Completed

Directly Observed Therapy (DOT) in HIV-Infected Adolescents: Part A-Focus Groups

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

From 16 to 21 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: April 2004
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2004

Actual date on which the first participant was enrolled.

The rate of HIV infection among adolescents is increasing at an alarming rate. Adherence to antiretroviral therapy has been a major challenge in achieving and maintaining adequate control of the disease in this population. DOT has been shown effective in individuals with tuberculosis (TB), but DOT in HIV infected populations has not been thoroughly examined. This study will collect information from HIV infected adolescents in order to establish a DOT program that will increase successful adherence to HIV treatment and will benefit the public by preventing development of viral resistance and reducing the risk of transmission. Adolescent participants in this study will be assigned to one of three 2-hour focus group sessions, each at a different site. The participants will complete a questionnaire and will give input about designing a DOT intervention model that will be accepted by adolescents. The model will then be used in a pilot study to determine the feasibility of implementing DOT programs in the community to help HIV infected adolescents.

Official TitleDirectly Observed Therapy (DOT) in HIV-Infected Adolescents: Part A-Focus Groups 
NCT00079729
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 16 to 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus Infections

Criteria

Inclusion Criteria: * HIV infected due to high-risk behavior * Regular attendee of local adolescent HIV support group * Current use of antiretrovirals or history of antiretroviral therapy * Permission of parent or legal guardian if participant is less than the legal age of consent. Assent of the minor participant should be obtained where required. Exclusion Criteria: * Perinatal HIV infection * Visibly distraught or emotionally unstable * Pregnancy or breast-feeding

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Los Angeles County Medical Center/USC

Los Angeles, United StatesSee the location
Suspended

University of Miami (Pediatric)

Miami, United States
Suspended

St. Jude Childrens Research Hospital, Memphis

Memphis, United States
Completed3 Study Centers