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Supplemental Digital Content is Available in the Text. Background: Persons with HIV (PWH) with high mobility face obstacles to HIV care engagement and viral suppression. We sought to understand whether a patient-centered intervention for mobile PWH would improve viral suppression and retention in care, and if so, which subgroups would benefit most. Methods: In a randomized trial, we evaluated the effect of an intervention designed to address barriers to care among mobile (≥2 weeks out of community in previous year) PWH with viral nonsuppression or recent missed visits in Kenya and Uganda (NCT04810650). The intervention included dynamic choice of a "travel pack" (emergency antiretroviral therapy [ART] supply, discrete ART packaging, and travel checklist), multimonth and offsite refills, facilitated transfer to out-of-community clinics, and hotline access to a mobility coordinator. The primary outcome was viral suppression (<400 copies/mL) at 48 weeks. Secondary outcomes included retention in care and ART possession. Results: From April 2021 to July 2022, 201 participants were enrolled and randomized (102 intervention, 99 control): 109 (54%) were female participants and 101 (50%) from Kenya; median age was 37 years (interquartile range: 29–43). At 48 weeks, there was no significant difference in viral suppression in intervention (85%) vs. control (86%). The intervention improved retention in care (risk ratio: 1.06[1.02–1.1]; P < 0.001) and ART possession (risk ratio: 1.07[1.03–1.11]; P < 0.001), with larger effect sizes among persons with baseline nonsuppression and high mobility (≥2 weeks out of community in previous 3 months). Conclusions: Mobile PWH-centered care should be considered for high-risk mobile populations, including nonsuppressed and highly mobile PWH, to improve retention in care and sustain viral suppression over time. Trial registration: NCT04810650. [ABSTRACT FROM AUTHOR]

Introduction: Optimizing HIV prevention may require structured approaches for providing client‐centred choices as well as community‐based entry points and delivery. We evaluated the effect of a dynamic choice model for HIV prevention, delivered by community health workers (CHWs) with clinician support, on the use of biomedical prevention among persons at risk of HIV in rural East Africa. Methods: We conducted a cluster randomized trial among persons (≥15 years) with current or anticipated HIV risk in 16 villages in Uganda and Kenya (SEARCH; NCT04810650). The intervention was a client‐centred HIV prevention model, including (1) structured client choice of product (pre‐exposure prophylaxis [PrEP] or post‐exposure prophylaxis [PEP]), service location (clinic or out‐of‐clinic) and HIV testing modality (self‐test or rapid test), with the ability to switch over time; (2) a structured assessment of patient barriers and development of a personalized support plan; and (3) phone access to a clinician 24/7. The intervention was delivered by CHWs and supported by clinicians who oversaw PrEP and PEP initiation and monitoring. Participants in control villages were referred to local health facilities for HIV prevention services, delivered by Ministry of Health staff. The primary outcome was biomedical prevention coverage: a proportion of 48‐week follow‐up with self‐reported PrEP or PEP use. Results: From May to July 2021, we enrolled 429 people (212 intervention; 217 control): 57% women and 35% aged 15–24 years. Among intervention participants, 58% chose PrEP and 58% chose PEP at least once over follow‐up; self‐testing increased from 52% (baseline) to 71% (week 48); ≥98% chose out‐of‐facility service delivery. Among 413 (96%) participants with the primary outcome ascertained, average biomedical prevention coverage was 28.0% in the intervention versus 0.5% in the control: a difference of 27.5% (95% CI: 23.0–31.9%, p<0.001). Impact was larger during periods of self‐reported HIV risk: 36.6% coverage in intervention versus 0.9% in control, a difference of 35.7% (95% CI: 27.5–43.9, p<0.001). Intervention effects were seen across subgroups defined by sex, age group and alcohol use. Conclusions: A client‐centred dynamic choice HIV prevention intervention, including the option to switch between products and CHW‐based delivery in the community, increased biomedical prevention coverage by 27.5%. However, substantial person‐time at risk of HIV remained uncovered. [ABSTRACT FROM AUTHOR]

As the science demonstrating strong evidence for voluntary medical male circumcision (VMMC) for HIV prevention has evolved, the President's Emergency Plan for AIDS Relief (PEPFAR) has collaborated with international agencies, donors, and partner country governments supporting VMMC programming. Mathematical models forecast that quickly reaching a large number of uncircumcised men with VMMC in strategically chosen populations may dramatically reduce community-level HIV incidence and save billions of dollars in HIV care and treatment costs. Because VMMC is a 1-time procedure that confers life-long partial protection against HIV, programs for adult men are vital short-term investments with long-term benefits. VMMC also provides a unique opportunity to reach boys and men with HIV testing and counseling services and referrals for other HIV services, including treatment. After formal recommendations by WHO in 2007, priority countries have pursued expansion of VMMC. More than 1 million males have received VMMC thus far, with the most notable successes coming from Kenya's Nyanza Province. However, a myriad of necessary cultural, political, and ethical considerations have moderated the pace of overall success. Because many millions more uncircumcised men would benefit from VMMC services now, US President Barack Obama committed PEPFAR to provide 4.7 million males with VMMC by 2014. Innovative circumcision methods—such as medical devices that remove the foreskin without injected anesthesia and/or sutures—are being rigorously evaluated. Incorporation of safe innovations into surgical VMMC programs may provide the opportunity to reach more men more quickly with services and dramatically reduce HIV incidence for all. [ABSTRACT FROM AUTHOR]

