NCT04201327

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

12 months

First QC Date

November 25, 2019

Last Update Submit

March 29, 2021

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (3)

  • PrEP Linkage

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

    6 months

  • PrEP Uptake

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

    6 months

  • PrEP Adherence

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

    6 months

Study Arms (4)

PrEP information only arm

ACTIVE COMPARATOR

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

Behavioral: Project Jumpstart

PrEP counseling arm

EXPERIMENTAL

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

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.

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.

Behavioral: Project Jumpstart

Interventions

Project JumpstartBEHAVIORAL

PrEP focused intervention to improve PrEP related health outcomes

PrEP counseling armPrEP counseling plus text messaging and on demand counselingPrEP counseling plus text messaging armPrEP information only arm

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Living with HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SHARE Project

Atlanta, Georgia, 30308, United States

Location

Related Publications (1)

  • 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.

    PMID: 37195906DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The investigator and the assessment staff are blind to the assignment of participants throughout the data collection phase of the study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 4 arm randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 25, 2019

First Posted

December 17, 2019

Study Start

January 1, 2020

Primary Completion

December 30, 2020

Study Completion

February 28, 2021

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)