Denial of Risk Behavior Does Not Exclude Asymptomatic Anorectal Sexually Transmitted Infection in HIV-Infected Men

BACKGROUND: The Centers for Disease Control recommend screening for asymptomatic sexually transmitted infection (STI) among HIV-infected men when there is self-report of unprotected anal-receptive exposure. The study goals were: (1) to estimate the validity and usefulness for screening policies of self-reported unprotected anal-receptive exposure as a risk indicator for asymptomatic anorectal infection with Neisseria gonorrhoeae (GC) and/or Chlamydia trachomatis (CT). (2) to estimate the number of infections that would be missed if anal diagnostic assays were not performed among patients who denied unprotected anorectal exposure in the preceding month. METHODS AND FINDINGS: Retrospective analysis in HIV primary care and high resolution anoscopy (HRA) clinics. HIV-infected adult men were screened for self-reported exposure during the previous month at all primary care and HRA appointments. Four sub-cohorts were defined based on microbiology methodology (GC culture and CT direct fluorescent antibody vs. GC/CT nucleic acid amplification test) and clinical setting (primary care vs. HRA). Screening question operating characteristics were estimated using contingency table methods and then pooled across subcohorts. Among 803 patients, the prevalence of anorectal GC/CT varied from 3.5-20.1% in the 4 sub-cohorts. The sensitivity of the screening question for self-reported exposure to predict anorectal STI was higher in the primary care than in the HRA clinic, 86-100% vs. 12-35%, respectively. The negative predictive value of the screening question to predict asymptomatic anorectal STI was > or = 90% in all sub-cohorts. In sensitivity analyses, the probability of being an unidentified case among those denying exposure increased from 0.4-8.1% in the primary care setting, and from 0.9-18.8% in the HRA setting as the prevalence varied from 1-20%. CONCLUSION: As STI prevalence increases, denial of unprotected anal-receptive exposure leads to an increasingly unacceptable proportion of unidentified asymptomatic anorectal STI if used as a criterion not to obtain microbiologic assays

Prevalence of Substance Use in an HIV Primary Care Safety Net Clinic: A Call for Screening.

Substance use complicates HIV care and prevention. Primary care clinics are an ideal setting to screen for and offer interventions for unhealthy alcohol and drug use; however, few HIV clinics routinely screen for substance use. We enrolled 208 clinic patients at an urban underserved HIV primary care clinic. We screened the patients for substance use with the Alcohol, Smoking, and Substance Involvement Score Test and measured urine toxicology. Of the 168 participants who completed screening, the majority reported tobacco or nonprescribed substance use in the previous 3 months. More African American participants reported low or no risk amphetamine use compared to Hispanic, White, or Other race participants (p < .001). Implementing standard clinic practice for screening and assessing substance use in HIV primary care clinics is needed

Incident HIV among pregnant and breast-feeding women in sub-Saharan Africa: a systematic review and meta-analysis

OBJECTIVES: A previous meta-analysis reported high HIV incidence among pregnant and breast-feeding women in sub-Saharan Africa (SSA), but limited evidence of elevated risk of HIV acquisition during pregnancy or breast-feeding when compared with nonpregnant periods. The rapidly evolving HIV prevention and treatment landscape since publication of this review may have important implications for maternal HIV incidence. DESIGN: Systematic review and meta-analysis. METHODS: We searched four databases and abstracts from relevant conferences through 1 December 2018, for literature on maternal HIV incidence in SSA. We used random-effects meta-analysis to summarize incidence rates and ratios, and to estimate 95% prediction intervals. We evaluated potential sources of heterogeneity with random-effects meta-regression. RESULTS: Thirty-seven publications contributed 100 758 person-years of follow-up. The estimated average HIV incidence rate among pregnant and breast-feeding women was 3.6 per 100 person-years (95% prediction interval: 1.2--11.1), while the estimated average associations between pregnancy and risk of HIV acquisition, and breast-feeding and risk of HIV acquisition, were close to the null. Wide 95% prediction intervals around summary estimates highlighted the variability of HIV incidence across populations of pregnant and breast-feeding women in SSA. Average HIV incidence appeared associated with age, partner HIV status, and calendar time. Average incidence was highest among studies conducted pre-2010 (4.1/100 person-years, 95% prediction interval: 1.1--12.2) and lowest among studies conducted post-2014 (2.1/100 person-years, 95% prediction interval: 0.7--6.5). CONCLUSION: Substantial HIV incidence among pregnant and breast-feeding women in SSA, even in the current era of combination HIV prevention and treatment, underscores the need for prevention tailored to high-risk pregnant and breast-feeding women

