Skip to main content
OpenTrials
Completed

NCT Number: NCT02696681

Addressing Psychosocial Comorbidities in HIV Treatment and Prevention

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Behavior Behavioral Symptoms Blood-Borne Infections Communicable Diseases Depression Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Health Personal Satisfaction Psychological Well-Being RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33146, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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

Primary outcomes

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

    Time frame: 4 months assessment

    Attaining viral suppression

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

    Time frame: 8 month assessment

    Attaining viral suppression

Secondary outcomes

  1. Adherence to antiretroviral therapy via real time monitoring

    Time frame: Changes over time from baseline to 8 month follow-up

    Adherence to ART will be measured using a real time monitoring devices that tracks when a pill box is opened and closed.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Addressing Psychosocial Comorbidities in HIV Treatment and Prevention: Phase 2

Acronym: APPROACH

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 2, 2016
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.