Adapting the "Do More, Feel Better" Intervention for Older People Living With HIV
NCT07915934, Not applicable, Not yet recruiting, University of Washington
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Adapting the "Do More, Feel Better" Intervention for Older People Living With HIV | ClinicalTrials.gov |
| NCT number | NCT07915934 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 48 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Washington | ClinicalTrials.gov |
| Conditions | Depression, HIV | ClinicalTrials.gov |
| Interventions | "Do More, Feel Better" for Older People with HIV | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Acceptability of Intervention Measure (AIM) | week 3 and 9 | 4-item scale with response options ranging from 1-5 per item, with a summed scale score ranging from 4-20 and mean scale score ranging from 1-5. Higher scores indicate greater acceptability of the intervention. | ClinicalTrials.gov |
| Primary | Intervention Appropriateness Measure (IAM) | week 3 and 9 | 4-item scale with response options ranging from 1-5 per item, with a summed scale score ranging from 4-20 and mean scale score ranging from 1-5. Higher scores indicate greater perceived appropriateness of the intervention. | ClinicalTrials.gov |
| Primary | Feasibility of Intervention Measure (FIM) | week 3 and 9 | 4-item scale with response options ranging from 1-5 per item, with a summed scale score ranging from 4-20 and mean scale score ranging from 1-5. Higher scores indicate greater perceived feasibility of the intervention. | ClinicalTrials.gov |
| Primary | Session attendance | week 9 | Session attendance will be calculated as the proportion of intervention sessions attended out of nine possible sessions. | ClinicalTrials.gov |
| Primary | Exit interview | week 9 | Qualitative feedback on the adapted DMFB intervention and clinician-delivered BA therapy will be collected in exit interviews with a sample of participants from each arm | ClinicalTrials.gov |
| Secondary | Hamilton Rating Scale for Depression (Ham-D) | Baseline, week 3, week 6, week 9, week 12 | The Ham-D 24-item scale is a semi-structured clinical interview that assesses depression severity. Scores range from 0 to 76, with higher scores indicating greater depressive-symptom severity. Scores 0-7 represent transient to no depressive symptoms; 8-13 mild depression; 14-18 moderate depression; 19-22 severe depression and above 22 very severe depression. | ClinicalTrials.gov |
| Secondary | Behavioral activation for depression scale (BADS) | Baseline, week 3, week 6, week 9, week 12 | The BADS is a 25-item scale assessing overall activity level based on four factors: activation, avoidance/rumination, work/school impairment and social impairment. Each item ranges from 0 ('not at all') to 6 ('completely'); total scores range from 0 to 150. Higher total scores indicate better behavioral activation and fewer depressive-avoidance behaviors. | ClinicalTrials.gov |
| Secondary | Three-item self-report measure for medication adherence | Baseline, week 9, week 12 | Wilson's three-item self-report measure for medication adherence assesses missed days during the past 30 days, frequency of taking medication as prescribed, and the person's rating of how well they took it. Scores range from 0-100 for the raw summary score, calculated as the mean of the three item scores. Higher scores indicate better medication adherence. | ClinicalTrials.gov |
| Secondary | Index of engagement in HIV care | Baseline, week 9, week 12 | The CFAR Network of Integrated Clinical Systems 10-item index of engagement in HIV care includes 10 items rated on a 5-point Likert scale. The range of summed scores is from 10-50 and mean scores range from 1-5. Higher scores indicate better HIV care engagement. | ClinicalTrials.gov |
| Secondary | HIV-1 RNA viral load | Baseline, week 12 | Dried blood spots will be collected for viral load testing through the University of Washington Department of Laboratory Medicine. Any viral load \<200 copies/mL will be considered suppressed. | ClinicalTrials.gov |
| Secondary | Date of last clinic visit | Baseline, week 24 | Provider-reported date of last clinic visit, obtained for participants who grant permission for release of this information. | ClinicalTrials.gov |
| Secondary | Most recent viral load | Baseline, week 24 | Provider-reported most recent viral load, obtained for participants who grant permission for release of this information. | ClinicalTrials.gov |
| Secondary | Most recent CD4 count | Baseline, week 24 | Provider-reported most recent CD4 count, obtained for participants who grant permission for release of this information. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R34MH143573 | Adapting the "Do More, Feel Better" intervention for older people living with HIV | Graham, Susan Marie | UNIVERSITY OF WASHINGTON | NATIONAL INSTITUTE OF MENTAL HEALTH | 2026 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)