scholarly journals Development of a Composite Measure of Product Adherence, Protocol Compliance, and Semen Exposure Using DNA and Protein Biomarkers for Topical HIV Prevention Studies

PLoS ONE ◽  
2014 ◽  
Vol 9 (12) ◽  
pp. e114368 ◽  
Author(s):  
Terry A. Jacot ◽  
Ashley Nelson ◽  
Andrea Thurman ◽  
Angela D. M. Kashuba ◽  
David F. Archer ◽  
...  
Keyword(s):  
Hiv Prevention ◽  
Composite Measure ◽  
Protein Biomarkers ◽  
Prevention Studies ◽  
Protocol Compliance

scholarly journals Application of a composite measure of product adherence, protocol compliance, and semen exposure to a phase III microbicide HIV prevention trial

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Terry A. Jacot ◽  
Meredith R. Clark ◽  
Oluwatosin E. Adedipe ◽  
Susan Godbout ◽  
Tina Cunningham ◽  
...  
Keyword(s):  
Hiv Prevention ◽  
Dna Markers ◽  
Phase Iii ◽  
Composite Measure ◽  
Strict Adherence ◽  
Exposure Biomarkers ◽  
Prevention Clinical Trial ◽  
Tandem Mass Spectroscopy ◽  
Topical Microbicides ◽  
Protocol Compliance

Abstract Background Strict adherence to antiretroviral-based microbicide use is important for effective HIV prevention. We previously developed a composite measure of product adherence, protocol compliance, and semen exposure for determining vaginal use of tenofovir (TFV) 1% gel applicators through biomarkers and residual drug analyses. In this study, we tested the ability of the composite measure in vaginally used TFV gel applicators from a Phase III HIV prevention clinical trial. Methods Used vaginal gel applicators from the FACTS 001 study were swabbed for detection of vaginal bacterial markers (vaginal insertion), semen DNA markers (semen exposure), and residual TFV gel (product use). Results Of 1,098 evaluable TFV and placebo applicators, 80% had detectable vaginal insertion biomarkers and 52% had semen biomarkers. Ninety-nine percent of vaginally inserted applicators TFV applicators had detectable residual TFV as measured by liquid chromatography with tandem mass spectroscopy (LC–MS/MS). Residual TFV levels were also successfully detected using Fourier Transform Infrared (FTIR)-based spectroscopy. Conclusions Vaginal insertion and semen exposure biomarkers were detectable on used TFV 1% gel applicators. Residual TFV on these gel applicators was detectable by LC–MS/MS and FTIR-based spectroscopy, which has potential to be a more convenient and quicker method for detecting drug use. With continual improvements, this composite measure of product adherence, protocol compliance, and semen exposure has potential to assess use of not only TFV gel but also other topical microbicides or products.

scholarly journals Development and clinical assessment of new objective adherence markers for four microbicide delivery systems used in HIV prevention studies

2018 ◽  
Vol 7 (1) ◽  
Author(s):  
Terry A. Jacot ◽  
Meredith R. Clark ◽  
Oluwatosin E. Adedipe ◽  
Susan Godbout ◽  
Abby G. Peele ◽  
...  
Keyword(s):  
Hiv Prevention ◽  
Clinical Assessment ◽  
Delivery Systems ◽  
Prevention Studies

scholarly journals From (Un)Willingness to InvolveMENt: Development of a Successful Study Brand for Recruitment of Diverse MSM to a Longitudinal HIV Research

2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
Paula M. Frew ◽  
Victoria A. Williams ◽  
Eve T. Shapiro ◽  
Travis Sanchez ◽  
Eli S. Rosenberg ◽  
...  
Keyword(s):  
Hiv Prevention ◽  
Brand Strategy ◽  
Black Msm ◽  
Prevention Research ◽  
Chi Square ◽  
Active Involvement ◽  
Brand Development ◽  
Prevention Studies ◽  
Hiv Research ◽  
Behavioral Communication

Background. HIV continues to be a major concern among MSM, yet Black MSM have not been enrolled in HIV research studies in proportionate numbers to White MSM. We developed an HIV prevention research brand strategy for MSM. Methods. Questionnaires and focus groups were conducted with 54 participants. Descriptive statistics and chi-square analyses were performed and qualitative data were transcribed and content analyzed to identify common themes. Results. Formative research results indicated that younger Black MSM (18–29 years) were less likely to think about joining prevention studies compared to older (≥30 years) Black MSM (x2=5.92, P=0.015). Qualitative and quantitative results indicate four prominent themes related to brand development: (1) communication sources (message deliverer), (2) message (impact of public health messaging on perceptions of HIV research), (3) intended audience (underlying issues that influence personal relevance of HIV research), and (4) communication channels (reaching intended audiences). Conclusion. The findings highlight the importance of behavioral communication translational research to effectively engage hard-to-reach populations. Despite reservations, MSM in our formative study expressed a need for active involvement and greater education to facilitate their engagement in HIV prevention research. Thus, the brand concept of “InvolveMENt” emerged.

Recruitment for Retention in Biomedical HIV Prevention Studies: Strategies, Challenges, Lessons Learned from MTN-020 (ASPIRE) Study, at Kampala Site

2014 ◽  
Vol 30 (S1) ◽  
pp. A170-A170
Author(s):  
Sophie Clare Nanziri ◽  
Patrick Ndawula ◽  
Teopista Nakyanzi ◽  
Brenda Gati ◽  
Flavia K. Matovu ◽  
...  
Keyword(s):  
Hiv Prevention ◽  
Lessons Learned ◽  
Biomedical Hiv Prevention ◽  
Prevention Studies

Ethical and regulatory considerations in HIV prevention studies employing respondent-driven sampling

2009 ◽  
Vol 20 (1) ◽  
pp. 14-27 ◽  
Author(s):  
Salaam Semaan ◽  
Scott Santibanez ◽  
Richard S. Garfein ◽  
Douglas D. Heckathorn ◽  
Don C. Des Jarlais
Keyword(s):  
Hiv Prevention ◽  
Respondent Driven Sampling ◽  
Prevention Studies

scholarly journals Willingness to Take a Free Home HIV Test and Associated Factors among Internet-Using Men Who Have Sex with Men

2011 ◽  
Vol 10 (6) ◽  
pp. 357-364 ◽  
Author(s):  
Akshay Sharma ◽  
Patrick S. Sullivan ◽  
Christine M. Khosropour
Keyword(s):  
Hiv Prevention ◽  
Anal Intercourse ◽  
Unprotected Anal Intercourse ◽  
Hiv Status ◽  
Prevention Study ◽  
Home Test ◽  
Home Testing ◽  
Hiv Test ◽  
Prevention Studies ◽  
Sex With Men

Objectives: Online HIV prevention studies have been limited in their ability to obtain biological specimens to measure study outcomes. We describe factors associated with willingness of men who have sex with men (MSM) to take a free home HIV test as part of an online HIV prevention study. Methods: Between March and April 2009, we interviewed 6163 HIV-negative MSM and assessed the willingness to test for HIV infection using a home collection kit. Results: Men reported being very likely (3833; 62%) or likely (1236; 20%) to accept a home HIV test as part of an online HIV prevention study. The odds of being willing to home test were higher for men who were offered incentives of $10 or $25, were black, had unprotected anal intercourse in the past 12 months, and were unaware of their HIV status. Conclusions: Home testing offered as part of online HIV prevention research is acceptable overall and in important subgroups of high-risk MSM.

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