Evaluation of GeneXpert and advanced biological laboratories UltraGene HCV diagnostic detection and performance against Roche real time PCR in Myanmar.

BACKGROUND: Developing countries experience limited access to HCV laboratory tests for different reasons. Providing near to real-time HCV testing and results especially to at-risk populations including those in rural settings for timely initiation to treatment is key. Within a rural Myanmar setting, we compared HCV diagnostic detection and quantification of the GeneXpert, and Advanced Biological Laboratories UltraGene-HCV assays against the gold standard and reference method Roche real-time HCV in Myanmar. METHODS: Blood samples from 158 high-risk individuals were assessed using three different methods at baseline. Results were checked for normality and log transformed. Log differences and bias between methods were calculated and correlated. Pearson's correlation coefficient was used to determine the association of HCV viral loads across all methods. The level of agreement with the standard method (Roche real time HCV) was assessed using Bland-Altman analyses. RESULTS: There was a strong positive correlation coefficient between all three methods with GeneXpert and Roche having the strongest, r = 0.96, (p<0.001). Compared to Roche, ABL (mean difference, 95 % limits of agreement; -0.063 and -1.4 to 1.3 Log10IU/mL) and GeneXpert (mean difference, 95 % limits of agreement; -0.28 and -0.7 to 1.8 Log10IU/mL) showed a good level of agreement with the GeneXpert being slightly superior. CONCLUSION: We demonstrate the excellent performance and no-inferiority, in terms of levels of agreements of both GeneXpert and ABL compared to the Roche platform and supporting the use of the POC assays as alternative a cost-effective methods in HCV detection and diagnosis in developing and low resource settings countries.

Evaluation of four interventions using behavioural economics insights to increase demand for voluntary medical male circumcision in South Africa through the MoyaApp: A quasi-experimental study.

Background: While voluntary medical male circumcision (VMMC) reduces the risk of HIV transmission by 60%, circumcision coverage falls short of the UNAIDS 90% target. We investigated whether behaviourally informed message framing increased demand for VMMC. Setting: Adult users of the MoyaApp, a data free application in South Africa, who viewed a form designed to generate interest in VMMC during August-November 2022. Methods: A quasi-experimental study was conducted to evaluate four MoyaApp VMMC intervention forms against the Standard of Care (SOC) form. All forms enabled users to provide contact details for follow-up engagement by a call centre. The primary outcome was the proportion of forms submitted. Secondary outcomes included successful contact with the user, VMMC bookings/referrals and confirmed circumcision. Multivariable ordinary least-squares regression was used for the analysis. Results: MoyaApp VMMC form viewers totalled 118,337 of which 6% submitted a form. Foot-in-the-Door form viewers were more likely (+1.3 percentage points, p<0.01) to submit a form compared to the SOC group (6.3%). Active Choice (-1.1 percentage points, p<0.01) and Reserved for You (-0.05 percentage points, p<0.05) form viewers were less likely to submit a form compared to SOC. Users submitting on Foot-in-the-Door were less likely to be booked/referred compared to SOC (-5 percentage points, p<0.05). There were no differences between the intervention and SOC forms for successful contact and circumcisions. Conclusions: Message framing using behavioural insights was able to nudge men to engage with VMMC services. However, more work is needed to understand how to convert initial interest into bookings and circumcisions. Trial registration: South African Clinical Trials Registry DOH-27-062022-7811Pan-African Clinical Trials Registry PACTR202112699416418.

Trends in COVID-19 admissions and deaths among people living with HIV in South Africa: analysis of national surveillance data.

BACKGROUND: In 2021, the HIV prevalence among South African adults was 18% and more than 2 million people had uncontrolled HIV and, therefore, had increased risk of poor outcomes with SARS-CoV-2 infection. We investigated trends in COVID-19 admissions and factors associated with in-hospital COVID-19 mortality among people living with HIV and people without HIV. METHODS: In this analysis of national surveillance data, we linked and analysed data collected between March 5, 2020, and May 28, 2022, from the DATCOV South African national COVID-19 hospital surveillance system, the SARS-CoV-2 case line list, and the Electronic Vaccination Data System. All analyses included patients hospitalised with SARS-CoV-2 with known in-hospital outcomes (ie, who were discharged alive or had died) at the time of data extraction. We used descriptive statistics for admissions and mortality trends. Using post-imputation random-effect multivariable logistic regression models, we compared characteristics and the case fatality ratio of people with HIV and people without HIV. Using modified Poisson regression models, we compared factors associated with mortality among all people with COVID-19 admitted to hospital and factors associated with mortality among people with HIV. FINDINGS: Among 397 082 people with COVID-19 admitted to hospital, 301 407 (75·9%) were discharged alive, 89 565 (22·6%) died, and 6110 (1·5%) had no recorded outcome. 270 737 (68·2%) people with COVID-19 had documented HIV status (22 858 with HIV and 247 879 without). Comparing characteristics of people without HIV and people with HIV in each COVID-19 wave, people with HIV had increased odds of mortality in the D614G (adjusted odds ratio 1·19, 95% CI 1·09-1·29), beta (1·08, 1·01-1·16), delta (1·10, 1·03-1·18), omicron BA.1 and BA.2 (1·71, 1·54-1·90), and omicron BA.4 and BA.5 (1·81, 1·41-2·33) waves. Among all COVID-19 admissions, mortality was lower among people with previous SARS-CoV-2 infection (adjusted incident rate ratio 0·32, 95% CI 0·29-0·34) and with partial (0·93, 0·90-0·96), full (0·70, 0·67-0·73), or boosted (0·50, 0·41-0·62) COVID-19 vaccination. Compared with people without HIV who were unvaccinated, people without HIV who were vaccinated had lower risk of mortality (0·68, 0·65-0·71) but people with HIV who were vaccinated did not have any difference in mortality risk (1·08, 0·96-1·23). In-hospital mortality was higher for people with HIV with CD4 counts less than 200 cells per µL, irrespective of viral load and vaccination status. INTERPRETATION: HIV and immunosuppression might be important risk factors for mortality as COVID-19 becomes endemic. FUNDING: South African National Institute for Communicable Diseases, the South African National Government, and the United States Agency for International Development.

Factors associated with viral load non-suppression in people living with HIV on ART in Nigeria: cross-sectional analysis from 2017 to 2021.

OBJECTIVES: Identify factors (demographic and clinical) associated with a non-suppressed viral load (VL) of people living with HIV (PLHIV) on antiretroviral therapy (ART) in Nigeria. DESIGN: Cross-sectional study. SETTING: Sixteen US Agency for International Development supported states in Nigeria. PARTICIPANTS: 585 632 PLHIV on ART. PRIMARY OUTCOME MEASURES: VL non-suppression (defined as having a VL of at least 1000 HIV RNA copies per mL of plasma). χ2 testing and multivariable modified Poisson regression with robust variance estimates were conducted on routinely collected ART programme data. RESULTS: Sixty-six per cent of the study population were females. The largest age groups were 25-34 and 35-44, accounting for 32.1% and 31.1%, respectively. Males had a 9% greater likelihood (adjusted prevalence ratio, APR=1.09) of being non-suppressed. The age groups below 60+ (APR=0.67) had a higher likelihood of a non-suppressed VL, with the highest in the 0-14 age group (APR=2.38). Clients enrolled at tertiary and secondary level facilities had the greatest likelihood of a non-suppressed VL. Clients who started ART between 2010 and 2015 had the greatest likelihood of viral non-suppression (APR=6.19). A shorter time on ART (<1 year (APR=3.92)) was associated with a higher likelihood of a non-suppressed VL. Clients receiving care at private facilities had a lower likelihood of viral non-suppression in the adjusted model. Clients in the Edo (APR=2.66) and Niger (APR=2.54) states had the greatest likelihood of viral non-suppression. CONCLUSIONS: Targeting males, clients of younger age, those on treatment for less than 3 years, clients at tertiary and secondary health facilities, small and medium facilities, and clients in the Edo, Niger and Borno states for interventions could lead to improvements in VL suppression in Nigeria. The independent factors associated with a non-suppressed VL can guide improvements in ART programme development and VL suppression of PLHIV on ART in Nigeria.

Comparison of Feeding Practices and Growth of Urbanized African Infants Aged 6-12 Months Old by Maternal HIV Status in Gauteng Province, South Africa.

