentation will be provided through self report and urine tests (UrSure).

Secondary Outcome Measures

Full Information

First Posted
November 25, 2019
Last Updated
March 29, 2021
Sponsor
University of Connecticut
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04201327
Brief Title
Project Jumpstart for Improving PrEP Care of Continuum Outcomes
Official Title
Unified Approach to Address PrEP Care Cascade
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
4 arm randomized controlled trial
Masking
InvestigatorOutcomes Assessor
Masking Description
The investigator and the assessment staff are blind to the assignment of participants throughout the data collection phase of the study.
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PrEP information only arm
Arm Type
Active Comparator
Arm Description
Information to for accessing HIV prevention tools will be provided to participants.
Arm Title
PrEP counseling arm
Arm Type
Experimental
Arm Description
Stigma focused counseling (one-session) aimed at addressing barriers to health care access will be provided.
Arm Title
PrEP counseling plus text messaging arm
Arm Type
Experimental
Arm Description
Stigma focused counseling (one-session) and interactive text messaging aimed at addressing barriers to health care access will be provided.
Arm Title
PrEP counseling plus text messaging and on demand counseling
Arm Type
Experimental
Arm Description
Ongoing stigma focused counseling and interactive text messaging aimed at addressing barriers to health care access will be provided.
Intervention Type
Behavioral
Intervention Name(s)
Project Jumpstart
Intervention Description
PrEP focused intervention to improve PrEP related health outcomes
Primary Outcome Measure Information:
Title
PrEP Linkage
Description
Number of participants who attend PrEP care appointment. Documentation will be provided from clinic.
Time Frame
6 months
Title
PrEP Uptake
Description
Number of participants who receive PrEP prescription from provider. Documentation will be provided from clinic.
Time Frame
6 months
Title
PrEP Adherence
Description
Number of participants who adhere to PrEP medications. Documentation will be provided through self report and urine tests (UrSure).
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Prior sex with a man, identify as Black, and HIV negative status. Exclusion Criteria: Living with HIV
Facility Information:
Facility Name
SHARE Project
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Project Jumpstart for Improving PrEP Care of Continuum Outcomes

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