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Meta-Analysis
. 2018 Feb 21;36(9):1235-1242.
doi: 10.1016/j.vaccine.2017.11.032.

Substance use patterns of HVTN phase I clinical trial participants: Enrollment, risk reduction counseling and retention

Arame Thiam-Diouf  1 , Barbara Metch  2 , Cameron Sharpe  3 , Robel Mulugeta  4 , Michele Peake Andrasik  5
Affiliations
Meta-Analysis

Substance use patterns of HVTN phase I clinical trial participants: Enrollment, risk reduction counseling and retention

Arame Thiam-Diouf et al. Vaccine. .

Abstract

Background: The primary objectives of HIV Vaccine Trials Network (HVTN) phase 1 preventive HIV vaccine clinical trials are to assess safety and immune response to study products. Participant alcohol and drug use may affect adherence, retention, and risk of HIV infection. Data on the effects of substance use are limited to medical care compliance and treatment adherence in HIV infected participants. To our knowledge, there are no data assessing substance use and retention in these vaccine trials.

Methods: We performed a meta-analysis on substance use and its impact on retention in HVTN phase I trials that recruited participants demonstrating lower risk profiles for HIV infection. Our analysis included data from 10 HVTN phase 1 clinical trials conducted between February 2009 and September 2014 in the Americas and Switzerland that utilized the identical interviewer-administered behavioral risk assessment questionnaire to capture participant self-report of substance use in the previous six months. Chi Square tests were used to assess statistical differences between variables.

Results: Among the 964 participants, 170 (18%) missed a clinic visit and 78 (8%) terminated early from clinic follow-up; 75/774 (10%) on studies with multiple vaccination timepoints did not complete their vaccinations. Neither frequency of alcohol use, binge drinking, marijuana, nor other drug use reported at screening visits were associated with the three adherence/retention measures. Binge drinking was associated with higher rates of unprotected sex while drunk (p < .001).

Conclusions: Light to moderate alcohol use does not negatively impact adherence or retention in phase I clinical trials. Based on these screening data and the low infection rate of participants during the trial period, the screening process for participation in HVTN phase 1 trials has largely been successful in enrolling and retaining individuals with lower risk profiles. Focusing on binge drinking and increased HIV/STI risk during risk reduction counseling may be warranted.

Keywords: Biomedical inmterventions; HIV; Substance use; Vaccine clinical trials.

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Conflict of interest statement

Conflict of Interest

All authors have reviewed the manuscript and approved submission for publication. The authors have declared no potential conflict of interest in the material included in this manuscript.

References

    1. Dyer TV, Khan MR, Sandoval M, Acheampong A, Regan R, Bolyard M, et al. Drug Use and Sexual HIV Transmission Risk Among Men Who have Sex with Men and Women (MSMW), Men Who have Sex with Men only (MSMO), and Men Who have Sex with Women Only (MSWO) and the Female Partners of MSMW and MSWO: A Network Perspective. AIDS Behav. 2017 doi: 10.1007/s10461-017-1736-3. - DOI - PMC - PubMed
    1. Zhang X, Wu L. Marijuana use and sex with multiple partners among lesbian, gay and bisexual youth: results from a national sample. BMC Public Health. 2017:1–8. doi: 10.1186/s12889-016-3905-0. - DOI - PMC - PubMed
    1. Knox J, Reddy V, Lane T, Hasin D, Sandfort T. Substance Use and Sexual Risk Behavior Among Black South African Men Who Have Sex With Men: The Moderating Effects of Reasons for Drinking and Safer Sex Intentions. AIDS Behav. 2016 doi: 10.1007/s10461-016-1652-y. - DOI - PMC - PubMed
    1. Harawa NT, McCuller WJ, Chavers C. HIV risk behaviors among Black/African American and Hispanic/Latina female partners of men who have sex with men and women. AIDS Behav. 2013;17:848–55. doi:1007/s10461-012-0138-9. - PMC - PubMed
    1. Center for Behavioral Health Statistics and Quality. Key substance use and mental health indicators in the United States: Results from the 2015 National Survey on Drug Use and Health. [Last accessed April 2017];HHS Publ No SMA 16-4984, NSDUH Ser H-51. n.d. https://www.samhsa.gov/data/sites/default/files/NSDUH-FFR1-2016/NSDUH-FF....

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