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Young Men's Health Project Targeting HIV Risk Reduction and Substance Abuse

Comparative Effectiveness Trial of Clinic-Based Delivery of an HIV Risk Reduction Intervention for Young Men Who Have Sex With Men (YMSM)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03577301
Acronym
YMHP
Enrollment
83
Registered
2018-07-05
Start date
2018-10-04
Completion date
2022-05-31
Last updated
2024-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV, Intervention, Men Who Have Sex with Men (MSM), PrEP, YMHP, YMSM

Brief summary

YMHP is a counseling intervention program for which the goals are to better understand HIV-prevention focused self-management behaviors among HIV-negative YMSM, and to study the implementation of YMHP to improve portability and scalability. The clinic sites will help investigators to assess and address practical problems at the frontline of service provision to pave the way for a comprehensive program to reduce HIV infection among YMSM that reflects the complexities of real world adolescent HIV clinics.

Detailed description

1. Adapt YMHP for clinic and phone delivery by existing HIV clinic staff community health workers (CHWs), who work with YMSM ages 15-24. Investigators will conduct focus groups with staff to obtain input on how best to implement YMHP to maximize feasibility, acceptability, and sustainability, as well as issues with adapting the YMHP for delivery to YMSM ages 15-18 and for phone delivery. 2. Compare the effectiveness of clinic-based versus phone-based delivery of YMHP in the context of health care access. In order to inform future implementation, investigators will test the effectiveness of YMHP delivered via these two modalities. 1. Assess the cost-effectiveness of both delivery formats of YMHP to enhance the likelihood of uptake of this best evidence intervention. The hypothesis is that phone-based will be more cost-effective than clinic-based 2. Assess the Five Components of the Self-Management Model and how these components vary over time, are directly improved by the interventions, and mediate intervention effects. 3. Test a sustainable model of YMHP implementation in real world adolescent clinics. Investigators will utilize local supervisors within the clinic setting to sustain the CHWs fidelity to delivering the motivational interviewing (MI)-based YMHP intervention. Fidelity will be monitored throughout the trial and assessments and qualitative interviews will be conducted with key stakeholders to determine the barriers and facilitators of YMHP implementation utilizing the Exploration, Preparation, Implementation, Sustainment model (EPIS). Aims will be achieved over two phases of the study. Phase I: Investigators will conduct research (Exploration and Preparation phases of EPIS model) to obtain implementation feedback to best adapt YMHP for clinic-based CHWs, further incorporate PrEP navigation services, and expand the YMHP protocol to be relevant for Telephone-based Motivational Interviewing (TBMI). We will train a minimum of 2 CHWs at each clinic drawing on the Implementation Science Core (ISC) to apply best-practices in training. Once CHWs demonstrate competence according to the Motivational Interviewing Treatment Integrity (MITI), Phase 2 will begin. Phase II: Personnel will recruit and enroll 180 YMSM, ages 15-24, 60 at each of the three sites. Sessions will be audio-recorded for MITI fidelity coding, and CHWs and supervisors will be given implementation support throughout. Prior to implementation, immediately at the conclusion of the intervention delivery phase, and one year after, the ISC will conduct interviews with CHWs, supervisors, and clinic leaders to obtain information about the barriers and facilitators of implementation and sustainment. Target n: 180 YMSM across three sites (60 per site).

Interventions

BEHAVIORALClinic-based Delivery

A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based intervention sessions.

BEHAVIORALRemote Delivery

A minimum of 2 community health workers (CHWs) will be trained to deliver intervention sessions to the participant in a location remote from the clinic setting.

BEHAVIORALMulti-modal Delivery

A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based or remote intervention sessions. First MI session is in person immediately after baseline. Sessions 2-4 can be delivered in person or remotely based on youth preference.

