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Adolescent Male Couples-Based HIV Testing Intervention (We Test): Protocol for a Type 1, Hybrid Implementation-Effectiveness Trial.
JMIR Res Protoc. 2019 Jun 07; 8(6):e11186.JR

Abstract

BACKGROUND

Young men who have sex with men (YMSM), particularly those who are partnered, are at unique risk for HIV. YMSM are among those at highest risk for HIV. Meanwhile, despite the fact that primary partners account for many-possibly most-new HIV infections, partnered men who have sex with men perceive themselves to be at much lower risk for HIV infection and therefore test less often than single men. In response to the risk of primary partner HIV transmission, couples HIV testing and counseling (CHTC) procedures have been developed for use in adult populations. Although promising, YMSM couples may require additional support to complete CHTC given their developmental context in which sexual and romantic relationships are relatively new, and communication skills are emergent.

OBJECTIVE

The aim of this study was to test the additive benefit of adjunct treatment components tailored for YMSM, which enhance communication skills before the completion of CHTC. The intervention tests a continuum of prevention packages including assertive communication training videos and motivational interviewing focused on assisting with identification and development (MI-AID) before entering into the dyadic intervention components. This protocol is part of the Adolescent Medicine Trials Network (ATN) Scale It Up program described in this issue.

METHODS

This is a comparative effectiveness trial that will be executed in 3 phases. Phase 1 will gather qualitative data related to intervention development and implementation from partnered YMSM at 4 subject recruitment venues (SRVs). Phase 2 will compare a continuum of these interventions in a pilot randomized controlled trial (RCT) at 2 SRVs. Phase 3 will compare the most successful adapted intervention package from phase 2 to CHTC as usual in a larger RCT at 4 SRVs. This phase is focused on implementation and sustainment phases of the Exploration, Preparation, Implementation, and Sustainment framework.

RESULTS

Phase 1 data will be drawn from qualitative interviews with partnered YMSM (n=24) and staff from ATN sites (n=20). Baseline enrollment for phase 2 is expected to begin across 2 SRVs in June 2018 (ncouples=36). In phase 2, survey data collection along with HIV and sexually transmitted infection (STI) testing will occur at baseline, and 1- and 3-month (postintervention) follow-ups. Phase 3 will begin enrollment across 4 SRVs in September 2019 (ncouples=144) and follow-ups will occur at 1, 3, 6, and 9 months postintervention.

CONCLUSIONS

Although MI-AID, video-based assertive communication training, and CHTC have established efficacy when administered on their own, this study will be the first to evaluate the strongest adjunctive version of these interventions to address the specific developmental needs of partnered YMSM.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03386110; http://clinicaltrials.gov/ct2/show/NCT03386110 (Archived by WebCite at http://www.webcitation.org/75mlO7GCx).

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)

DERR1-10.2196/11186.

Authors+Show Affiliations

Center for HIV Educational Studies and Training, Hunter College, City University of New York, New York, NY, United States. Hunter College 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.Department of Psychiatry, Oregon Health & Science University, Portland, OR, United States.Department of Psychiatry, Oregon Health & Science University, Portland, OR, United States. Center to Improve Veteran Involvement in Care, VA Portland Health Care System, Portland, OR, 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.Center for HIV Educational Studies and Training, Hunter College, City University of New York, New York, NY, United States. Hunter College 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.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31199341

