Evidence map›Paper›PMID 27658881›Full record

Trial reportThe lancet. HIV2016

Cognitive behavioural therapy for adherence and depression in patients with HIV: a three-arm randomised controlled trial.

Steven A Safren, C Andres Bedoya, Conall O'Cleirigh, Katie B Biello, Megan M Pinkston, Michael D Stein, Lara Traeger, Erna Kojic, Gregory K Robbins, Jonathan A Lerner and 3 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The lancet. HIV, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07032363 (Implementing Depression and Adherence Treatment in South Africa HIV Care), which is not on this map. Cited by 96 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
96citing papers in PubMed, 6 pooled it
8.9field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07032363 narecruitingnot on this mapstarted 2026, after this paper: background citation

Implementing Depression and Adherence Treatment in South Africa HIV Care

TypeinterventionalSponsorUniversity of MiamiRan2026 to 2030Enrolled10ConditionsDepression, HIV, Adherence, Treatment, AIDSArmsCore Implementation Strategies, Enhanced Implementation Strategies
3 · Its place in the literature

Who cites it

96 citing papers in PubMed, 6 syntheses or guidelines pooled it, 153 citations in OpenAlex.

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36 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 1 country.

Steven A SafrenDepartment of Psychology, University of Miami, Miami, FL, USA; Behavioral Medicine, Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA; The Fenway Institute at Fenway Health, Boston, MA, USA. Electronic address: ssafren@miami.edu.
C Andres BedoyaBehavioral Medicine, Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.
Conall O'CleirighBehavioral Medicine, Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA; The Fenway Institute at Fenway Health, Boston, MA, USA.
Katie B BielloThe Fenway Institute at Fenway Health, Boston, MA, USA; Department of Behavioral & Social Health Sciences and Epidemiology, School of Public Health, Brown University, Providence, RI, USA; Department of Psychiatry & Human Behavior, Alpert Medical School, Brown University, Providence, RI, USA; Institute for Community Health Promotion, Brown University, Providence, RI, USA.
Megan M PinkstonImmunology and Infectious Diseases, Brown University, Providence, RI, USA; The Miriam Hospital, Providence, RI, USA.
Michael D SteinDepartment of Health Law, Policy & Management, Boston University School of Public Health, Boston, MA, USA.
Lara TraegerBehavioral Medicine, Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.
Erna KojicThe Miriam Hospital, Providence, RI, USA.
Gregory K RobbinsDivision of Infectious Diseases, Massachusetts General Hospital, Boston, MA, USA; Department of Medicine, Harvard Medical School, Boston, MA, USA.
Jonathan A LernerBehavioral Medicine, Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.
Debra S HermanDepartment of Psychiatry and Human Behavior, Butler Hospital, Providence, RI, USA.
Matthew J MimiagaThe Fenway Institute at Fenway Health, Boston, MA, USA; Department of Behavioral & Social Health Sciences and Epidemiology, School of Public Health, Brown University, Providence, RI, USA; Department of Psychiatry & Human Behavior, Alpert Medical School, Brown University, Providence, RI, USA; Institute for Community Health Promotion, Brown University, Providence, RI, USA; Department of Epidemiology, T H Chan Harvard School of Public Health, Boston, MA, USA.
Kenneth H MayerDepartment of Medicine, Harvard Medical School, Boston, MA, USA; The Fenway Institute at Fenway Health, Boston, MA, USA; Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Harvard University · USFenway Health · USBeth Israel Deaconess Medical Center · USBoston University · USBrown University · USButler Hospital · USInstitute for Community Health · USMassachusetts General Hospital · USMiriam Hospital · US

Funding

The impact of HIV viral diversity and cellular immunity on HIV pathogenesisP30AI060354 · NIAID · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI RAJESH T GANDHI · 2004 to 2026
$94.4M
Translational ScienceP30AI042853 · NIAID · MIRIAM HOSPITAL · PI CURT G BECKWITH · 1998 to 2026
$51.7M
University of Miami Developmental Center for AIDS Research (D-CFAR)P30AI073961 · NIAID · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI GWENDOLYN Barbara SCOTT · 2007 to 2026
$33.8M
Efficacy of CBT for Adherence and Depression in HIV Care SettingsR01MH084757 · NIMH · MASSACHUSETTS GENERAL HOSPITAL · PI SAFREN, STEVEN A · 2008 to 2012
$4.8M
NIAID NIH HHS P30 AI042853NIAID NIH HHS P30 AI060354NIAID NIH HHS P30 AI073961NIMH NIH HHS R01 MH084757
6 · The paper itself

Abstract

backgroundDepression is highly prevalent in people with HIV and has consistently been associated with poor antiretroviral therapy (ART) adherence. Integrating cognitive behavioural therapy (CBT) for depression with adherence counselling using the Life-Steps approach (CBT-AD) has an emerging evidence base. The aim of this study was to test the efficacy of CBT-AD.

methodsIn this three-arm randomised controlled trial in HIV-positive adults with depression, we compared CBT-AD with information and supportive psychotherapy plus adherence counselling using the Life-Steps approach (ISP-AD), and with enhanced treatment as usual (ETAU) including Life-Steps adherence counselling only. Participants were recruited from three sites in New England, USA (two hospital settings and one community health centre). Patients were randomly assigned (2:2:1) to receive CBT-AD (one Life-Steps session plus 11 weekly integrated sessions lasting up to 1 h each), ISP-AD (one Life-Steps session plus 11 weekly integrated sessions lasting up to 1 h each), or ETAU (one Life-Steps session and five assessment visits roughly every 2 weeks), randomisation was done with allocation software, in pairs, and stratified by three variables: study site, whether or not participants had been prescribed antidepressant medication, and whether or not participants had a history of injection drug use. The primary outcome was ART adherence at the end of treatment (4 month assessment) assessed via electronic pill caps (Medication Event Monitoring System [MEMS]) with correction for pocketed doses, analysed by intention to treat.

findingsPatients were recruited from Feb 26, 2009, to June 21, 2012. Patients who were assigned to CBT-AD (94 randomly assigned, 83 completed assessment) had greater improvements in adherence (estimated difference 1·00 percentage point per visit, 95% CI 0·34 to 1·66, p=0·003) and depression (Center for Epidemiological Studies depression [CESD] score estimated difference -0·41, -0·66 to -0·16, p=0·001; Montgomery-Asberg depression rating scale [MADRS] score -4·69, -8·09 to -1·28, p=0·007; clinical global impression [CGI] score -0·66, -1·11 to -0·21, p=0·005) than did patients who had ETAU (49 assigned, 46 completed assessment) after treatment (4 months). No significant differences in adherence were noted between CBT-AD and ISP-AD (97 assigned, 87 completed assessment). No study-related adverse events were reported.

interpretationIntegrating evidenced-based treatment for depression with evidenced-based adherence counselling is helpful for individuals living with HIV/AIDS and depression. Future efforts should examine how to best disseminate effective psychosocial depression treatments such as CBT-AD to people living with HIV/AIDS and examine the cost-effectiveness of such approaches.

fundingNational Institute of Mental Health, National Institute of Allergy and Infectious Diseases.

Indexed as

Cognitive Behavioral TherapyAdolescentAdultCost-Benefit AnalysisCounselingDepressionFemaleHIV InfectionsHumansMaleMedication AdherenceQuality-Adjusted Life YearsSubstance Abuse, IntravenousTreatment OutcomeUnited StatesYoung Adult

Identifiers

PMID27658881
PMCPMC5321546
OpenAlexW2473209452

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.