Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting (SPARK)
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ClinicalTrials.gov Identifier: NCT02037594 |
Recruitment Status
:
Active, not recruiting
First Posted
: January 16, 2014
Last Update Posted
: January 5, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Human Immunodeficiency Virus (HIV) | Behavioral: Sexual Health Counseling Behavioral: Enhanced Adherence Intervention Behavioral: PrEP Information (Active Control) Behavioral: Standard of Care Adherence Support (Active Control) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 445 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting |
Actual Study Start Date : | January 30, 2014 |
Actual Primary Completion Date : | June 1, 2017 |
Estimated Study Completion Date : | June 1, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Counseling + SOC Adherence
Sexual Health Counseling followed by Standard of Care Adherence Support
|
Behavioral: Sexual Health Counseling
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.
Behavioral: Standard of Care Adherence Support (Active Control)
Standard of care information and instruction about PrEP adherence.
|
Experimental: Counseling + Enhanced Adherence
Sexual Health Counseling followed by Enhanced Adherence Intervention
|
Behavioral: Sexual Health Counseling
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.
Behavioral: Enhanced Adherence Intervention
This brief intervention is provides standard of care PrEP adherence information plus specific counseling, troubleshooting, and support.
|
Experimental: Information + SOC Adherence
PrEP Information followed by Standard of Care Adherence Support
|
Behavioral: PrEP Information (Active Control)
Standard of Care Information about PrEP
Behavioral: Standard of Care Adherence Support (Active Control)
Standard of care information and instruction about PrEP adherence.
|
Experimental: Information + Enhanced Adherence
PrEP Information followed by Enhanced Adherence Intervention
|
Behavioral: Enhanced Adherence Intervention
This brief intervention is provides standard of care PrEP adherence information plus specific counseling, troubleshooting, and support.
Behavioral: PrEP Information (Active Control)
Standard of Care Information about PrEP
|
- PrEP Uptake [ Time Frame: BL through 3-months ]Whether or not the patient decides to take PrEP
- PrEP Persistence [ Time Frame: BL through 12-months ]Whether or not patients who decide to take PrEP persist with the medication for the duration of the study.
- PrEP Adherence [ Time Frame: BL through 12 months ]Biological measure of medication adherence using dried blood spots, and self-report measure of adherence using VAS.
- Sexual Risk Behavior [ Time Frame: BL through 12-months ]Measured through STI testing and self-report.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Past history of PrEP use or currently taking PrEP

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037594
United States, New York | |
Callen-Lorde Community Health Center | |
New York, New York, United States, 10011 |
Principal Investigator: | Sarit A Golub, PhD, MPH | Hunter College, CUNY |
Additional Information:
Responsible Party: | Sarit Golub, Associate Professor, Hunter College of City University of New York |
ClinicalTrials.gov Identifier: | NCT02037594 History of Changes |
Other Study ID Numbers: |
349555-6 R01AA022067 ( U.S. NIH Grant/Contract ) |
First Posted: | January 16, 2014 Key Record Dates |
Last Update Posted: | January 5, 2018 |
Last Verified: | January 2018 |
Keywords provided by Sarit Golub, Hunter College of City University of New York:
HIV Pre-exposure prophylaxis PrEP MSM Demonstration Project |
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |