Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting
SPARK
2 other identifiers
interventional
438
1 country
1
Brief Summary
This study identifies social and behavioral factors likely to influence PrEP acceptability and adherence among men who have sex with men (MSM), and collaborates with a community health center to evaluate a two-stage intervention to improve PrEP decision-making, as well as persistence and adherence for those who chose to take PrEP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2014
CompletedFirst Posted
Study publicly available on registry
January 16, 2014
CompletedStudy Start
First participant enrolled
January 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedOctober 11, 2018
October 1, 2018
3.3 years
January 14, 2014
October 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
PrEP Uptake
Whether or not the patient decides to take PrEP
BL through 3-months
PrEP Persistence
Whether or not patients who decide to take PrEP persist with the medication for the duration of the study.
BL through 12-months
PrEP Adherence
Biological measure of medication adherence using dried blood spots, and self-report measure of adherence using VAS.
BL through 12 months
Sexual Risk Behavior
Measured through STI testing and self-report.
BL through 12-months
Study Arms (4)
Counseling + SOC Adherence
EXPERIMENTALSexual Health Counseling followed by Standard of Care Adherence Support
Counseling + Enhanced Adherence
EXPERIMENTALSexual Health Counseling followed by Enhanced Adherence Intervention
Information + SOC Adherence
EXPERIMENTALPrEP Information followed by Standard of Care Adherence Support
Information + Enhanced Adherence
EXPERIMENTALPrEP Information followed by Enhanced Adherence Intervention
Interventions
This brief intervention presents PrEP within the context of a patient's comprehensive sexual health plan and is designed to enhance decision-making around PrEP use and decrease sexual risk taking.
This brief intervention is provides standard of care PrEP adherence information plus specific counseling, troubleshooting, and support.
Standard of Care Information about PrEP
Standard of care information and instruction about PrEP adherence.
Eligibility Criteria
You may qualify if:
- Registered patient receiving medical or health services at Callen-Lorde Community Health Center
- Male sex (at birth) and reported sex with men or transwomen
- At least 18 years of age
- HIV-negative
- At risk for HIV acquisition
You may not qualify if:
- Past history of PrEP use or currently taking PrEP
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Callen-Lorde Community Health Center
New York, New York, 10011, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarit A Golub, PhD, MPH
Hunter College, CUNY
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 14, 2014
First Posted
January 16, 2014
Study Start
January 30, 2014
Primary Completion
June 1, 2017
Study Completion
June 1, 2018
Last Updated
October 11, 2018
Record last verified: 2018-10