Men who have sex with men (MSM) who use methamphetamine face a disproportionate burden of HIV and are significantly less likely to maintain high levels of adherence to pre-exposure prophylaxis (PrEP), despite its proven efficacy in preventing HIV.
Methamphetamine use, which is 20 times more prevalent among MSM than among heterosexual men, is associated with a four-fold increase in HIV seroconversion compared to MSM who do not use meth, and is strongly linked to PrEP nonadherence and disengagement. Innovative, scalable interventions are needed to support this priority population. This randomized controlled trial (RCT) aims to evaluate the efficacy of Intervention of Self-monitoring & Telehealth Counseling for PrEP Adherence, a novel intervention that combines at-home point-of-care (POC) urine tenofovir (TFV) immunoassay testing with telehealth-based motivational interviewing (MI) to promote sustained PrEP.
This intervention builds upon robust pilot data demonstrating feasibility, acceptability, and initial efficacy, and integrates real-time adherence feedback with personalized, remote counseling—addressing both structural and behavioral barriers to adherence in a low-cost, scalable manner. A total of 240 HIV-negative MSM who use meth and report suboptimal PrEP adherence will be enrolled and randomized 1:1 to either the intervention or standard care. The intervention group will receive monthly at-home POC TFV tests and two telehealth MI sessions; the control group will receive routine clinical support. The primary outcome is long-term PrEP adherence, measured through hair TFV concentration levels—a validated, cumulative biomarker of PrEP use. Data will be collected at baseline and at 3, 6, 9, and 12 months.
Aim 1 evaluates the impact of the intervention on cumulative PrEP adherence over 12 months, using hair TFV levels, analyzed via mixed-effects models under an intent-to-treat framework.
Aim 2 assesses secondary outcomes, including stimulant use intensity (measured via hair toxicology and self-report), PrEP persistence (current self-reported use), retention in care (clinical and lab records), and prevention-effective adherence (hair TFV >0.023 ng/mg, reflecting ≥4 doses/week).
A third exploratory aim will explore mediators (e.g., self-efficacy, positive affect) and moderators (e.g., depressive symptoms, race/ethnicity) of the intervention’s effects using structural equation modeling and causal inference methods. Guided by a multidisciplinary team with deep expertise in HIV prevention, substance use, and mHealth, and leveraging the rich data from the ongoing AMETHST cohort (n > 5,000 MSM, including 2,800 who use meth), this RCT addresses a critical gap in the HIV prevention continuum.
If successful, this intervention will be among the first scalable, evidence-based interventions to deliver low-cost, real-time, self-administered adherence monitoring with telehealth counseling for a high-priority, underserved population. This study aligns with national goals to end the HIV epidemic and holds strong potential for rapid implementation in clinical and community-based settings.
Project Investigators
Christian Grov
Distinguished Professor, Department of Community Health and Social Sciences