Sponsors

Florida State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
15 Years to 24 Years
Healthy volunteers
Yes

Inclusion criteria

* HIV-negative test result from the past 90 days * 15-24 years of age * Born biologically male or currently identifying as male * Sex with men in the past 90 days * ≥ 3 days of illicit drug use in the past 90 days * ≥ 1 episode of Condomless Anal Sex (CAS) in the past 90 days, or a positive STI test result in the past 90 days. * Able to communicate in English

Exclusion criteria

* Serious cognitive or psychiatric impairments * Currently taking Truvada as Pre-Exposure Prophylaxis (PrEP)

Design outcomes

Primary

MeasureTime frameDescription
Illicit Drug Use Daysbaseline, 3 months, 6 months, 9 months, 12 monthsThe self-reported number of illicit drug use days (not including marijuana) in the past 30 days
Condomless Anal Sex Actsbaseline, 3 months, 6 months, 9 months, 12 monthsThe self-reported number of condomless anal sex acts with male partners in the last 30 days prior to assessment point.
Marijuana Use Daysbaseline, 3 months, 6 months, 9 months, 12 monthsThe self-reported number of marijuana use days in the past 30 days prior to assessment point.

Secondary

MeasureTime frameDescription
Alcohol Use Daysbaseline, 3 months, 6 months, 9 months, 12 monthsThe self-reported number of alcohol use days in the past 30 days

Countries

United States

Participant flow

Participants by arm

ArmCount
Clinic-based Delivery
Participants will receive the intervention in person following HIV counseling and testing. The intervention involves completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis (PrEP) information and navigation services to interested participants. This arm is closed to enrollment. Clinic-based Delivery: A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based intervention sessions.
24
Remote Delivery
Participants will receive the intervention by remote delivery following HIV counseling and testing. Just as the clinic-based participants, he intervention involves completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis (PrEP) information and navigation services to interested participants. This arm is closed to enrollment. Remote Delivery: A minimum of 2 community health workers (CHWs) will be trained to deliver intervention sessions to the participant in a location remote from the clinic setting.
21
Multi-modal Delivery
A 4 session MI intervention. Session 1 is always delivered in person immediately after baseline. Session 2-4 can be delivered in person or remotely based upon youth preference. This arm is open to enrollment as of 11/15/2019. Multi-modal Delivery: A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based or remote intervention sessions. First MI session is in person immediately after baseline. Sessions 2-4 can be delivered in person or remotely based on youth preference.
16
Treatment as Usual
Treatment as usual control = individual HIV testing with referrals and link age to care as provided by the sites under routine circumstances. This arm is open to enrollment as of 11/15/2019.
22
Total83

Baseline characteristics

CharacteristicMulti-modal DeliveryTreatment as UsualTotalClinic-based DeliveryRemote Delivery
Age, Categorical
<=18 years
3 Participants1 Participants12 Participants1 Participants7 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
13 Participants21 Participants71 Participants23 Participants14 Participants
Education
4-Year College Degree or more
2 Participants5 Participants15 Participants6 Participants2 Participants
Education
Some college of Associates Degree
12 Participants13 Participants45 Participants10 Participants10 Participants
Education
Some High School
2 Participants4 Participants23 Participants8 Participants9 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Black
6 Participants9 Participants31 Participants7 Participants9 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Latino
8 Participants7 Participants30 Participants9 Participants6 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Other/Multiracial
0 Participants1 Participants8 Participants4 Participants3 Participants
Race/Ethnicity, Customized
Race/Ethnicity
White
2 Participants5 Participants14 Participants4 Participants3 Participants
Relationship Status
Partnered
10 Participants11 Participants36 Participants8 Participants7 Participants
Relationship Status
Single
6 Participants11 Participants47 Participants16 Participants14 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Male
16 Participants22 Participants83 Participants24 Participants21 Participants
Sexual Identity
Bisexual/Other
4 Participants5 Participants19 Participants6 Participants4 Participants
Sexual Identity
Gay/Queer
12 Participants17 Participants64 Participants18 Participants17 Participants
Site
Site 1
2 Participants5 Participants16 Participants4 Participants5 Participants
Site
Site 2
14 Participants13 Participants50 Participants12 Participants11 Participants
Site
Site 3
0 Participants4 Participants17 Participants8 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 240 / 210 / 160 / 22
other
Total, other adverse events
0 / 240 / 210 / 160 / 22
serious
Total, serious adverse events
0 / 240 / 210 / 160 / 22

Outcome results

Primary

Condomless Anal Sex Acts

The self-reported number of condomless anal sex acts with male partners in the last 30 days prior to assessment point.

