NCT02562092

Brief Summary

This study aims to understand the barriers to receiving HIV testing and retention of care for at risk and HIV positive young adults. This study also seeks to determine the feasibility and acceptability of HIV testing in a non-clinical setting.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

September 24, 2015

Last Update Submit

January 19, 2021

Conditions

HIV

Keywords

AIDSHealth Promotion

Outcome Measures

Primary Outcomes (1)

  • Days to Linkage to Care

    For participants who test positive, linkage to care is measured as the number of days to seek HIV treatment.

    Post Diagnosis (Up to 3 months)

Secondary Outcomes (7)

  • Number of medical care visits

    Post Diagnosis (Up to one year)

  • Change in CD4 count

    Baseline (Post Diagnosis), One year assessment (Up to one year)

  • Change in viral load

    Baseline (Post Diagnosis), One year assessment (Up to one year)

  • Rate of venue acceptance

    One year assessment (Up to one year)

  • Rate of study subject acceptance

    One year assessment (Up to one year)

  • +2 more secondary outcomes

Study Arms (3)

Focus Group

NO INTERVENTION

Participants will complete a questionnaire and will be involved in a group discussion regarding good sites within the community to perform HIV testing.

Venue Testing Group- Negative Test

OTHER

Participants will perform a rapid HIV test and will be asked to answer questions about their sexual life and living situation. No followup is needed for a negative HIV test.

Behavioral: Reducing Risk Behavior

Venue Testing Group- Positive Test

OTHER

Participants will perform a rapid HIV test and will be asked to answer questions about their sexual life and living situation. Participants with a positive HIV test will receive care from a psychologist and case manager for one year.

Behavioral: Support and Guidance

Interventions

Reducing Risk BehaviorBEHAVIORAL

A small survey will be conducted to identify risk factors and assess demographics. Participants will receive psychological support and counseling on reducing risk behavior for one year.

Venue Testing Group- Negative Test
Support and GuidanceBEHAVIORAL

A small survey will be conducted to identify risk factors and assess demographics. Participants with a positive HIV test will receive standard HIV care, support, and guidance from a psychologist and case manager including an assessment of basic needs (food, clothing, shelter), and counseling on risk taking behaviors for one year.

Venue Testing Group- Positive Test

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Sexually active
  • HIV positive or negative
  • Latino youth ages 18-24 years
  • Residents of the state of Georgia and can understand spoken and written English or Spanish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Ponce De Leon Center

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Palliative CareCounseling

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health Services

Study Officials

  • Andres Camacho-Gonzalez

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

September 24, 2015

First Posted

September 29, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

January 22, 2021

Record last verified: 2021-01

Locations

US(2)