Background: Monitoring and evaluation (M&E) of HIV care and treatment programs is impacted by losses to follow-up (LTFU) in the patient population. The severity of this effect is undeniable but its extent unknown. Tracing all lost patients addresses this but census methods are not feasible in programs involving rapid scale-up of HIV treatment in the developing world. Sampling-based approaches and statistical adjustment are the only scaleable methods permitting accurate estimation of M&E indices. Methodology/Principal Findings: In a large antiretroviral therapy (ART) program in western Kenya, we assessed the impact of LTFU on estimating patient mortality among 8,977 adult clients of whom, 3,624 were LTFU. Overall, dropouts were more likely male (36.8% versus 33.7%; p = 0.003), and younger than non-dropouts (35.3 versus 35.7 years old; p = 0.020), with lower median CD4 count at enrollment (160 versus 189 cells/ml; p,0.001) and WHO stage 3-4 disease (47.5% versus 41.1%; p,0.001). Urban clinic clients were 75.0% of non-dropouts but 70.3% of dropouts (p,0.001). Of the 3,624 dropouts, 1,143 were sought and 621 had their vital status ascertained. Statistical techniques were used to adjust mortality estimates based on information obtained from located LTFU patients. Observed mortality estimates one year after enrollment were 1.7% (95% CI 1.3%-2.0%), revised to 2.8% (2.3%-3.1%) when deaths discovered through outreach were added and adjusted to 9.2% (7.8%-10.6%) and 9.9% (8.4%-11.5%) through statistical modeling depending on the method used. The estimates 12 months after ART initiation were 1.7% (1.3%-2.2%), 3.4% (2.9%-4.0%), 10.5% (8.7%-12.3%) and 10.7% (8.9%-12.6%) respectively. Conclusions/Significance Abstract: Assessment of the impact of LTFU is critical in program M&E as estimated mortality based on passive monitoring may underestimate true mortality by up to 80%. This bias can be ameliorated by tracing a sample of dropouts and statistically adjust the mortality estimates to properly evaluate and guide large HIV care and treatment programs. [ABSTRACT FROM AUTHOR]

Ron Gray and colleagues report on complications of circumcision in HIV-infected and HIV-uninfected men from two related trials in Uganda, finding increased risk with intercourse before wound healing. [ABSTRACT FROM AUTHOR]

Associate Editor Michael G. Wyllie Editorial Board Ian Eardley, UK Jean Fourcroy, USA Sidney Glina, Brazil Julia Heiman, USA Chris McMahon, Australia Bob Millar, UK Alvaro Morales, Canada Michael Perelman, USA Marcel Waldinger, Netherlands OBJECTIVE To investigate the relationship between adult male circumcision and sexual satisfaction and function in men, as observational studies on the effect of adult male circumcision on sexual satisfaction show conflicting results. SUBJECTS AND METHODS We investigated self-reported sexual satisfaction and function among men enrolled in a randomized trial of male circumcision for human immunodeficiency virus (HIV) prevention conducted in Rakai, Uganda. In all, 4456 sexually experienced HIV-negative males aged 15–49 years were enrolled; 2210 were randomized to receive immediate circumcision (intervention arm) and 2246 to circumcision delayed for 24 months (control arm). Men were followed up at 6, 12 and 24 months, and information on sexual desire, satisfaction and erectile dysfunction was collected. These variables were compared between the study arms and over time within the study arms, using chi-square or Fisher’s exact tests. The trial registration number is NCT00425984. RESULTS There were no differences between the study arms at enrolment and problems with sexual satisfaction and function were reported by <2% of participants in both study arms at all time points. At 6 months, no difficulty with penetration was reported by 98.6% of circumcised men and 99.4% of controls ( P = 0.02), and no pain on intercourse was reported by 99.4% circumcised and 98.8% of uncircumcised men ( P = 0.05). There were no differences between the study arms in penetration or dyspareunia at later visits. Sexual satisfaction increased from 98.0% at enrolment to 99.9% at 2 years among the controls ( P < 0.001), but there was no trend in satisfaction among circumcised men (enrolment 98.5%, 2 years 98.4%, P = 0.8). CONCLUSION Adult male circumcision does not adversely affect sexual satisfaction or clinically significant function in men. [ABSTRACT FROM AUTHOR]

The article presents a randomized clinical trial of men in Rakai, Uganda that examined whether circumcision reduced the risk of the men acquiring HIV. Men were randomly assigned to either receive an immediate circumcision or to be circumcised after 24 months. The men were assessed through HIV testing, physical examinations, and interviews. The authors found that male circumcision did reduce the incidence of HIV infections in the men without behavioral disinhibition and thus recommend the procedure for HIV prevention in men.

