Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinic-based Delivery | Active Comparator | 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. |
|
| Remote Delivery | Active Comparator | 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. |
|
| Multi-modal Delivery | Active Comparator | 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. |
|
| Treatment as Usual | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinic-based Delivery | Behavioral | A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based intervention sessions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Illicit Drug Use Days | The self-reported number of illicit drug use days (not including marijuana) in the past 30 days | baseline, 3 months, 6 months, 9 months, 12 months |
| 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. | baseline, 3 months, 6 months, 9 months, 12 months |
| Marijuana Use Days | The self-reported number of marijuana use days in the past 30 days prior to assessment point. | baseline, 3 months, 6 months, 9 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Use Days | The self-reported number of alcohol use days in the past 30 days | baseline, 3 months, 6 months, 9 months, 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Born biologically male or currently identifying as male
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sylvie Naar, PhD | Florida State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States | ||
| Wayne State University |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Illicit Drug Use Days | The self-reported number of illicit drug use days (not including marijuana) in the past 30 days | Intent to treat population | Posted | Mean | Standard Deviation | Number of Days | baseline, 3 months, 6 months, 9 months, 12 months |
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sylvie Naar, PhD; Distinguished Endowed Professor | Florida State University | 18506442334 | sylvie.naar@med.fsu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 1, 2021 | May 19, 2023 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 18, 2021 | May 22, 2023 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 3, 2020 | Apr 5, 2024 | ICF_003.pdf |
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006716 | Homosexuality |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Remote Delivery | Behavioral | 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. |
|
| Multi-modal Delivery | Behavioral | 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. |
|
| Detroit |
| Michigan |
| 48202 |
| United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Sexual Identity | Count of Participants | Participants |
|
| Site | Count of Participants | Participants |
|
| Relationship Status | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
|
| 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. | Intent to treat population | Posted | Mean | Standard Deviation | Acts in the past 30 days | baseline, 3 months, 6 months, 9 months, 12 months |
|
|
|
|
| Primary | Marijuana Use Days | The self-reported number of marijuana use days in the past 30 days prior to assessment point. | Intent to treat population | Posted | Mean | Standard Deviation | Number of Days | baseline, 3 months, 6 months, 9 months, 12 months |
|
|
|
|
| Secondary | Alcohol Use Days | The self-reported number of alcohol use days in the past 30 days | Intent to treat population | Posted | Mean | Standard Deviation | Number of Days | baseline, 3 months, 6 months, 9 months, 12 months |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | 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. | 0 | 21 | 0 | 21 | 0 | 21 |
| EG002 | 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. | 0 | 16 | 0 | 16 | 0 | 16 |
| EG003 | 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. | 0 | 22 | 0 | 22 | 0 | 22 |
Not provided
Not provided
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
| 3 Month |
|
| 6 Month |
|
| 9 Month |
|
| 12 Month |
|
| Negative Binomial Regression |
Model testing whether condition predicted condomless anal sex acts at 6 months. |
| 0.74 |
| Wald Chi Square |
| 1.26 |
| 2-Sided |
| Superiority |
| Negative Binomial Regression | Model testing whether condition predicted condomless anal sex acts at 9 months. | 0.74 | Wald Chi Square | 1.27 | 2-Sided | Superiority |
| Negative Binomial Regression | Model testing whether condition predicted condomless anal sex acts at 12 months. | 0.300 | Slope | 3.66 | 2-Sided | Superiority |
| 3 Month |
|
| 6 Month |
|
| 9 Month |
|
| 12 Month |
|
Model testing whether condition predicted marijuana use days at 6 months. |
| 0.64 |
| Wald Chi Square |
| 1.68 |
| 2-Sided |
| Superiority |
| Negative Binomial Regression | Model testing whether condition predicted marijuana use days at 9 months. | 0.89 | Wald Chi Square | 0.64 | 2-Sided | Superiority |
| Negative Binomial Regression | Model testing whether condition predicted marijuana use days at 12 months. | 0.78 | Wald Chi Square | 1.08 | 2-Sided | Superiority |
| 3 Month |
|
| 6 Month |
|
| 9 Month |
|
| 12 Month |
|
Model testing whether condition predicted alcohol use days at 6 months. |
| 0.34 |
| Wald Chi Square |
| 2.98 |
| 2-Sided |
| Superiority |
| Negative Binomial Regression | Model testing whether condition predicted alcohol use days at 9 months. | 0.66 | Wald Chi Square | 1.59 | 2-Sided | Superiority |
| Negative Binomial Regression | Model testing whether condition predicted alcohol use days at 12 months. | 0.43 | Wald Chi Square | 2.74 | 2-Sided | Superiority |