NCT02696681

Brief Summary

Project AProaCH is an open pilot trial of a cognitive behavioral therapy (CBT) for individuals with HIV with various psychological comorbidities, which the investigators call "syndemics". Syndemics are co-occurring psychosocial problems that interact with each other and with health behavior such as HIV sexual transmission risk behavior and adherence to self care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2018

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

2.6 years

First QC Date

February 18, 2016

Last Update Submit

August 2, 2019

Conditions

Human Immunodeficiency VirusDepressionMental Health

Outcome Measures

Primary Outcomes (2)

  • Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load

    Attaining viral suppression

    4 months assessment

  • Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load

    Attaining viral suppression

    8 month assessment

Secondary Outcomes (1)

  • Adherence to antiretroviral therapy via real time monitoring

    Changes over time from baseline to 8 month follow-up

Study Arms (1)

Cognitive Behavioral Therapy

EXPERIMENTAL

Integrating CBT for any substance use or mental health problems with CBT for adherence/self-care

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

Integrating CBT for mental health and substance issues concern with CBT for health behavior change

Cognitive Behavioral Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV+ individuals
  • Uncontrolled virus (plasma HIV RNA concentrations that reach detectable limits) or being diagnosed with a sexually transmitted infection (STI) (gonorrhea, chlamydia, syphilis, trichomoniasis (female only)) currently or within the past 3 months.

You may not qualify if:

  • Unable or unwilling to provide informed consent
  • Active untreated, unstable, major mental illness (i.e., untreated psychosis or mania) that would interfere with study participation
  • Opinion of the PI that the participant would be at risk for harm to himself or others as a result of study participation,
  • Under the age of 18 or over the age of 65,
  • Current CBT for a psychiatric disorder, or a course of CBT in the past year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33146, United States

Location

Related Publications (1)

  • Safren SA, Harkness A, Lee JS, Rogers BG, Mendez NA, Magidson JF, Blashill AJ, Bainter S, Rodriguez A, Ironson G. Addressing Syndemics and Self-care in Individuals with Uncontrolled HIV: An Open Trial of a Transdiagnostic Treatment. AIDS Behav. 2020 Nov;24(11):3264-3278. doi: 10.1007/s10461-020-02900-7.

    PMID: 32410049DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeDepressionPsychological Well-Being

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavioral SymptomsBehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Steven A Safren, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 18, 2016

First Posted

March 2, 2016

Study Start

March 1, 2016

Primary Completion

September 18, 2018

Study Completion

September 18, 2018

Last Updated

August 6, 2019

Record last verified: 2019-08

Locations

US(1)