Appropriate feeding practices are protective against malnutrition and poor growth. We compared feeding practices and growth in HIV-exposed-uninfected (HEU) and HIV-unexposed-uninfected (HUU) between 6-12 months of age in urbanized African infants in South Africa. A repeated cross-sectional analysis was used to determine differences in infant feeding practices and anthropometric measures by HIV exposure status at 6, 9, and 12 months in the Siyakhula study. The study included 181 infants (86 HEU; 95 HUU). Breastfeeding rates were lower in HEU vs. HUU infants at 9 (35.6% vs. 57.3%; p = 0.013) and 12 months (24.7% vs. 48.0%; p = 0.005). Introduction to early complementary foods was common (HEU = 16.2 ± 11.0 vs. HUU = 12.8 ± 9.3 weeks; p = 0.118). Lower weight-for-age Z-scores (WAZ) and head circumference-for-age Z-scores (HCZ) were found in HEU infants at birth. At 6 months, WAZ, length-for-age Z-scores (LAZ), HCZ, and mid-upper-arm circumference-for-age Z-scores (MUACAZ) were lower in HEU vs. HUU infants. At 9 months, lower WAZ, LAZ, and MUACAZ were found in HEU vs. HUU infants. At 12 months, lower WAZ, MUACAZ, and weight-for-length Z-scores (-0.2 ± 1.2 vs. 0.2 ± 1.2; p = 0.020) were observed. HEU infants had lower rates of breastfeeding and poorer growth compared to HUU infants. Maternal HIV exposure affects the feeding practices and growth of infants.

Trends in Cases, Hospitalizations, and Mortality Related to the Omicron BA.4/BA.5 Subvariants in South Africa.

BACKGROUND: In this study, we compared admission incidence risk and the risk of mortality in the Omicron BA.4/BA.5 wave to previous waves. METHODS: Data from South Africa's SARS-CoV-2 case linelist, national COVID-19 hospital surveillance system, and Electronic Vaccine Data System were linked and analyzed. Wave periods were defined when the country passed a weekly incidence of 30 cases/100 000 population. In-hospital case fatality ratios (CFRs) during the Delta, Omicron BA.1/BA.2, and Omicron BA.4/BA.5 waves were compared using post-imputation random effect multivariable logistic regression models. RESULTS: The CFR was 25.9% (N = 37 538 of 144 778), 10.9% (N = 6123 of 56 384), and 8.2% (N = 1212 of 14 879) in the Delta, Omicron BA.1/BA.2, and Omicron BA.4/BA.5 waves, respectively. After adjusting for age, sex, race, comorbidities, health sector, and province, compared with the Omicron BA.4/BA.5 wave, patients had higher risk of mortality in the Omicron BA.1/BA.2 wave (adjusted odds ratio [aOR], 1.3; 95% confidence interval [CI]: 1.2-1.4) and Delta wave (aOR, 3.0; 95% CI: 2.8-3.2). Being partially vaccinated (aOR, 0.9; 95% CI: .9-.9), fully vaccinated (aOR, 0.6; 95% CI: .6-.7), and boosted (aOR, 0.4; 95% CI: .4-.5) and having prior laboratory-confirmed infection (aOR, 0.4; 95% CI: .3-.4) were associated with reduced risks of mortality. CONCLUSIONS: Overall, admission incidence risk and in-hospital mortality, which had increased progressively in South Africa's first 3 waves, decreased in the fourth Omicron BA.1/BA.2 wave and declined even further in the fifth Omicron BA.4/BA.5 wave. Mortality risk was lower in those with natural infection and vaccination, declining further as the number of vaccine doses increased.

Applying machine learning and predictive modeling to retention and viral suppression in South African HIV treatment cohorts.

HIV treatment programs face challenges in identifying patients at risk for loss-to-follow-up and uncontrolled viremia. We applied predictive machine learning algorithms to anonymised, patient-level HIV programmatic data from two districts in South Africa, 2016-2018. We developed patient risk scores for two outcomes: (1) visit attendance ≤ 28 days of the next scheduled clinic visit and (2) suppression of the next HIV viral load (VL). Demographic, clinical, behavioral and laboratory data were investigated in multiple models as predictor variables of attending the next scheduled visit and VL results at the next test. Three classification algorithms (logistical regression, random forest and AdaBoost) were evaluated for building predictive models. Data were randomly sampled on a 70/30 split into a training and test set. The training set included a balanced set of positive and negative examples from which the classification algorithm could learn. The predictor variable data from the unseen test set were given to the model, and each predicted outcome was scored against known outcomes. Finally, we estimated performance metrics for each model in terms of sensitivity, specificity, positive and negative predictive value and area under the curve (AUC). In total, 445,636 patients were included in the retention model and 363,977 in the VL model. The predictive metric (AUC) ranged from 0.69 for attendance at the next scheduled visit to 0.76 for VL suppression, suggesting that the model correctly classified whether a scheduled visit would be attended in 2 of 3 patients and whether the VL result at the next test would be suppressed in approximately 3 of 4 patients. Variables that were important predictors of both outcomes included prior late visits, number of prior VL tests, time since their last visit, number of visits on their current regimen, age, and treatment duration. For retention, the number of visits at the current facility and the details of the next appointment date were also predictors, while for VL suppression, other predictors included the range of the previous VL value. Machine learning can identify HIV patients at risk for disengagement and unsuppressed VL. Predictive modeling can improve the targeting of interventions through differentiated models of care before patients disengage from treatment programmes, increasing cost-effectiveness and improving patient outcomes.

