NCT03483740: IN-HAND

Psychosocial Intervention for Older HIV+ Adults With HAND

Completed NA Results posted Last updated 29 March 2024

What this trial tests

NA trial testing CRGT in HIV/AIDS in 12 participants. Completed in 31 December 2019.

Timeline

6 August 2018

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	12
Start date	6 August 2018
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	3 locations across Canada

Drugs / interventions tested

• CRGT
• HIV group therapy

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →
• Aging — all drugs for Aging →
• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
• Group, Peer — all drugs for Group, Peer →

Sponsor

University Health Network, Toronto

Who can join

40 and older, any sex, with HIV/AIDS or Aging. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility - Session Attendance Primary · Three months

Number of Participants who Attended at least 80% of the Group Sessions.

Group	Value	95% CI
Cognitive Remediation Group Therapy	5
Mutual Aid Support Group	5

Acceptability - Participant Satisfaction With Group Sessions Primary · Three months

Participants will complete the Helping Characteristics of Self-Help and Support Groups Measure that will be complemented by questions about session length, number of sessions, activities used, and evaluation of facilitators. The Helping Characteristics of Self-Help and Support Group Measure contains 22 items that are scored on a 5-point-Likert style scale for a minimum score of 22 and a maximum score of 110. Higher scores indicate better outcome (outcome being satisfaction with support group). There are no subscales.

Group	Value	95% CI
Cognitive Remediation Group Therapy	90	74 – 100
Mutual Aid Support Group	85	58 – 100

Sponsor's own description

CTNPT 029 will test the feasibility and acceptability of cognitive remediation group therapy in older adults living with HIV who have been diagnosed with HIV-associated neurocognitive disorder (HAND). The cognitive remediation therapy will include tablet-based cognitive training and mindfulness-based stress reduction sessions.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. CNS Neurotoxicity of Antiretrovirals.
   Lanman T, Letendre S, Ma Q, Bang A, et al · · 2021 · cited 81× · PMID 31823251 · DOI 10.1007/s11481-019-09886-7
2. Mechanisms underlying HIV-associated cognitive impairment and emerging therapies for its management.
   Ellis RJ, Marquine MJ, Kaul M, Fields JA, et al · · 2023 · cited 66× · PMID 37816937 · DOI 10.1038/s41582-023-00879-y
3. Protocol for a pilot randomised controlled trial evaluating feasibility and acceptability of cognitive remediation group therapy compared with mutual aid group therapy for people ageing with HIV-associated neurocognitive disorder (HAND) in Toronto, Canada.
   Eaton AD, Walmsley SL, Craig SL, Rourke SB, et al · · 2019 · cited 5× · PMID 31676660 · DOI 10.1136/bmjopen-2019-033183
4. Cognitive remediation group therapy versus mutual aid group therapy: A pilot randomized, controlled trial to determine the feasibility and acceptability of group therapy for people aging with HIV facing cognitive challenges
   Eaton AD, Craig SL, Rourke SB, Sota T, et al · · 2020 · DOI 10.21203/rs.3.rs-21835/v1