HIV Clinical Trial
Official title:
Impact of Cognitive Training on Medication Adherence in HIV-infected Individuals
The proposed study will test the efficacy of a cognitive training program to improve working
memory in a sample of HIV-infected persons. Investigators will assign 40 HIV-infected adults
with poor medication adherence to one of two conditions (20/group): the experimental
cognitive training intervention or a control training condition. Participants will complete
12 training sessions across 10 weeks and will complete assessments at baseline and
post-training. The specific aims are to:
1. Investigate the effects of the cognitive training intervention on working memory and
delay discounting in HIV-infected persons.
Hypothesis 1: Participants assigned to active cognitive training, compared to those in
the attention-matched control group, will have greater improvements in working memory
and reductions in delay discounting.
2. Characterize adherence to antiretroviral medications in this population and examine
medication adherence after cognitive training.
Hypothesis 2: Participants assigned to active cognitive training, compared to those in the
attention-matched control group, will have greater improvements in medication adherence.
This study tests the feasibility and preliminary efficacy of a computerized cognitive
training program to improve working memory and decrease impulsivity among HIV-infected
individuals with poor medication adherence. The specific aims are to: (1) Investigate the
effects of the cognitive training intervention on working memory and delay discounting in
HIV-infected persons; and (2) Characterize adherence to antiretroviral medications in this
population and examine medication adherence after cognitive training.
The research design includes two parts: an eligibility screening and the Cognitive Training
study. In Part 1, Eligibility Screening, participants will complete a 2-3 hour battery of
standardized measures to assess for study eligibility. Eligible individuals will then be
invited to enroll in Part 2, Cognitive Training Study. Part 1 of the study will involved
screening approximately 60 participants, with an estimated eligibility rate of 67% for Part
2. In Part 2, participants will be assigned to one of two groups (active cognitive training
or control training; 20 participants per group) and will complete 12 training sessions over
10 weeks. Participants assigned to the active cognitive training group will complete
computerized modules designed to enhance working memory, while those assigned to the
attention-matched control group will complete inactive modules that are not designed to
enhance memory. All Part 2 participants will complete assessments at baseline and
post-training to evaluate the impact of the training program.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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