Factors associated with an interruption in treatment of people living with HIV in USAID-supported states in Nigeria: a retrospective study from 2000-2020.

BACKGROUND: Patient interruption of antiretroviral therapy (ART) continues to limit HIV programs' progress toward epidemic control. Multiple factors have been associated with client interruption in treatment (IIT)- including age, gender, CD4 count, and education level. In this paper, we explore the factors associated with IIT in people living with HIV (PLHIV) in United States Agency for International Development (USAID)-supported facilities under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) program in Nigeria. METHODS: We conducted cross-sectional analyses on data obtained from Nigeria's National Data Repository (NDR), representing a summarized record of 573 630 ART clients that received care at 484 PEPFAR/USAID-supported facilities in 16 states from 2000-2020. IIT was defined as no clinical contact for 28 days or more after the last expected clinical contact. Univariate and multivariate logistic regression models were computed to explore the factors associated with IIT. The variables included in the analysis were sex, age group, zone, facility level, regimen line, multi-month dispensing (MMD), and viral load category. RESULTS: Of the 573 630 clients analysed in this study, 32% have been recorded as having interrupted treatment. Of the clients investigated, 66% were female (32% had interrupted treatment), 39% were aged 25-34 at their last ART pick-up date (with 32% of them interrupted treatment), 59% received care at secondary level facilities (37% interrupted treatment) and 38% were last receiving between three- to five-month MMD (with 10% of these interrupted treatment). Those less likely to interrupt ART were males (aOR = 0.91), clients on six-month MMD (aOR = 0.01), adults on 2nd line regimen (aOR = 0.09), and paediatrics on salvage regimen (aOR = 0.02). Clients most likely to interrupt ART were located in the South West Zone (aOR = 1.99), received treatment at a tertiary level (aOR = 12.34) or secondary level facilities (aOR = 4.01), and had no viral load (VL) on record (aOR =10.02). Age group was not significantly associated with IIT. CONCLUSIONS: Sex, zone, facility level, regimen line, MMD, and VL were significantly associated with IIT. MMD of three months and longer (especially six months) had better retention on ART than those on shorter MMD. Not having a VL on record was associated with a considerable risk of IIT.

Multimonth dispensing of up to 6 months of antiretroviral therapy in Malawi and Zambia (INTERVAL): a cluster-randomised, non-blinded, non-inferiority trial.

BACKGROUND: Facility-based, multimonth dispensing of antiretroviral therapy (ART) for HIV could reduce burdens on patients and providers and improve retention in care. We assessed whether 6-monthly ART dispensing was non-inferior to standard of care and 3-monthly ART dispensing. METHODS: We did a pragmatic, cluster-randomised, unblinded, non-inferiority trial (INTERVAL) at 30 health facilities in Malawi and Zambia. Eligible participants were aged 18 years or older, HIV-positive, and were clinically stable on ART. Before randomisation, health facilities (clusters) were matched on the basis of country, ART cohort size, facility type (ie, hospital vs health centre), and region or province. Matched clusters were randomly allocated (1:1:1) to standard of care, 3-monthly ART dispensing, or 6-monthly ART dispensing using a simple random allocation sequence. The primary outcome was retention in care at 12 months, defined as the proportion of patients with less than 60 consecutive days without ART during study follow-up, analysed by intention to treat. A 2·5% margin was used to assess non-inferiority. This study is registered with ClinicalTrials.gov, NCT03101592. FINDINGS: Between May 15, 2017, and April 30, 2018, 9118 participants were randomly assigned, of whom 8719 participants (n=3012, standard of care group; n=2726, 3-monthly ART dispensing group; n=2981, 6-monthly ART dispensing group) had primary outcome data available at 12 months and were included in the primary analysis. The median age of participants was 42·7 years (IQR 36·1-49·9) and 5774 (66·2%) of 8719 were women. The primary outcome was met by 2478 (82·3%) of 3012 participants in the standard of care group, 2356 (86·4%) of 2726 participants in the 3-monthly ART dispensing group, and 2729 (91·5%) of 2981 participants in the 6-monthly ART dispensing group. After adjusting for clustering, for retention in care at 12 months, the 6-monthly ART dispensing group was non-inferior to the standard of care group (percentage-point increase 9·1 [95% CI 0·9-17·2]) and to the 3-monthly ART dispensing group (5·0% [1·0-9·1]). INTERPRETATION: Clinical visits with ART dispensing every 6 months was non-inferior to standard of care and 3-monthly ART dispensing. 6-monthly ART dispensing is a promising strategy for the expansion of ART provision and achievement of HIV treatment targets in resource-constrained settings. FUNDING: US Agency for International Development.

