Behavioral Intervention to Enhance HIV Test/Treat

HIV/AIDS Clinical Trial

Official title:

Behavioral Intervention to Enhance HIV Test/Treat

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752777
• Other study ID #: H11-159
• Status: Completed
• Phase: N/A
• Start date: February 1, 2012
• Est. completion date: February 1, 2018

Study information

• Verified date: May 2018
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prevention strategies that aim to test and treat people for HIV infection are undermined by HIV treatment non-adherence and sexually transmitted co-infections (STI). The proposed study will test a theory-based behavioral intervention to reduce HIV infectiousness by simultaneously improving HIV treatment adherence and reducing sexually transmitted co-infections in people living with HIV-AIDS who use alcohol and other drugs. The intervention is delivered in a single office-based counseling session followed by 4 cell phone delivered counseling sessions in a model that will be ready for immediate dissemination to case management and clinical services for people living with HIV/AIDS in resource constrained settings.

Description:

Prevention strategies that aim to test and treat people for HIV infection are undermined by HIV treatment non-adherence and sexually transmitted co-infections (STI). Scalable interventions are urgently needed to sustain low infectiousness by improving HIV treatment adherence and reducing risks for transmitting HIV. This application proposes to test a theory-based behavioral intervention to simultaneously improve HIV treatment adherence and reduce HIV transmission risk behaviors in people living with HIV/AIDS who use alcohol and other drugs. Grounded in Conflict Theory of Decision Making, the intervention will be delivered in a mixed format, with one office-based counseling session followed by four cell phone delivered counseling sessions. The intervention will be conducted in Atlanta and surrounding impoverished areas. Men (n = 250) and women (n = 250) receiving HIV treatment will be recruited from AIDS services and infectious disease clinics. Following informed consent and baseline assessments, participants will be randomly assigned to either an (a) integrated HIV treatment adherence - risk reduction intervention or (b) a time-matched non-contaminating attention control condition. Participants will be followed for 12-months using office-based computerized interviews, unannounced pill counts, and medical chart abstraction. The study will test the hypothesis that a unified, integrated theory-based HIV treatment and risk reduction intervention will reduce HIV transmission risk behaviors, improve HIV treatment adherence, reduce viral load and prevent new STI. The study will also examine the influence of theoretical constructs and structural barriers on intervention outcomes. Factors that predict relapse to non-adherence and risk behaviors in relation to changes in viral load and STI over the 12-month follow-up period will also be a focal point of the study. The intervention under investigation will be among the first to simultaneously address treatment adherence and risk behavior in an integrated model for substance using HIV positive men and women. If shown effective, the intervention model will be ready for immediate dissemination to community and clinical services for people living with HIV/AIDS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age 18 and older

• HIV positive

• Sexually active in the previous Month

• Active substance use

Exclusion Criteria:

Related Conditions & MeSH terms

• HIV/AIDS

Intervention

Behavioral:
• Infectiousness Risk Reduction
Behavioral counseling conducted in one office session followed by 4 cell-phone-based sessions. Counseling is based on models of behavioral self-management and cognitive decision making with the primary aim to increase antiretroviral adherence, engagement in HIV care, and reduction of sexual risk behaviors for HIV transmission.
• General Health Improvement
Educational counseling to help link participants to social serves and health related strategies.

Locations

Country	Name	City	State
United States	Southeast HIV/AIDS Research and Evaluation Project	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV RNA Viral Load	HIV RNA viral load determined by blood plasma PCR	12 month
Secondary	Sexual Transmission Risk Behaviors	Sexual behaviors that create risks for HIV transmission and protective actions against transmission risks	3 month