Two strategies for partner notification and partner HIV self-testing reveal no evident predictors of male partner HIV testing in antenatal settings: A secondary analysis

BackgroundTo meet global targets for the elimination of mother-to-child HIV transmission, tailored approaches to HIV testing strategies need prioritizing. Herein, we sought to identify individual-level factors associated with male partner HIV testing.MethodsWe conducted a secondary analysis of data from two parallel randomized trials of pregnant women living with HIV and those HIV-negative in Lusaka, Zambia. Across both trials, control groups received partner notification services only, while intervention groups received partner notification services plus HIV self-test kits for their partners. Associations between baseline factors and male partner testing were estimated using a probability difference. The outcome of interest was uptake of male partner HIV testing of any kind within 30 days of randomization.ResultsThe parent study enrolled 326 participants. Among the 151 women in the control groups, no clear associations were noted between maternal or male partner characteristics and reported uptake of male partner HIV testing. There were positive trends favouring partner testing among women who completed primary school education, had larger households (>2 members), and whose partners were circumcised. Likewise, no clear predictors of male partner testing were identified among the 149 women in the intervention groups. However, negative trends favouring no testing were noted among older, multiparous women from larger households.ConclusionNo consistent predictors for male partner HIV testing across two compared strategies were observed. Our findings suggest that differentiated strategies for male partner HIV testing may not be necessary. Instead, consideration should be given to universal approaches when bringing such services to scale

Combination adherence strategy to support HIV antiretroviral therapy and pre-exposure prophylaxis adherence during pregnancy and breastfeeding: protocol for a pair of pilot randomised trials.

INTRODUCTION To realise the expected gains from prevention of mother-to-child HIV transmission initiatives, adherence to preventative and therapeutic antiretroviral regimens is critical and interventions deployable in busy programmatic settings with a high HIV burden are needed. Based on formative research, we developed an approach that integrates patient-centred counselling and engagement of an adherence supporter for pregnant and breastfeeding women initiating HIV treatment (ie, antiretroviral therapy (ART)) or biomedical HIV prevention (ie, pre-exposure prophylaxis (PrEP)). METHODS Tonse Pamodzi 2 is a pilot study designed to provide acceptability, fidelity and clinical outcomes data on a set of behavioural interventions for adherence support. The study comprises two parallel randomised trials, enrolling HIV-positive pregnant women initiating ART (Trial 1, n=100) and HIV-negative pregnant women with risk of HIV acquisition and willing to initiate PrEP (Trial 2, n=200). Within each trial, participants are randomised 1:1 to either the intervention or control group. The Tonse Pamodzi adherence intervention comprises patient-centred counselling (adapted Integrated Next Step Counseling(iNSC)) and external adherence support tailored to the clinical context (ie, for ART or PrEP). Participants randomly assigned to the control group receive standard counselling based on local HIV guidelines. Participants are followed for 6 months. To assess intervention acceptability, we will employ a mixed method approach to describe participant engagement, satisfaction, and discussion content. We will audit and score recorded counselling sessions to evaluate the implementation fidelity of iNSC sessions. We will also assess clinical outcomes at 3 and 6 months for both Trial 1 (retention in care and viral suppression of HIV) and Trial 2 (retention in care, and plasma and intracellular tenofovir drug concentrations). ETHICS AND DISSEMINATION The study protocol was approved by the Malawi National Health Science Research Committee (19/05/2334) and the University of North Carolina at Chapel Hill Institutional Review Board (19-1060). TRIAL REGISTRATION NUMBER NCT04330989

The landscape for HIV pre-exposure prophylaxis during pregnancy and breastfeeding in Malawi and Zambia: A qualitative study.

