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

NCT ID: NCT03910218

Last Updated: 2025-06-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

474 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-11

Study Completion Date

2024-04-03

Brief Summary

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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).

Detailed Description

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Conditions

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Behavior, Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type EXPERIMENTAL

NCM4HIV

Intervention Type BEHAVIORAL

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

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

Group Type PLACEBO_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Diane Santa Maria

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diane Santa Maria, DrPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

References

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Maria DS, Nyamathi A, Lightfoot M, Paul M, Quadri Y, Padhye N, Businelle M, Fernandez-Sanchez H, Jones JT. Results of a Randomized Wait-List Controlled Trial of CAYA: A Nurse Case Management HIV Prevention Intervention for Youth Experiencing Homelessness. AIDS Behav. 2025 Feb;29(2):613-625. doi: 10.1007/s10461-024-04544-3. Epub 2024 Nov 12.

Reference Type DERIVED
PMID: 39531116 (View on PubMed)

Santa Maria DM, Padhye N, Ostrosky-Zeichner L, Grimes CZ, Nyamathi A, Lightfoot M, Quadri Y, Paul ME, Jones JT. COVID-19 Vaccination Uptake, Infection Rates, and Seropositivity Among Youth Experiencing Homelessness in the United States. Nurs Res. 2024 Sep-Oct 01;73(5):373-380. doi: 10.1097/NNR.0000000000000747. Epub 2024 May 10.

Reference Type DERIVED
PMID: 38809559 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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HSC-SN-18-0993

Identifier Type: -

Identifier Source: org_study_id

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