HIV Infections
Conditions
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
A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based intervention sessions.
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.
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Illicit Drug Use Days | 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 |
| Condomless Anal Sex Acts | 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. |
| Marijuana Use Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Use Days | baseline, 3 months, 6 months, 9 months, 12 months | The self-reported number of alcohol use days in the past 30 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 83 |
Baseline characteristics
| Characteristic | Multi-modal Delivery | Treatment as Usual | Total | Clinic-based Delivery | Remote Delivery |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 1 Participants | 12 Participants | 1 Participants | 7 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 21 Participants | 71 Participants | 23 Participants | 14 Participants |
| Education 4-Year College Degree or more | 2 Participants | 5 Participants | 15 Participants | 6 Participants | 2 Participants |
| Education Some college of Associates Degree | 12 Participants | 13 Participants | 45 Participants | 10 Participants | 10 Participants |
| Education Some High School | 2 Participants | 4 Participants | 23 Participants | 8 Participants | 9 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 6 Participants | 9 Participants | 31 Participants | 7 Participants | 9 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Latino | 8 Participants | 7 Participants | 30 Participants | 9 Participants | 6 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other/Multiracial | 0 Participants | 1 Participants | 8 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 2 Participants | 5 Participants | 14 Participants | 4 Participants | 3 Participants |
| Relationship Status Partnered | 10 Participants | 11 Participants | 36 Participants | 8 Participants | 7 Participants |
| Relationship Status Single | 6 Participants | 11 Participants | 47 Participants | 16 Participants | 14 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 16 Participants | 22 Participants | 83 Participants | 24 Participants | 21 Participants |
| Sexual Identity Bisexual/Other | 4 Participants | 5 Participants | 19 Participants | 6 Participants | 4 Participants |
| Sexual Identity Gay/Queer | 12 Participants | 17 Participants | 64 Participants | 18 Participants | 17 Participants |
| Site Site 1 | 2 Participants | 5 Participants | 16 Participants | 4 Participants | 5 Participants |
| Site Site 2 | 14 Participants | 13 Participants | 50 Participants | 12 Participants | 11 Participants |
| Site Site 3 | 0 Participants | 4 Participants | 17 Participants | 8 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 21 | 0 / 16 | 0 / 22 |
| other Total, other adverse events | 0 / 24 | 0 / 21 | 0 / 16 | 0 / 22 |
| serious Total, serious adverse events | 0 / 24 | 0 / 21 | 0 / 16 | 0 / 22 |
Outcome results
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinic-based Delivery | Condomless Anal Sex Acts | 9 Month | 11.0 Acts in the past 30 days | Standard Deviation 14.75 |
| Clinic-based Delivery | Condomless Anal Sex Acts | 3 Month | 3.1 Acts in the past 30 days | Standard Deviation 4.44 |
| Clinic-based Delivery | Condomless Anal Sex Acts | 12 Month | 10.8 Acts in the past 30 days | Standard Deviation 18.3 |
| Clinic-based Delivery | Condomless Anal Sex Acts | 6 Month | 5.4 Acts in the past 30 days | Standard Deviation 8.18 |
| Clinic-based Delivery | Condomless Anal Sex Acts | Baseline | 5.9 Acts in the past 30 days | Standard Deviation 4.91 |
| Remote Delivery | Condomless Anal Sex Acts | 6 Month | 4.4 Acts in the past 30 days | Standard Deviation 10.57 |
| Remote Delivery | Condomless Anal Sex Acts | 9 Month | 13.6 Acts in the past 30 days | Standard Deviation 30.07 |
| Remote Delivery | Condomless Anal Sex Acts | 12 Month | 2.3 Acts in the past 30 days | Standard Deviation 5.58 |
