A randomized controlled efficacy trial of behavioral activation for concurrent stimulant use and sexual risk for HIV acquisition among MSM: Project IMPACT study protocol

Matthew J. Mimiaga, David W. Pantalone, Katie B. Biello, Tiffany Rose Glynn, Christopher M. Santostefano, Jennifer Olson, Dana J. Pardee, Jaclyn M.W. Hughto, Josibel Garcia Valles, Adam Carrico, Kenneth H. Mayer, Steven Safren

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: In the United States, problematic stimulant use is a prevalent and difficult to treat problem among men who have sex with men (MSM), as well as a major driver of HIV transmission through the large number of sexual partners and concomitant condomless anal sex (CAS). Evidence-based behavioral studies that address problematic stimulant use in MSM at risk for HIV infection are also lacking. In this paper, we describe the design of a behavioral intervention trial to reduce sexual risk behavior and stimulant use in HIV-uninfected MSM. Methods: This study, funded by the National Institute on Drug Abuse (NIDA), is a randomized controlled trial (RCT) testing an integrated HIV risk reduction and behavioral activation counseling intervention (IMPACT) for HIV-uninfected, stimulant using MSM in Boston, MA, and Miami, FL. Participants are randomized (2:2:1) to either (1) the IMPACT intervention; (2) a relaxation condition, an active therapy time- and intensity-matched control; or (3) a standard of care risk reduction counseling comparison. At enrollment, all participants receive an HIV test and pre- and post-test counseling. The primary outcome is the difference in the rate of change in the number of self-reported condomless anal sex acts without the protection of consistent Pre-Exposure Prophylaxis (PrEP) use, as well as reductions in stimulant use during the prior 4-months. Major assessments are conducted at baseline, 4-, 8-, and 12-month follow-up visits. Discussion: Effective and sustainable behavioral interventions are sorely needed to reduce HIV acquisition in stimulant using MSM at risk for HIV infection. In this study, we will evaluate the evidence of efficacy of the IMPACT intervention to reduce HIV acquisition in HIV-uninfected, stimulant-using MSM. If found effective, the intervention tested here holds promise for being readily integrated into real-world clinical settings.

Original languageEnglish (US)
Article number914
JournalBMC Public Health
Volume18
Issue number1
DOIs
StatePublished - Jul 25 2018

Fingerprint

Randomized Controlled Trials
HIV
Sexual Behavior
Counseling
Risk Reduction Behavior
HIV Infections
National Institute on Drug Abuse (U.S.)
Sexual Partners
Standard of Care
Risk-Taking

Keywords

  • Behavioral activation
  • HIV
  • Men who have sex with men (MSM)
  • Sexual risk
  • Stimulant use

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

Cite this

A randomized controlled efficacy trial of behavioral activation for concurrent stimulant use and sexual risk for HIV acquisition among MSM : Project IMPACT study protocol. / Mimiaga, Matthew J.; Pantalone, David W.; Biello, Katie B.; Glynn, Tiffany Rose; Santostefano, Christopher M.; Olson, Jennifer; Pardee, Dana J.; Hughto, Jaclyn M.W.; Garcia Valles, Josibel; Carrico, Adam; Mayer, Kenneth H.; Safren, Steven.

In: BMC Public Health, Vol. 18, No. 1, 914, 25.07.2018.

Research output: Contribution to journalArticle

Mimiaga, Matthew J. ; Pantalone, David W. ; Biello, Katie B. ; Glynn, Tiffany Rose ; Santostefano, Christopher M. ; Olson, Jennifer ; Pardee, Dana J. ; Hughto, Jaclyn M.W. ; Garcia Valles, Josibel ; Carrico, Adam ; Mayer, Kenneth H. ; Safren, Steven. / A randomized controlled efficacy trial of behavioral activation for concurrent stimulant use and sexual risk for HIV acquisition among MSM : Project IMPACT study protocol. In: BMC Public Health. 2018 ; Vol. 18, No. 1.
@article{0b9c7b4783e942b69be0972001ca48bb,
title = "A randomized controlled efficacy trial of behavioral activation for concurrent stimulant use and sexual risk for HIV acquisition among MSM: Project IMPACT study protocol",
abstract = "Background: In the United States, problematic stimulant use is a prevalent and difficult to treat problem among men who have sex with men (MSM), as well as a major driver of HIV transmission through the large number of sexual partners and concomitant condomless anal sex (CAS). Evidence-based behavioral studies that address problematic stimulant use in MSM at risk for HIV infection are also lacking. In this paper, we describe the design of a behavioral intervention trial to reduce sexual risk behavior and stimulant use in HIV-uninfected MSM. Methods: This study, funded by the National Institute on Drug Abuse (NIDA), is a randomized controlled trial (RCT) testing an integrated HIV risk reduction and behavioral activation counseling intervention (IMPACT) for HIV-uninfected, stimulant using MSM in Boston, MA, and Miami, FL. Participants are randomized (2:2:1) to either (1) the IMPACT intervention; (2) a relaxation condition, an active therapy time- and intensity-matched control; or (3) a standard of care risk reduction counseling comparison. At enrollment, all participants receive an HIV test and pre- and post-test counseling. The primary outcome is the difference in the rate of change in the number of self-reported condomless anal sex acts without the protection of consistent Pre-Exposure Prophylaxis (PrEP) use, as well as reductions in stimulant use during the prior 4-months. Major assessments are conducted at baseline, 4-, 8-, and 12-month follow-up visits. Discussion: Effective and sustainable behavioral interventions are sorely needed to reduce HIV acquisition in stimulant using MSM at risk for HIV infection. In this study, we will evaluate the evidence of efficacy of the IMPACT intervention to reduce HIV acquisition in HIV-uninfected, stimulant-using MSM. If found effective, the intervention tested here holds promise for being readily integrated into real-world clinical settings.",
keywords = "Behavioral activation, HIV, Men who have sex with men (MSM), Sexual risk, Stimulant use",
author = "Mimiaga, {Matthew J.} and Pantalone, {David W.} and Biello, {Katie B.} and Glynn, {Tiffany Rose} and Santostefano, {Christopher M.} and Jennifer Olson and Pardee, {Dana J.} and Hughto, {Jaclyn M.W.} and {Garcia Valles}, Josibel and Adam Carrico and Mayer, {Kenneth H.} and Steven Safren",
year = "2018",
month = "7",
day = "25",
doi = "10.1186/s12889-018-5856-0",
language = "English (US)",
volume = "18",
journal = "BMC Public Health",
issn = "1471-2458",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - A randomized controlled efficacy trial of behavioral activation for concurrent stimulant use and sexual risk for HIV acquisition among MSM

T2 - Project IMPACT study protocol

AU - Mimiaga, Matthew J.

AU - Pantalone, David W.

AU - Biello, Katie B.

AU - Glynn, Tiffany Rose

AU - Santostefano, Christopher M.

AU - Olson, Jennifer

AU - Pardee, Dana J.

AU - Hughto, Jaclyn M.W.

AU - Garcia Valles, Josibel

AU - Carrico, Adam

AU - Mayer, Kenneth H.

AU - Safren, Steven

PY - 2018/7/25

Y1 - 2018/7/25

N2 - Background: In the United States, problematic stimulant use is a prevalent and difficult to treat problem among men who have sex with men (MSM), as well as a major driver of HIV transmission through the large number of sexual partners and concomitant condomless anal sex (CAS). Evidence-based behavioral studies that address problematic stimulant use in MSM at risk for HIV infection are also lacking. In this paper, we describe the design of a behavioral intervention trial to reduce sexual risk behavior and stimulant use in HIV-uninfected MSM. Methods: This study, funded by the National Institute on Drug Abuse (NIDA), is a randomized controlled trial (RCT) testing an integrated HIV risk reduction and behavioral activation counseling intervention (IMPACT) for HIV-uninfected, stimulant using MSM in Boston, MA, and Miami, FL. Participants are randomized (2:2:1) to either (1) the IMPACT intervention; (2) a relaxation condition, an active therapy time- and intensity-matched control; or (3) a standard of care risk reduction counseling comparison. At enrollment, all participants receive an HIV test and pre- and post-test counseling. The primary outcome is the difference in the rate of change in the number of self-reported condomless anal sex acts without the protection of consistent Pre-Exposure Prophylaxis (PrEP) use, as well as reductions in stimulant use during the prior 4-months. Major assessments are conducted at baseline, 4-, 8-, and 12-month follow-up visits. Discussion: Effective and sustainable behavioral interventions are sorely needed to reduce HIV acquisition in stimulant using MSM at risk for HIV infection. In this study, we will evaluate the evidence of efficacy of the IMPACT intervention to reduce HIV acquisition in HIV-uninfected, stimulant-using MSM. If found effective, the intervention tested here holds promise for being readily integrated into real-world clinical settings.

AB - Background: In the United States, problematic stimulant use is a prevalent and difficult to treat problem among men who have sex with men (MSM), as well as a major driver of HIV transmission through the large number of sexual partners and concomitant condomless anal sex (CAS). Evidence-based behavioral studies that address problematic stimulant use in MSM at risk for HIV infection are also lacking. In this paper, we describe the design of a behavioral intervention trial to reduce sexual risk behavior and stimulant use in HIV-uninfected MSM. Methods: This study, funded by the National Institute on Drug Abuse (NIDA), is a randomized controlled trial (RCT) testing an integrated HIV risk reduction and behavioral activation counseling intervention (IMPACT) for HIV-uninfected, stimulant using MSM in Boston, MA, and Miami, FL. Participants are randomized (2:2:1) to either (1) the IMPACT intervention; (2) a relaxation condition, an active therapy time- and intensity-matched control; or (3) a standard of care risk reduction counseling comparison. At enrollment, all participants receive an HIV test and pre- and post-test counseling. The primary outcome is the difference in the rate of change in the number of self-reported condomless anal sex acts without the protection of consistent Pre-Exposure Prophylaxis (PrEP) use, as well as reductions in stimulant use during the prior 4-months. Major assessments are conducted at baseline, 4-, 8-, and 12-month follow-up visits. Discussion: Effective and sustainable behavioral interventions are sorely needed to reduce HIV acquisition in stimulant using MSM at risk for HIV infection. In this study, we will evaluate the evidence of efficacy of the IMPACT intervention to reduce HIV acquisition in HIV-uninfected, stimulant-using MSM. If found effective, the intervention tested here holds promise for being readily integrated into real-world clinical settings.

KW - Behavioral activation

KW - HIV

KW - Men who have sex with men (MSM)

KW - Sexual risk

KW - Stimulant use

UR - http://www.scopus.com/inward/record.url?scp=85050734726&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85050734726&partnerID=8YFLogxK

U2 - 10.1186/s12889-018-5856-0

DO - 10.1186/s12889-018-5856-0

M3 - Article

C2 - 30045702

AN - SCOPUS:85050734726

VL - 18

JO - BMC Public Health

JF - BMC Public Health

SN - 1471-2458

IS - 1

M1 - 914

ER -