Trial Outcomes & Findings for Multi-Component Intervention to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV (NCT NCT04549259)

Results Overview

Proportion of participants with HIV viral load ≥832 copies/mL, as measured through use of HemaSpot dried blood spot (DBS) testing. At baseline and follow-up, participants were sent dried blood spot (DBS) kits by mail to complete self-collection of blood samples for HIV viral load testing. Following specimen collection, participants placed the filled HemaSpot container into the shipping envelope, which sent the specimen directly to the clinical laboratory for testing. HemaSpot devices with sufficient blood volume were tested using Abbott m2000 RealTime HIV-1 dried blood spot (DBS) quantitative assay, with 832 copies/mL limit of detection. DBS viral load results were classified in three categories: 1. Detected and quantifiable at ≥832 copies/mL; 2. Detected and non-quantifiable, estimated between \<832 and \>300 copies/mL; and 3. Not detected, estimated to be \<300 copies/mL.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

61 participants

Primary outcome timeframe

3 months following enrollment/baseline survey

Results posted on

2023-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	Social Support + Stigma Reduction + SBCM + Tech Detailing Group-Based Social Support Intervention + Group-Based HIV Stigma Reduction Intervention + Individual Strengths-Based Case Management Intervention + Individual Personalized Technology Detailing Intervention	Social Support + Stigma Reduction + SBCM Group-Based Social Support Intervention + Group-Based HIV Stigma Reduction Intervention + Individual Strengths-Based Case Management Intervention	Social Support + Stigma Reduction + Technology Detailing Group-Based Social Support Intervention + Group-Based HIV Stigma Reduction Intervention + Individual Personalized Technology Detailing Intervention	Social Support + Stigma Reduction Group-Based Social Support Intervention + Group-Based HIV Stigma Reduction Intervention	Social Support + SBCM + Technology Detailing Group-Based Social Support Intervention + Individual Strengths-Based Case Management Intervention + Individual Personalized Technology Detailing Intervention	Social Support + SBCM Group-Based Social Support Intervention + Individual Strengths-Based Case Management Intervention	Social Support + Technology Detailing Group-Based Social Support Intervention + Individual Personalized Technology Detailing Intervention	Social Support Group-Based Social Support Intervention	Stigma Reduction + SBCM + Technology Detailing Group-Based HIV Stigma Reduction Intervention + Individual Strengths-Based Case Management Intervention + Individual Personalized Technology Detailing Intervention	Stigma Reduction + SBCM Group-Based HIV Stigma Reduction Intervention + Individual Strengths-Based Case Management Intervention	Stigma Reduction + Technology Detailing Group-Based HIV Stigma Reduction Intervention + Individual Personalized Technology Detailing Intervention	Stigma Reduction Group-Based HIV Stigma Reduction Intervention	SBCM + Technology Detailing Individual Strengths-Based Case Management Intervention + Individual Personalized Technology Detailing Intervention	SBCM Individual Strengths-Based Case Management Intervention	Technology Detailing Individual Personalized Technology Detailing Intervention	HIV Information Only This arm will not receive any of the 4 intervention components but will receive information on successfully aging with HIV.
Overall Study STARTED	4	4	3	3	4	4	4	4	4	3	4	4	4	4	4	4
Overall Study COMPLETED	4	4	3	2	4	2	3	2	3	3	4	3	3	3	4	4
Overall Study NOT COMPLETED	0	0	0	1	0	2	1	2	1	0	0	1	1	1	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multi-Component Intervention to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Social Support + Stigma Reduction + SBCM + Tech Detailing n=4 Participants Group-Based Social Support Intervention + Group-Based HIV Stigma Reduction Intervention + Individual Strengths-Based Case Management Intervention + Individual Personalized Technology Detailing Intervention	Social Support + Stigma Reduction + SBCM n=4 Participants Group-Based Social Support Intervention + Group-Based HIV Stigma Reduction Intervention + Individual Strengths-Based Case Management Intervention	Social Support + Stigma Reduction + Technology Detailing n=3 Participants Group-Based Social Support Intervention + Group-Based HIV Stigma Reduction Intervention + Individual Personalized Technology Detailing Intervention	Social Support + Stigma Reduction n=3 Participants Group-Based Social Support Intervention + Group-Based HIV Stigma Reduction Intervention	Social Support + SBCM + Technology Detailing n=4 Participants Group-Based Social Support Intervention + Individual Strengths-Based Case Management Intervention + Individual Personalized Technology Detailing Intervention	Social Support + SBCM n=4 Participants Group-Based Social Support Intervention + Individual Strengths-Based Case Management Intervention	Social Support + Technology Detailing n=4 Participants Group-Based Social Support Intervention + Individual Personalized Technology Detailing Intervention	Social Support n=4 Participants Group-Based Social Support Intervention	Stigma Reduction + SBCM + Technology Detailing n=4 Participants Group-Based HIV Stigma Reduction Intervention + Individual Strengths-Based Case Management Intervention + Individual Personalized Technology Detailing Intervention	Stigma Reduction + SBCM n=3 Participants Group-Based HIV Stigma Reduction Intervention + Individual Strengths-Based Case Management Intervention	Stigma Reduction + Technology Detailing n=4 Participants Group-Based HIV Stigma Reduction Intervention + Individual Personalized Technology Detailing Intervention	Stigma Reduction n=4 Participants Group-Based HIV Stigma Reduction Intervention	SBCM + Technology Detailing n=4 Participants Individual Strengths-Based Case Management Intervention + Individual Personalized Technology Detailing Intervention	SBCM n=4 Participants Individual Strengths-Based Case Management Intervention	Technology Detailing n=4 Participants Individual Personalized Technology Detailing Intervention	HIV Information Only n=4 Participants This arm will not receive any of the 4 intervention components but will receive information on successfully aging with HIV.	Total n=61 Participants Total of all reporting groups
Age, Continuous	53 years n=5 Participants	59 years n=7 Participants	55 years n=5 Participants	52 years n=4 Participants	54.5 years n=21 Participants	54 years n=10 Participants	59.5 years n=115 Participants	61 years n=6 Participants	55 years n=6 Participants	62 years n=64 Participants	61 years n=17 Participants	62 years n=21 Participants	61 years n=22 Participants	58.5 years n=8 Participants	54 years n=16 Participants	55 years n=135 Participants	57 years n=136 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=64 Participants	1 Participants n=17 Participants	1 Participants n=21 Participants	0 Participants n=22 Participants	1 Participants n=8 Participants	2 Participants n=16 Participants	1 Participants n=135 Participants	15 Participants n=136 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=10 Participants	3 Participants n=115 Participants	3 Participants n=6 Participants	3 Participants n=6 Participants	3 Participants n=64 Participants	3 Participants n=17 Participants	3 Participants n=21 Participants	4 Participants n=22 Participants	3 Participants n=8 Participants	2 Participants n=16 Participants	3 Participants n=135 Participants	46 Participants n=136 Participants
Race/Ethnicity, Customized Race/Ethnicity · White, Non-Hispanic	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=10 Participants	4 Participants n=115 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	2 Participants n=64 Participants	3 Participants n=17 Participants	2 Participants n=21 Participants	4 Participants n=22 Participants	2 Participants n=8 Participants	2 Participants n=16 Participants	4 Participants n=135 Participants	39 Participants n=136 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black or African American or Caribbean, Non-Hispanic	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=6 Participants	3 Participants n=6 Participants	1 Participants n=64 Participants	1 Participants n=17 Participants	1 Participants n=21 Participants	0 Participants n=22 Participants	2 Participants n=8 Participants	2 Participants n=16 Participants	0 Participants n=135 Participants	19 Participants n=136 Participants
Race/Ethnicity, Customized Race/Ethnicity · Latino/Hispanic, Any Race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	1 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants	0 Participants n=135 Participants	3 Participants n=136 Participants

PRIMARY outcome

Timeframe: 3 months following enrollment/baseline survey

Population: Analysis included all participants with follow-up HemaSpot DBS data (N = 49). Participants were included in outcome analyses in assigned arm regardless of intervention participation/attendance.

