Feasibility of Using a Structured Daily Diary

University of North Carolina (UNC)

Status: Completed

Conditions: HIV Infection

Treatments: Behavioral: Structured daily diary

Study type: Interventional

Funder types: Other

Identifiers

NCT01953653

ATN 112

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: Male

Ages: 16 to 24 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

A: Begin with Interactive Voice Response (IVR) System

Other group

Description:

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.

Treatment:

Behavioral: Structured daily diary

B: Begin with Interactive Web Response (IWR) System

Other group

Description:

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.

Treatment:

Behavioral: Structured daily diary