Trial Outcomes & Findings for Depression and ART Adherence in HIV+ Latinos (NCT NCT01411839)

Last Updated: 2018-03-19

Results Overview

1. Clinician-administered ratings are scored on the MADRS. The MADRS is a 10-item, past 7-day clinician administered scripted rating scale of depressive symptoms (each of the ten items is scored from 0-6, with total scores ranging from 0 to 60). The areas are: apparent and reported sadness, inner tension, reduced sleep/appetite, concentration difficulties, lassitude, inability to feel, pessimistic and suicidal thoughts. Higher scores indicate the presence of more depressive symptoms. 2. Participant self-report ratings are scored on the BDI-1a. The BDI-1a is assessed at each time point using the revised Beck Depression Inventory-Ia (BDI-Ia), which consists of 21 items, each with a 4-point response scale anchored with descriptive statements. Scores can range from 0-63, and scores of 10 or higher are presumptive of mild depressive severity. The BDI scores presented were added up and higher scores indicate worse depression. The MADRS and BDI-Ia is scored a total units on the scale.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

MADRS and BDI-1a scores at 6 and 9-month follow-up

Results posted on

2018-03-19

Participant Flow

Data were collected in a two-stage process from 10/21/2009 - 8/31/2011 at a publicly-funded community health clinic in El Paso, TX, on the U.S.-Mexico border.

Eligible participants were randomly assigned to the intervention or treatment as usual (TAU) control condition, both enhanced with the notification letter to provider. An external statistician had used a computerized random number generator to select random permuted blocks of four.

Participant milestones

Participant milestones
Measure	Cognitive-Behavioral Therapy (CBT-AD) CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session. Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions	Control-Standard Care Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
Overall Study STARTED	20	20
Overall Study COMPLETED	16	17
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Cognitive-Behavioral Therapy (CBT-AD) CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session. Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions	Control-Standard Care Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
Overall Study Lost to Follow-up	4	3

Baseline Characteristics

Depression and ART Adherence in HIV+ Latinos

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive-Behavioral Therapy (CBT-AD) n=20 Participants CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session. Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions	Control-Standard Care n=20 Participants Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=93 Participants	20 Participants n=4 Participants	40 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	47.3 years STANDARD_DEVIATION 10.7 • n=93 Participants	44.8 years STANDARD_DEVIATION 10.7 • n=4 Participants	46 years STANDARD_DEVIATION 10.6 • n=27 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants
Sex: Female, Male Male	15 Participants n=93 Participants	14 Participants n=4 Participants	29 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=93 Participants	20 Participants n=4 Participants	40 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Beck Depression Inventory 1a	22 units on a scale STANDARD_DEVIATION 9.2 • n=93 Participants	16.8 units on a scale STANDARD_DEVIATION 6.3 • n=4 Participants	19.4 units on a scale STANDARD_DEVIATION 8.2 • n=27 Participants
Visual Analog Scale 30-day Adherence	84.4 Percent of doses taken STANDARD_DEVIATION 24.4 • n=93 Participants	90.6 Percent of doses taken STANDARD_DEVIATION 11.1 • n=4 Participants	87.2 Percent of doses taken STANDARD_DEVIATION 19.5 • n=27 Participants
Electronic Drug Adherence Monitoring	43.2 Percent Adherence STANDARD_DEVIATION 43.5 • n=93 Participants	55.6 Percent Adherence STANDARD_DEVIATION 47.6 • n=4 Participants	49.4 Percent Adherence STANDARD_DEVIATION 40.6 • n=27 Participants
Montgomery-Asberg Depression Rating Scale (MADRS)	25.1 units on a scale STANDARD_DEVIATION 9.7 • n=93 Participants	22.1 units on a scale STANDARD_DEVIATION 9.8 • n=4 Participants	23.6 units on a scale STANDARD_DEVIATION 9.7 • n=27 Participants

PRIMARY outcome

Timeframe: MADRS and BDI-1a scores at 6 and 9-month follow-up

Outcome measures

Outcome measures
Measure	Cognitive-Behavioral Therapy (CBT-AD) n=20 Participants CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session. Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions	Control-Standard Care n=20 Participants Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a MADRS at 6-month follow-up	17.8 Units on a scale Standard Deviation 12.2	19.2 Units on a scale Standard Deviation 11.2
Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a MADRS at 9-month follow-up	19.7 Units on a scale Standard Deviation 12.7	17.7 Units on a scale Standard Deviation 12.9
Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a BDI-1a at 6-month follow-up	15.0 Units on a scale Standard Deviation 7.4	11.8 Units on a scale Standard Deviation 7.0
Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a BDI-1a at 9-month follow-up	14.2 Units on a scale Standard Deviation 7.0	13.5 Units on a scale Standard Deviation 9.0

SECONDARY outcome

Timeframe: Self-reported adherence at 6 and 9-month follow-up

Self-reported adherence was assessed with the visual analog scale (VAS). The VAS is a 10cm line that is shown to patients who then mark on the line (from 0 to 100% in 1cm intervals) how much medication they have taken. Higher scores indicate better adherence.

Outcome measures

Outcome measures
Measure	Cognitive-Behavioral Therapy (CBT-AD) n=20 Participants CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session. Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions	Control-Standard Care n=20 Participants Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
Self-Report Adherence Self-report adherence at 6-month follow-up	92.6 Percent of all doses of medication taken Standard Deviation 9.4	86 Percent of all doses of medication taken Standard Deviation 14.7
Self-Report Adherence Self-report adherence at 9-month follow-up	93.5 Percent of all doses of medication taken Standard Deviation 9.0	91.9 Percent of all doses of medication taken Standard Deviation 7.7

SECONDARY outcome

Timeframe: 6 and 9 month follow-up adherence scores

The MedSignals electronic pill-box is a storage bin that allows participants to store medications. In the treatment condition, the pill-box provides audio commands to alarm participants that it is time to take their medication. The pill-box stores adherence data (time, number of openings). In the control condition, the pill-box does not alarm participants but serves in the same capacity otherwise. All data is uploaded electronically. Higher numbers indicate better adherence that correspond to pill-box openings corresponding to the designated time of taking their medication.

Outcome measures

Outcome measures
Measure	Cognitive-Behavioral Therapy (CBT-AD) n=20 Participants CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session. Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions	Control-Standard Care n=20 Participants Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
MedSignals Electronic Pill-box for Adherence Electronic Adherence at 6-month Follow-Up	45.8 Percent adherence Standard Deviation 47.8	28.8 Percent adherence Standard Deviation 31
MedSignals Electronic Pill-box for Adherence Electronic Adherence at 9-month Follow-Up	31.1 Percent adherence Standard Deviation 44.9	20.0 Percent adherence Standard Deviation 31.5

Adverse Events

Cognitive-Behavioral Therapy (CBT-AD)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control-Standard Care

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

Dr. John A. Sauceda

University of California, San Francisco

Phone: 415-460-6045

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place