Feasibility of Using a Structured Daily Diary



Status:Completed
Conditions:HIV / AIDS, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:16 - 24
Updated:3/1/2017
Start Date:February 2013
End Date:February 2014

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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

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.


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.
We found this trial at
3
sites
5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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Aurora, Colorado 80045
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Aurora, CO
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