Time frame: baseline, 3 months, 6 months, 9 months, 12 months

Population: Intent to treat population

ArmMeasureGroupValue (MEAN)Dispersion
Clinic-based DeliveryCondomless Anal Sex Acts9 Month11.0 Acts in the past 30 daysStandard Deviation 14.75
Clinic-based DeliveryCondomless Anal Sex Acts3 Month3.1 Acts in the past 30 daysStandard Deviation 4.44
Clinic-based DeliveryCondomless Anal Sex Acts12 Month10.8 Acts in the past 30 daysStandard Deviation 18.3
Clinic-based DeliveryCondomless Anal Sex Acts6 Month5.4 Acts in the past 30 daysStandard Deviation 8.18
Clinic-based DeliveryCondomless Anal Sex ActsBaseline5.9 Acts in the past 30 daysStandard Deviation 4.91
Remote DeliveryCondomless Anal Sex Acts6 Month4.4 Acts in the past 30 daysStandard Deviation 10.57
Remote DeliveryCondomless Anal Sex Acts9 Month13.6 Acts in the past 30 daysStandard Deviation 30.07
Remote DeliveryCondomless Anal Sex Acts12 Month2.3 Acts in the past 30 daysStandard Deviation 5.58
Remote DeliveryCondomless Anal Sex Acts3 Month5.9 Acts in the past 30 daysStandard Deviation 12.81
Remote DeliveryCondomless Anal Sex ActsBaseline4.5 Acts in the past 30 daysStandard Deviation 8.6
Multi-modal DeliveryCondomless Anal Sex Acts6 Month8.9 Acts in the past 30 daysStandard Deviation 13.74
Multi-modal DeliveryCondomless Anal Sex ActsBaseline6.9 Acts in the past 30 daysStandard Deviation 8.98
Multi-modal DeliveryCondomless Anal Sex Acts3 Month6.8 Acts in the past 30 daysStandard Deviation 10.2
Multi-modal DeliveryCondomless Anal Sex Acts9 Month13.2 Acts in the past 30 daysStandard Deviation 18.19
Multi-modal DeliveryCondomless Anal Sex Acts12 Month11.9 Acts in the past 30 daysStandard Deviation 16.98
Treatment as UsualCondomless Anal Sex Acts9 Month20.6 Acts in the past 30 daysStandard Deviation 48.34
Treatment as UsualCondomless Anal Sex Acts3 Month10.2 Acts in the past 30 daysStandard Deviation 20.2
Treatment as UsualCondomless Anal Sex ActsBaseline10.0 Acts in the past 30 daysStandard Deviation 14.54
Treatment as UsualCondomless Anal Sex Acts6 Month10.6 Acts in the past 30 daysStandard Deviation 23.93
Treatment as UsualCondomless Anal Sex Acts12 Month1.2 Acts in the past 30 daysStandard Deviation 1.3
p-value: 0.38Negative Binomial Regression
p-value: 0.74Negative Binomial Regression
p-value: 0.74Negative Binomial Regression
p-value: 0.3Negative Binomial Regression
Primary

Illicit Drug Use Days

The self-reported number of illicit drug use days (not including marijuana) in the past 30 days

Time frame: baseline, 3 months, 6 months, 9 months, 12 months

Population: Intent to treat population

ArmMeasureGroupValue (MEAN)Dispersion
Clinic-based DeliveryIllicit Drug Use DaysUse at 9 Months1.58 Number of DaysStandard Deviation 3.7
Clinic-based DeliveryIllicit Drug Use DaysUse at 3 Months9.00 Number of DaysStandard Deviation 19.16
Clinic-based DeliveryIllicit Drug Use DaysUse at 12 Months9.91 Number of DaysStandard Deviation 27.7
Clinic-based DeliveryIllicit Drug Use DaysUse at 6 Months9.64 Number of DaysStandard Deviation 24.38
Clinic-based DeliveryIllicit Drug Use DaysUse at Baseline3.17 Number of DaysStandard Deviation 4.1
Remote DeliveryIllicit Drug Use DaysUse at 6 Months5.93 Number of DaysStandard Deviation 16.04
Remote DeliveryIllicit Drug Use DaysUse at 9 Months3.46 Number of DaysStandard Deviation 8.35
Remote DeliveryIllicit Drug Use DaysUse at 12 Months3.80 Number of DaysStandard Deviation 9.27
Remote DeliveryIllicit Drug Use DaysUse at 3 Months5.12 Number of DaysStandard Deviation 10.89
Remote DeliveryIllicit Drug Use DaysUse at Baseline3.10 Number of DaysStandard Deviation 7.37
Multi-modal DeliveryIllicit Drug Use DaysUse at 6 Months3.23 Number of DaysStandard Deviation 9.03
Multi-modal DeliveryIllicit Drug Use DaysUse at Baseline3.25 Number of DaysStandard Deviation 5.99
Multi-modal DeliveryIllicit Drug Use DaysUse at 3 Months2.55 Number of DaysStandard Deviation 5.66
Multi-modal DeliveryIllicit Drug Use DaysUse at 9 Months7.45 Number of DaysStandard Deviation 23.09
Multi-modal DeliveryIllicit Drug Use DaysUse at 12 Months1.00 Number of DaysStandard Deviation 1.89
Treatment as UsualIllicit Drug Use DaysUse at 9 Months10.93 Number of DaysStandard Deviation 34.99
Treatment as UsualIllicit Drug Use DaysUse at 3 Months9.21 Number of DaysStandard Deviation 29.62
Treatment as UsualIllicit Drug Use DaysUse at Baseline2.86 Number of DaysStandard Deviation 6.76
Treatment as UsualIllicit Drug Use DaysUse at 6 Months2.64 Number of DaysStandard Deviation 6.17
Treatment as UsualIllicit Drug Use DaysUse at 12 Months1.33 Number of DaysStandard Deviation 1.21
p-value: 0.35Negative Binomial Regression
p-value: 0.58Negative Binomial Regression
p-value: 0.64Negative Binomial Regression
p-value: 0.76Negative Binomial Regression
Primary

Marijuana Use Days

The self-reported number of marijuana use days in the past 30 days prior to assessment point.

