Addressing Psychosocial Comorbidities in HIV Treatment and Prevention

Addressing Psychosocial Comorbidities in HIV Treatment and Prevention: Phase 2

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02696681

Acronym

APPROACH

Enrollment

Registered

2016-03-02

Start date

2016-03-31

Completion date

2018-09-18

Last updated

2019-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Human Immunodeficiency Virus, Mental Health

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.

Interventions

BEHAVIORALCognitive Behavioral Therapy

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load	4 months assessment	Attaining viral suppression

Secondary

Measure	Time frame	Description
Adherence to antiretroviral therapy via real time monitoring	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026