ATN 158: LSPY Number: NCT03805451

Study Summary:

New HIV infections occur at a disproportionately high rate among young men who have sex with men (YMSM), and it is essential that comprehensive HIV prevention strategies, specifically tailored to the needs and perceptions of YMSM, are developed, tested and disseminated. Pre-exposure prophylaxis (PrEP), is effective in decreasing HIV transmission among MSM; however adherence is critical to its efficacy. In prior open-label studies among YMSM, adherence was suboptimal. Bio-behavioral PrEP interventions for adherence, tailored to meet unique needs of YMSM, are urgently needed. LifeSteps, an evidence-based HIV medication adherence intervention for individuals living with HIV developed by Safren et al., has been adapted for diverse populations, including HIV-infected adolescents in a project led by co-Investigator M. Mimiaga, called “Positive STEPS.”

Positive STEPS was successful in improving ART adherence relative to a standard of care comparison group in a pilot RCT among youth living with HIV, aged 16 to 24 in the U.S., and is currently being evaluated in an NIH-funded, two-city efficacy trial. Additionally, the current study team adapted LifeSteps for PrEP use in adults, and found that a 4-session, nurse-delivered cognitive behavioral therapy (CBT)-based counseling intervention for at risk MSM aged 18 or older resulted in excellent adherence to PrEP and higher drug levels in the intervention condition as compared to a time- and attention-match control condition.

The ATN’s LSPY protocol will entail a two-phase study that includes individual, qualitative interviews with approximately 20 YMSM and 10 key informants for intervention adaptation and refinement; and a pilot randomized controlled trial (RCT) of up to 50 YMSM to assess feasibility, acceptability and preliminary efficacy of the LSPY compared to standard of PrEP care only to improve PrEP adherence. All participants will be recruited at three ATN sites in the United States.

Phase 1 has been completed, and enrollment of the pilot RCT is anticipated to begin in early summer 2019. Our long-term goal is to develop scalable protocols to optimize at risk YMSM’s PrEP uptake and adherence in order to decrease HIV incidence. The adaptation for LifeSteps for PrEP for YMSM will be informed, developed, and refined through formative research that involves YMSM at all levels.

Study Details:

Study Duration:

The pilot RCT will last for 6 months.

Sample Size:

Phase I: Up to 20 in-depth interviews, and up to 10 key informants interviews


  • Age 16-24
  • HIV-uninfected by self-report
  • Assigned male sex at birth
  • At risk for HIV acquisition defined by specific criteria
  • Own a cellphone with an active cellular plan
  • More information on eligibility and exclusion criteria available on

Primary Objectives:

  1. Feasibility and acceptability of the intervention
  2. PrEP adherence as measured by dried blood spot (DBS) testing of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP)—and retention in PrEP care—as measured by attendance at quarterly clinic appointments—at 3 and 6 months post baseline

Protocol Chairs:

Kenneth Mayer, MD
Christina Psaros, PhD