Time frame: baseline, 3 months, 6 months, 9 months, 12 months

Population: Intent to treat population

ArmMeasureGroupValue (MEAN)Dispersion
Clinic-based DeliveryMarijuana Use Days9 Month42.00 Number of DaysStandard Deviation 41.6
Clinic-based DeliveryMarijuana Use Days3 Month40.00 Number of DaysStandard Deviation 37.21
Clinic-based DeliveryMarijuana Use Days12 Month41.82 Number of DaysStandard Deviation 36.61
Clinic-based DeliveryMarijuana Use Days6 Month41.71 Number of DaysStandard Deviation 38.43
Clinic-based DeliveryMarijuana Use DaysBaseline31.38 Number of DaysStandard Deviation 34.01
Remote DeliveryMarijuana Use Days6 Month32.57 Number of DaysStandard Deviation 35.67
Remote DeliveryMarijuana Use Days9 Month33.08 Number of DaysStandard Deviation 35.44
Remote DeliveryMarijuana Use Days12 Month37.20 Number of DaysStandard Deviation 38.6
Remote DeliveryMarijuana Use Days3 Month32.75 Number of DaysStandard Deviation 36.56
Remote DeliveryMarijuana Use DaysBaseline34.09 Number of DaysStandard Deviation 38.48
Multi-modal DeliveryMarijuana Use Days6 Month28.77 Number of DaysStandard Deviation 32.72
Multi-modal DeliveryMarijuana Use DaysBaseline32.00 Number of DaysStandard Deviation 35.4
Multi-modal DeliveryMarijuana Use Days3 Month26.00 Number of DaysStandard Deviation 32.66
Multi-modal DeliveryMarijuana Use Days9 Month22.27 Number of DaysStandard Deviation 30.05
Multi-modal DeliveryMarijuana Use Days12 Month34.80 Number of DaysStandard Deviation 38.01
Treatment as UsualMarijuana Use Days9 Month24.71 Number of DaysStandard Deviation 34.73
Treatment as UsualMarijuana Use Days3 Month20.16 Number of DaysStandard Deviation 28.71
Treatment as UsualMarijuana Use DaysBaseline19.00 Number of DaysStandard Deviation 29.3
Treatment as UsualMarijuana Use Days6 Month19.50 Number of DaysStandard Deviation 28.25
Treatment as UsualMarijuana Use Days12 Month18.50 Number of DaysStandard Deviation 24.07
p-value: 0.73Negative Binomial Regression
p-value: 0.64Negative Binomial Regression
p-value: 0.89Negative Binomial Regression
p-value: 0.78Negative Binomial Regression
Secondary

Alcohol Use Days

The self-reported number of alcohol use days in the past 30 days

Time frame: baseline, 3 months, 6 months, 9 months, 12 months

Population: Intent to treat population

ArmMeasureGroupValue (MEAN)Dispersion
Clinic-based DeliveryAlcohol Use Days9 Month15.00 Number of DaysStandard Deviation 14.34
Clinic-based DeliveryAlcohol Use Days3 Month20.60 Number of DaysStandard Deviation 17.52
Clinic-based DeliveryAlcohol Use DaysBaseline20.17 Number of DaysStandard Deviation 17.82
Clinic-based DeliveryAlcohol Use Days6 Month18.78 Number of DaysStandard Deviation 18.63
Clinic-based DeliveryAlcohol Use Days12 Month20.91 Number of DaysStandard Deviation 23.34
Remote DeliveryAlcohol Use Days6 Month9.78 Number of DaysStandard Deviation 10.49
Remote DeliveryAlcohol Use DaysBaseline13.71 Number of DaysStandard Deviation 15.35
Remote DeliveryAlcohol Use Days9 Month14.61 Number of DaysStandard Deviation 15.84
Remote DeliveryAlcohol Use Days3 Month12.06 Number of DaysStandard Deviation 12.54
Remote DeliveryAlcohol Use Days12 Month13.50 Number of DaysStandard Deviation 22.15
Multi-modal DeliveryAlcohol Use Days9 Month13.27 Number of DaysStandard Deviation 17.27
Multi-modal DeliveryAlcohol Use Days12 Month22.33 Number of DaysStandard Deviation 18.49
Multi-modal DeliveryAlcohol Use Days3 Month13.45 Number of DaysStandard Deviation 13.57
Multi-modal DeliveryAlcohol Use Days6 Month10.15 Number of DaysStandard Deviation 11.01
Multi-modal DeliveryAlcohol Use DaysBaseline17.62 Number of DaysStandard Deviation 20.03
Treatment as UsualAlcohol Use Days12 Month15.30 Number of DaysStandard Deviation 23.76
Treatment as UsualAlcohol Use Days3 Month16.89 Number of DaysStandard Deviation 15.49
Treatment as UsualAlcohol Use Days6 Month17.36 Number of DaysStandard Deviation 15.96
Treatment as UsualAlcohol Use Days9 Month17.43 Number of DaysStandard Deviation 14.05
Treatment as UsualAlcohol Use DaysBaseline17.27 Number of DaysStandard Deviation 15.22
p-value: 0.5Negative Binomial Regression
p-value: 0.34Negative Binomial Regression
p-value: 0.66Negative Binomial Regression
p-value: 0.43Negative Binomial Regression

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026