Dataset Information

Hypothetical Rectal Microbicide Acceptability and Factors Influencing It among Men Who Have Sex with Men in Tianjin, China.

ABSTRACT: OBJECTIVES:To measure potential acceptability of rectal microbicides and to explore factors likely to affect their acceptability among men who have sex with men (MSM). METHODS:Cross-sectional and retrospective surveys were conducted in this study. A questionnaire and a scale were used to measure the acceptability score for physical and functional characteristics of hypothetical rectal microbicides. We also evaluated the involvement of other factors such as sexual behaviors, social context, etc. RESULTS:MSMs we interviewed showed a high acceptability to rectal microbicides, indicated by the mean acceptability score of 2.92 (SD, 0.54, scale of 1-4). The results also suggested that microbicides were preferred in a cream form that can moisten and lubricate the rectum, prevent HIV infection and go unnoticed by their partners. Multivariate analysis showed that the microbicides acceptability varied significantly by education level (? = 0.135; P = 0.028), having casual partners (? = 0.174; P = 0.007), frequency of lubricant use (? = 0.134; P = 0.031), history of HIV test (? = 0.129; P = 0.036), willingness to use lubricant (? = 0.126; P = 0.045), locus of control by partners regarding STI infection (? = 0.168; P = 0.009). CONCLUSIONS:A positive response to rectal microbicides among MSMs was found in our study, suggesting that rectal microbicides might have a potential market in MSMs and they might play an important role in HIV/STIs prevention as a supplement. Further studies may be considered to combine the acceptability study with clinical research together to understand the true feelings of MSMs when they use the products.

SUBMITTER: Zhang G

PROVIDER: S-EPMC4887105 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Hypothetical Rectal Microbicide Acceptability and Factors Influencing It among Men Who Have Sex with Men in Tianjin, China.

Zhang Guohong G Zhang Huifang H Yu Hongxuyang H Zhao Zheng Z Yang Jie J Zhang Mianzhi M Zhang Minying M

PloS one 20160531 5

<h4>Objectives</h4>To measure potential acceptability of rectal microbicides and to explore factors likely to affect their acceptability among men who have sex with men (MSM).<h4>Methods</h4>Cross-sectional and retrospective surveys were conducted in this study. A questionnaire and a scale were used to measure the acceptability score for physical and functional characteristics of hypothetical rectal microbicides. We also evaluated the involvement of other factors such as sexual behaviors, social ...[more]

PMID: 27243457

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Project description:BackgroundRectal microbicides, if proven effective, may aid in reducing human immunodeficiency virus (HIV) incidence; however, demonstration of efficacy and effectiveness is contingent on accurate measurement of product adherence. Delays in self-report, in particular, may affect the accuracy of behavioral data.ObjectiveThe aim of this study was to capitalize on mobile phone use by young men who have sex with men (YMSM), and examine the use of an interactive voice response system (IVRS) by YMSM aged 18-30 years enrolled in a multisite, 12-week microbicide safety and acceptability trial.MethodsYMSM (N=95) enrolled across 3 sites (Boston, Pittsburgh, and San Juan) were asked to report their use of an applicator applied placebo rectal gel product during receptive anal intercourse (RAI) using the IVRS. IVRS was available in Spanish and English. After the 12-week trial, we examined whether IVRS problems were associated with YMSM's sociodemographic characteristics (eg, age, race and ethnicity, and education), sexual behavior, or recruitment site. We used a multinomial logistic regression to compare YMSM who experienced no IVRS problems (n=40) with those who reported one IVRS problem (n=25) or two or more IVRS problems (n=30).ResultsWe recorded 1494 IVRS calls over 12 weeks. Over half of the participants (55/95; 58%) experienced challenges using the IVRS during the 12-week trial. YMSM reporting greater RAI occasions during the trial were more likely to experience one (odds ratio [OR]=1.08, 95% CI (1.02-1.14); P ≤.01) or more (OR=1.10, 95% CI (1.03-1.16); P ≤.001) IVRS challenges. Greater educational attainment was associated with multiple IVRS challenges (OR=7.08, 95% CI (1.6-31.6); P ≤.01). Participants in the Puerto Rico site were most likely to report multiple IVRS problems.ConclusionsAlthough IVRS was a useful data collection technology in our trial, several challenges experienced by English and Spanish speaking YMSM diminish its overall acceptability. We discuss strategies to optimize future development of IVRS data quality protocols based on lessons learned.

Project description:Preexposure prophylaxis (PrEP) of HIV infection with tenofovir-containing regimens is effective, but plagued by poor adherence in some studies. Options for safe, effective, and acceptable PrEP products, especially for men and women at risk of HIV via receptive anal intercourse (RAI), are needed. We performed a randomized, partially blinded, first-in-human evaluation of four candidate rectal microbicide vehicles-aqueous gel, aqueous fluid, lipid gel, and lipid fluid-to select a prototype for further clinical development. Eight seronegative participants received three doses of each product with each dose separated by at least 2 weeks: one dose was given alone without simulated RAI in clinic, another dose was followed by simulated RAI in clinic, and another dose was self-administered at home in the context of RAI with a partner. Assessments included safety, acceptability, colon histology, ex vivo HIV infectivity of colon tissue explants, and colonic luminal distribution of vehicle and HIV surrogates. Adverse events were all mild and mainly sigmoidoscopy associated. There were minor differences in colon distribution of products and little effect of RAI. Vehicle distribution covered 95% (±7% standard deviation) of the distribution of an HIV surrogate in the colonic lumen. The lipid fluid vehicle increased HIV colon tissue infectability 5-fold [log10 p24 0.68 (95% confidence interval 0.08, 1.28)] and aqueous gel provided 6-fold protection [log10 p24 0.80 (95% confidence interval 0.20, 1.41)] compared to no product baseline. Colon permeability of lipid vehicles was more than 10-fold greater than aqueous vehicles. All products received similar acceptability ratings, though trends favored the gel products. Intensive simultaneous assessment of safety and toxicity, luminal and tissue distribution, ex vivo HIV infectivity, and product acceptability in relevant sexual contexts provided clear differentiation among candidate gels very early in product development. We selected the aqueous gel for further development as a rectal microbicide vehicle.

Project description:BackgroundMen who have sex with men (MSM), including both gay and bisexual men, have a high prevalence of HIV and sexually transmitted infections (STIs) in China. However, healthcare seeking behaviors and engagement in clinical services among MSM are often suboptimal. Global evidence shows that embedding online HIV or sexual health services into gay social networking applications holds promise for facilitating higher rates of healthcare utilization among MSM. We developed a prototype of a gay-friendly health services platform, designed for integration within a popular gay social networking app (Blued) in China.ObjectiveThe purpose of this study was to evaluate the acceptability of the platform and ask for user feedback through focus group interviews with young MSM in Guangzhou and Shenzhen, cities in Southern China.MethodsThe prototype was developed through an open, national crowdsourcing contest. Open crowdsourcing contests solicit community input on a topic in order to identify potential improvements and implement creative solutions. The prototype included a local, gay-friendly, STI physician finder tool and online psychological consulting services. Semistructured focus group discussions were conducted with MSM to ask for their feedback on the platform, and a short survey was administered following discussions. Thematic analysis was used to analyze the data in NVivo, and we developed a codebook based on the first interview. Double coding was conducted, and discrepancies were discussed with a third individual until consensus was reached. We then carried out descriptive analysis of the survey data.ResultsA total of 34 participants attended four focus group discussions. The mean age was 27.3 years old (SD 4.6). A total of 32 (94%) participants obtained at least university education, and 29 (85%) men had seen a doctor at least once before. Our survey results showed that 24 (71%) participants had interest in using the online health services platform and 25 (74%) thought that the system was easy to use. Qualitative data also revealed that there was a high demand for gay-friendly healthcare services which could help with care seeking. Men felt that the platform could bridge gaps in the existing HIV or STI service delivery system, specifically by identifying local gay-friendly physicians and counselors, providing access to online physician consultation and psychological counseling services, creating space for peer support, and distributing pre-exposure prophylaxis and sexual health education.ConclusionsCrowdsourcing can help develop a community-centered online platform linking MSM to local gay-friendly HIV or STI services. Further research on developing social media-based platforms for MSM and evaluating the effectiveness of such platforms may be useful for improving sexual health outcomes.

Project description:Trials to assess microbicide safety require strict adherence to prescribed regimens. If adherence is suboptimal, safety cannot be adequately assessed. MTN-017 was a phase 2, randomized sequence, open-label, expanded safety and acceptability crossover study comparing 1) daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), 2) daily use of reduced-glycerin 1% tenofovir (RG-TFV) gel applied rectally, and 3) RG-TFV gel applied before and after receptive anal intercourse (RAI)-if participants had no RAI in a week, they were asked to use two doses of gel within 24 hours. Product use was assessed by mixed methods including unused product return count, text messaging reports, and qualitative plasma TFV pharmacokinetic (PK) results. Convergence interviews engaged participants in determining the most accurate number of doses used based on product count and text messaging reports. Client-centered adherence counseling was also used. Participants (N = 187) were men who have sex with men and transgender women enrolled in the United States (42%), Thailand (29%), Peru (19%) and South Africa (10%). Mean age was 31.4 years (range 18-64 years). Based on convergence interviews, over an 8-week period, 94% of participants had ?80% adherence to daily tablet, 41% having perfect adherence; 83% had ?80% adherence to daily gel, 29% having perfect adherence; and 93% had ?80% adherence to twice-weekly use during the RAI-associated gel regimen, 75% having perfect adherence and 77% having ?80% adherence to gel use before and after RAI. Only 4.4% of all daily product PK results were undetectable and unexpected (TFV concentrations <0.31 ng/mL) given self-reported product use near sampling date. The mixed methods adherence measurement indicated high adherence to product use in all three regimens. Adherence to RAI-associated rectal gel use was as high as adherence to daily oral PrEP. A rectal microbicide gel, if efficacious, could be an alternative for individuals uninterested in daily oral PrEP.

Dataset Information

Hypothetical Rectal Microbicide Acceptability and Factors Influencing It among Men Who Have Sex with Men in Tianjin, China.

Publications

Hypothetical Rectal Microbicide Acceptability and Factors Influencing It among Men Who Have Sex with Men in Tianjin, China.

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