Feasibility of Using a Structured Daily Diary

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01953653
First received: January 19, 2013
Last updated: August 13, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
HIV Infection
Behavioral: Structured daily diary

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Feasibility of Using a Structured Daily Diary to Assess Mood, Stressful Events, Support, Substance Use, and Sexual Behavior in HIV-Positive Young Men Who Have Sex With Men

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Number of Participants who Complete the 66-Day Structured Daily Diary [ Time Frame: 66 days ] [ Designated as safety issue: No ]
    The first primary objective of this study is to implement a 66-day structured daily diary with 90 HIV-positive YMSM to explore relationships among daily mood, stressful events, social support, substance use, sexual behavior, and adherence to ART among youth who are currently prescribed to take medication.

  • Rate of Completion of 66-Day Structured Daily Diary by Modality Type [ Time Frame: 66 days ] [ Designated as safety issue: No ]
    The second primary objective is to explore the feasibility and acceptability of using two daily diary modalities (IVR and IWR) as (1) a novel method of data collection in research involving HIV-positive YMSM, and (2) a potential tool to provide personalized feedback and/or assist with self-monitoring among HIV-positive YMSM.

  • Reasons and Rate of for Non-completion of 66-Day Structured Daily Diary [ Time Frame: 66 days ] [ Designated as safety issue: No ]
    The second primary objective is to explore the feasibility and acceptability of using two daily diary modalities (IVR and IWR) as (1) a novel method of data collection in research involving HIV-positive YMSM, and (2) a potential tool to provide personalized feedback and/or assist with self-monitoring among HIV-positive YMSM.


Secondary Outcome Measures:
  • Participant Responses to how Diary can Provide Personalized Feedback on Triggers to Risk Behaviors [ Time Frame: 66 days ] [ Designated as safety issue: No ]
    The secondary objective of this study is to obtain feedback from HIV-positive YMSM on how the diary could be used to provide personalized feedback on triggers to risk behaviors, such as substance use, unprotected sexual behavior, and poor medication adherence. These data will be obtained through debriefing interviews.


Enrollment: 67
Study Start Date: February 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: 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.
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.
Behavioral: 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.

  Eligibility

Ages Eligible for Study:   16 Years to 24 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01953653

Locations
United States, Colorado
Children's Hospital of Denver
Aurora, Colorado, United States, 80045
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, Pennsylvania
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Investigators
Study Chair: Patrick Wilson, PhD Columbia University
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01953653     History of Changes
Other Study ID Numbers: ATN 112
Study First Received: January 19, 2013
Last Updated: August 13, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 18, 2014