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OpenTrials
Completed

NCT Number: NCT01032824

Self-Managing HIV and Chronic Disease

The purpose of this study is to conduct a randomized control trial of a behavioral intervention delivered by counselors via telephone to determine if this is an efficacious method for improving medication adherence and health-related quality of life for persons who are 50 and older and living with HIV/AIDS and other chronic conditions.

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Key information

About this study

450 adult HIV+ patients aged 50 or older will be randomized to one of three arms. 150 will be assigned to receive a series of ten 30-minute phone calls every two weeks from a counselor. 150 will be assigned to an attention-matched comparison arm, and will receive 10 sessions in a didactic telephone group. 150 will be assigned to a information-matched control arm and will receive the book Living Well with HIV & AIDS. Letters will be sent by AIDS Service Organizations inviting interested clients to call the study's 800 number to learn more about the study and to be screened for enrollment. Posters and brochures will also be posted in public areas of the ASOs. The individualized intervention combines problem-solving, with motivation and self-management. This trial will allow us to evaluate the effectiveness of a multi-component intervention on both specific HIV behavioral outcomes and non-disease-specific outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 50 years or older
  • HIV-positive serostatus
  • currently prescribed antiretroviral medication
  • antiretroviral nonadherence reported in past 30 days
  • provision of oral informed consent

Exclusion criteria

  • hearing problems that preclude participation in a telephone study
  • presence of probable dementia or acute psychosis detectable by screening interview

Treatment and study plan

Individual Telephone Counseling Intervention

Behavioral

10-session, 5-month HIV adherence and chronic disease self-management individual telephone counseling intervention.

Other names: telephone counseling

Group Arm

Other

10-session didactic telephone group

Other names: Attention-matched comparison arm

Book Arm

Other

Book only.

Other names: Information-matched comparison arm

Primary outcomes

  1. antiretroviral (ART) adherence

    Time frame: Pre-treatment Screening and Baseline, 6, 9, and 12 months f/u.

  2. health-related quality of life (physical, mental health, and social function)

    Time frame: Baseline, 6, 9, 12 mo f/u

Secondary outcomes

  1. chronic disease treatment adherence

    Time frame: baseline, 6, 9 and 12 months f/u

  2. Self-efficacy and readiness to change

    Time frame: baseline, 6, 9, 12 months f/u

  3. perceived stress and depression

    Time frame: baseline, 6, 9, and 12 months f/u

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

Community-based Self-management of HIV and Chronic Disease

Acronym: PRIME

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Dec 16, 2009
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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