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Clinic-Based Delivery of the Young Men's Health Project (YMHP) Targeting HIV Risk Reduction and Substance Use Among Young Men Who Have Sex with Men: Protocol for a Type 2, Hybrid Implementation-Effectiveness Trial.
JMIR Res Protoc. 2019 May 21; 8(5):e11184.JR

Abstract

BACKGROUND

Young men who have sex with men (YMSM) are disproportionately at risk for HIV and sexually transmitted infections. Adapting and testing the effectiveness of the Young Men's Health Project (YMHP), an efficacious intervention designed to reduce substance use and condomless anal sex (CAS) among YMSM, at clinics in Miami, Detroit, and Philadelphia has the potential to reduce HIV and STI disparities among urban YMSM.

OBJECTIVE

This study (Adolescent Medicine Trials Network for HIV/AIDS Interventions [ATN] 145 YMHP) aims to adapt YMHP for clinic and remote delivery by existing clinic staff and compare their effectiveness in real-world adolescent HIV clinics. This protocol is part of the ATN Scale It Up program described in a recently published article by Naar et al.

METHODS

This is a comparative effectiveness hybrid type-2 trial of the YMHP intervention with 2 delivery formats-clinic-based versus remote delivery-offered following HIV counseling and testing. Phase 1 includes conducting focus groups with youth to obtain implementation feedback about the delivery of the YMHP intervention and intervention components to ensure culturally competent, feasible, and scalable implementation. Phase 2 includes recruitment and enrollment of 270 YMSM, aged 15 to 24 years, 90 at each of the 3 sites. Enrollment will be limited to HIV-negative YMSM who report recent substance use and either CAS or a positive STI test result. Participants will be randomized to receive the YMHP intervention either in person or by remote delivery. Both conditions involve completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis information and navigation services. A minimum of 2 community health workers (CHWs) will be trained to deliver the intervention sessions at each site. Sessions will be audio-recorded for Motivational Interviewing Treatment Integrity (MITI) fidelity coding, and CHWs and supervisors will be given implementation support throughout the study period.

RESULTS

Phase 1 focus groups were completed in July 2017 (n=25). Feedback from these focus groups at the 3 sites informed adaptations to the YMHP intervention manual, implementation of the intervention, and recruitment plans for phase 2. Baseline enrollment for phase 2 began in November 2018, and assessments will be at immediate posttest (IP)-, 3-, 6-, 9-, and 12-months after the intervention. Upon collection of both baseline and follow-up data, we will compare the effectiveness and cost-effectiveness of clinic-based versus remote delivery of YMHP in the context of health care access.

CONCLUSIONS

We are conducting YMHP in 3 cities with high rates of YMSM at risk for HIV and STIs. When adapted for real-world clinics, this study will help substance-using YMSM at risk for HIV and STIs and allow us to examine differences in effectiveness and cost by the method of delivery.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03488914; https://clinicaltrials.gov/ct2/show/NCT03488914 (Archived by WebCite at http://www.webcitation.org/770WaWWfi).

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)

DERR1-10.2196/11184.

Authors+Show Affiliations

Center for HIV Educational Studies and Training, Hunter College, City University of New York, New York, NY, United States. Hunter Department of Psychology, Hunter College, City University of New York, New York, NY, United States. Health Psychology and Clinical Science Doctoral Program, Graduate Center, City University of New York, New York, NY, United States.Center for HIV Educational Studies and Training, Hunter College, City University of New York, New York, NY, United States. Hunter Department of Psychology, Hunter College, City University of New York, New York, NY, United States. Health Psychology and Clinical Science Doctoral Program, Graduate Center, City University of New York, New York, NY, United States.Center for HIV Educational Studies and Training, Hunter College, City University of New York, New York, NY, United States.Center for HIV Educational Studies and Training, Hunter College, City University of New York, New York, NY, United States.Center for HIV Educational Studies and Training, Hunter College, City University of New York, New York, NY, United States.College of Medicine, Florida State University, Tallahassee, FL, United States.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31115346