| Remote Delivery | Condomless Anal Sex Acts | 3 Month | 5.9 Acts in the past 30 days | Standard Deviation 12.81 |
| Remote Delivery | Condomless Anal Sex Acts | Baseline | 4.5 Acts in the past 30 days | Standard Deviation 8.6 |
| Multi-modal Delivery | Condomless Anal Sex Acts | 6 Month | 8.9 Acts in the past 30 days | Standard Deviation 13.74 |
| Multi-modal Delivery | Condomless Anal Sex Acts | Baseline | 6.9 Acts in the past 30 days | Standard Deviation 8.98 |
| Multi-modal Delivery | Condomless Anal Sex Acts | 3 Month | 6.8 Acts in the past 30 days | Standard Deviation 10.2 |
| Multi-modal Delivery | Condomless Anal Sex Acts | 9 Month | 13.2 Acts in the past 30 days | Standard Deviation 18.19 |
| Multi-modal Delivery | Condomless Anal Sex Acts | 12 Month | 11.9 Acts in the past 30 days | Standard Deviation 16.98 |
| Treatment as Usual | Condomless Anal Sex Acts | 9 Month | 20.6 Acts in the past 30 days | Standard Deviation 48.34 |
| Treatment as Usual | Condomless Anal Sex Acts | 3 Month | 10.2 Acts in the past 30 days | Standard Deviation 20.2 |
| Treatment as Usual | Condomless Anal Sex Acts | Baseline | 10.0 Acts in the past 30 days | Standard Deviation 14.54 |
| Treatment as Usual | Condomless Anal Sex Acts | 6 Month | 10.6 Acts in the past 30 days | Standard Deviation 23.93 |
| Treatment as Usual | Condomless Anal Sex Acts | 12 Month | 1.2 Acts in the past 30 days | Standard Deviation 1.3 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinic-based Delivery | Illicit Drug Use Days | Use at 9 Months | 1.58 Number of Days | Standard Deviation 3.7 |
| Clinic-based Delivery | Illicit Drug Use Days | Use at 3 Months | 9.00 Number of Days | Standard Deviation 19.16 |
| Clinic-based Delivery | Illicit Drug Use Days | Use at 12 Months | 9.91 Number of Days | Standard Deviation 27.7 |
| Clinic-based Delivery | Illicit Drug Use Days | Use at 6 Months | 9.64 Number of Days | Standard Deviation 24.38 |
| Clinic-based Delivery | Illicit Drug Use Days | Use at Baseline | 3.17 Number of Days | Standard Deviation 4.1 |
| Remote Delivery | Illicit Drug Use Days | Use at 6 Months | 5.93 Number of Days | Standard Deviation 16.04 |
| Remote Delivery | Illicit Drug Use Days | Use at 9 Months | 3.46 Number of Days | Standard Deviation 8.35 |
| Remote Delivery | Illicit Drug Use Days | Use at 12 Months | 3.80 Number of Days | Standard Deviation 9.27 |
| Remote Delivery | Illicit Drug Use Days | Use at 3 Months | 5.12 Number of Days | Standard Deviation 10.89 |
| Remote Delivery | Illicit Drug Use Days | Use at Baseline | 3.10 Number of Days | Standard Deviation 7.37 |
| Multi-modal Delivery | Illicit Drug Use Days | Use at 6 Months | 3.23 Number of Days | Standard Deviation 9.03 |
| Multi-modal Delivery | Illicit Drug Use Days | Use at Baseline | 3.25 Number of Days | Standard Deviation 5.99 |
| Multi-modal Delivery | Illicit Drug Use Days | Use at 3 Months | 2.55 Number of Days | Standard Deviation 5.66 |
| Multi-modal Delivery | Illicit Drug Use Days | Use at 9 Months | 7.45 Number of Days | Standard Deviation 23.09 |
| Multi-modal Delivery | Illicit Drug Use Days | Use at 12 Months | 1.00 Number of Days | Standard Deviation 1.89 |
| Treatment as Usual | Illicit Drug Use Days | Use at 9 Months | 10.93 Number of Days | Standard Deviation 34.99 |
| Treatment as Usual | Illicit Drug Use Days | Use at 3 Months | 9.21 Number of Days | Standard Deviation 29.62 |
| Treatment as Usual | Illicit Drug Use Days | Use at Baseline | 2.86 Number of Days | Standard Deviation 6.76 |
| Treatment as Usual | Illicit Drug Use Days | Use at 6 Months | 2.64 Number of Days | Standard Deviation 6.17 |
| Treatment as Usual | Illicit Drug Use Days | Use at 12 Months | 1.33 Number of Days | Standard Deviation 1.21 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinic-based Delivery | Marijuana Use Days | 9 Month | 42.00 Number of Days | Standard Deviation 41.6 |
| Clinic-based Delivery | Marijuana Use Days | 3 Month | 40.00 Number of Days | Standard Deviation 37.21 |
