The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
NCT Number: NCT03910218
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).
Looking for future studies?
Notify Me16 year–25 year
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: baseline
Time frame: At completion of the 3-month intervention (Month 3)
Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
Time frame: 3 months after intervention (Month 6)
Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
Time frame: 6 months after intervention (Month 9)
Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
Time frame: 9 months after intervention (Month 12)
Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
Time frame: baseline
Time frame: At completion of the 3-month intervention (Month 3)
Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
Time frame: 3 months after intervention (Month 6)
Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
Time frame: 6 months after intervention (Month 9)
Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
Time frame: 9 months after intervention (Month 12)
Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
Time frame: baseline
An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported.
Time frame: At completion of the 3-month intervention (Month 3)
An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported.\\
Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
Time frame: 3 months after intervention (Month 6)
An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported.
Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
Time frame: 6 months after intervention (Month 9)
An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported.
Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
Time frame: 9 months after intervention (Month 12)
An item from the Youth Risk Behavior Survey was used to assess this outcome. The items asked if a condom was used at last sex. The number of participants who answered yes is reported.
Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
Time frame: Baseline
Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea.
Time frame: At completion of the 3-month intervention (Month 3)
Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea.
Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
Time frame: 3 months after intervention (Month 6)
Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea.
Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
Time frame: 6 months after intervention (Month 9)
Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea.
Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
Time frame: 9 months after intervention (Month 12)
Sexually Transmitted Infection tested includes syphilis, chlamydia and gonorrhea.
Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
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.
Time frame: At completion of the 3-month intervention (Month 3)
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.
Time frame: 3 months after intervention (Month 6)
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.
Time frame: 6 months after intervention (Month 9)
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.
Time frame: 9 months after intervention (Month 12)
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.
Time frame: baseline
Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.
Time frame: At completion of the 3-month intervention (Month 3)
Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.
Time frame: 3 months after intervention (Month 6)
Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.
Time frame: 6 months after intervention (Month 9)
Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.
Time frame: 9 months after intervention (Month 12)
Participants will be asked if they live in a shelter, apartment/house, with someone, outside, or in a car, etc.
Time frame: At completion of the 3-month intervention (Month 3), 3 months after intervention (Month 6), 6 months after intervention (Month 9), 9 months after intervention (Month 12)
An item from the Texas Christian University (TCU) drug screen II was used to assess this outcome. The item listed various drug substances and asked whether any of those listed had been used in the past 30 days. The number of participants who answered yes is reported.
Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
Time frame: baseline
The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression
Time frame: At completion of the 3-month intervention (Month 3)
The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression.
Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
Time frame: 3 months after intervention (Month 6)
The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression.
Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
Time frame: 6 months after intervention (Month 9)
The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression.
Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
Time frame: 9 months after intervention (Month 12)
The Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27, with higher scores indicating more severe depression.
Multiple imputation was used because there were high missing fractions for many variables. This approach assumed that data were missing at random (MAR) and the imputation model used the same multilevel modeling approach that was used for analysis. The models made use of the correlations among repeated measurements for participants to estimate missing values. The descriptive statistics represent averages across 10 imputed data sets.
Time frame: baseline
An item from the Texas Christian University (TCU) drug screen II was used to assess this outcome. The item listed various drug substances and asked whether any of those listed had been used in the past 30 days. The number of participants who answered yes is reported.
The University of Texas Health Science Center, Houston
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03911024
Behavior, Behavior, Risk
Houston, Texas, United States
View Trial DetailsNCT07320664
Behavior, Behavior, Risk
Columbus, Ohio, United States
View Trial DetailsNCT06192316
Behavior, Behavior, Risk
Columbus, Ohio, United States
View Trial DetailsNCT04360018
Alcohol Consumption, Alcohol Drinking
Bethesda, Maryland, United States
View Trial Details