Citation

Parsons, Jeffrey T., et al. "Clinic-Based Delivery of the Young Men's Health Project (YMHP) Targeting HIV Risk Reduction and Substance Use Among Young Men Who Have Sex With Men: Protocol for a Type 2, Hybrid Implementation-Effectiveness Trial." JMIR Research Protocols, vol. 8, no. 5, 2019, pp. e11184.
Parsons JT, Starks T, Gurung S, et al. Clinic-Based Delivery of the Young Men's Health Project (YMHP) Targeting HIV Risk Reduction and Substance Use Among Young Men Who Have Sex with Men: Protocol for a Type 2, Hybrid Implementation-Effectiveness Trial. JMIR Res Protoc. 2019;8(5):e11184.
Parsons, J. T., Starks, T., Gurung, S., Cain, D., Marmo, J., & Naar, S. (2019). Clinic-Based Delivery of the Young Men's Health Project (YMHP) Targeting HIV Risk Reduction and Substance Use Among Young Men Who Have Sex with Men: Protocol for a Type 2, Hybrid Implementation-Effectiveness Trial. JMIR Research Protocols, 8(5), e11184. https://doi.org/10.2196/11184
Parsons JT, et al. Clinic-Based Delivery of the Young Men's Health Project (YMHP) Targeting HIV Risk Reduction and Substance Use Among Young Men Who Have Sex With Men: Protocol for a Type 2, Hybrid Implementation-Effectiveness Trial. JMIR Res Protoc. 2019 May 21;8(5):e11184. PubMed PMID: 31115346.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinic-Based Delivery of the Young Men's Health Project (YMHP) Targeting HIV Risk Reduction and Substance Use Among Young Men Who Have Sex with Men: Protocol for a Type 2, Hybrid Implementation-Effectiveness Trial. AU - Parsons,Jeffrey T, AU - Starks,Tyrel, AU - Gurung,Sitaji, AU - Cain,Demetria, AU - Marmo,Jonathan, AU - Naar,Sylvie, Y1 - 2019/05/21/ PY - 2018/05/30/received PY - 2019/01/31/accepted PY - 2018/12/31/revised PY - 2019/5/23/entrez PY - 2019/5/23/pubmed PY - 2019/5/23/medline KW - HIV KW - adolescents KW - comparative effectiveness research KW - men who have sex with men KW - motivational interviewing SP - e11184 EP - e11184 JF - JMIR research protocols JO - JMIR Res Protoc VL - 8 IS - 5 N2 - BACKGROUND: Young men who have sex with men (YMSM) are disproportionately at risk for HIV and sexually transmitted infections. Adapting and testing the effectiveness of the Young Men's Health Project (YMHP), an efficacious intervention designed to reduce substance use and condomless anal sex (CAS) among YMSM, at clinics in Miami, Detroit, and Philadelphia has the potential to reduce HIV and STI disparities among urban YMSM. OBJECTIVE: This study (Adolescent Medicine Trials Network for HIV/AIDS Interventions [ATN] 145 YMHP) aims to adapt YMHP for clinic and remote delivery by existing clinic staff and compare their effectiveness in real-world adolescent HIV clinics. This protocol is part of the ATN Scale It Up program described in a recently published article by Naar et al. METHODS: This is a comparative effectiveness hybrid type-2 trial of the YMHP intervention with 2 delivery formats-clinic-based versus remote delivery-offered following HIV counseling and testing. Phase 1 includes conducting focus groups with youth to obtain implementation feedback about the delivery of the YMHP intervention and intervention components to ensure culturally competent, feasible, and scalable implementation. Phase 2 includes recruitment and enrollment of 270 YMSM, aged 15 to 24 years, 90 at each of the 3 sites. Enrollment will be limited to HIV-negative YMSM who report recent substance use and either CAS or a positive STI test result. Participants will be randomized to receive the YMHP intervention either in person or by remote delivery. Both conditions involve completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis information and navigation services. A minimum of 2 community health workers (CHWs) will be trained to deliver the intervention sessions at each site. Sessions will be audio-recorded for Motivational Interviewing Treatment Integrity (MITI) fidelity coding, and CHWs and supervisors will be given implementation support throughout the study period. RESULTS: Phase 1 focus groups were completed in July 2017 (n=25). Feedback from these focus groups at the 3 sites informed adaptations to the YMHP intervention manual, implementation of the intervention, and recruitment plans for phase 2. Baseline enrollment for phase 2 began in November 2018, and assessments will be at immediate posttest (IP)-, 3-, 6-, 9-, and 12-months after the intervention. Upon collection of both baseline and follow-up data, we will compare the effectiveness and cost-effectiveness of clinic-based versus remote delivery of YMHP in the context of health care access. CONCLUSIONS: We are conducting YMHP in 3 cities with high rates of YMSM at risk for HIV and STIs. When adapted for real-world clinics, this study will help substance-using YMSM at risk for HIV and STIs and allow us to examine differences in effectiveness and cost by the method of delivery. TRIAL REGISTRATION: ClinicalTrials.gov NCT03488914; https://clinicaltrials.gov/ct2/show/NCT03488914 (Archived by WebCite at http://www.webcitation.org/770WaWWfi). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11184. SN - 1929-0748 UR - https://www.unboundmedicine.com/medline/citation/31115346/Clinic_Based_Delivery_of_the_Young_Men's_Health_Project__YMHP__Targeting_HIV_Risk_Reduction_and_Substance_Use_Among_Young_Men_Who_Have_Sex_with_Men:_Protocol_for_a_Type_2_Hybrid_Implementation_Effectiveness_Trial_ L2 - https://www.researchprotocols.org/2019/5/e11184/ DB - PRIME DP - Unbound Medicine ER -
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