CDC recommendations identify MSM in non-monogamous relationships and those in relationships with an HIV positive partner as candidates for PrEP. Estimates suggest as many as 79% of new HIV infections among young MSM (YMSM; ages 18-29) are transmitted between main partners. Drug use is an established correlate of HIV transmission risk. For partnered men, relational factors (e.g., sexual agreements) contextualize drug use and both drug use and sexual agreements predict receptivity to PrEP. Together, these findings point to the need for integrated intervention services ? targeting drug use and sexual health ?tailored for partnered YMSM. Such services are essential to addressing the HIV epidemic in the US. In response, our team has developed a 4-session MI-based intervention targeting PrEP uptake/adherence, HIV TRB, and drug use among partnered YMSM. PARTNER (Prevention And Risk: Treatment with a New Emphasis on Relationships) is delivered to individual YMSM in relationships (not couples), which enhances the scalability of the proposed intervention. Our preliminary pilot work has established the acceptability and feasibility of PARTNER. The primary goal of the current study is to test the efficacy of PARTNER relative to an attention-matched educational control condition used in previously funded NIH studies with HIV-negative YMSM. We propose to recruit 240 HIV-negative partnered YMSM who report recent drug use and sexual behavior consistent with CDC guidance for PrEP candidacy into a randomized control trial. As part of a secondary aim, this project seeks to enhance the range of biological measures for PrEP adherence currently available. The field standard for assessing tenofovir metabolites is dried blood spot assay; however, fingernail assay has high acceptability and lower cost. We propose to validate fingernail samples for PrEP adherence by correlating results obtained from fingernail samples with dried blood spot data. The study team is led by Dr. Tyrel J. Starks (PI), a new investigator with substantial experience in the study of relationship factors associated with sexual health and MSM in relationships. He has collaborated on numerous projects examining the nature of sexual agreements and their association with substance use and HIV transmission risk behavior. He is supported by a study team which includes Dr. Jeffrey Parsons, the PI of multiple intervention studies targeting sexual health and substance use. He is also joined by Dr. Monica Gandhi, an expert in biological assessment for PrEP adherence who has pioneered the use of novel matrices in previous NIH- funded studies. The team brings extensive experience in behavioral intervention research, relationship research, and biomedical assessment.

Public Health Relevance

? Public Health Significance Recommendations from the CDC identify MSM in relationships with an HIV-positive or a non- monogamous HIV-negative partner as candidates for PrEP. HIV prevention strategies that address the specific needs of YMSM (ages 18-29) in relationships with men are needed in response to accumulating evidence which points to the unique vulnerability of these men. The proposed project tests the efficacy of an individually-delivered intervention tailored for YMSM in relationships. The intervention ? termed PARTNER ? utilizes a brief (4 session) MI format to target PrEP uptake/adherence, HIV transmission risk behavior, and associated drug use. We propose an RCT involving 240 HIV-negative partnered YMSM who report the recent use of drugs and sexual behavior consistent with CDC guidance for PrEP candidacy. Participants are randomly assigned to receive either PARTNER or a education control condition which has been used in previous NIH-funded studies of HIV-negative YMSM. As a secondary aim, the study aims to validate the use of fingernail assay as a low-cost highly-acceptable alternative biological marker of PrEP adherence by correlating TDF/FTC levels in fingernails with dried blood spots.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA045613-03
Application #
9695969
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Jenkins, Richard A
Project Start
2017-07-01
Project End
2022-05-31
Budget Start
2019-06-01
Budget End
2020-05-31
Support Year
3
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Hunter College
Department
Psychology
Type
Schools of Arts and Sciences
DUNS #
620127915
City
New York
State
NY
Country
United States
Zip Code
10065