Title:	Network of AIDS Researchers in Los Angeles (NARLA), Project 2:  Enrollment in Research Registry for Microbicide Clinical Trials
Principal Investigator:	Ronald Mitsuyasu, M.D. (UCLA Center for Clinical AIDS Research and Education)
Project Principal investigator:	Pamina Gorbach, Ph.D. (UCLA Dept. of Public Health)
Site Principal Investigator:	Cathy J. Reback, Ph.D.
Program Coordinator:	Galina Inzhakova, M.P.H.
Funded by:	California HIV/AIDS Research Program
Grant Number:	CH05-FRII-611
Total Project Period:	7/05 – 6/09
Project Description:

Anal intercourse is a widely practiced behavior among men who have sex with men (MSM).  Receptive anal intercourse is clearly associated with a higher risk of HIV transmission than either insertive anal intercourse or oral sex, making it probable that much HIV transmission occurs via this route.   Rectal microbicides to inhibit the rectal transmission of sexually transmitted infections (STIs), including HIV, are in development.  The public knows little about microbicides and even less about rectal microbicides.   Clinical trials of rectal microbicides will require that the individuals likely to benefit from them can be recruited into those trials.  Given the sensitive nature of this novel approach to HIV prevention, specially designed materials may be required for their introduction both in a clinical trial setting and to enhance the acceptance of microbicides as medical prevention for HIV transmission.   In order to provide the background information necessary to begin clinical trials of rectal microbicides as soon as they are developed, this study is designed to develop educational materials (video and brochure) for MSM about rectal microbicides; assess the best format in which to deliver such information; consider potential barriers to microbicide trial participation by analyzing factors that facilitate enrollment in a microbicide trial registry; and assist in building the capacity of the community organizations to serve as coordinating sites for future clinical trials and to describe the participant population (including incidence of HIV/STIs) which the community organizations could recruit for enrollment in future clinical trials.  This study is conducting a randomized controlled trial of the effectiveness of two patient information formats describing rectal microbicides and evaluating the effectiveness of each information format on participants’ willingness to enroll in the registry, knowledge of microbicides, attitudes about clinical trials for novel methods of HIV prevention, and their HIV-related sexual and drug risk behaviors.  The study is recruiting 225 HIV-positive MSM and 225 individuals at high risk for infection with HIV (e.g., HIV-negative partners of HIV-positive men, drug-using MSM) from three Los Angeles sites which provide HIV services.  At Friends Community Center, recruitment occurs through WeHo Streets and The G.U.Y.S. Program.   A two-group experimental design randomly assigns participants to one of two conditions: a patient-centered video about rectal microbicides (n=225) or a standard information condition in which a study coordinator provides a brochure about microbicides (n=225).  Outcomes will include attitudes and beliefs about microbicides, HIV risk, and clinical trials; in addition, participants are asked if they are willing to be included in a research registry to participate in future microbicide clinical trials. 

 

Title:	Project Tech Support
Principal Investigator:	Cathy J. Reback, Ph.D.
Co-Investigators:	Steven Shoptaw, Ph.D. (UCLA School of Medicine) Michael Green, Ph.D. (Los Angeles County, Department of Public Health, Office of AIDS Programs and Policy)
Program Coordinator:	TBH
Funded by:	Centers for Disease Control and Prevention
Grant Number:	7UR6PS000312
Total Project Period:	9/06 – 10/08
Project Description:

Out-of-treatment, methamphetamine-using men who have sex with men (MSM) are at extreme risk of HIV acquisition and transmission, predominantly through high-risk sexual behaviors that are facilitated by use of the drug.  Project Tech Support study enrolls 72 out-of-treatment, methamphetamine-using MSM into an information technology (IT) communication intervention. Field workers conduct outreach in identified venues in the natural settings where out-of-treatment, methamphetamine-using MSM congregate.  Over the course of two weeks, participants engage in a variety of communication technologies (e.g., text messaging, emails, instant messaging) and receive real-time HIV prevention messages, social support and referrals for healthier, prosocial choices regarding drug- and sexual-risk behaviors.  The study aims to (1) conduct formative work to assist in the development of an IT communication intervention for reducing methamphetamine use and high-risk sexual behaviors among out-of-treatment MSM; (2) assess the feasibility and utility of the behavioral intervention on the target population; and (3) gather indicators of the mechanism of action for this intervention, a dose-response association will be evaluated between the extent of use of IT communication system and the degree of reduction in methamphetamine use and concomitant sexual risk behaviors.  Evaluations, including biological markers for drug use and HIV serostatus are collected at baseline and two months post intervention.  Cognitive and behavioral outcomes are measured.  Findings from this study will inform the field on the feasibility of adapting an IT communication intervention for reducing sexual risk behaviors and HIV acquisition and transmission among out-of-treatment, methamphetamine-using MSM.

Also see www.projecttechsupport.org

 

 

 

 

 

 

 

 

Homeless, gay and bisexual male abusers suffer approximately 80% seroprevalence and often engage in exchange sex and resist treatment for substance abuse.  Contingency management interventions, which provide positive incentives for behavior change, may be particularly well suited for this disenfranchised, high-risk cohort.  Specifically, voucher-based incentive therapies may be effective since they have established potency for increasing prosocial behaviors that successfully compete with taking drugs and for reducing drug use.  A randomize, controlled trial assigns 130 non-treatment seeking gay, bisexual or MSM substance users to either voucher-based incentive therapy or control groups for 24 weeks, with follow-up evaluations at 7, 9 and 12 months post randomization.  The voucher-based group earns vouchers in exchange for completing prosocial and healthy behaviors, and/or submitting drug-negative urine and alcohol-negative breath samples, and/or attendance in a standard HIV prevention program, OAPP-funded The G.U.Y.S. Program. The control group receives feedback regarding behaviors performed and urinalysis and breathe alcohol tests, but does not receive voucher points for these behaviors, but does receive vouchers for attendance in a standard HIV prevention program, The G.U.Y.S. Program.  Vouchers are redeemable for goods located in an onsite voucher store or purchased for the participant.  The study will assess the efficacy of the voucher-based intervention for increasing prosocial and healthy behavior and reducing substance abuse among these non-treatment seeking gay, bisexual and MSM substance users receiving standard HIV prevention services. The study will also assess the impact of the voucher-based incentive therapy on other measures of therapeutic change consistent with a harm reduction approach, including reduction of psychiatric symptoms, decreased injection drug use and high-risk sexual behavior, increased participation in The G.U.Y.S. Program, and improvement in different domains of overall functioning (medical/social/vocational).