High HIV incidence rates have been observed among pregnant and breastfeeding women in sub-Saharan Africa. Oral pre-exposure prophylaxis (PrEP) can effectively reduce HIV acquisition in women during these periods; however, understanding of its acceptability and feasibility in antenatal and postpartum populations remains limited. To address this gap, we conducted in-depth interviews with 90 study participants in Malawi and Zambia: 39 HIV-negative pregnant/breastfeeding women, 14 male partners, 19 healthcare workers, and 18 policymakers. Inductive and deductive approaches were used to identify themes related to PrEP. As a public health intervention, PrEP was not well-known among patients and healthcare workers; however, when it was described to participants, most expressed positive views. Concerns about safety and adherence were raised, highlighting two critical areas for community outreach. The feasibility of introducing PrEP into antenatal services was also a concern, especially if introduced within already strained health systems. Support for PrEP varied among policymakers in Malawi and Zambia, reflecting the ongoing policy discussions in their respective countries. Implementing PrEP during the pregnancy and breastfeeding periods will require addressing barriers at the individual, facility, and policy levels. Multi- level approaches should be considered in the design of new PrEP programs for antenatal and postpartum populations

Sexual Risk Behavior in Men who have Sex with Men in an Era of Pre Exposure Prophylaxis (PrEP) for HIV Prevention.

Background - Pre-exposure prophylaxis (PrEP) provides protection against HIV transmission but not against other sexually transmitted infections (STIs), which disproportionally affect men who have sex with men (MSM).This dissertation examines the association of PrEP initiation with subsequent patterns of condom use and STIs in MSM. A cohort of 525 MSM, 18 years and older, who self-identified as either high or low risk for HIV acquisition was followed for 13 months after initiating PrEP at a sexual health clinic in San Francisco. Dissertation Aims - 1) review the literature to examine if PrEP is associated with changes in risk behavior in MSM; 2) determine the reasons why MSM who self-identify as low risk for HIV request PrEP; and 3) determine how PrEP use affects condom use and STIs rates in MSM who self-identify as high risk for HIV.Methods – A systematic literature review was completed. The cohort was followed over 13 months subsequent to initiating PrEP. Questionnaires were used to examine condom use and biological assays were used to measure the frequency and type of STIs. Frequencies and descriptive analyses were completed, and multilevel logistic regression modeling was used to predict associations of condom use and STIs before and after initiation of PrEP. Framework analysis was used to identify themes and to develop a descriptive understanding of why low-risk MSM initiated and remained on PrEP. Findings - No conclusive evidence was found that PrEP use leads to increased sexual risk behaviors. Overall, condom use decrease peaked at ~ 6 months and returned to baseline rates at ~12 months. Disparities in condom use and STI rates were observed within sub-populations of MSM, and condom use was found to be influenced by perceived risk. In both the low- and high-risk cohorts, anal GC/CT and syphilis decreased and pharyngeal GC/CT either remained constant or increased. MSM do not use PrEP solely to replace condoms, rather PrEP provides, peace of mind, sexual pleasure and safety and security.Conclusion - In order to improve sexual health for MSM PrEP, STI screening and condom use education should be tailored to meet differing needs of sub populations. Sexual health discussion should include education on substance use, transmission of pharyngeal GC/CT and how MSM perceive sexual risk. Further research is needed to assess when more intensive counselling regarding condom use would be beneficial, how MSM perceive sexual risk and ways to reduce pharyngeal infections

Misclassification of sexual health risks in a self-identified low risk cohort of men who have sex with men (MSM) enrolled in a community based PrEP program.

The CDC recommends PrEP for MSM at substantial risk of HIV acquisition, leaving clinicians unsure whether to prescribe PrEP to MSM who do not disclose HIV risk factors. A longitudinal cohort of MSM requesting PrEP despite reporting during a clinical visit either 100% condom use or participation in oral sex only and no other risk factors was followed over 13 months at a community clinic in San Francisco to assess the accuracy of their HIV risk perception. Participants completed a sexual and substance use behavior questionnaire at baseline, outside of the clinical visit and were followed by quarterly HIV/STI testing and condom use change questionnaires. Condomless sex increased from 0% at baseline to 12% at month 1, peaked at 34% at month 7, and then decreased again to 8% at month 13. Rates of pharyngeal GC/CT varied from 7% at baseline to 12% at month 13, while rectal GC/CT decreased from 6% at baseline to 0% at month 13. The rate of syphilis was 1% both at baseline and at month 13, however, 11% and 15% of clients tested positive for syphilis at months 1 and 7 respectively