Aaron J. Siegler

Applying a PrEP Continuum of Care for Men Who Have Sex With Men in Atlanta, Georgia

Reductions in human immunodeficiency virus (HIV) incidence with pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM) will require significant coverage of those at risk. We propose a simplified framework, similar to the HIV care continuum, to achieve protection with PrEP as follows: 1. At-risk MSM; 2. Awareness of and willingness to take PrEP; 3. Access to healthcare; 4. Receiving a prescription; and 5. Adhering to effective PrEP. We evaluated the PrEP care continuum on an Atlanta cohort of MSM and projected how many MSM might achieve protection from HIV. Even with optimistic estimates, few Atlanta MSM (15%) are projected to achieve protection from HIV with PrEP given the significant barriers described. Each continuum step represents an important point for intervention that could substantially increase the overall effectiveness of PrEP. In addition, novel strategies for PrEP delivery are needed to achieve the necessary effectiveness for Atlanta MSM at risk of HIV.

Barriers to cervical cancer screening in Mulanje, Malawi: a qualitative study.

Background: In Malawi, cervical cancer is the most prevalent form of cancer among women, with an 80% mortality rate. The Mulanje Mission Hospital has offered free cervical cancer screening for eight years; however, patients primarily seek medical help for gynecologic complaints after the disease is inoperable. Methods: We investigated how women in rural Malawi make health-seeking decisions regarding cervical cancer screening using qualitative research methods. The study was conducted between May and August of 2009 in Mulanje, Malawi. Results: This study found that the primary cue to action for cervical cancer screening was symptoms of cervical cancer. Major barriers to seeking preventative screening included low knowledge levels, low perceived susceptibility and low perceived benefits from the service. Study participants did not view cervical cancer screening as critical health care. Interviews suggested that use of the service could increase if women are recruited while visiting the hospital for a different service. Conclusion: This study recommends that health care providers and health educators target aspects of perceived susceptibility among their patients, including knowledge levels and personal risk assessment. We believe that continued support and advertisement of cervical cancer screening programs along with innovative recruitment strategies will increase usage density and decrease unnecessary deaths from cervical cancer in Malawi.

Challenges in Translating Prep Interest Into Uptake in an Observational Study of Young Black Msm

Background: HIV incidence among US young, black men who have sex with men (YBMSM) is high, and structural barriers (eg lack of health insurance) may limit access to Pre-exposure prophylaxis (PrEP). Research studies conducted with YBMSM must ensure access to the best available HIV prevention methods, including PrEP. Methods: We implemented an optional, nonincentivized PrEP program in addition to the standard HIV prevention services in a prospective, observational cohort of HIV-negative YBMSM in Atlanta, GA. Provider visits and laboratory costs were covered; participant insurance plans and/or the manufacturer assistance program were used to obtain drugs. Factors associated with PrEP initiation were assessed with prevalence ratios and time to PrEP initiation with Kaplan–Meier methods. Results: Of 192 enrolled YBMSM, 4% were taking PrEP at study entry. Of 184 eligible men, 63% indicated interest in initiating PrEP, 10% reported no PrEP interest, and 27% wanted to discuss PrEP again at a future study visit. Of 116 interested men, 46% have not attended a PrEP initiation appointment. Sixty-three men (63/184; 34%) initiated PrEP; 11/63 (17%) subsequently discontinued PrEP. The only factor associated with PrEP initiation was reported sexually transmitted infection in the previous year (prevalence ratio 1.50, 95% confidence interval: 1.002 to 2.25). Among interested men, median time to PrEP initiation was 16 weeks (95% confidence interval: 7 to 36). Conclusions: Despite high levels of interest, PrEP uptake may be suboptimal among YBMSM in our cohort even with amelioration of structural barriers that can limit use. PrEP implementation as the standard of HIV prevention care in observational studies is feasible; however, further research is needed to optimize uptake for YBMSM.

The role of intent in serosorting behaviors among men who have sex with men sexual partnerships.

