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Come As You Are - Assessing the Efficacy of a Nurse Case Management HIV Prevention and Care Intervention Among Homeless Youth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03910218
Recruitment Status : Recruiting
First Posted : April 10, 2019
Last Update Posted : October 20, 2020
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Diane Santa Maria, The University of Texas Health Science Center, Houston

Brief Summary:
The purpose of this study is to to determine the efficacy of the Nurse Case Management HIV (NCM4HIV) intervention on HIV prevention compared to usual care among Youth Experiencing Homelessness (YEH).

Condition or disease Intervention/treatment Phase
Behavior, Risk Behavioral: NCM4HIV Behavioral: Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Come As You Are - Assessing the Efficacy of a Nurse Case Management HIV Prevention and Care Intervention Among Homeless Youth
Actual Study Start Date : October 21, 2019
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NCM4HIV
Participant will receive NCM4HIV intervention which includes Personalized HIV prevention education, behavior goal-setting,behavioral self-monitoring,Pre exposure prophylaxis (PrEP) eligibility screening,PrEP/non occupational post exposure prophylaxis(nPEP)services (labs, medication), healthcare planning/coordination, Motivational Interviewing (MI) counseling approach, assisting with cognitive appraisals (clarifying misconceptions),promoting health seeking and coping behaviors that incorporate the situational, personal, social, and resource needs affecting health
Behavioral: NCM4HIV
Participant will receive NCM4HIV intervention which includes Personalized HIV prevention education, behavior goal-setting,behavioral self-monitoring, PrEP eligibility screening,PrEP/nPEP services (labs, medication), healthcare planning/coordination, MI counseling approach, assisting with cognitive appraisals (clarifying misconceptions),promoting health seeking and coping behaviors that incorporate the situational, personal, social, and resource needs affecting health

Placebo Comparator: Usual care
Participants will receive the usual care which includes Housing, food, and clothing needs,health assessment, basic healthcare, limited anticipatory guidance, mental health counseling,substance use treatment referrals,PrEP/nPEP referrals
Behavioral: Usual Care
Participant will receive usual care which includes Housing, food, and clothing needs,health assessment, basic healthcare, limited anticipatory guidance, mental health counseling, substance use treatment referrals, PrEP/nPEP referrals




Primary Outcome Measures :
  1. Number of participants who use preventive prophylaxis (PrEP) [ Time Frame: baseline ]
  2. Number of participants who use preventive prophylaxis (PrEP) [ Time Frame: immediately after intervention (at end of 3-month intervention) ]
  3. Number of participants who use preventive prophylaxis (PrEP) [ Time Frame: 3 months after intervention ]
  4. Number of participants who use preventive prophylaxis (PrEP) [ Time Frame: 6 months after intervention ]
  5. Number of participants who use preventive prophylaxis (PrEP) [ Time Frame: 9 months after intervention ]
  6. Number of participants who use non-occupational post-exposure prophylaxis (nPEP) [ Time Frame: baseline ]
  7. Number of participants who use non-occupational post-exposure prophylaxis (nPEP) [ Time Frame: immediately after intervention (at end of 3-month intervention) ]
  8. Number of participants who use non-occupational post-exposure prophylaxis (nPEP) [ Time Frame: 3 months after intervention ]
  9. Number of participants who use non-occupational post-exposure prophylaxis (nPEP) [ Time Frame: 6 months after intervention ]
  10. Number of participants who use non-occupational post-exposure prophylaxis (nPEP) [ Time Frame: 9 months after intervention ]
  11. Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey [ Time Frame: baseline ]
  12. Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey [ Time Frame: immediately after intervention (at end of 3-month intervention) ]
  13. Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey [ Time Frame: 3 months after intervention ]
  14. Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey [ Time Frame: 6 months after intervention ]
  15. Number of participants who use condoms at last sex as measured by the Youth Risk Behavior Survey [ Time Frame: 9 months after intervention ]
  16. Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests [ Time Frame: Baseline ]
  17. Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests [ Time Frame: immediately after intervention (at end of 3-month intervention) ]
  18. Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests [ Time Frame: 3 months after intervention ]
  19. Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests [ Time Frame: 6 months after intervention ]
  20. Number of participants who take the HIV and Sexually Transmitted Infection (STI) tests [ Time Frame: 9 months after intervention ]

Secondary Outcome Measures :
  1. Mental health as measured by the Brief Symptom Index-18 [ Time Frame: baseline ]
    The Brief Symptom Inventory 18 (BSI-18) consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days). Total score ranges from 0 to 72, with higher scores indicating greater distress.

  2. Mental health as measured by the Brief Symptom Index-18 [ Time Frame: immediately after intervention (at end of 3-month intervention) ]
    The BSI-18 consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days). Total score ranges from 0 to 72, with higher scores indicating greater distress.

  3. Mental health as measured by the Brief Symptom Index-18 [ Time Frame: 3 months after intervention ]
    The BSI-18 consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days). Total score ranges from 0 to 72, with higher scores indicating greater distress.

  4. Mental health as measured by the Brief Symptom Index-18 [ Time Frame: 6 months after intervention ]
    The BSI-18 consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days). Total score ranges from 0 to 72, with higher scores indicating greater distress.

  5. Mental health as measured by the Brief Symptom Index-18 [ Time Frame: 9 months after intervention ]
    The BSI-18 consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days). Total score ranges from 0 to 72, with higher scores indicating greater distress.

  6. Housing status [ Time Frame: baseline ]
    Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.

  7. Housing status [ Time Frame: immediately after intervention (at end of 3-month intervention) ]
    Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.

  8. Housing status [ Time Frame: 3 months after intervention ]
    Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.

  9. Housing status [ Time Frame: 6 months after intervention ]
    Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.

  10. Housing status [ Time Frame: 9 months after intervention ]
    Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.

  11. Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II [ Time Frame: baseline ]
  12. Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II [ Time Frame: immediately after intervention (at end of 3-month intervention) ]
  13. Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II [ Time Frame: 3 months after intervention ]
  14. Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II [ Time Frame: 6 months after intervention ]
  15. Status of substance use of a participant as measured by the Texas Christian University (TCU) drug screen II [ Time Frame: 9 months after intervention ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • youth engaged in high-risk sexual activity or intravenous drug use
  • speak English
  • homeless
  • not planning to move out of the metro area during the study

Exclusion Criteria:

  • youth with very low literacy
  • severe acute mental symptoms

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910218


Contacts
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Contact: Diane Santa Maria, DrPH (713)500-2187 diane.m.santamaria@uth.tmc.edu
Contact: Jennifer Torres, MPH 713-500-9928 jennifer.d.torres@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Diane Santa Maria, DrPH    713-500-2187    diane.m.santamaria@uth.tmc.edu   
Contact: Jennifer Torres, MPH    713-500-9928    jennifer.d.torres@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Diane Santa Maria, DrPH The University of Texas Health Science Center, Houston
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Responsible Party: Diane Santa Maria, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03910218    
Other Study ID Numbers: HSC-SN-18-0993
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Diane Santa Maria, The University of Texas Health Science Center, Houston:
HIV prevention
homeless