Skip to content

Self-Managing HIV and Chronic Disease

Community-based Self-management of HIV and Chronic Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01032824
Acronym
PRIME
Enrollment
452
Registered
2009-12-16
Start date
2007-10-31
Completion date
2011-02-28
Last updated
2017-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Keywords

Complementary Therapies

Brief summary

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.

Detailed 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.

Interventions

BEHAVIORALIndividual Telephone Counseling Intervention

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

OTHERGroup Arm

10-session didactic telephone group

OTHERBook Arm

Book only.

Sponsors

Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
antiretroviral (ART) adherencePre-treatment Screening and Baseline, 6, 9, and 12 months f/u.
health-related quality of life (physical, mental health, and social function)Baseline, 6, 9, 12 mo f/u

Secondary

MeasureTime frame
chronic disease treatment adherencebaseline, 6, 9 and 12 months f/u
Self-efficacy and readiness to changebaseline, 6, 9, 12 months f/u
perceived stress and depressionbaseline, 6, 9, and 12 months f/u

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026