Last reviewed · How we verify

NCT03577301: YMHP

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

Completed NA Results posted Last updated 3 September 2024
What this trial tests

NA trial testing Clinic-based Delivery in HIV Infections in 83 participants. Completed in 31 May 2022.

Timeline
4 October 2018
Primary endpoint
31 May 2022
31 May 2022

Quick facts

Lead sponsorFlorida State University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment83
Start date4 October 2018
Primary completion31 May 2022
Estimated completion31 May 2022
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Florida State University

Who can join

Adults 15 to 24, male only, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Illicit Drug Use Days Primary · baseline, 3 months, 6 months, 9 months, 12 months

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

Use at Baseline
GroupValue95% CI
Clinic-based Delivery3.17± 4.10
Remote Delivery3.10± 7.37
Multi-modal Delivery3.25± 5.99
Treatment as Usual2.86± 6.76
Use at 3 Months
GroupValue95% CI
Clinic-based Delivery9.00± 19.16
Remote Delivery5.12± 10.89
Multi-modal Delivery2.55± 5.66
Treatment as Usual9.21± 29.62
Use at 6 Months
GroupValue95% CI
Clinic-based Delivery9.64± 24.38
Remote Delivery5.93± 16.04
Multi-modal Delivery3.23± 9.03
Treatment as Usual2.64± 6.17
Use at 9 Months
GroupValue95% CI
Clinic-based Delivery1.58± 3.70
Remote Delivery3.46± 8.35
Multi-modal Delivery7.45± 23.09
Treatment as Usual10.93± 34.99
Use at 12 Months
GroupValue95% CI
Clinic-based Delivery9.91± 27.70
Remote Delivery3.80± 9.27
Multi-modal Delivery1.00± 1.89
Treatment as Usual1.33± 1.21
Condomless Anal Sex Acts Primary · baseline, 3 months, 6 months, 9 months, 12 months

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

Baseline
GroupValue95% CI
Clinic-based Delivery5.9± 4.91
Remote Delivery4.5± 8.6
Multi-modal Delivery6.9± 8.98
Treatment as Usual10.0± 14.54
3 Month
GroupValue95% CI
Clinic-based Delivery3.1± 4.44
Remote Delivery5.9± 12.81
Multi-modal Delivery6.8± 10.20
Treatment as Usual10.2± 20.20
6 Month
GroupValue95% CI
Clinic-based Delivery5.4± 8.18
Remote Delivery4.4± 10.57
Multi-modal Delivery8.9± 13.74
Treatment as Usual10.6± 23.93
9 Month
GroupValue95% CI
Clinic-based Delivery11.0± 14.75
Remote Delivery13.6± 30.07
Multi-modal Delivery13.2± 18.19
Treatment as Usual20.6± 48.34
12 Month
GroupValue95% CI
Clinic-based Delivery10.8± 18.30
Remote Delivery2.3± 5.58
Multi-modal Delivery11.9± 16.98
Treatment as Usual1.2± 1.30
Marijuana Use Days Primary · baseline, 3 months, 6 months, 9 months, 12 months

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

Baseline
GroupValue95% CI
Clinic-based Delivery31.38± 34.01
Remote Delivery34.09± 38.48
Multi-modal Delivery32.00± 35.40
Treatment as Usual19.00± 29.30
3 Month
GroupValue95% CI
Clinic-based Delivery40.00± 37.21
Remote Delivery32.75± 36.56
Multi-modal Delivery26.00± 32.66
Treatment as Usual20.16± 28.71
6 Month
GroupValue95% CI
Clinic-based Delivery41.71± 38.43
Remote Delivery32.57± 35.67
Multi-modal Delivery28.77± 32.72
Treatment as Usual19.50± 28.25
9 Month
GroupValue95% CI
Clinic-based Delivery42.00± 41.60
Remote Delivery33.08± 35.44
Multi-modal Delivery22.27± 30.05
Treatment as Usual24.71± 34.73
12 Month
GroupValue95% CI
Clinic-based Delivery41.82± 36.61
Remote Delivery37.20± 38.60
Multi-modal Delivery34.80± 38.01
Treatment as Usual18.50± 24.07
Alcohol Use Days Secondary · baseline, 3 months, 6 months, 9 months, 12 months

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

Baseline
GroupValue95% CI
Clinic-based Delivery20.17± 17.82
Remote Delivery13.71± 15.35
Multi-modal Delivery17.62± 20.03
Treatment as Usual17.27± 15.22
3 Month
GroupValue95% CI
Clinic-based Delivery20.60± 17.52
Remote Delivery12.06± 12.54
Multi-modal Delivery13.45± 13.57
Treatment as Usual16.89± 15.49
6 Month
GroupValue95% CI
Clinic-based Delivery18.78± 18.63
Remote Delivery9.78± 10.49
Multi-modal Delivery10.15± 11.01
Treatment as Usual17.36± 15.96
9 Month
GroupValue95% CI
Clinic-based Delivery15.00± 14.34
Remote Delivery14.61± 15.84
Multi-modal Delivery13.27± 17.27
Treatment as Usual17.43± 14.05
12 Month
GroupValue95% CI
Clinic-based Delivery20.91± 23.34
Remote Delivery13.50± 22.15
Multi-modal Delivery22.33± 18.49
Treatment as Usual15.30± 23.76

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for HIV Infections

Currently open trials in the same condition.

Other Florida State University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03577301.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing