Trial Outcomes & Findings for Skills Based Counseling for Adherence and Depression in HIV+ Methadone Patients - 1 (NCT NCT00218634)

NCT ID: NCT00218634

Last Updated: 2018-01-02

Results Overview

Post-treatment assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

89 participants

Primary outcome timeframe

3-month assessment

Results posted on

2018-01-02

Participant Flow

First participants from methadone clinics, remainder from MGH or RIH clinics.

Participants had to screen for study inclusion/exclusion criteria before randomization.

Participant milestones

Participant milestones
Measure	CBT-AD Cognitive behavioral therapy for adherence and depression	ETAU Enhanced Treatment as Usual
Overall Study STARTED	44	45
Overall Study COMPLETED	36	30
Overall Study NOT COMPLETED	8	15

Reasons for withdrawal

Reasons for withdrawal
Measure	CBT-AD Cognitive behavioral therapy for adherence and depression	ETAU Enhanced Treatment as Usual
Overall Study Lost to Follow-up	8	15

Baseline Characteristics

Skills Based Counseling for Adherence and Depression in HIV+ Methadone Patients - 1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CBT-AD n=44 Participants Cognitive behavioral therapy for adherence and depression	ETAU n=45 Participants Enhanced Treatment as Usual	Total n=89 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants	45 Participants n=7 Participants	89 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	47.05 years STANDARD_DEVIATION 7.34 • n=5 Participants	46.67 years STANDARD_DEVIATION 7.05 • n=7 Participants	46.85 years STANDARD_DEVIATION 7.15 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants	45 participants n=7 Participants	89 participants n=5 Participants

PRIMARY outcome

Timeframe: 3-month assessment

Population: We used hierarchical linear modeling (HLM) methods and intent to treat for all randomized participants.

Post-treatment assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.

Outcome measures

Outcome measures
Measure	CBT-AD n=44 Participants Cognitive behavioral therapy for adherence and depression	ETAU n=45 Participants Enhanced treatment as usual
Percent Medication Adherence at 3-month Follow-up Assessment	79.02 percent (doses taken/doses prescribed) Standard Deviation 23.23	73.66 percent (doses taken/doses prescribed) Standard Deviation 25.15

PRIMARY outcome

Timeframe: 12-month follow-up assessment

Population: We used intent to treat for all data analysis.

Follow-up assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.

Outcome measures

Outcome measures
Measure	CBT-AD n=44 Participants Cognitive behavioral therapy for adherence and depression	ETAU n=45 Participants Enhanced treatment as usual
Percent Medication Adherence at 12-month Follow-up Assessment	64.49 percent (doses taken/doses prescribed) Standard Deviation 31.34	61.11 percent (doses taken/doses prescribed) Standard Deviation 34.94

SECONDARY outcome

Timeframe: 3 month follow-up

Population: We used intent to treat for all data analysis.

Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression.

Outcome measures

Outcome measures
Measure	CBT-AD n=44 Participants Cognitive behavioral therapy for adherence and depression	ETAU n=45 Participants Enhanced treatment as usual
Clinician-assessed Depression Rating at 3 Month Follow-up Assessment	17.02 Units on scale Standard Deviation 10.62	22.7 Units on scale Standard Deviation 10.19

SECONDARY outcome

Timeframe: 12-month follow-up assessment

Population: We used intent to treat for all data analysis.

HIV plasma RNA (log HIV viral load)at the 12-month follow-up assessment.

Outcome measures

Outcome measures
Measure	CBT-AD n=44 Participants Cognitive behavioral therapy for adherence and depression	ETAU n=45 Participants Enhanced treatment as usual
HIV Viral Load at 12-month Follow-up Assessment	2.203 log10 copies/mL Standard Deviation 0.687	2.177 log10 copies/mL Standard Deviation 0.820

SECONDARY outcome

Timeframe: 12-month follow-up assessment

Population: We used intent to treat for all data analysis.

CD4+ lymphocyte cell count at 12-month follow-up assessment.

Outcome measures

Outcome measures
Measure	CBT-AD n=44 Participants Cognitive behavioral therapy for adherence and depression	ETAU n=45 Participants Enhanced treatment as usual
CD4+ Lymphocyte Count at 12-month Follow-up Assessment.	452.94 cells/mm^3 Standard Deviation 235.00	502.33 cells/mm^3 Standard Deviation 314.19

SECONDARY outcome

Timeframe: 12-month follow-up assessment

Population: We used intent to treat for all data analysis.

Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression.

Outcome measures

Outcome measures
Measure	CBT-AD n=44 Participants Cognitive behavioral therapy for adherence and depression	ETAU n=45 Participants Enhanced treatment as usual
Clinician-assessed Depression at 12-month Follow-up Assessment	15.28 Units on scale Standard Deviation 9.22	20.00 Units on scale Standard Deviation 10.97

SECONDARY outcome

Timeframe: 3-month assessment

Population: We used intent to treat for all data analysis.

HIV plasma RNA (log HIV viral load)at the 3-month follow-up assessment.

Outcome measures

Outcome measures
Measure	CBT-AD n=44 Participants Cognitive behavioral therapy for adherence and depression	ETAU n=45 Participants Enhanced treatment as usual
HIV Viral Load at 3-month Follow-up Assessment	2.349 log10 copies/mL" Standard Deviation 0.928	2.044 log10 copies/mL" Standard Deviation 0.509

SECONDARY outcome

Timeframe: 3-month assessment

Population: We used intent to treat for all analysis.

CD4+ lymphocyte cell count at 3-month follow-up assessment.

Outcome measures

Outcome measures
Measure	CBT-AD n=44 Participants Cognitive behavioral therapy for adherence and depression	ETAU n=45 Participants Enhanced treatment as usual
CD4+ Lymphocyte Count at 3-month Follow-up Assessment.	380.97 cells/mm3 Standard Deviation 266.62	539.29 cells/mm3 Standard Deviation 293.61

Adverse Events

CBT-AD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ETAU

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven Safren

Mass General Hospital

Phone: 617 724 0817

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place