Background:Serosorting is increasingly assessed in studies of men who have sex with men (MSM). Most research studies have measured serosorting by combining reported unprotected anal intercourse (UAI) and the occurrence of participant and partner same HIV status (seroconcordance). The Centers for Disease Control and Prevention’s definition of serosorting also incorporates intent to be in such a partnership, although few studies incorporate both intent and behavior into their measures. Methods:Using data from a national, online survey of 3519 US MSM, we assessed the role of intention in seroconcordant partnerships, as measured by participant rating of the importance of shared serostatus when selecting a sex partner. Results:For HIV+ men, 30% partnerships were seroconcordant; of these, 48% reported intent to be in such a partnership (intentional seroconcordance). For HIV− men, 64% partnerships were seroconcordant; of these, 80% reported intentional seroconcordance. Intentional seroconcordance was associated with UAI for HIV+ partnerships [odds ratio (OR): 1.9; 95% confidence interval (CI): 1.3 to 2.9] but not significant for HIV− partnerships (OR: 1.1; CI: 0.99 to 1.3). In separate models where intent was not considered, seroconcordance was associated with UAI for HIV+ partnerships (OR: 3.2; 95% CI: 2.2 to 4.6) and for HIV− partnerships (OR: 1.2; 95% CI: 1.0 to 1.3; P = 0.03). Conclusions:Regardless of intentionality, seroconcordance was strongly associated with UAI for HIV+ men and weakly associated with UAI for HIV− men. Intentional seroconcordance was not associated with UAI more strongly than was seroconcordance in absence of consideration of intent. Intentionality may not be a critical element of the relationship between seroconcordance and UAI.

How often do condoms fail? A cross-sectional study exploring incomplete use of condoms, condom failures and other condom problems among black and white MSM in southern USA

Objectives To compare the occurrence of risk-inducing condom events (condom failures and incomplete use) and the frequency of their antecedents (condom errors, fit/feel problems and erection problems) between black and white men who have sex with men (MSM), and determine the associations between risk-inducing condom events and their antecedents. Methods We studied cross-sectional data of 475 MSM who indicated using a condom as an insertive partner in the previous 6 months enrolled in a cohort study in Atlanta, Georgia, USA. Results Nearly 40% of black MSM reported breakage or incomplete use, and they were more likely to report breakage, early removal and delayed application of a condom than white MSM. Only 31% and 54% of MSM reported correct condom use and suboptimal fit/feel of a condom, respectively. The use of oil-based lubricants and suboptimal fit/feel were associated with higher odds of reporting breakage (p=0.009). Suboptimal fit/feel was also associated with higher odds of incomplete use of condoms (p<0.0001). Conclusions Incomplete use of condoms and condom failures were especially common among black MSM. Our findings indicate that condoms likely offered them less protection against HIV/sexually transmitted infection when compared with white MSM. More interventions are needed, particularly addressing the use of oil-based lubricants and suboptimal fit/feel of condoms.

Elements of Condom-Use Decision Making among South African Men Who Have Sex with Men

South African men who have sex with men (MSM) are at increased risk for HIV infection, and male condoms are fundamental to HIV prevention programs. We explored condom use experiences through in-depth interviews with 34 South African MSM from Cape Town and Port Elizabeth. For data analysis, we generated a codebook and used the constant comparison method. Condom use reinforcing elements included use of alternative sexual strategies, having a high level of self-worth that was linked to protective behaviors, and use of ready-made condom negotiation scripts. Elements inhibiting condom use included perceiving substantial declines in sexual pleasure/performance, experiences of condom failure (possibly related to petroleum-based lubricant), and being in trusted relationships. Our findings suggest nuanced HIV prevention approaches such as bolstering condom negotiation skills based on successful tactics already in use. Further research is needed to address how to mitigate perceptions and experiences that condoms negatively impact sexual pleasure and performance.

Condoms “contain worms” and “cause HIV” in Tanzania: Negative Condom Beliefs Scale development and implications for HIV prevention