Proportion of participants with HIV viral load ≥832 copies/mL, as measured through use of HemaSpot dried blood spot (DBS) testing. At baseline and follow-up, participants were sent dried blood spot (DBS) kits by mail to complete self-collection of blood samples for HIV viral load testing. Following specimen collection, participants placed the filled HemaSpot container into the shipping envelope, which sent the specimen directly to the clinical laboratory for testing. HemaSpot devices with sufficient blood volume were tested using Abbott m2000 RealTime HIV-1 dried blood spot (DBS) quantitative assay, with 832 copies/mL limit of detection. DBS viral load results were classified in three categories: 1. Detected and quantifiable at ≥832 copies/mL; 2. Detected and non-quantifiable, estimated between \<832 and \>300 copies/mL; and 3. Not detected, estimated to be \<300 copies/mL.

Outcome measures

Outcome measures
Measure	Social Support Intervention: Yes n=22 Participants Those randomized to group-based social support intervention.	Social Support Intervention: No n=27 Participants Those not randomized to group-based social support intervention.	Stigma Reduction Intervention: Yes n=24 Participants Those randomized to group-based stigma reduction intervention.	Stigma Reduction Intervention: No n=25 Participants Those not randomized to group-based stigma reduction intervention.	Strengths-Based Case Management Intervention: Yes n=24 Participants Those randomized to individual strengths-based case management intervention.	Strengths-Based Case Management Intervention: No n=25 Participants Those not randomized to individual strengths-based case management intervention.	Technology Detailing Intervention: Yes n=27 Participants Those randomized to individual personalized technology detailing intervention.	Technology Detailing Intervention: No n=22 Participants Those not randomized to individual personalized technology detailing intervention.
Proportion of Participants With HIV Viral Load ≥832 Copies/mL (HemaSpot DBS)	5 Participants	7 Participants	8 Participants	4 Participants	6 Participants	6 Participants	8 Participants	4 Participants

PRIMARY outcome

Timeframe: 3 months following enrollment/baseline survey

Population: Analysis included all participants with follow-up survey data (N = 51). Participants were included in outcome analyses in assigned arm regardless of intervention participation/attendance.

Based on full scale scores from the 31-item WHOQOL-HIV BREF (O'Connell \& Skevington, 2012), with scores ranging from 0 to 100. Higher scores indicate higher (better) quality of life. Quality of life was assessed with 31 items from the WHOQOL-HIV BREF (O'Connell \& Skevington, 2012). Domains assessed include physical health; psychological health; level of independence; social relationships; environmental health; and personal beliefs. Additionally, two individual items focus on overall quality of life and general health. Domain scores were created as described by the WHO, and we created a composite quality of life score by equally weighting the 6 domains, overall quality of life item, and general health item. The composite score was rescaled such that overall scores ranged from 0 to 100, with higher scores indicating better health-related quality of life.

Outcome measures

Outcome measures
Measure	Social Support Intervention: Yes n=24 Participants Those randomized to group-based social support intervention.	Social Support Intervention: No n=27 Participants Those not randomized to group-based social support intervention.	Stigma Reduction Intervention: Yes n=26 Participants Those randomized to group-based stigma reduction intervention.	Stigma Reduction Intervention: No n=25 Participants Those not randomized to group-based stigma reduction intervention.	Strengths-Based Case Management Intervention: Yes n=26 Participants Those randomized to individual strengths-based case management intervention.	Strengths-Based Case Management Intervention: No n=25 Participants Those not randomized to individual strengths-based case management intervention.	Technology Detailing Intervention: Yes n=28 Participants Those randomized to individual personalized technology detailing intervention.	Technology Detailing Intervention: No n=23 Participants Those not randomized to individual personalized technology detailing intervention.
Health-Related Quality of Life	68.54 score on a scale Standard Deviation 15.37	64.97 score on a scale Standard Deviation 15.32	65.83 score on a scale Standard Deviation 13.96	67.51 score on a scale Standard Deviation 16.82	66.50 score on a scale Standard Deviation 16.75	66.81 score on a scale Standard Deviation 13.96	68.01 score on a scale Standard Deviation 15.64	65.00 score on a scale Standard Deviation 15.04

SECONDARY outcome

Timeframe: 3 months following enrollment/baseline survey

Population: Analysis included all participants with follow-up survey data (N = 51). Participants were included in outcome analyses in assigned arm regardless of intervention participation/attendance.

