Human Immunodeficiency Virus (HIV)SPARKNCT02037594
Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting
A study testing Sexual Health Counseling and Enhanced Adherence Intervention in people with Human Immunodeficiency Virus (HIV), run by Hunter College of City University of New York at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus (HIV)
- What is being tested?
- Sexual Health Counseling and Enhanced Adherence Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2014to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Past history of PrEP use or currently taking PrEP
Trial locations and contacts
1 site in 1 country.
United States1 site
Callen-Lorde Community Health Center
New York, New York, 10011
About this study
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.
Read the detailed description
Pre-exposure prophylaxis (PrEP) refers to daily or intermittent oral administration of antiretroviral drugs designed to protect high-risk HIV-negative individuals from infection. In order for PrEP to become an effective prevention tool, three critical factors must be addressed: a) acceptability, i.e., individuals who would benefit from PrEP must know about it and be willing to take it; b) adherence, i.e., individuals who choose to PrEP as a prevention strategy must take the pills as prescribed; and c) implementation, i.e., processes and protocols must be developed to allow for the integration of PrEP delivery and programs into real world settings in a way that is feasible, scalable, and realistic. This project has three specific aims: 1) Identifying social and behavioral factors that are likely to influence PrEP implementation, acceptance, and use/adherence by men who have sex with men (MSM) in NYC, including factors at individual-, community-, and organizational-levels; 2) Examining social and behavioral factors associated with disparities in access to prevention and care services among MSM in NYC that might directly impact PrEP implementation programs and policies; and 3) Evaluating an intervention in which PrEP is introduced, provided, and supported as part of a prevention package delivered in an community health center. The project has the potential to exert a sustained and powerful influence not only on the effectiveness of PrEP interventions for MSM, but also on dissemination and scalability of a targeted intervention within community-based settings and in a manner that reduces disparities in access and maximizes cultural competence and acceptability.
- Conditions
- Human Immunodeficiency Virus (HIV)
- Being tested
- Sexual Health Counseling, Enhanced Adherence Intervention, PrEP Information (Active Control), Standard of Care Adherence Support (Active Control)
- Keywords
- HIV, Pre-exposure prophylaxis, PrEP, MSM, Demonstration Project
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual Health CounselingBehavioural
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.
Enhanced Adherence InterventionBehavioural
This brief intervention is provides standard of care PrEP adherence information plus specific counseling, troubleshooting, and support.
PrEP Information (Active Control)Behavioural
Standard of Care Information about PrEP
Standard of Care Adherence Support (Active Control)Behavioural
Standard of care information and instruction about PrEP adherence.
| Study group | Role | What they receive |
|---|---|---|
| Counseling + SOC Adherence | Experimental | Sexual Health Counseling followed by Standard of Care Adherence Support Receives: Behavioral: Sexual Health Counseling; Behavioral: Standard of Care Adherence Support (Active Control) |
| Counseling + Enhanced Adherence | Experimental | Sexual Health Counseling followed by Enhanced Adherence Intervention Receives: Behavioral: Sexual Health Counseling; Behavioral: Enhanced Adherence Intervention |
| Information + SOC Adherence | Experimental | PrEP Information followed by Standard of Care Adherence Support Receives: Behavioral: PrEP Information (Active Control); Behavioral: Standard of Care Adherence Support (Active Control) |
| Information + Enhanced Adherence | Experimental | PrEP Information followed by Enhanced Adherence Intervention Receives: Behavioral: Enhanced Adherence Intervention; Behavioral: PrEP Information (Active Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Uptake
Whether or not the patient decides to take PrEP
Measured: 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.
Measured: BL through 12-months
PrEP Adherence
Biological measure of medication adherence using dried blood spots, and self-report measure of adherence using VAS.
Measured: BL through 12 months
Sexual Risk Behavior
Measured through STI testing and self-report.
Measured: BL through 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study start30 Jan 2014
- Primary completion1 Jun 2017
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter College of City University of New York
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Gilead Sciences
- Responsible party
- Principal investigator, Sarit Golub, Hunter College of City University of New York
- Investigators
- Sarit A Golub, PhD, MPH, Principal investigator, Hunter College, CUNY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037594
- Sponsor's protocol ID
- 349555-6
- Other IDs
- R01AA022067
- Acronym
- SPARK
- Status last verified
- Oct 2018
- First submitted
- 14 Jan 2014
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting
- ClinicalTrials.gov ID
- NCT02037594
- Acronym / sponsor ID
- SPARK / 349555-6
- Conditions
- Human Immunodeficiency Virus (HIV)
- Keywords
- HIV, Pre-exposure prophylaxis, PrEP, MSM, Demonstration Project
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Gilead Sciences
- Study start
- 30 Jan 2014 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 16 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pre-exposure prophylaxis (PrEP) refers to daily or intermittent oral administration of antiretroviral drugs designed to protect high-risk HIV-negative individuals from infection. In order for PrEP to become an effective prevention tool, three critical factors must be addressed: a) acceptability, i.e., individuals who would benefit from PrEP must know about it and be willing to take it; b) adherence, i.e., individuals who choose to PrEP as a prevention strategy must take the pills as prescribed; and c) implementation, i.e., processes and protocols must be developed to allow for the integration of PrEP delivery and programs into real world settings in a way that is feasible, scalable, and realistic. This project has three specific aims: 1) Identifying social and behavioral factors that are likely to influence PrEP implementation, acceptance, and use/adherence by men who have sex with men (MSM) in NYC, including factors at individual-, community-, and organizational-levels; 2) Examining social and behavioral factors associated with disparities in access to prevention and care services among MSM in NYC that might directly impact PrEP implementation programs and policies; and 3) Evaluating an intervention in which PrEP is introduced, provided, and supported as part of a prevention package delivered in an community health center. The project has the potential to exert a sustained and powerful influence not only on the effectiveness of PrEP interventions for MSM, but also on dissemination and scalability of a targeted intervention within community-based settings and in a manner that reduces disparities in access and maximizes cultural competence and acceptability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Counseling + SOC Adherence | Experimental | Behavioral: Sexual Health Counseling, Behavioral: Standard of Care Adherence Support (Active Control)Sexual Health Counseling followed by Standard of Care Adherence Support |
| Counseling + Enhanced Adherence | Experimental | Behavioral: Sexual Health Counseling, Behavioral: Enhanced Adherence InterventionSexual Health Counseling followed by Enhanced Adherence Intervention |
| Information + SOC Adherence | Experimental | Behavioral: PrEP Information (Active Control), Behavioral: Standard of Care Adherence Support (Active Control)PrEP Information followed by Standard of Care Adherence Support |
| Information + Enhanced Adherence | Experimental | Behavioral: Enhanced Adherence Intervention, Behavioral: PrEP Information (Active Control)PrEP Information followed by Enhanced Adherence Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Past history of PrEP use or currently taking PrEP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sexual Health CounselingThis 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. | Behavioural | Counseling + Enhanced Adherence, Counseling + SOC Adherence |
| Enhanced Adherence InterventionThis brief intervention is provides standard of care PrEP adherence information plus specific counseling, troubleshooting, and support. | Behavioural | Counseling + Enhanced Adherence, Information + Enhanced Adherence |
| PrEP Information (Active Control)Standard of Care Information about PrEP | Behavioural | Information + Enhanced Adherence, Information + SOC Adherence |
| Standard of Care Adherence Support (Active Control)Standard of care information and instruction about PrEP adherence. | Behavioural | Counseling + SOC Adherence, Information + SOC Adherence |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Study WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarit A Golub, PhD, MPH principal investigator
Hunter College, CUNY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual Health Counseling and Enhanced Adherence Intervention in people with Human Immunodeficiency Virus (HIV), run by Hunter College of City University of New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP Uptake (time frame: BL through 3-months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.