Clinical trial NCT01953653: Feasibility of Using a Structured Daily Diary
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2013-10-01
Enrollment: 67
Sex: MALE
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Number of Participants who Complete the 66-Day Structured Daily Diary
timeFrame: 66 days
measure: Rate of Completion of 66-Day Structured Daily Diary by Modality Type
timeFrame: 66 days
measure: Reasons and Rate of for Non-completion of 66-Day Structured Daily Diary
timeFrame: 66 days
Secondary outcomes:
measure: Participant Responses to how Diary can Provide Personalized Feedback on Triggers to Risk Behaviors
timeFrame: 66 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital of Denver
state: Colorado
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Philadelphia
country: United States
facility: Childrens Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Columbia University
name: Patrick Wilson, PhD
role: STUDY_CHAIR
References: