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An HIV prevention adaptation of an evidence-based adherence intervention, LifeSteps

 

LifeSteps PrEP for Youth logoNew 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 entailed a two-phase study that included 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 were recruited in: Austin, TX; Connecticut; Georgia; Illinois; Gary, IN; Durham, NH; Rhode Island.

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 was informed, developed, and refined through formative research that involves YMSM at all levels.

Principal Investigators:
Kenneth Mayer, MD | The Fenway Institute
Christina Psaros, PhD | Massachusetts General Hospital

ClinicalTrials.gov Number: NCT03805451

The pilot RCT lasted for 6 months.

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

Phase II: Up to 50 YMSM in: Austin, TX; Connecticut; Georgia; Illinois; Gary, IN; Durham, NH; Rhode Island.

  • Between 16 and 24 years of age
  • HIV-uninfected
  • Assigned male sex at birth and identifies as male
  • Recently initiated PrEP for HIV prevention
  • High-risk for acquiring HIV via sexual transmission
  • Full list of eligibility and exclusion criteria available on ClinicalTrials.gov
  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

Findings

Coming soon!
Coming soon!

Coming soon!