Project Jumpstart for Improving PrEP Care of Continuum Outcomes

HIV Infections Clinical Trial

Official title:

Unified Approach to Address PrEP Care Cascade

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04201327
• Other study ID #: H17-335
• Secondary ID: R34MH115798
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: March 2021
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: February 28, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Living with HIV

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Project Jumpstart
PrEP focused intervention to improve PrEP related health outcomes

Locations

Country	Name	City	State
United States	SHARE Project	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PrEP Linkage	Number of participants who attend PrEP care appointment. Documentation will be provided from clinic.	6 months
Primary	PrEP Uptake	Number of participants who receive PrEP prescription from provider. Documentation will be provided from clinic.	6 months
Primary	PrEP Adherence	Number of participants who adhere to PrEP medications. Documentation will be provided through self report and urine tests (UrSure).	6 months