Feasibility of Using a Structured Daily Diary
1 other identifier
interventional
67
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2013
3 active sites
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
First Submitted
Initial submission to the registry
January 19, 2013
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedFirst Posted
Study publicly available on registry
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFebruary 28, 2017
March 1, 2016
1 year
January 19, 2013
February 27, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
Number of Participants who Complete the 66-Day Structured Daily Diary
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.
66 days
Rate of Completion of 66-Day Structured Daily Diary by Modality Type
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.
66 days
Reasons and Rate of for Non-completion of 66-Day Structured Daily Diary
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.
66 days
Secondary Outcomes (1)
Participant Responses to how Diary can Provide Personalized Feedback on Triggers to Risk Behaviors
66 days
Study Arms (2)
A: Begin with Interactive Voice Response (IVR) System
OTHERGroup 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.
B: Begin with Interactive Web Response (IWR) System
OTHERGroup 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.
Interventions
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 Criteria
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Children's Hospital of Denver
Aurora, Colorado, 80045, United States
Wayne State University
Detroit, Michigan, 48201, United States
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Patrick Wilson, PhD
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2013
First Posted
October 1, 2013
Study Start
February 1, 2013
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
February 28, 2017
Record last verified: 2016-03