| Clinic-based Delivery | Marijuana Use Days | 12 Month | 41.82 Number of Days | Standard Deviation 36.61 |
| Clinic-based Delivery | Marijuana Use Days | 6 Month | 41.71 Number of Days | Standard Deviation 38.43 |
| Clinic-based Delivery | Marijuana Use Days | Baseline | 31.38 Number of Days | Standard Deviation 34.01 |
| Remote Delivery | Marijuana Use Days | 6 Month | 32.57 Number of Days | Standard Deviation 35.67 |
| Remote Delivery | Marijuana Use Days | 9 Month | 33.08 Number of Days | Standard Deviation 35.44 |
| Remote Delivery | Marijuana Use Days | 12 Month | 37.20 Number of Days | Standard Deviation 38.6 |
| Remote Delivery | Marijuana Use Days | 3 Month | 32.75 Number of Days | Standard Deviation 36.56 |
| Remote Delivery | Marijuana Use Days | Baseline | 34.09 Number of Days | Standard Deviation 38.48 |
| Multi-modal Delivery | Marijuana Use Days | 6 Month | 28.77 Number of Days | Standard Deviation 32.72 |
| Multi-modal Delivery | Marijuana Use Days | Baseline | 32.00 Number of Days | Standard Deviation 35.4 |
| Multi-modal Delivery | Marijuana Use Days | 3 Month | 26.00 Number of Days | Standard Deviation 32.66 |
| Multi-modal Delivery | Marijuana Use Days | 9 Month | 22.27 Number of Days | Standard Deviation 30.05 |
| Multi-modal Delivery | Marijuana Use Days | 12 Month | 34.80 Number of Days | Standard Deviation 38.01 |
| Treatment as Usual | Marijuana Use Days | 9 Month | 24.71 Number of Days | Standard Deviation 34.73 |
| Treatment as Usual | Marijuana Use Days | 3 Month | 20.16 Number of Days | Standard Deviation 28.71 |
| Treatment as Usual | Marijuana Use Days | Baseline | 19.00 Number of Days | Standard Deviation 29.3 |
| Treatment as Usual | Marijuana Use Days | 6 Month | 19.50 Number of Days | Standard Deviation 28.25 |
| Treatment as Usual | Marijuana Use Days | 12 Month | 18.50 Number of Days | Standard Deviation 24.07 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinic-based Delivery | Alcohol Use Days | 9 Month | 15.00 Number of Days | Standard Deviation 14.34 |
| Clinic-based Delivery | Alcohol Use Days | 3 Month | 20.60 Number of Days | Standard Deviation 17.52 |
| Clinic-based Delivery | Alcohol Use Days | Baseline | 20.17 Number of Days | Standard Deviation 17.82 |
| Clinic-based Delivery | Alcohol Use Days | 6 Month | 18.78 Number of Days | Standard Deviation 18.63 |
| Clinic-based Delivery | Alcohol Use Days | 12 Month | 20.91 Number of Days | Standard Deviation 23.34 |
| Remote Delivery | Alcohol Use Days | 6 Month | 9.78 Number of Days | Standard Deviation 10.49 |
| Remote Delivery | Alcohol Use Days | Baseline | 13.71 Number of Days | Standard Deviation 15.35 |
| Remote Delivery | Alcohol Use Days | 9 Month | 14.61 Number of Days | Standard Deviation 15.84 |
| Remote Delivery | Alcohol Use Days | 3 Month | 12.06 Number of Days | Standard Deviation 12.54 |
| Remote Delivery | Alcohol Use Days | 12 Month | 13.50 Number of Days | Standard Deviation 22.15 |
| Multi-modal Delivery | Alcohol Use Days | 9 Month | 13.27 Number of Days | Standard Deviation 17.27 |
| Multi-modal Delivery | Alcohol Use Days | 12 Month | 22.33 Number of Days | Standard Deviation 18.49 |
| Multi-modal Delivery | Alcohol Use Days | 3 Month | 13.45 Number of Days | Standard Deviation 13.57 |
| Multi-modal Delivery | Alcohol Use Days | 6 Month | 10.15 Number of Days | Standard Deviation 11.01 |
| Multi-modal Delivery | Alcohol Use Days | Baseline | 17.62 Number of Days | Standard Deviation 20.03 |
| Treatment as Usual | Alcohol Use Days | 12 Month | 15.30 Number of Days | Standard Deviation 23.76 |
| Treatment as Usual | Alcohol Use Days | 3 Month | 16.89 Number of Days | Standard Deviation 15.49 |
| Treatment as Usual | Alcohol Use Days | 6 Month | 17.36 Number of Days | Standard Deviation 15.96 |
| Treatment as Usual | Alcohol Use Days | 9 Month | 17.43 Number of Days | Standard Deviation 14.05 |
| Treatment as Usual | Alcohol Use Days | Baseline | 17.27 Number of Days | Standard Deviation 15.22 |