Project Jumpstart for Improving PrEP Care of Continuum Outcomes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Unified Approach to Address PrEP Care Cascade

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: Project Jumpstart


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prior sex with a man, identify as Black, and HIV negative status. Exclusion Criteria: Living with HIV

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 4 arm randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PrEP information only arm<br>Information to for accessing HIV prevention tools will be provided to participants. | Behavioral: Project Jumpstart<br>* PrEP focused intervention to improve PrEP related health outcomes<br>|
| Experimental: PrEP counseling arm<br>Stigma focused counseling (one-session) aimed at addressing barriers to health care access will be provided. | Behavioral: Project Jumpstart<br>* PrEP focused intervention to improve PrEP related health outcomes<br>|
| Experimental: PrEP counseling plus text messaging arm<br>Stigma focused counseling (one-session) and interactive text messaging aimed at addressing barriers to health care access will be provided. | Behavioral: Project Jumpstart<br>* PrEP focused intervention to improve PrEP related health outcomes<br>|
| Experimental: PrEP counseling plus text messaging and on demand counseling<br>Ongoing stigma focused counseling and interactive text messaging aimed at addressing barriers to health care access will be provided. | Behavioral: Project Jumpstart<br>* PrEP focused intervention to improve PrEP related health outcomes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |