Feasibility of Using a Structured Daily Diary

NCT ID: NCT01953653

Last Updated: 2017-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-02-28

Brief Summary

This protocol explores the feasibility and acceptability of using two daily diary methods to analyze state-dependent variables and psychosocial health outcomes in Human Immunodeficiency Virus (HIV)-positive young men who have sex with men (YMSM). The study will explore the potential of diaries for use in feedback-based interventions.

Conditions

HIV Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

A: Begin with Interactive Voice Response (IVR) System

Group A participants are randomized the IVR system as Modality #1. After 33 days of diary completion using IVR, they switch to the interactive web response system (IWR)as Modality #2.

Group Type: OTHER

Structured daily diary

Intervention Type: BEHAVIORAL

The intervention is a structured daily diary to describe fluctuations in key psychological and behavioral variables impacting daily risk behavior among HIV-positive young men who have sex with men (YMSM), aged 16 to 24 years old who engage in substance use and sexual risk behaviors.

B: Begin with Interactive Web Response (IWR) System

Group B participants are randomized to the IWR system as Modality #1. After 33 days of diary completion using IWR, they switch to the interactive voice response (IVR)system as Modality #2.

Group Type: OTHER

Structured daily diary

Intervention Type: BEHAVIORAL

The intervention is a structured daily diary to describe fluctuations in key psychological and behavioral variables impacting daily risk behavior among HIV-positive young men who have sex with men (YMSM), aged 16 to 24 years old who engage in substance use and sexual risk behaviors.

Interventions

Structured daily diary

The intervention is a structured daily diary to describe fluctuations in key psychological and behavioral variables impacting daily risk behavior among HIV-positive young men who have sex with men (YMSM), aged 16 to 24 years old who engage in substance use and sexual risk behaviors.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Receives services at one of the selected Adolescent Medicine Trial Unit (AMTU) sites;
• HIV-1 infection as documented in the participant's medical record by at least one of the following criteria:

• Reactive HIV screening test result with an antibody-based, Food and Drug Administration (FDA)-licensed assay followed by a positive supplemental assay (e.g., HIV-1 Western Blot, HIV-1 indirect immunofluorescence);
• Positive HIV-1 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay;
• Plasma HIV-1 quantitative ribonucleic acid (RNA) assay >1,000 copies/mL; or
• Positive plasma HIV-1 RNA qualitative assay
• Between the ages of 16-24 years, inclusive, at the time of screening;
• Born biologically male and self-identifies as male at the time of screening;
• HIV-infected through sexual behavior;
• At least one self-reported sexual encounter with another man involving oral or anal sex in the past 12 months prior to screening;
• At least one self-reported episode of unprotected vaginal or anal intercourse within the past 90 days prior to screening and/or substance use, defined as at least one occasion in which four or more alcoholic beverages were consumed and/or two or more occasions of illicit drug use, in the past 90 days, as assessed by the Assessment of Substance Use and Sexual Behavior questionnaire (CRF (F107));
• Has active cell phone service; is able to access his cell phone seven days a week between 6:00 PM and 6:00 AM the next morning; and is willing and able to use approximately 10 minutes of talk time and receive two text messages per day;
• Consistent internet access seven days a week between 6:00 PM and 6:00 AM the next morning;
• Ability to understand, read, and speak English;
• Ability to read at a fifth grade level, as assessed by the Rapid Estimate of Adolescent Literacy in Medicine (REALM)-TEEN; and
• Willingness to provide signed informed consent for study participation.

Exclusion Criteria

• HIV infected via modes other than sexual behavior (e.g., perinatally, via shared needles, or blood transfusion, etc.);
• Previously enrolled in Adolescent Trials Network (ATN) 112;
• Active psychiatric condition that in the opinion of the site Principal Investigator (PI) or designee would interfere with the ability to give true informed consent and to adhere to the study requirements;
• Visibly distraught and/or visibly emotionally unstable (e.g., exhibiting suicidal, homicidal, impulsive or violent behavior);
• Active drug or alcohol use or dependence that, in the opinion of the site personnel, would interfere with the ability to give true informed consent and to adhere to the study requirements;
• Acute illness that, in the opinion of the treating clinician, would interfere with the participant's ability to adhere to the protocol requirements and/or interfere with the protocol objectives.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Wilson, PhD

Role: STUDY_CHAIR

Columbia University

Locations

Children's Hospital of Denver

Aurora, Colorado, United States

Wayne State University

Detroit, Michigan, United States

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Related Links

http://www.atnonline.org

ATN website

Other Identifiers

ATN 112

Identifier Type: -

Identifier Source: org_study_id