Abstract: Background: The evidence that drug treatment programs are associated with changes in sexual behavior and, thus, have prevention benefits beyond addiction is inconclusive. We examined whether entry into drug treatment was associated with subsequent alterations in sexual behavior among a group of drug-using women. Methods: Data were collected semiannually via structured interviews over 8 years. Generalized estimating equations evaluated the relationship between self-reported drug treatment at each visit and sexual abstinence and consistent condom use in the subsequent 6-month period. Results: In this sample (N = 1,658; mean age, 37.3 years; 57.5% African American; 80.3% HIV positive; 49.6% crack/cocaine users), 40% reported being in a variety of drug treatment programs. Those undergoing drug treatment (vs. those not) were less likely to become sexually active (adjusted odds ratio [AOR], 0.83; 95% confidence interval [CI], 0.76–0.91); this association was unchanged when the frequency of attendance and number of different drug treatment programs were evaluated. Drug treatment was not associated with subsequent consistent condom, regardless of frequency of attendance, but involvement in at least three treatment programs was (AOR, 1.40; 95% CI, 1.00–1.97). Conclusions: Additional efforts are needed to integrate effective sexual risk reduction programs into drug treatment settings; expanding access to different types of drug treatment modalities may be indicated. [Copyright &y& Elsevier]

Context Recent cervical cancer screening guidelines state that the interval between screenings can be safely extended to 3 years in healthy women 30 years or older who have normal cytology results and have negative test results for oncogenic human papillomavirus (HPV) DNA. Objective To determine the incidence of squamous intraepithelial lesions (SILs) in HIV-seropositive women with normal cytology results, by baseline HPV DNA results. Design, Setting, and Patients Participants were HIV-seropositive (n = 855; mean age, 36 years) and HIV-seronegative (n = 343; mean age, 34 years) US women with normal baseline cervical cytology who were enrolled in the Women’s Interagency HIV Study (WIHS), a large, multi-institutional prospective cohort study. Since their recruitment during 1994-1995, WIHS participants have been followed up semi-annually with repeated Pap smears for a median of 7 years. Main Outcome Measure The cumulative incidence of any SIL and high-grade SIL or cancer (HSIL+) was estimated according to baseline HPV DNA results, stratified by HIV serostatus and CD4 T-cell count. Results Development of any SIL in women with negative HPV results (both oncogenic and nononcogenic) at 2 years was as follows: in HIV-seropositive women with CD4 counts less than 200/μL, 9% (95% CI, 1%-18%); with CD4 counts between 200/μL and 500/μL, 9% (95% CI, 4%-13%); and with CD4 counts greater than 500/μL, 4% (95% CI, 1%-7%). The CIs for these estimates overlapped with those for HIV-seronegative women with normal baseline cytology who were HPV-negative (3%; 95% CI, 1%-5%), indicating that at 2 years, there were no large absolute differences in the cumulative incidence of any SIL between groups. Furthermore, no HPV-negative participants in any group developed HSIL+ lesions within 3 years. Multivariate Cox models showed that on a relative scale, the incidence of any SIL among HIV-seropositive women with CD4 counts greater than 500/μL (hazard ratio [HR], 1.2; 95% CI, 0.5-3.0), but not those with CD4 counts less than or equal to 500/μL (HR, 2.9; 95% CI, 1.2-7.1), was similar to that in HIV-seronegative women. Conclusion The similar low cumulative incidence of any SIL among HIV-seronegative and HIV-seropositive women with CD4 counts greater than 500/μL and who had normal cervical cytology and HPV-negative test results suggests that similar cervical cancer screening practices may be applicable to both groups, although this strategy warrants evaluation in an appropriate clinical trial. [ABSTRACT FROM AUTHOR]

Background. Smoking may increase the risk of cervical cancer, a disease that is related to human papillomavirus (HPV) infection. However, the effects of smoking on the natural history of HPV are poorly understood, especially in women coinfected with human immunodeficiency virus (HIV). Methods. HIV-infected (n = 1797) and HIV-uninfected (n = 496) women were assessed every 6 months for type-specific HPV DNA. Smoking status was self-reported. Covariates included age, parity, sexual behavior, HIV load, CD4+ T cell count, and antiretroviral therapy. Results. Smoking was positively associated with HPV prevalence at baseline in HIV-infected women (P = .002) and was significantly associated with type-specific HPV detection (e.g., type 18, odds ratio [OR], 2.45; 95% confidence interval [CI], 1.86-3.22). In Cox models, detection of HPV was significantly associated with smoking in HIV-infected women (relative hazard [RH], 1.33; 95% CI, 1.10-1.60; P = .003), but HPV persistence was not (RH, 0.97; 95% CI, 80-1.16; P = .72). The overall likelihood of acquiring persistent HPV was higher in smokers (OR, 1.39; 95% CI, 1.05-1.86; P = .023) because of greater incidence. Conclusions. Among HIV-infected women, smoking is associated with a significantly higher prevalence and incidence of HPV infection. Smoking during HIV infection may alter the natural history of HPV infection and increase the risk of cervical disease. [ABSTRACT FROM AUTHOR]