NCT01752777

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

6 years

First QC Date

December 16, 2012

Last Update Submit

May 8, 2018

Conditions

Keywords

HIV/AIDS, HIV infectiousness, Medication adherence, Sexual risks reduction

Outcome Measures

Primary Outcomes (1)

  • HIV RNA Viral Load

    HIV RNA viral load determined by blood plasma PCR

    12 month

Secondary Outcomes (1)

  • Sexual Transmission Risk Behaviors

    3 month

Study Arms (2)

Infectiousness Risk Reduction

EXPERIMENTAL

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.

Behavioral: Infectiousness Risk Reduction

General Health Improvement

SHAM COMPARATOR

Participants in this condition receive education conducted in one office session followed by 4 cell-phone-based sessions. The education sessions focus on raising awareness of health services and health improvement strategies.

Behavioral: General Health Improvement

Interventions

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.

Infectiousness Risk Reduction

Educational counseling to help link participants to social serves and health related strategies.

General Health Improvement

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and older
  • HIV positive
  • Sexually active in the previous Month
  • Active substance use

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southeast HIV/AIDS Research and Evaluation Project

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeMedication Adherence

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 DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 16, 2012

First Posted

December 19, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations