Testing an Intervention to Increase HIV Self-Testing Among Young, Black MSM

HIV Testing Clinical Trial

— TRUST  

Official title:

Testing an Intervention to Increase HIV Self-Testing Among Young, Black MSM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04210271
• Other study ID #: 648283
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2018

Study information

• Verified date: December 2019
• Source: New York Blood Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators propose a study to design and test a brief intervention to increase uptake of consistent HIV self-testing among YBMSM using a novel and culturally-relevant "buddy system" approach. In the model, peer educators train pairs of YBMSM (or "buddies") to initiate self-testing and support each other in consistent self-testing (past 3 months) and sexual and AOD use risk reduction.

The specific aims of this developmental R01 study are:

1. To conduct qualitative formative research to adapt couples testing for self-testing with a buddy;

2. To assess the preliminary efficacy of the intervention to increase the proportion of YBMSM who self-test regularly over 12 months using a 2-arm randomized, controlled study design.

Description:

Increasing HIV testing rates among young, Black men who have sex with men (YBMSM) is critical to reducing the disproportionate disease burden in the Black community. MSM comprised almost two-thirds of new HIV diagnoses in the United States (US) in 2010. We propose a study to design and test a brief intervention to increase uptake of consistent HIV self-testing among YBMSM using a novel and culturally-relevant "buddy system" approach. In our model, peer educators train pairs of YBMSM (or "buddies") to initiate self-testing and support each other in consistent self-testing (past 3 months) and sexual and AOD use risk reduction. We propose a study to design and test a brief intervention to increase uptake of consistent HIV self-testing among YBMSM using a novel and culturally-relevant "buddy system" approach. In the model, peer educators train pairs of YBMSM (or "buddies") to initiate self-testing and support each other in consistent self-testing (past 3 months) and sexual and AOD use risk reduction.

The specific aims of this developmental R01 study are:

1. To conduct qualitative formative research to adapt couples testing for self-testing with a buddy;

2. To assess the preliminary efficacy of the intervention to increase the proportion of YBMSM who self-test regularly (i.e., past three months) over 12 months using a 2-arm randomized, controlled study design.

The investigators will achieve the aims of the study in three phases, recruiting YBMSM using web- and app-based approaches. In Phase 1, the investigators conducted 30 in-depth interviews to identify barriers to, facilitators of, perceptions of and preferences for regular HIV self-testing, describe how AOD use and sexual behavior influence HIV self-testing behaviors, and assess participant perspectives on the proposed buddy intervention. In Phase 2, based on the formative research, the investigators adapted couples testing, integrating enhanced motivational interviewing techniques to create a brief, peer educator-delivered, face-to-face intervention. In Phase 3, for which the investigators currently seek IRB approval, the investigators will use web- and app-based, face-to-face and word-of-mouth approaches to recruit 376 HIV-negative, BMSM aged 18 to 34 who will be randomized as pairs to either the intervention arm (HIV testing together, HIV self-testing screening information and skills training; free test kits on demand; tailored booster messages) or the control arm (HIV testing separately, generic health screening information; free test kits on demand) and followed for 12 months to estimate the intervention's efficacy in increasing regular HIV self-testing according to self-report. If demonstrated to be efficacious, this innovative and efficient approach can be adapted easily for widespread distribution, with the potential to diffuse along naturally occurring, social networks among YBMSM.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 34 Years

Eligibility

Inclusion Criteria:

• biological male at birth

• between 18 and 34 years of age

• self-identify Black, African American, Caribbean Black, African Black, multiethnic Black OR Latino/Hispanic

• reside in the NYC metropolitan area

• not HIV-infected (self-report)

• report insertive or receptive anal intercourse with another man in the past year

• ability to communicate in English

• provide informed consent for the study.

• willing to participate in the study with a friend or buddy.

Exclusion Criteria:

• currently enrolled in any other HIV research study involving HIV testing or an HIV vaccine trial

Related Conditions & MeSH terms

• HIV Testing

Intervention

Behavioral:
• Buddy self-testing condition

• Control self-screening condition

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New York Blood Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consistent HIV self-testing	One or more HIV self-test in past three months	12 months
Primary	Consistent HIV testing	One or more HIV test (any type) in past three months	12 months