Condom promotion remains a key component of HIV prevention programs, complimenting recent successes in biomedical HIV prevention. Although condom use has increased in much of East Africa, it remains substantially below optimal levels. Negative rumors about condoms have been documented in East Africa, yet the prevalence and effects of belief in the negative rumors have not been explored. This study evaluated levels of belief in negative rumors about condoms, developed a Negative Condom Beliefs Scale, and assessed its accuracy in predicting willingness to use condoms. A cross-sectional, cluster survey (n = 370) was conducted representing adults in two rural districts in Northern Tanzania in 2008. Item agreement ranged from 35 to 53% for the following rumors regarding condoms: causing cancer, having holes, containing HIV, having worms, and the worms causing HIV. Items loaded on a single latent factor and had high internal consistency and convergent validity. In a multivariate model, negative condom score (AOR = 0.67, 95% CI = 0.6, 0.8) was the strongest single predictor of willingness to use condoms, followed by greater perceived anonymity in acquiring condoms (AOR = 4.36, 95% CI = 2.2, 8.6) and higher condom self-efficacy (AOR = 4.24, 95% CI = 2.0, 8.9). Our findings indicate high levels of subscription to negative beliefs about condoms, with two out of three respondents affirming belief in at least one negative condom rumor. This study highlights the relation between condom rumor beliefs and willingness to use condoms, and indicates avenues for future research and means for improving the design of HIV prevention programs.

Usability and Acceptability of a Mobile Comprehensive HIV Prevention App for Men Who Have Sex With Men: A Pilot Study

Background Men who have sex with men (MSM) are the group most impacted by the human immunodeficiency virus (HIV) epidemic and the only subgroup in the United States among which new HIV diagnoses are not decreasing. To achieve the US National HIV/AIDS (acquired immunodeficiency syndrome) Strategy goals of reducing new diagnoses by 25%, high (eg, 30-50%) coverage of multiple HIV prevention interventions is needed in both urban and rural areas. Mobile phone “apps” are an important channel through which prevention services could be provided at scale and at low marginal cost. Objective The aim of this study was to evaluate the usability and acceptability of a theory-based Android mobile phone app for HIV prevention. Methods The app included self-assessment tools; prevention recommendations; commodity (condoms, HIV self-tests) ordering; reminders to MSM for basic HIV prevention services, HIV testing, condom use, screening for preexposure prophylaxis (PrEP) and nonoccupational postexposure prophylaxis (nPEP); and prevention and treatment provider locators. The study recruited HIV-negative, Android-using MSM in Atlanta and Seattle who were asked to use the app for 4 months and complete a post-use survey. We measured the use of the app and its features, ordering of commodities, self-report of establishing an HIV testing plan, being HIV tested in the community, and starting PrEP or using nPEP. Usability was assessed using the system usability scale (SUS). Results A total of 121 MSM were enrolled (59.5%, 72/121 from Atlanta; 40.5%, 49/121 from Seattle). Median age was 28. Nearly half (48.8%, 59/121) were nonwhite, and most (85.9%, 104/121) were gay-identified. Most had tested for HIV in the past (85.1%, 103/121), and 52 (43.0%, 52/121) had a plan to test for HIV regularly. Men used the app for an average of 17.7 minutes over the first 4 months. Over the 4-month period, over half ordered condoms (63.6%, 77/121) and HIV test kits (52.8%, 64/121) on the app. Eight of 86 (9%) PrEP-eligible MSM started PrEP during the 4-month period; of those, 6 of the 8 reported that the app influenced their decision to start PrEP. The mean SUS was 73 (above average). Conclusions A theory-based mobile phone app was acceptable to MSM and was rated as having above-average usability. Most men used the commodity-ordering features of the app during the 4-month evaluation period, and nearly 1 in 10 PrEP-eligible men started PrEP, with most attributing their decision to start PrEP in part to the app. A broader, randomized controlled study of the impact of the app on uptake of prevention behaviors for MSM is warranted.

Sibanye Methods for Prevention Packages Program Project Protocol: Pilot Study of HIV Prevention Interventions for Men Who Have Sex With Men in South Africa

Background Human immunodeficiency virus (HIV) prevention intervention programs and related research for men who have sex with men (MSM) in the southern African region remain limited, despite the emergence of a severe epidemic among this group. With a lack of understanding of their social and sexual lives and HIV risks, and with MSM being a hidden and stigmatized group in the region, optimized HIV prevention packages for southern African MSM are an urgent public health and research priority. Objective The objective of the Sibanye Health Project is to develop and evaluate a combination package of biomedical, behavioral, and community-level HIV prevention interventions and services for MSM in South Africa. Methods The project consists of three phases: (1) a comprehensive literature review and summary of current HIV prevention interventions (Phase I), (2) agent-based mathematical modeling of HIV transmission in southern African MSM (Phase II), and (3) formative and stigma-related qualitative research, community engagement, training on providing health care to MSM, and the pilot study (Phase III). The pilot study is a prospective one-year study of 200 men in Cape Town and Port Elizabeth, South Africa. The study will assess a package of HIV prevention services, including condom and condom-compatible lubricant choices, risk-reduction counseling, couples HIV testing and counseling, pre-exposure prophylaxis (PrEP) for eligible men, and non-occupational post-exposure prophylaxis for men with a high risk exposure. The pilot study will begin in October 2014. Results Preliminary results from all components but the pilot study are available. We developed a literature review database with meta-data extracted from 3800 documents from 67 countries. Modeling results indicate that regular HIV testing and promotion of condom use can significantly impact new HIV infections among South African MSM, even in the context of high coverage of early treatment of HIV-positive men and high coverage of PrEP for at-risk HIV-negative men. Formative qualitative research consisted of 79 in-depth interviews, and six focus group discussions in Cape Town and Port Elizabeth. Analysis of these data has informed pilot study protocol development and has been documented in peer-reviewed manuscripts. Qualitative work regarding stigma faced by South African MSM resulted in finalized scales for use in the pilot study questionnaire. A total of 37 health care providers completed training designed to facilitate clinically and culturally competent care for MSM in the Eastern Cape. Conclusions The design of a future, larger study of the HIV prevention package will be conducted at the end of the pilot study, powered to detect efficacy of the prevention package. Data from the updated mathematical model, results of the pilot study, acceptability data, and advancements in HIV prevention sciences will be considered in developing the final proposed package and study design. Trial Registration ClinicalTrials.gov NCT02043015; http://clinicaltrials.gov/show/NCT02043015 (Archived by WebCite at http://www.webcitation.org/6THvp7rAj).

Developing a Web-Based Geolocated Directory of HIV Pre-Exposure Prophylaxis-Providing Clinics: The PrEP Locator Protocol and Operating Procedures

Background Human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV transmission, yet patients interested in learning more about PrEP or in getting a PrEP prescription may not be able to find local medical providers willing to prescribe PrEP. Objective We sought to create a national database of PrEP-providing clinics to allow for patients to have access to a unified, vetted source of PrEP providers in an easily accessible database. Methods To develop the protocol and operating procedures for the PrEP Locator, we conducted a series of 7 key informant interviews with experts who had organized PrEP or other HIV service directories. We convened an external advisory committee and a collaborators board to gain expert and community-situated perspectives. Results At its public release in September 2016, the database included 1,272 PrEP-providing clinics, including clinics in all 50 states and in Puerto Rico. Web searches, referrals, and outreach to state health departments identified 58 unique lists of PrEP-providing clinics, with 33 from state health departments, 6 from government localities, 2 from professional medical organizations, and 19 from nongovernmental organizations. Out of the 2,420 clinics identified from the lists and Web searches, we removed 798 as duplicate entries, and we determined that 350 were ineligible for listing. The most common reasons for ineligibility were not having the appropriate medical licensure to prescribe PrEP (67/350) or not prescribing PrEP, based on self-report (192/350). Key informant interviews shaped important protocol decisions, such as listing clinics instead of individual clinicians as the primary data element and streamlining data collection to facilitate scalability. We developed a Web interface to provide public access to the data, with geolocated data display, search filter functionality, a webform for public suggestions of new clinics, and a publicly available directory Web tool that can be embedded in websites. In the 6 months following release, preplocator.org and hosting websites had received over 35,000 unique views and 300 clinic additions, and 5 websites had initiated hosting of the widget. Conclusions Directories exist for many preventive and treatment services. As new medical applications become available, there will be a corresponding need to develop new directories for service provision. Geolocated directories can assist patients in accessing care and have the potential to increase demand for and access to newer, more efficacious medical interventions. Early choices in the development of service directories have long-lasting impact, because once data collection begins, it can be challenging to reverse course. The PrEP Locator protocol may inform early decisions in the development of future service directories. Additionally, the case study on developing the PrEP Locator demonstrates the importance of formative work in identifying service-specific factors that can guide decisions on directory development.