Citation

Starks, Tyrel J., et al. "Adolescent Male Couples-Based HIV Testing Intervention (We Test): Protocol for a Type 1, Hybrid Implementation-Effectiveness Trial." JMIR Research Protocols, vol. 8, no. 6, 2019, pp. e11186.
Starks TJ, Feldstein Ewing SW, Lovejoy T, et al. Adolescent Male Couples-Based HIV Testing Intervention (We Test): Protocol for a Type 1, Hybrid Implementation-Effectiveness Trial. JMIR Res Protoc. 2019;8(6):e11186.
Starks, T. J., Feldstein Ewing, S. W., Lovejoy, T., Gurung, S., Cain, D., Fan, C. A., Naar, S., & Parsons, J. T. (2019). Adolescent Male Couples-Based HIV Testing Intervention (We Test): Protocol for a Type 1, Hybrid Implementation-Effectiveness Trial. JMIR Research Protocols, 8(6), e11186. https://doi.org/10.2196/11186
Starks TJ, et al. Adolescent Male Couples-Based HIV Testing Intervention (We Test): Protocol for a Type 1, Hybrid Implementation-Effectiveness Trial. JMIR Res Protoc. 2019 Jun 7;8(6):e11186. PubMed PMID: 31199341.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Adolescent Male Couples-Based HIV Testing Intervention (We Test): Protocol for a Type 1, Hybrid Implementation-Effectiveness Trial. AU - Starks,Tyrel J, AU - Feldstein Ewing,Sarah W, AU - Lovejoy,Travis, AU - Gurung,Sitaji, AU - Cain,Demetria, AU - Fan,Carolyn A, AU - Naar,Sylvie, AU - Parsons,Jeffrey T, Y1 - 2019/06/07/ PY - 2018/05/30/received PY - 2018/11/16/accepted PY - 2018/10/24/revised PY - 2019/6/15/entrez PY - 2019/6/15/pubmed PY - 2019/6/15/medline KW - HIV KW - adolescents KW - comparative effectiveness research KW - men who have sex with men SP - e11186 EP - e11186 JF - JMIR research protocols JO - JMIR Res Protoc VL - 8 IS - 6 N2 - BACKGROUND: Young men who have sex with men (YMSM), particularly those who are partnered, are at unique risk for HIV. YMSM are among those at highest risk for HIV. Meanwhile, despite the fact that primary partners account for many-possibly most-new HIV infections, partnered men who have sex with men perceive themselves to be at much lower risk for HIV infection and therefore test less often than single men. In response to the risk of primary partner HIV transmission, couples HIV testing and counseling (CHTC) procedures have been developed for use in adult populations. Although promising, YMSM couples may require additional support to complete CHTC given their developmental context in which sexual and romantic relationships are relatively new, and communication skills are emergent. OBJECTIVE: The aim of this study was to test the additive benefit of adjunct treatment components tailored for YMSM, which enhance communication skills before the completion of CHTC. The intervention tests a continuum of prevention packages including assertive communication training videos and motivational interviewing focused on assisting with identification and development (MI-AID) before entering into the dyadic intervention components. This protocol is part of the Adolescent Medicine Trials Network (ATN) Scale It Up program described in this issue. METHODS: This is a comparative effectiveness trial that will be executed in 3 phases. Phase 1 will gather qualitative data related to intervention development and implementation from partnered YMSM at 4 subject recruitment venues (SRVs). Phase 2 will compare a continuum of these interventions in a pilot randomized controlled trial (RCT) at 2 SRVs. Phase 3 will compare the most successful adapted intervention package from phase 2 to CHTC as usual in a larger RCT at 4 SRVs. This phase is focused on implementation and sustainment phases of the Exploration, Preparation, Implementation, and Sustainment framework. RESULTS: Phase 1 data will be drawn from qualitative interviews with partnered YMSM (n=24) and staff from ATN sites (n=20). Baseline enrollment for phase 2 is expected to begin across 2 SRVs in June 2018 (ncouples=36). In phase 2, survey data collection along with HIV and sexually transmitted infection (STI) testing will occur at baseline, and 1- and 3-month (postintervention) follow-ups. Phase 3 will begin enrollment across 4 SRVs in September 2019 (ncouples=144) and follow-ups will occur at 1, 3, 6, and 9 months postintervention. CONCLUSIONS: Although MI-AID, video-based assertive communication training, and CHTC have established efficacy when administered on their own, this study will be the first to evaluate the strongest adjunctive version of these interventions to address the specific developmental needs of partnered YMSM. TRIAL REGISTRATION: ClinicalTrials.gov NCT03386110; http://clinicaltrials.gov/ct2/show/NCT03386110 (Archived by WebCite at http://www.webcitation.org/75mlO7GCx). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11186. SN - 1929-0748 UR - https://www.unboundmedicine.com/medline/citation/31199341/Adolescent_Male_Couples_Based_HIV_Testing_Intervention__We_Test_:_Protocol_for_a_Type_1_Hybrid_Implementation_Effectiveness_Trial_ L2 - https://www.researchprotocols.org/2019/6/e11186/ DB - PRIME DP - Unbound Medicine ER -
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