Study Aims to Improve PrEP Adherence for Those on Medication for Opioid Use Disorder With Cognitive Dysfunction

A new study aims to utilize multiphase optimization strategy (MOST) to optimize HIV prevention and pre-exposure prophylaxis (PrEP) adherence among those who inject drugs, are taking medication for opioid use disorder (MOUD), and have cognitive dysfunction, according to a protocol published in BMJ Open.

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Recruitment of participants for the study began in March 2023 and is expected to conclude in January 2027. The enrollment guidelines include those who meet criteria for opioid dependence and are entering MOUD treatment, have mild cognitive impairment (MCI), have initiated PrEP in the past week, have confirmed HIV-negative-status, and have reported recent unsafe drug injection or unprotected sex, among others, the study authors explained.

Patients will then be screened for cognitive impairment using the Montreal Cognitive Assessment (MoCA), which is a brief questionnaire designed to measure cognitive function on a global scale. If the results fall within the MCI range, then a participant will be eligible for study inclusion, with an estimated rate of MCI of 60%-65%, the investigators wrote.

Once enrolled in the study, participants of all conditions will receive routine services—including daily methadone and 1 hour monthly with a counselor or case manager —in addition to community-friendly health recovery program (CHRP) activities, such as 4 weekly, 50-minute HIV reduction and PrEP adherence group sessions, the study authors explained.

Further, patients will receive elements of 4 complementary components of CHRP: attention (i.e., increased frequency of meetings, distributed practice), executive function (i.e., linking actions to a triggering cue, valuing future events), memory (i.e., summarizing information, memory aids) and information processing (i.e., slowly presenting information, multimodal presentation of content), according to the study investigators.

The primary outcome of the study is PrEP adherence, while secondary outcomes include reducing sex- and drug-related HIV risk. PrEP adherence will be measured at postintervention and at 3-, 6-, and 9-month follow-ups using biomedical and behavioral approaches.

The researchers noted that the incidence of HIV in the United States has remained largely stagnant over the past 15 years, specifically among people who inject drugs (PWID), as they have consistently contributed to approximately 10% of new HIV cases each year.

Further, they discussed the dilemma of existing evidence-based interventions that require patients to have cognitive functioning in order to process and effectively utilize intervention content, including PrEP.

Investigators pointed out that cognitive dysfunction —particularly for those with opioid use disorder and those on MOUD—can impede individuals’ ability to process and use information for higher levels of PrEP adherence, which can serve as a significant barrier for the large-scale treatment of PWID for HIV.

The MOST framework consists of 3 phases of research: preparation, optimization, and evaluation. This framework, in conjunction with CHRP, could help create an efficient pathway to enhancing understanding and participation in PrEP for PWID, the investigators explained.

The study authors discussed how their research could align with the CDC’s Ending the HIV Epidemic plan, with aims to diagnose all people with HIV as early as possible, treat people with HIV rapidly and effectively, prevent new HIV transmissions, and respond quickly to potential HIV outbreaks.

“There is a high likelihood that these goals can be met through this line of research. If this trial leads to the optimization of a PrEP-focused primary HIV prevention intervention among high-risk PWID with cognitive dysfunction, it is likely to become a resource-efficient approach for use in treatment settings targeting PWID,” the investigators concluded.

Reference

Mistler C B, Shrestha R, Gunstad J, et al. Application of the multiphase optimisation strategy (MOST) to optimise HIV prevention targeting people on medication for opioid use disorder (MOUD) who have cognitive dysfunction: protocol for a MOST study. BMJ Open. 2023;13:e071688. doi:10.1136/bmjopen-2023-071688