Medication Adherence in Human Immunodeficiency Virus (HIV)

The proposed pilot study will utilize a randomized controlled trial to estimate the feasibility, acceptability, and preliminary efficacy of a novel intervention for AYAs diagnosed with behaviorally-acquired HIV initiating HAART.

Standard care for HIV at St. Jude Children's Research Hospital (SJCRH) includes a placebo pill trial to assess patient readiness for therapy prior to starting HAART. Participants on this study will be randomized to either: a control arm of standard therapy, or standard therapy plus an individualized behavioral, staff-delivered intervention (Pill Trial+).

Participants in the control arm will receive standard clinical care. Participants in the Pill Trial+ arm will receive standard therapy plus three 25-minute individualized, behavioral, staff-delivered intervention sessions at HAART initiation, and 1-, and 3-month follow-up visits. Two brief booster sessions will also be provided to the Pill Trial+ arm following sessions 1 (in clinic) and 2 (by phone). In-person intervention sessions and all questionnaires will be completed in conjunction with scheduled clinical care visits. Sessions and measures will be completed by phone at designated time points if a participant becomes unavailable to return to clinic due to extenuating circumstances.

As recommended by Panel guidelines, discussion of placebo pill trial adherence during the first 25-minute session will provide a novel mechanism to discuss barriers to adherence and provide intervention prior to HAART initiation. Remaining sessions will promote adherence following HAART initiation using behavioral problem-solving and motivational interviewing strategies.

Primary Objective:

• To estimate a) rate of consent to the randomized trial and b) differences between the intervention and control conditions with respect to HAART adherence, as measured by pill count.

Secondary Objectives:

• To estimate differences between the intervention and control conditions with respect to other measures of adherence, including HAART self-reported adherence, HAART pharmacy refill, and clinic attendance.
• To examine disease and patient-reported outcomes during the first 6 months following HAART initiation and their relationship to participation in the Pill Trial+ intervention.