Multi-Component Intervention to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV
NCT ID: NCT04549259
Last Updated: 2023-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2021-04-14
2022-05-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Social Support + Stigma Reduction + SBCM + Tech Detailing
Group-Based Social Support
This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 8 consecutive weeks. The calls will last approximately 90 minutes and will include 5-8 individuals per group. Groups will follow pre-determined topic areas, with participants encouraged to explore their feelings about the difficulties associated with normal aging, being HIV-positive, and living with HIV/AIDS as an older adult. Therapists will facilitate mutual support among group members, encourage greater openness and emotional expressiveness, and help participants to improve their social and family support and enhance their quality of life. This intervention is an adaptation of Telephone Supportive-Expressive Group Therapy (Heckman et al., 2013).
HIV Stigma Reduction
This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 6 consecutive weeks. The calls will last approximately 60-90 minutes and will include 5-8 individuals per group. This intervention is grounded in minority stress theory and will use cognitive-behavioral strategies to help empower participants to cope with stressful and stigmatizing experiences. Intervention components may include minimizing self-stigmatizing attitudes, reducing engulfment, developing a sense of future and hope, and developing and pursuing meaningful life goals. This intervention is an adaptation of "Ending Self Stigma" (Lucksted et al., 2011).
Strengths-Based Case Management (SBCM)
The investigators have adapted an individually-tailored strengths-based case management (SBCM) intervention to help address the multiple structural barriers faced by rural older PLH. The adapted intervention, delivered by trained research staff, will include two 60-minute telephone-based SBCM counseling sessions with shorter follow-up phone calls to check-in on progress and help patients navigate identified barriers. The case manager will provide tailored sessions based on individually-identified needs and proximal life stressors. Capitalizing on participants' personal strengths, case managers will help empower participants to navigate issues related to employment, insurance, mental health, housing, or transportation. This may include assistance understanding, applying for, and accessing benefits or programs.
Personalized Technology Detailing
Participants will be called by a technology-fluent study staff member, who will assess the current state of their technology literacy, access, and use. Detailing will focus on advancing the participant along the technology use cascade (using the internet, possessing a device and service to access internet at home, using the internet to access their electronic health record and pharmacy services, seeking HIV-related information, and finding social support). Each participant will be provided with personalized assistance based on their local and personal circumstances. Because of the individualized advice provided, there will be a range of contacts between 1 and 5, at customized intervals. Detailing protocols include the option of providing the participant with a tablet including cellular service (for 3 months) when in-home internet service is not available or is cost prohibitive.
Social Support + Stigma Reduction + SBCM
Group-Based Social Support
This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 8 consecutive weeks. The calls will last approximately 90 minutes and will include 5-8 individuals per group. Groups will follow pre-determined topic areas, with participants encouraged to explore their feelings about the difficulties associated with normal aging, being HIV-positive, and living with HIV/AIDS as an older adult. Therapists will facilitate mutual support among group members, encourage greater openness and emotional expressiveness, and help participants to improve their social and family support and enhance their quality of life. This intervention is an adaptation of Telephone Supportive-Expressive Group Therapy (Heckman et al., 2013).
HIV Stigma Reduction
This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 6 consecutive weeks. The calls will last approximately 60-90 minutes and will include 5-8 individuals per group. This intervention is grounded in minority stress theory and will use cognitive-behavioral strategies to help empower participants to cope with stressful and stigmatizing experiences. Intervention components may include minimizing self-stigmatizing attitudes, reducing engulfment, developing a sense of future and hope, and developing and pursuing meaningful life goals. This intervention is an adaptation of "Ending Self Stigma" (Lucksted et al., 2011).
