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Feasibility of Using a Structured Daily Diary | Clinical Trials | Clareo Health

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Feasibility of Using a Structured Daily Diary

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

NCT01953653•University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

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

Age

16 - 24 years

Sex

MALE

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;
+6 more 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.

Locations (3)

Children's Hospital of Denver

Aurora, Colorado, United States

Wayne State University

Detroit, Michigan, United States

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

February 1, 2013

Primary Completion Date

February 1, 2014

Completion Date

February 1, 2014

Last Updated

February 28, 2017

Enrollment

ACTUAL participants

Conditions

HIV Infection

Interventions

Structured daily diary

BEHAVIORAL

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RECRUITINGPHASE3

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

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HIV Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Feasibility of Using a Structured Daily Diary

Inclusion Criteria

Exclusion Criteria

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

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