Trial Outcomes & Findings for Pilot Testing of a Behavioral Intervention for Chronic Pain in Individuals With HIV (NCT NCT02824562)

NCT ID: NCT02824562

Last Updated: 2018-10-10

Results Overview

Participants are expected to attend 6 one-on-one sessions and 6 group sessions. Maximum sessions if all attended per participant would be 12 sessions.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 44 participants
• Primary outcome timeframe: From baseline throughout the entire 16 week intervention period
• Results posted on: 2018-10-10

Participant Flow

Participant milestones

Measure	Intervention The intervention group will receive treatment as usual plus a chronic pain self-management program which includes six one-on-one sessions facilitated by a trained interventionist and six group sessions facilitated by a trained interventionist and a peer. A peer is an HIV-infected patient living with chronic pain, who has completed all ten of the one-on-one sessions offered, received training to co-facilitate the six group sessions with the interventionist, and is successfully self-managing his/her chronic pain. Behavioral intervention for chronic pain in HIV	Control The control group will receive "treatment as usual". The "treatment as usual" or control group refers to the standard of care that patients receive for their chronic pain. This standard of care allows patients to discuss chronic pain with their providers at their discretion. Although highly variable, providers can recommend and prescribe pharmacologic (e.g., opioid and other pain medication), non-pharmacologic (e.g., physical therapy, referral to psychology) approaches for pain. This study will not interfere in any way with usual care. No additional treatment will be provided to participants allocated to the control group.
Overall Study STARTED	22	22
Overall Study COMPLETED	19	17
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Measure	Intervention The intervention group will receive treatment as usual plus a chronic pain self-management program which includes six one-on-one sessions facilitated by a trained interventionist and six group sessions facilitated by a trained interventionist and a peer. A peer is an HIV-infected patient living with chronic pain, who has completed all ten of the one-on-one sessions offered, received training to co-facilitate the six group sessions with the interventionist, and is successfully self-managing his/her chronic pain. Behavioral intervention for chronic pain in HIV	Control The control group will receive "treatment as usual". The "treatment as usual" or control group refers to the standard of care that patients receive for their chronic pain. This standard of care allows patients to discuss chronic pain with their providers at their discretion. Although highly variable, providers can recommend and prescribe pharmacologic (e.g., opioid and other pain medication), non-pharmacologic (e.g., physical therapy, referral to psychology) approaches for pain. This study will not interfere in any way with usual care. No additional treatment will be provided to participants allocated to the control group.
Overall Study Lost to Follow-up	3	4
Overall Study Death	0	1

Baseline Characteristics

Pilot Testing of a Behavioral Intervention for Chronic Pain in Individuals With HIV

Baseline characteristics by cohort

Measure	Intervention n=22 Participants The intervention group will receive treatment as usual plus a chronic pain self-management program which includes six one-on-one sessions facilitated by a trained interventionist and six group sessions facilitated by a trained interventionist and a peer. A peer is an HIV-infected patient living with chronic pain, who has completed all ten of the one-on-one sessions offered, received training to co-facilitate the six group sessions with the interventionist, and is successfully self-managing his/her chronic pain.	Control n=22 Participants The control group will receive "treatment as usual". The "treatment as usual" or control group refers to the standard of care that patients receive for their chronic pain. This standard of care allows patients to discuss chronic pain with their providers at their discretion. Although highly variable, providers can recommend and prescribe pharmacologic (e.g., opioid and other pain medication), non-pharmacologic (e.g., physical therapy, referral to psychology) approaches for pain. This study will not interfere in any way with usual care. No additional treatment will be provided to participants allocated to the control group.	Total n=44 Participants Total of all reporting groups
Age, Continuous	51 years n=5 Participants	51 years n=7 Participants	51 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Number of participants with undetectable viral load (blood test, measured in copies/mL)	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline throughout the entire 16 week intervention period

Population: All 22 participants were assessed.

Participants are expected to attend 6 one-on-one sessions and 6 group sessions. Maximum sessions if all attended per participant would be 12 sessions.

Outcome measures

Measure	Intervention n=22 Participants The intervention group will receive treatment as usual plus a chronic pain self-management program which includes six one-on-one sessions facilitated by a trained interventionist and six group sessions facilitated by a trained interventionist and a peer. A peer is an HIV-infected patient living with chronic pain, who has completed all ten of the one-on-one sessions offered, received training to co-facilitate the six group sessions with the interventionist, and is successfully self-managing his/her chronic pain. Behavioral intervention for chronic pain in HIV	Control The control group will receive "treatment as usual". The "treatment as usual" or control group refers to the standard of care that patients receive for their chronic pain. This standard of care allows patients to discuss chronic pain with their providers at their discretion. Although highly variable, providers can recommend and prescribe pharmacologic (e.g., opioid and other pain medication), non-pharmacologic (e.g., physical therapy, referral to psychology) approaches for pain. This study will not interfere in any way with usual care. No additional treatment will be provided to participants allocated to the control group.
Intervention Feasibility: Median Number of Study Intervention Sessions Attended by Participants	9 Study Sessions Interval 8.0 to 11.0	—

SECONDARY outcome

Timeframe: From the conclusion of the intervention through 30 days (Intervention Group). From the last group session through 30 days (Control Group).

Population: All 22 participants in each arm were analyzed.

Outcome assessments are administered to participants by study staff.

Outcome measures

Measure	Intervention n=22 Participants The intervention group will receive treatment as usual plus a chronic pain self-management program which includes six one-on-one sessions facilitated by a trained interventionist and six group sessions facilitated by a trained interventionist and a peer. A peer is an HIV-infected patient living with chronic pain, who has completed all ten of the one-on-one sessions offered, received training to co-facilitate the six group sessions with the interventionist, and is successfully self-managing his/her chronic pain. Behavioral intervention for chronic pain in HIV	Control n=22 Participants The control group will receive "treatment as usual". The "treatment as usual" or control group refers to the standard of care that patients receive for their chronic pain. This standard of care allows patients to discuss chronic pain with their providers at their discretion. Although highly variable, providers can recommend and prescribe pharmacologic (e.g., opioid and other pain medication), non-pharmacologic (e.g., physical therapy, referral to psychology) approaches for pain. This study will not interfere in any way with usual care. No additional treatment will be provided to participants allocated to the control group.
Outcome Assessment Feasibility: Number (Percentage) of Participants Who Complete Outcome Assessments Within One Month Completed outcome assessment	19 Participants	17 Participants
Outcome Assessment Feasibility: Number (Percentage) of Participants Who Complete Outcome Assessments Within One Month Did not complete outcome assessment	3 Participants	5 Participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jessica Merlin

UAB

Phone: 2059967894

Email: jmerlin@uabmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place