Strengths-Based Case Management (SBCM)
The investigators have adapted an individually-tailored strengths-based case management (SBCM) intervention to help address the multiple structural barriers faced by rural older PLH. The adapted intervention, delivered by trained research staff, will include two 60-minute telephone-based SBCM counseling sessions with shorter follow-up phone calls to check-in on progress and help patients navigate identified barriers. The case manager will provide tailored sessions based on individually-identified needs and proximal life stressors. Capitalizing on participants' personal strengths, case managers will help empower participants to navigate issues related to employment, insurance, mental health, housing, or transportation. This may include assistance understanding, applying for, and accessing benefits or programs.
Social Support + Stigma Reduction + Technology Detailing
Group-Based Social Support
This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 8 consecutive weeks. The calls will last approximately 90 minutes and will include 5-8 individuals per group. Groups will follow pre-determined topic areas, with participants encouraged to explore their feelings about the difficulties associated with normal aging, being HIV-positive, and living with HIV/AIDS as an older adult. Therapists will facilitate mutual support among group members, encourage greater openness and emotional expressiveness, and help participants to improve their social and family support and enhance their quality of life. This intervention is an adaptation of Telephone Supportive-Expressive Group Therapy (Heckman et al., 2013).
HIV Stigma Reduction
This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 6 consecutive weeks. The calls will last approximately 60-90 minutes and will include 5-8 individuals per group. This intervention is grounded in minority stress theory and will use cognitive-behavioral strategies to help empower participants to cope with stressful and stigmatizing experiences. Intervention components may include minimizing self-stigmatizing attitudes, reducing engulfment, developing a sense of future and hope, and developing and pursuing meaningful life goals. This intervention is an adaptation of "Ending Self Stigma" (Lucksted et al., 2011).
Personalized Technology Detailing
Participants will be called by a technology-fluent study staff member, who will assess the current state of their technology literacy, access, and use. Detailing will focus on advancing the participant along the technology use cascade (using the internet, possessing a device and service to access internet at home, using the internet to access their electronic health record and pharmacy services, seeking HIV-related information, and finding social support). Each participant will be provided with personalized assistance based on their local and personal circumstances. Because of the individualized advice provided, there will be a range of contacts between 1 and 5, at customized intervals. Detailing protocols include the option of providing the participant with a tablet including cellular service (for 3 months) when in-home internet service is not available or is cost prohibitive.
Social Support + Stigma Reduction
Group-Based Social Support
This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 8 consecutive weeks. The calls will last approximately 90 minutes and will include 5-8 individuals per group. Groups will follow pre-determined topic areas, with participants encouraged to explore their feelings about the difficulties associated with normal aging, being HIV-positive, and living with HIV/AIDS as an older adult. Therapists will facilitate mutual support among group members, encourage greater openness and emotional expressiveness, and help participants to improve their social and family support and enhance their quality of life. This intervention is an adaptation of Telephone Supportive-Expressive Group Therapy (Heckman et al., 2013).
HIV Stigma Reduction
This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 6 consecutive weeks. The calls will last approximately 60-90 minutes and will include 5-8 individuals per group. This intervention is grounded in minority stress theory and will use cognitive-behavioral strategies to help empower participants to cope with stressful and stigmatizing experiences. Intervention components may include minimizing self-stigmatizing attitudes, reducing engulfment, developing a sense of future and hope, and developing and pursuing meaningful life goals. This intervention is an adaptation of "Ending Self Stigma" (Lucksted et al., 2011).
Social Support + SBCM + Technology Detailing
Group-Based Social Support
This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 8 consecutive weeks. The calls will last approximately 90 minutes and will include 5-8 individuals per group. Groups will follow pre-determined topic areas, with participants encouraged to explore their feelings about the difficulties associated with normal aging, being HIV-positive, and living with HIV/AIDS as an older adult. Therapists will facilitate mutual support among group members, encourage greater openness and emotional expressiveness, and help participants to improve their social and family support and enhance their quality of life. This intervention is an adaptation of Telephone Supportive-Expressive Group Therapy (Heckman et al., 2013).
Strengths-Based Case Management (SBCM)
The investigators have adapted an individually-tailored strengths-based case management (SBCM) intervention to help address the multiple structural barriers faced by rural older PLH. The adapted intervention, delivered by trained research staff, will include two 60-minute telephone-based SBCM counseling sessions with shorter follow-up phone calls to check-in on progress and help patients navigate identified barriers. The case manager will provide tailored sessions based on individually-identified needs and proximal life stressors. Capitalizing on participants' personal strengths, case managers will help empower participants to navigate issues related to employment, insurance, mental health, housing, or transportation. This may include assistance understanding, applying for, and accessing benefits or programs.
Personalized Technology Detailing
Participants will be called by a technology-fluent study staff member, who will assess the current state of their technology literacy, access, and use. Detailing will focus on advancing the participant along the technology use cascade (using the internet, possessing a device and service to access internet at home, using the internet to access their electronic health record and pharmacy services, seeking HIV-related information, and finding social support). Each participant will be provided with personalized assistance based on their local and personal circumstances. Because of the individualized advice provided, there will be a range of contacts between 1 and 5, at customized intervals. Detailing protocols include the option of providing the participant with a tablet including cellular service (for 3 months) when in-home internet service is not available or is cost prohibitive.
Social Support + SBCM
Group-Based Social Support
This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 8 consecutive weeks. The calls will last approximately 90 minutes and will include 5-8 individuals per group. Groups will follow pre-determined topic areas, with participants encouraged to explore their feelings about the difficulties associated with normal aging, being HIV-positive, and living with HIV/AIDS as an older adult. Therapists will facilitate mutual support among group members, encourage greater openness and emotional expressiveness, and help participants to improve their social and family support and enhance their quality of life. This intervention is an adaptation of Telephone Supportive-Expressive Group Therapy (Heckman et al., 2013).
Strengths-Based Case Management (SBCM)
The investigators have adapted an individually-tailored strengths-based case management (SBCM) intervention to help address the multiple structural barriers faced by rural older PLH. The adapted intervention, delivered by trained research staff, will include two 60-minute telephone-based SBCM counseling sessions with shorter follow-up phone calls to check-in on progress and help patients navigate identified barriers. The case manager will provide tailored sessions based on individually-identified needs and proximal life stressors. Capitalizing on participants' personal strengths, case managers will help empower participants to navigate issues related to employment, insurance, mental health, housing, or transportation. This may include assistance understanding, applying for, and accessing benefits or programs.
Social Support + Technology Detailing
Group-Based Social Support
This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 8 consecutive weeks. The calls will last approximately 90 minutes and will include 5-8 individuals per group. Groups will follow pre-determined topic areas, with participants encouraged to explore their feelings about the difficulties associated with normal aging, being HIV-positive, and living with HIV/AIDS as an older adult. Therapists will facilitate mutual support among group members, encourage greater openness and emotional expressiveness, and help participants to improve their social and family support and enhance their quality of life. This intervention is an adaptation of Telephone Supportive-Expressive Group Therapy (Heckman et al., 2013).
Personalized Technology Detailing
Participants will be called by a technology-fluent study staff member, who will assess the current state of their technology literacy, access, and use. Detailing will focus on advancing the participant along the technology use cascade (using the internet, possessing a device and service to access internet at home, using the internet to access their electronic health record and pharmacy services, seeking HIV-related information, and finding social support). Each participant will be provided with personalized assistance based on their local and personal circumstances. Because of the individualized advice provided, there will be a range of contacts between 1 and 5, at customized intervals. Detailing protocols include the option of providing the participant with a tablet including cellular service (for 3 months) when in-home internet service is not available or is cost prohibitive.
Social Support
Group-Based Social Support
This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 8 consecutive weeks. The calls will last approximately 90 minutes and will include 5-8 individuals per group. Groups will follow pre-determined topic areas, with participants encouraged to explore their feelings about the difficulties associated with normal aging, being HIV-positive, and living with HIV/AIDS as an older adult. Therapists will facilitate mutual support among group members, encourage greater openness and emotional expressiveness, and help participants to improve their social and family support and enhance their quality of life. This intervention is an adaptation of Telephone Supportive-Expressive Group Therapy (Heckman et al., 2013).
Stigma Reduction + SBCM + Technology Detailing
HIV Stigma Reduction
This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 6 consecutive weeks. The calls will last approximately 60-90 minutes and will include 5-8 individuals per group. This intervention is grounded in minority stress theory and will use cognitive-behavioral strategies to help empower participants to cope with stressful and stigmatizing experiences. Intervention components may include minimizing self-stigmatizing attitudes, reducing engulfment, developing a sense of future and hope, and developing and pursuing meaningful life goals. This intervention is an adaptation of "Ending Self Stigma" (Lucksted et al., 2011).
Strengths-Based Case Management (SBCM)
The investigators have adapted an individually-tailored strengths-based case management (SBCM) intervention to help address the multiple structural barriers faced by rural older PLH. The adapted intervention, delivered by trained research staff, will include two 60-minute telephone-based SBCM counseling sessions with shorter follow-up phone calls to check-in on progress and help patients navigate identified barriers. The case manager will provide tailored sessions based on individually-identified needs and proximal life stressors. Capitalizing on participants' personal strengths, case managers will help empower participants to navigate issues related to employment, insurance, mental health, housing, or transportation. This may include assistance understanding, applying for, and accessing benefits or programs.
Personalized Technology Detailing
Participants will be called by a technology-fluent study staff member, who will assess the current state of their technology literacy, access, and use. Detailing will focus on advancing the participant along the technology use cascade (using the internet, possessing a device and service to access internet at home, using the internet to access their electronic health record and pharmacy services, seeking HIV-related information, and finding social support). Each participant will be provided with personalized assistance based on their local and personal circumstances. Because of the individualized advice provided, there will be a range of contacts between 1 and 5, at customized intervals. Detailing protocols include the option of providing the participant with a tablet including cellular service (for 3 months) when in-home internet service is not available or is cost prohibitive.
Stigma Reduction + SBCM
HIV Stigma Reduction
This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 6 consecutive weeks. The calls will last approximately 60-90 minutes and will include 5-8 individuals per group. This intervention is grounded in minority stress theory and will use cognitive-behavioral strategies to help empower participants to cope with stressful and stigmatizing experiences. Intervention components may include minimizing self-stigmatizing attitudes, reducing engulfment, developing a sense of future and hope, and developing and pursuing meaningful life goals. This intervention is an adaptation of "Ending Self Stigma" (Lucksted et al., 2011).
Strengths-Based Case Management (SBCM)
The investigators have adapted an individually-tailored strengths-based case management (SBCM) intervention to help address the multiple structural barriers faced by rural older PLH. The adapted intervention, delivered by trained research staff, will include two 60-minute telephone-based SBCM counseling sessions with shorter follow-up phone calls to check-in on progress and help patients navigate identified barriers. The case manager will provide tailored sessions based on individually-identified needs and proximal life stressors. Capitalizing on participants' personal strengths, case managers will help empower participants to navigate issues related to employment, insurance, mental health, housing, or transportation. This may include assistance understanding, applying for, and accessing benefits or programs.
Stigma Reduction + Technology Detailing
HIV Stigma Reduction
This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 6 consecutive weeks. The calls will last approximately 60-90 minutes and will include 5-8 individuals per group. This intervention is grounded in minority stress theory and will use cognitive-behavioral strategies to help empower participants to cope with stressful and stigmatizing experiences. Intervention components may include minimizing self-stigmatizing attitudes, reducing engulfment, developing a sense of future and hope, and developing and pursuing meaningful life goals. This intervention is an adaptation of "Ending Self Stigma" (Lucksted et al., 2011).
Personalized Technology Detailing
Participants will be called by a technology-fluent study staff member, who will assess the current state of their technology literacy, access, and use. Detailing will focus on advancing the participant along the technology use cascade (using the internet, possessing a device and service to access internet at home, using the internet to access their electronic health record and pharmacy services, seeking HIV-related information, and finding social support). Each participant will be provided with personalized assistance based on their local and personal circumstances. Because of the individualized advice provided, there will be a range of contacts between 1 and 5, at customized intervals. Detailing protocols include the option of providing the participant with a tablet including cellular service (for 3 months) when in-home internet service is not available or is cost prohibitive.
Stigma Reduction
HIV Stigma Reduction
This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 6 consecutive weeks. The calls will last approximately 60-90 minutes and will include 5-8 individuals per group. This intervention is grounded in minority stress theory and will use cognitive-behavioral strategies to help empower participants to cope with stressful and stigmatizing experiences. Intervention components may include minimizing self-stigmatizing attitudes, reducing engulfment, developing a sense of future and hope, and developing and pursuing meaningful life goals. This intervention is an adaptation of "Ending Self Stigma" (Lucksted et al., 2011).
SBCM + Technology Detailing
Strengths-Based Case Management (SBCM)
The investigators have adapted an individually-tailored strengths-based case management (SBCM) intervention to help address the multiple structural barriers faced by rural older PLH. The adapted intervention, delivered by trained research staff, will include two 60-minute telephone-based SBCM counseling sessions with shorter follow-up phone calls to check-in on progress and help patients navigate identified barriers. The case manager will provide tailored sessions based on individually-identified needs and proximal life stressors. Capitalizing on participants' personal strengths, case managers will help empower participants to navigate issues related to employment, insurance, mental health, housing, or transportation. This may include assistance understanding, applying for, and accessing benefits or programs.
Personalized Technology Detailing
Participants will be called by a technology-fluent study staff member, who will assess the current state of their technology literacy, access, and use. Detailing will focus on advancing the participant along the technology use cascade (using the internet, possessing a device and service to access internet at home, using the internet to access their electronic health record and pharmacy services, seeking HIV-related information, and finding social support). Each participant will be provided with personalized assistance based on their local and personal circumstances. Because of the individualized advice provided, there will be a range of contacts between 1 and 5, at customized intervals. Detailing protocols include the option of providing the participant with a tablet including cellular service (for 3 months) when in-home internet service is not available or is cost prohibitive.
SBCM
Strengths-Based Case Management (SBCM)
The investigators have adapted an individually-tailored strengths-based case management (SBCM) intervention to help address the multiple structural barriers faced by rural older PLH. The adapted intervention, delivered by trained research staff, will include two 60-minute telephone-based SBCM counseling sessions with shorter follow-up phone calls to check-in on progress and help patients navigate identified barriers. The case manager will provide tailored sessions based on individually-identified needs and proximal life stressors. Capitalizing on participants' personal strengths, case managers will help empower participants to navigate issues related to employment, insurance, mental health, housing, or transportation. This may include assistance understanding, applying for, and accessing benefits or programs.
Technology Detailing
Personalized Technology Detailing
Participants will be called by a technology-fluent study staff member, who will assess the current state of their technology literacy, access, and use. Detailing will focus on advancing the participant along the technology use cascade (using the internet, possessing a device and service to access internet at home, using the internet to access their electronic health record and pharmacy services, seeking HIV-related information, and finding social support). Each participant will be provided with personalized assistance based on their local and personal circumstances. Because of the individualized advice provided, there will be a range of contacts between 1 and 5, at customized intervals. Detailing protocols include the option of providing the participant with a tablet including cellular service (for 3 months) when in-home internet service is not available or is cost prohibitive.
HIV Information Only
This arm will not receive any of the 4 intervention components but will receive information on successfully aging with HIV.
No interventions assigned to this group
Interventions
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Group-Based Social Support
This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 8 consecutive weeks. The calls will last approximately 90 minutes and will include 5-8 individuals per group. Groups will follow pre-determined topic areas, with participants encouraged to explore their feelings about the difficulties associated with normal aging, being HIV-positive, and living with HIV/AIDS as an older adult. Therapists will facilitate mutual support among group members, encourage greater openness and emotional expressiveness, and help participants to improve their social and family support and enhance their quality of life. This intervention is an adaptation of Telephone Supportive-Expressive Group Therapy (Heckman et al., 2013).
HIV Stigma Reduction
This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 6 consecutive weeks. The calls will last approximately 60-90 minutes and will include 5-8 individuals per group. This intervention is grounded in minority stress theory and will use cognitive-behavioral strategies to help empower participants to cope with stressful and stigmatizing experiences. Intervention components may include minimizing self-stigmatizing attitudes, reducing engulfment, developing a sense of future and hope, and developing and pursuing meaningful life goals. This intervention is an adaptation of "Ending Self Stigma" (Lucksted et al., 2011).
Strengths-Based Case Management (SBCM)
The investigators have adapted an individually-tailored strengths-based case management (SBCM) intervention to help address the multiple structural barriers faced by rural older PLH. The adapted intervention, delivered by trained research staff, will include two 60-minute telephone-based SBCM counseling sessions with shorter follow-up phone calls to check-in on progress and help patients navigate identified barriers. The case manager will provide tailored sessions based on individually-identified needs and proximal life stressors. Capitalizing on participants' personal strengths, case managers will help empower participants to navigate issues related to employment, insurance, mental health, housing, or transportation. This may include assistance understanding, applying for, and accessing benefits or programs.
Personalized Technology Detailing
Participants will be called by a technology-fluent study staff member, who will assess the current state of their technology literacy, access, and use. Detailing will focus on advancing the participant along the technology use cascade (using the internet, possessing a device and service to access internet at home, using the internet to access their electronic health record and pharmacy services, seeking HIV-related information, and finding social support). Each participant will be provided with personalized assistance based on their local and personal circumstances. Because of the individualized advice provided, there will be a range of contacts between 1 and 5, at customized intervals. Detailing protocols include the option of providing the participant with a tablet including cellular service (for 3 months) when in-home internet service is not available or is cost prohibitive.
Eligibility Criteria
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Inclusion Criteria
* Living in a zip code classified as a "Small and Isolated Small Rural Town" area by Rural-Urban Commuting Area Codes (RUCAs), and/or in a county classified as rural based on RUCAs, and/or in a county with a score of .4 or higher on the index of relative rurality (IRR)
* Living in Alabama, Arkansas, Georgia, Kentucky, Mississippi, Missouri, Oklahoma, South Carolina, or Tennessee
* Living with HIV
* Indicates willingness to participate in support groups
* Indicates willingness to self-collect a dried blood spot sample
* Has a telephone at home
* Able to provide informed consent
Exclusion Criteria
50 Years
ALL
No
Sponsors
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Medical College of Wisconsin
OTHER
Responsible Party
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Jennifer Walsh
Associate Professor
Principal Investigators
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Jennifer Walsh, PhD
Role: PRINCIPAL_INVESTIGATOR
Center for AIDS Intervention Research, Medical College of Wisconsin
Andrew Petroll, MD
Role: PRINCIPAL_INVESTIGATOR
Center for AIDS Intervention Research, Medical College of Wisconsin
Locations
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Center for AIDS Intervention Research, Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Wilson IB, Lee Y, Michaud J, Fowler FJ Jr, Rogers WH. Validation of a New Three-Item Self-Report Measure for Medication Adherence. AIDS Behav. 2016 Nov;20(11):2700-2708. doi: 10.1007/s10461-016-1406-x.
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
O'Connell KA, Skevington SM. An international quality of life instrument to assess wellbeing in adults who are HIV-positive: a short form of the WHOQOL-HIV (31 items). AIDS Behav. 2012 Feb;16(2):452-60. doi: 10.1007/s10461-010-9863-0.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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