Adherence Intervention for People With Low-literacy

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01061762
• Date of registration: 01/02/2010
• Primary sponsor: University of Connecticut
• Public title: Adherence Intervention for People With Low-literacy
• Scientific title: HIV Treatment Adherence Intervention for People With Poor Literacy Skills
• Date of first enrolment: February 2008
• Target sample size: 450
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01061762
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: Seth C Kalichman, PhD
• Affiliation: University of Connecticut

Key inclusion & exclusion criteria

Inclusion Criteria:

- 18 years or older,

- HIV positive,

- receiving antiretroviral medications, and

- score below cut-off on a standard health literacy test.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Behavioral: Health Counseling

Behavioral: Standard medication adherence counseling

Behavioral: Stick To It

Primary Outcome(s)

Unannounced Phone Based Pill Counts for Medication Adherence [Time Frame: Baseline, monthly for 12 months]

Secondary Outcome(s)

Theoretical Constructs derived from the Information-Motivation-Behavioral Skills Model assessed by psychometric scales of AIDS knowledge, behavioral intentions, adherence self-efficacy, adherence strategies/skills [Time Frame: Baseline, 3, 6, and 9 months]

Secondary ID(s)

H07-266

R01MH082633-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Mental Health (NIMH)