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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Individual telephone counseling intervention. |
|
| Group Arm | Other | Attention-matched comparison arm |
|
| Book Arm | Other | Information-matched control arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individual Telephone Counseling Intervention | Behavioral | 10-session, 5-month HIV adherence and chronic disease self-management individual telephone counseling intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| antiretroviral (ART) adherence | Pre-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 |
| Measure | Description | Time Frame |
|---|---|---|
| chronic disease treatment adherence | baseline, 6, 9 and 12 months f/u | |
| Self-efficacy and readiness to change | baseline, 6, 9, 12 months f/u | |
| perceived stress and depression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheryl L Catz, PhD | Group Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Group Health Research Institute | Seattle | Washington | 98101 | United States |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| Group Arm | Other | 10-session didactic telephone group |
|
|
| Book Arm | Other | Book only. |
|
|
| baseline, 6, 9, and 12 months f/u |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |