Urethrocutaneous fistulas after voluntary medical male circumcision for HIV prevention-15 African Countries, 2015-2019.

BACKGROUND: Voluntary medical male circumcision (VMMC) is an HIV prevention strategy recommended to partially protect men from heterosexually acquired HIV. From 2015 to 2019, the President's Emergency Plan for AIDS Relief (PEPFAR) has supported approximately 14.9 million VMMCs in 15 African countries. Urethrocutaneous fistulas, abnormal openings between the urethra and penile skin through which urine can escape, are rare, severe adverse events (AEs) that can occur with VMMC. This analysis describes fistula cases, identifies possible risks and mechanisms of injury, and offers mitigation actions. METHODS: Demographic and clinical program data were reviewed from all reported fistula cases during 2015 to 2019, descriptive analyses were performed, and an odds ratio was calculated by patient age group. RESULTS: In total, 41 fistula cases were reported. Median patient age for fistula cases was 11 years and 40/41 (98%) occurred in patients aged < 15 years. Fistulas were more often reported among patients < 15 compared to ≥ 15 years old (0.61 vs. 0.01 fistulas per 100,000 VMMCs, odds ratio 50.9 (95% confidence interval [CI] = 8.6-2060.0)). Median time from VMMC surgery to appearance of fistula was 20 days (interquartile range (IQR) 14-27). CONCLUSIONS: Urethral fistulas were significantly more common in patients under age 15 years. Thinner tissue overlying the urethra in immature genitalia may predispose boys to injury. The delay between procedure and symptom onset of 2-3 weeks indicates partial thickness injury or suture violation of the urethral wall as more likely mechanisms of injury than intra-operative urethral transection. This analysis helped to inform PEPFAR's recent decision to change VMMC eligibility policy in 2020, raising the minimum age to 15 years.

Bleeding and Blood Disorders in Clients of Voluntary Medical Male Circumcision for HIV Prevention - Eastern and Southern Africa, 2015-2016.

Male circumcision reduces the risk for female-to-male human immunodeficiency virus (HIV) transmission by approximately 60% (1) and has become a key component of global HIV prevention programs in countries in Eastern and Southern Africa where HIV prevalence is high and circumcision coverage is low. Through September 2017, the President's Emergency Plan for AIDS Relief (PEPFAR) had supported 15.2 million voluntary medical male circumcisions (VMMCs) in 14 priority countries in Eastern and Southern Africa (2). Like any surgical intervention, VMMC carries a risk for complications or adverse events. Adverse events during circumcision of males aged ≥10 years occur in 0.5% to 8% of procedures, though the majority of adverse events are mild (3,4). To monitor safety and service quality, PEPFAR tracks and reports qualifying notifiable adverse events. Data reported from eight country VMMC programs during 2015-2016 revealed that bleeding resulting in hospitalization for ≥3 days was the most commonly reported qualifying adverse event. In several cases, the bleeding adverse event revealed a previously undiagnosed or undisclosed bleeding disorder. Bleeding adverse events in men with potential bleeding disorders are serious and can be fatal. Strategies to improve precircumcision screening and performance of circumcisions on clients at risk in settings where blood products are available are recommended to reduce the occurrence of these adverse events or mitigate their effects (5).

Notes from the Field: Tetanus Cases After Voluntary Medical Male Circumcision for HIV Prevention--Eastern and Southern Africa, 2012-2015.

Voluntary medical male circumcision (VMMC) decreases the risk for female-to-male HIV transmission by approximately 60%, and the President's Emergency Plan for AIDS Relief (PEPFAR) is supporting the scale-up of VMMC for adolescent and adult males in countries with high prevalence of human immunodeficiency virus (HIV) and low coverage of male circumcision. As of September 2015, PEPFAR has supported approximately 8.9 million VMMCs.

Implementation and Operational Research: Strengthening HIV Test Access and Treatment Uptake Study (Project STATUS): A Randomized Trial of HIV Testing and Counseling Interventions.

OBJECTIVE: To determine which of 3 HIV testing and counseling (HTC) models in outpatient departments (OPDs) increases HIV testing and entry of newly identified HIV-infected patients into care. DESIGN: Randomized trial of HTC interventions. METHODS: Thirty-six OPDs in South Africa, Tanzania, and Uganda were randomly assigned to 3 different HTC models: (A) health care providers referred eligible patients (aged 18-49, not tested in the past year, not known HIV positive) to on-site voluntary counseling and testing for HTC offered and provided by voluntary counseling and testing counselors after clinical consultation; (B) health care providers offered and provided HTC to eligible patients during clinical consultation; and (C) nurse or lay counselors offered and provided HTC to eligible patients before clinical consultation. Data were collected from October 2011 to September 2012. We describe testing eligibility and acceptance, HIV prevalence, and referral and entry into care. Chi-square analyses were conducted to examine differences by model. RESULTS: Of 79,910 patients, 45% were age eligible and 16,099 (45%) age eligibles were tested. Ten percent tested HIV positive. Significant differences were found in percent tested by model. The proportion of age eligible patients tested by Project STATUS was highest for model C (54.1%, 95% confidence interval [CI]: 42.4 to 65.9), followed by model A (41.7%, 95% CI: 30.7 to 52.8), and then model B (33.9%, 95% CI: 25.7 to 42.1). Of the 1596 newly identified HIV positive patients, 94% were referred to care (96.1% in model A, 94.7% in model B, and 94.9% in model C), and 58% entered on-site care (74.4% in model A, 54.8% in model B, and 55.6% in model C) with no significant differences in referrals or care entry by model. CONCLUSIONS: Model C resulted in the highest proportion of all age-eligible patients receiving a test. Although 94% of STATUS patients with a positive test result were referred to care, only 58% entered care. We found no differences in patients entering care by HTC model. Routine HTC in OPDs is acceptable to patients and effective for identifying HIV-infected persons, but additional efforts are needed to increase entry to care.

"Maybe his blood is still strong": a qualitative study among HIV-sero-discordant couples on ART in rural Uganda.

BACKGROUND: HIV-negative members of sero-discordant couples are at high risk for HIV acquisition but few behavioral prevention interventions have been implemented in sub-Saharan Africa and discordance is not well understood by couples themselves. METHODS: In this nested sub-study, we interviewed 40 HIV sero-discordant couples before and after a 6-month behavioral intervention that was comprised of four group discussions on specific HIV prevention and care topics. The content of the sessions included: 1) understanding HIV serodiscordance and reducing risk, 2) couple communication, 3) reproductive health and HIV serodiscordance, 4) coping with HIV serodiscordance and ongoing support. Couple members were interviewed individually. Data were analyzed thematically using 'Framework Analysis' which incorporated dyadic factors to address couple issues. RESULTS: Analysis revealed pre-identified concepts and emergent themes that were relevant to the final conceptual model. Four major categories of factors affecting couple relations, beliefs and current risk behaviors emerged: intervention factors, structural/contextual factors, physical health factors, and past risk behavior. The topics within the intervention most relevant were communication and reproductive health. The contextual factors highlighted by couples were gender norms around sexual decision-making and multiple partnerships. Individual beliefs regarding HIV serodiscordance persisted over all time points for some couples. Interestingly, some couple members had divergent views about their HIV status; some believing the HIV-negative member was negative while others described multiple beliefs around the negative member's blood surely being positive for HIV. Couple communication emerged as an important theme mediating beliefs and behavior. CONCLUSIONS: In addition to biomedical and behavioral interventions, HIV-serodiscordant couple interventions must embrace the contextual complexity and cultural understanding of HIV infection and discordance as well as the dynamic nature of couple communication to influence risk behavior.

Measuring quality of life in rural Uganda: reliability and validity of summary scores from the medical outcomes study HIV health survey (MOS-HIV).

PURPOSE: Summary scores derived from the medical outcomes study HIV health survey (MOS-HIV) are used to assess treatment impacts among HIV-infected patients in Western settings, but have yet to be validated in rural, African settings. We examined the reliability, validity and responsiveness of scores among a prospective cohort of 947 HIV-1-infected adults initiating antiretroviral therapy between May 2003 and May 2004 in rural Uganda. METHODS: Physical (PHS) and mental health (MHS) summary scores were developed from baseline MOS-HIV sub-domains using exploratory factor analysis. Construct and discriminant validity were established by comparing mean summary scores across known groups of sociodemographic, clinical and health status characteristics. Effect sizes were calculated to assess responsiveness to therapy. RESULTS: Reliability of the PHS and MHS scores was 0.79 and 0.85, respectively. Mean baseline PHS and MHS scores varied significantly by CD4 cell count, HIV viral load, WHO stage of disease and Karnofsky performance status scores. By 12 months on antiretroviral therapy, PHS and MHS scores improved by 14.6 points (P < 0.001) and 13.9 points (P < 0.001), respectively. CONCLUSIONS: PHS and MHS scores can be derived from the MOS-HIV and used to assess health status among cohorts of patients taking antiretroviral therapy in rural Uganda.

Coming back from the dead: living with HIV as a chronic condition in rural Africa.

Scaling-up of anti-retroviral therapy (ART) in resource-poor settings has dramatically reduced mortality and morbidity for those with access, but considerable challenges remain for people who are trying to live with HIV as a manageable chronic condition. A return to 'normal life' for people on ART depends on the assurance of an uninterrupted, affordable and accessible supply of medication. However, many poor people also require economic support to re-establish their livelihoods, particularly where productive and financial assets have been depleted because of long-term illness. ART programmes need to seek convergence with economic programmes that have expertise in livelihood support and promotion, and with social protection initiatives. The future for those on ART depends not only on the provision of medicine but also on economic and social support for rebuilding lives and livelihoods.

Home-based antiretroviral care is associated with positive social outcomes in a prospective cohort in Uganda.

BACKGROUND: Home-based antiretroviral therapy (ART) care in Africa has expanded; but social outcomes of home-based ART programs are unknown. METHODS: Social experiences of participants in an antiretroviral therapy program involving weekly home visits in Uganda were assessed through interviews at enrollment and after 3 months and analyzed using generalized estimating equations. RESULTS: Of 654 participants, 72% were women; median baseline CD4 cell-count was 123 cells/muL. At follow-up, participants were more likely to report community support (adjusted odds ratio [OR] 2.10, 95% confidence interval [CI]: 1.46 to 3.03, P < 0.001), family support (OR 2.65, CI: 2.01 to 3.49, P < 0.001), and relationship strengthening (OR 2.10, CI: 1.46 to 3.03, P = 0.001) than at baseline; 84% attributed these experiences to antiretroviral therapy program participation. There was no change in incidence of negative experiences (P = 0.3). Forty-six percent of women reported a history of partner abuse, but abuse rates 3 months before and after program initiation were low (1% vs. 2%, OR 3.20, CI: 0.94 to 10.9, P = 0.063). Of five women who reported abuse associated with program participation, all had history of domestic violence. Of all participants reporting outcomes associated with antiretroviral therapy program participation at follow-up, 464 (79%) had only positive experiences, 35 (6%) had both positive and negative experiences, and <1% had only negative experiences. CONCLUSIONS: Participation in a home-based antiretroviral therapy program was associated with multiple positive social outcomes.

Adherence to antiretroviral therapy in a home-based AIDS care programme in rural Uganda.

BACKGROUND: Poverty and limited health services in rural Africa present barriers to adherence to antiretroviral therapy that necessitate innovative options other than facility-based methods for delivery and monitoring of such therapy. We assessed adherence to antiretroviral therapy in a cohort of HIV-infected people in a home-based AIDS care programme that provides the therapy and other AIDS care, prevention, and support services in rural Uganda. METHODS: HIV-infected individuals with advanced HIV disease or a CD4-cell count of less than 250 cells per muL were eligible for antiretroviral therapy. Adherence interventions included group education, personal adherence plans developed with trained counsellors, a medicine companion, and weekly home delivery of antiretroviral therapy by trained lay field officers. We analysed factors associated with pill count adherence (PCA) of less than 95%, medication possession ratio (MPR) of less than 95%, and HIV viral load of 1000 copies per mL or more at 6 months (second quarter) and 12 months (fourth quarter) of follow-up. FINDINGS: 987 adults who had received no previous antiretroviral therapy (median CD4-cell count 124 cells per muL, median viral load 217,000 copies per mL) were enrolled between July, 2003, and May, 2004. PCA of less than 95% was calculated for 0.7-2.6% of participants in any quarter and MPR of less than 95% for 3.3-11.1%. Viral load was below 1000 copies per mL for 894 (98%) of 913 participants in the second quarter and for 860 (96%) of 894 of participants in the fourth quarter. In separate multivariate models, viral load of at least 1000 copies per mL was associated with both PCA below 95% (second quarter odds ratio 10.6 [95% CI 2.45-45.7]; fourth quarter 14.5 [2.51-83.6]) and MPR less than 95% (second quarter 9.44 [3.40-26.2]; fourth quarter 10.5 [4.22-25.9]). INTERPRETATION: Good adherence and response to antiretroviral therapy can be achieved in a home-based AIDS care programme in a resource-limited rural African setting. Health-care systems must continue to implement, evaluate, and modify interventions to overcome barriers to comprehensive AIDS care programmes, especially the barriers to adherence with antiretroviral therapy.

Undiagnosed HIV infection and couple HIV discordance among household members of HIV-infected people receiving antiretroviral therapy in Uganda.

INTRODUCTION: Systematic efforts to identify HIV-infected members and HIV-discordant couples in households of individuals taking antiretroviral therapy (ART) could theoretically reduce HIV transmission and improve ART adherence. METHODS: We enrolled HIV-infected clients of an AIDS support organization in a randomized evaluation of different ART monitoring regimens that offered home-based ART care to them and their clinically eligible household members. At baseline, counselors visited participants' homes and offered voluntary counseling and testing (VCT) to all household members. We assessed uptake, HIV prevalence, HIV discordance, and rate of ART eligibility. RESULTS: Of the 2373 household members, 2348 (99%) accepted VCT. HIV prevalence among household members was 7.5% and varied by age with 9.5% among children aged 0 to 5 years, 2.9% among persons aged 6 to 24 years, and 37.1% among adults aged 25 to 44 years. Of the household members with HIV, 74% had never been previously tested, and 39% of these were clinically eligible for ART. Of the 120 spouses of ART patients that were tested for HIV, 52 (43%) were HIV negative, and of these, 99% had not been previously tested. CONCLUSIONS: Provision of home-based VCT to household members of people initiating ART was well accepted and resulted in the detection of a large number of previously undiagnosed HIV infections and HIV-discordant relationships.

Depression and CD4 cell count among persons with HIV infection in Uganda.

Despite the importance of mental illness and the high prevalence of HIV in Africa, few studies have documented depressive symptoms among HIV-infected persons in Africa. We assessed factors associated with depression among HIV-infected adults undergoing anti-retroviral eligibility screening in Eastern Uganda. Depressive symptoms were measured using the Center for Epidemiologic Studies Depression Scale (CES-D). Univariate and multiple regression analyses were conducted to identify socio-demographic characteristics and disease-related factors associated with depression. Among 1017 HIV-infected participants assessed for depression, 47% (476/1017) reported depressive symptoms (CES-D >/= 23). Adjusting for age, gender, education, and source of income, patients with CD4 counts <50 cells/microl were more likely to be depressed (odds ratio 2.34, 95% confidence interval, 1.39-3.93, P = 0.001). Women, participants >50 years, and those without an income source were more likely to be depressed. Depression was common among HIV-infected persons in rural Uganda and was associated with low CD4 cell counts. Appropriate screening and treatment for depression should be considered for comprehensive HIV care.

Changes in sexual behavior and risk of HIV transmission after antiretroviral therapy and prevention interventions in rural Uganda.

BACKGROUND: The impact of antiretroviral therapy (ART) on sexual risk behavior and HIV transmission among HIV-infected persons in Africa is unknown. OBJECTIVE: To assess changes in risky sexual behavior and estimated HIV transmission from HIV-infected adults after 6 months of ART. DESIGN AND METHODS: A prospective cohort study was performed in rural Uganda. Between May 2003 and December 2004 a total of 926 HIV-infected adults were enrolled and followed in a home-based ART program that included prevention counselling, voluntary counseling and testing (VCT) for cohabitating partners and condom provision. At baseline and follow-up, participants' HIV plasma viral load and partner-specific sexual behaviors were assessed. Risky sex was defined as inconsistent or no condom use with partners of HIV-negative or unknown serostatus in the previous 3 months. The rates of risky sex were compared using a Poisson regression model and transmission risk per partner was estimated, based on established viral load-specific transmission rates. RESULTS: Six months after initiating ART, risky sexual behavior reduced by 70% [adjusted risk ratio, 0.3; 95% confidence interval (CI), 0.2-0.7; P = 0.0017]. Over 85% of risky sexual acts occurred within married couples. At baseline, median viral load among those reporting risky sex was 122 500 copies/ml, and at follow-up, < 50 copies/ml. Estimated risk of HIV transmission from cohort members declined by 98%, from 45.7 to 0.9 per 1000 person years. CONCLUSIONS: Providing ART, prevention counseling, and partner VCT was associated with reduced sexual risk behavior and estimated risk of HIV transmission among HIV-infected Ugandan adults during the first 6 months of therapy. Integrated ART and prevention programs may reduce HIV transmission in Africa.