Adherence to HIV antiretroviral medications in the past 30 days was assessed with the 3 items from the Wilson adherence scale (Wilson et al., 2017; αs = .71-.79). This scale was scored in line with Wilson et al., with scores ranging from 0 to 100 and higher scores indicating better adherence. Due to significant skew in this outcome, we created a binary variable indicating perfect adherence to HIV medications.

Outcome measures

Outcome measures
Measure	Social Support Intervention: Yes n=24 Participants Those randomized to group-based social support intervention.	Social Support Intervention: No n=27 Participants Those not randomized to group-based social support intervention.	Stigma Reduction Intervention: Yes n=26 Participants Those randomized to group-based stigma reduction intervention.	Stigma Reduction Intervention: No n=25 Participants Those not randomized to group-based stigma reduction intervention.	Strengths-Based Case Management Intervention: Yes n=26 Participants Those randomized to individual strengths-based case management intervention.	Strengths-Based Case Management Intervention: No n=25 Participants Those not randomized to individual strengths-based case management intervention.	Technology Detailing Intervention: Yes n=28 Participants Those randomized to individual personalized technology detailing intervention.	Technology Detailing Intervention: No n=23 Participants Those not randomized to individual personalized technology detailing intervention.
Medication Adherence	13 Participants	14 Participants	13 Participants	14 Participants	14 Participants	13 Participants	14 Participants	13 Participants

SECONDARY outcome

Timeframe: 3 months following enrollment/baseline survey

Population: Analysis included all participants with follow-up survey data (N = 51). Participants were included in outcome analyses in assigned arm regardless of intervention participation/attendance.

Depressive symptoms during the past 2 weeks were assessed with the 9 items from the Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001; αs = .87-.90). Participants indicated how often they had experienced different depressive symptoms (e.g., "Feeling down, depressed, or hopeless"). Responses ranged from not at all (0) to nearly every day (3). Items were summed to yield scores ranging from 0 to 27, with higher scores indicating more depressive symptoms.

Outcome measures

Outcome measures
Measure	Social Support Intervention: Yes n=24 Participants Those randomized to group-based social support intervention.	Social Support Intervention: No n=27 Participants Those not randomized to group-based social support intervention.	Stigma Reduction Intervention: Yes n=26 Participants Those randomized to group-based stigma reduction intervention.	Stigma Reduction Intervention: No n=25 Participants Those not randomized to group-based stigma reduction intervention.	Strengths-Based Case Management Intervention: Yes n=26 Participants Those randomized to individual strengths-based case management intervention.	Strengths-Based Case Management Intervention: No n=25 Participants Those not randomized to individual strengths-based case management intervention.	Technology Detailing Intervention: Yes n=28 Participants Those randomized to individual personalized technology detailing intervention.	Technology Detailing Intervention: No n=23 Participants Those not randomized to individual personalized technology detailing intervention.
Depressive Symptoms	6.84 score on a scale Standard Deviation 6.62	9.33 score on a scale Standard Deviation 6.74	8.47 score on a scale Standard Deviation 6.59	7.84 score on a scale Standard Deviation 7.00	8.08 score on a scale Standard Deviation 7.32	8.25 score on a scale Standard Deviation 6.22	7.50 score on a scale Standard Deviation 7.43	8.96 score on a scale Standard Deviation 5.84

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jennifer Walsh and Dr. Andrew Petroll

Center for AIDS Intervention Research, Medical College of Wisconsin

Phone: 414-955-7710

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place