Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04210271
Study type Interventional
Source New York Blood Center
Contact
Status Completed
Phase N/A
Start date June 2016
Completion date December 2018

See also
  Status Clinical Trial Phase
Recruiting NCT04033718 - Inpatient Package to Reduce HIV and AIDS-related Death in Zambia N/A
Withdrawn NCT03938077 - A Community-University Approach to Preventing HIV N/A
Recruiting NCT05615935 - Experiential HIV Testing Increasing Testing Related Knowledge and Practice, and Reduce Stigma Toward HIV of Nurses. N/A
Active, not recruiting NCT06150937 - HST for Female Sex Workers/Drug Users in Kazakhstan N/A
Completed NCT01637324 - Multidisciplinary Services to Enhance HIV Testing and Linkage to Care Among MSM N/A
Completed NCT05388084 - Peer Led Outreach to Engage Male Partners of Pregnant Women in Uganda (Okutuuka Study) N/A
Active, not recruiting NCT05306938 - Adolescent Wellness Visits in Tanzania N/A
Recruiting NCT05384145 - Implementation Trial to Evaluate a Population Health Combination Intervention to Meet HIV Testing, Linkage, and Viral Suppression Goals in Alabama N/A
Recruiting NCT05020353 - OraQuick® HIV Self-Test Study in Canada N/A
Active, not recruiting NCT02834572 - Using Technology to Match Young Black Men and Transwomen Who Have Sex With Men or Transwomen to HIV Testing Options N/A
Active, not recruiting NCT04810559 - Near Patient Study of the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test in Oral Fluid and Fingerstick Whole Blood N/A
Completed NCT03939455 - Mobile Augmented Screening Tool to Increase Adolescent HIV Testing and Linkage to Care N/A
Not yet recruiting NCT02154802 - Increasing HIV Testing in Urban Emergency Departments Via Mobile Technology N/A
Completed NCT05685498 - Peer-led HIV Self-testing Among Men in Two Ugandan Fishing Communities N/A
Recruiting NCT04030689 - Free HIV Testing in Private Biological Laboratories: A New Offer to Encourage HIV Testing
Completed NCT02714140 - Does Preference-based HIV Testing Increase Uptake in High Risk Populations? N/A
Completed NCT05107401 - Crowdsourcing to Reduce HIV Stigma Among Adolescents and Young Adults in Kazakhstan N/A
Completed NCT01760057 - Evaluating the Effect of a Novel Web-based Intervention to Increase HIV Testing in Men Who Have Sex With Men N/A
Completed NCT04754386 - Caregiver-Assisted Oral Fluid-based HIV Screening in Children: Zambia
Recruiting NCT03757104 - Home-based Intervention to Test and Start N/A