CompletedNCT01953653Updated Feb 28, 2017

Feasibility of Using a Structured Daily Diary

An interventional study of Structured daily diary in HIV Infection, sponsored by University of North Carolina, Chapel Hill. Completed at 3 sites in United States. Open to male participants aged 16 Years to 24 Years. Per ClinicalTrials.gov, last updated 2017-02-28.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Supportive care

Phase: Not applicable
Study type: Interventional
Enrollment: 67
Allocation: Non-randomized
Ages: 16 Years to 24 Years
Sex: Male

Study 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.

Conditions studied

HIV Infection

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HIV Infections 4,340

In context

HIV Infections

4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 67 is below the median of 83 across 3,312 interventional studies indexed under HIV Infections.

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Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,366 studies on the registry; 133 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 139 (88%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 16 Years to 24 Years
Sexes eligible: Male
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Non-randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 67 participants (actual)

Study arms

Other
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
Other
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

Interventions

BehavioralStructured 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.

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 66 days

Secondary outcomes

Participant Responses to how Diary can Provide Personalized Feedback on Triggers to Risk Behaviors
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.
Time frame: 66 days

Study locations

3 sites

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

References and documents

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2013, a primary completion of Feb 2014 and a completion of Feb 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 19, 2013
First posted: Oct 1, 2013
Start: Feb 2013
Primary completionActual: Feb 2014
CompletionActual: Feb 2014
Last update: Feb 28, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01953653
Lead sponsor: University of North Carolina, Chapel Hill
Responsible party: Sponsor
First posted: Oct 1, 2013
Start date: Feb 2013
Primary completion: Feb 2014
Completion: Feb 2014
Last update: Feb 28, 2017

Study contacts

Patrick Wilson, PhD

study chair · Columbia University

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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