Biobehavioral Interventions for HIV-negative, Stimulant Using Men Who Have Sex With Men

This was a prospective, randomized study. 170 participants who met inclusion and exclusion criteria were randomized to CM or NCYC (non-contingent yoked-control condition) arms. They were provided with a 4-day starter-pack of PEP medication (tenofovir + emtricitabine, Truvada) to be started only in the event of a high-risk sexual exposure. The two interventions were implemented simultaneously:

The CM or NCYC intervention, remunerating (via vouchers) the participant based on his own (CM) or a yoked-participant's (NCYC) stimulant-metabolite-free urine samples for 8 weeks;

and,

Post-exposure prophylaxis, providing risk reduction counseling, adherence counseling and PEP medication for 28 days in the event of a high-risk sexual exposure to HIV.

All participants were followed for 24 weeks, or 24-weeks post-HIV-exposure, whichever was longer.

Inclusion criteria

• Male who has sex with other men (MSM) by self-report
• At least 18 years of age
• HIV-negative serostatus on baseline rapid oral HIV antibody test, and no signs or symptoms consistent with primary HIV infection (PHI)
• Self-reported stimulant use within the previous 30 days
• Self-report of unprotected anal intercourse (either receptive or insertive) with an HIV-positive or status unknown partner within the previous 3 months
• Self-report of no previous hypersensitivity to any of the components of Truvada (tenofovir disoproxil fumarate or emtricitabine)
• In the opinion of the study medical provider, no contraindication to PEP medication treatment (laboratory testing, medical/drug interaction, or other)
• Has not used PEP in the previous 6 months
• A current resident of Los Angeles County
• Does not have a plan to move away from Los Angeles County in the next 6 months
• Willing and able to provide informed consent
• Willing and able to comply with study requirements

Exclusion criteria

• Does not identify as a male who has sex with other men
• Under 18 years of age
• HIV positive by self-report or as indicated by the results on baseline rapid oral HIV antibody testing
• Has not used a stimulant in the previous 30 days by self-report
• Has not had unprotected anal intercourse (either receptive or insertive) with an HIV-positive or status unknown partner within the previous 3 months
• Creatinine clearance <30 ml/min and not on dialysis
• Self-reports any previous hypersensitivity to any of the components of Truvada (tenofovir disoproxil fumarate or emtricitabine);
• In the opinion of the study medical provider, there exists a contraindication to administering Truvada-based post-exposure prophylaxis (laboratory testing, medical/drug interaction, or other)
• Has used PEP in the previous six months
• Not a current resident of Los Angeles County
• Unwilling or unable to provide informed consent
• Unwilling or unable to comply with study requirements