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Self-Managing HIV and Chronic Disease (PRIME)

Kaiser Permanente logo

Kaiser Permanente

Status

Completed

Conditions

HIV/AIDS

Treatments

Behavioral: Individual Telephone Counseling Intervention
Other: Book Arm
Other: Group Arm

Study type

Interventional

Funder types

Other

Identifiers

NCT01032824
5R01MH074380

Details and patient eligibility

About

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.

Full description

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.

Enrollment

452 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

452 participants in 3 patient groups

Intervention
Experimental group
Description:
Individual telephone counseling intervention.
Treatment:
Behavioral: Individual Telephone Counseling Intervention
Group Arm
Other group
Description:
Attention-matched comparison arm
Treatment:
Other: Group Arm
Book Arm
Other group
Description:
Information-matched control arm.
Treatment:
Other: Book Arm

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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