Provider experiences with three- and six-month antiretroviral therapy dispensing for stable clients in Zambia.

Multi-month dispensing of antiretroviral therapy (ART) has been taken to scale in many settings in sub-Saharan Africa with the benefits of improved client satisfaction and decreased client costs. Six-month ART dispensing may further increase these benefits; however, data are lacking. Within a cluster-randomized trial of three- versus six-month dispensing in Malawi and Zambia, we performed a sub-study to explore Zambian provider experiences with multi-month dispensing. We conducted 18 in-depth interviews with clinical officers and nurses dispensing ART as part of INTERVAL in Zambia. Interview questions focused on provider perceptions of client acceptability, views on client sharing and selling of ART, and perceptions on provider workload and clinic efficiency, with a focus on differences between three- and six-month dispensing. Interviews were analyzed using inductive thematic analysis to identify key themes and patterns within the data. Providers perceived significant benefits of multi-month dispensing, with advantages of six-month over three-month dispensing related to a reduced burden on clients, and for reductions in their own workload and clinic congestion. Among nearly all providers, the six-month dispensing strategy was perceived as ideal. Further research is needed to quantify clinical outcomes of six-month dispensing and feasibility of scaling-up this intervention in resource-limited settings.Clinical Trial Number: NCT03101592.

Eligibility for differentiated models of HIV treatment service delivery: an estimate from Malawi and Zambia.

BACKGROUND: Little is known about the proportion of HIV-positive clients on antiretroviral therapy (ART) who meet stability criteria for differentiated service delivery (DSD) models. We report the proportion of ART clients meeting stability criteria as part of screening for a randomized trial of multimonth dispensing in Malawi and Zambia. METHODS: For a DSD trial now underway, we screened HIV-positive clients aged at least 18 years presenting for HIV treatment in 30 adult ART clinics in Malawi and Zambia to determine eligibility for DSD. Stability was defined as on first-line ART (efavirenz/tenofovir/lamivudine) for at least 6 months, no ART side effects, no toxicity or infectious complications, no noncommunicable diseases being treated in ART clinic, no lapses in ART adherence in the prior 6 months (>30 days without taking ART), and if female, not pregnant or breastfeeding. RESULTS: In total, 3465 adult ART clients were approached between 10 May 2017 and 30 April 2018 (Malawi: 1680; Zambia: 1785). Of the 2938 who answered screening questions (Malawi: 1527; Zambia: 1411), 2173 (73.5%) met criteria for DSD eligibility (Malawi: 72.8%; Zambia: 74.3%). The most common reasons for ineligibility were being on ART less than 6 months (9.6%) and a regimen other than standard first-line (7.9%). CONCLUSION: Approximately three-quarters of all adult clients presenting at ART clinics in Malawi and Zambia were eligible for DSD using a typical definition of stability. High uptake of DSD models by eligible clients would have a major impact on the infrastructure and the allocation of HIV treatment resources.

Prevalent, persistent anal HPV infection and squamous intraepithelial lesions: Findings from a cohort of men living with HIV in South Africa.

OBJECTIVE: To estimate the prevalence, incidence and persistence of anal HPV infection and squamous intra-epithelial lesions (SILs) among men living with HIV (MLHIV), and determine their risk factors. METHODS: We enrolled MLHIV ≥18 years, who attended 6-monthly visits for 18 months. Socio-behavioural data were collected by questionnaire. Clinicians collected blood sample (CD4+ count and HIV plasma viral load), anal swabs (HPV DNA testing) and anal smears (Bethesda classification) at each visit. HPV DNA testing and classification of smears were done at enrolment and last follow-up visit (two time points). Factors associated with persistent anal HPV infection and SILs were evaluated with generalized estimating equations logistic regression and standard logistic regression respectively. RESULTS: Mean age of 304 participants was 38 (Standard Deviation, 8) years; 25% reported >1 sexual partner in the past 3 months. Only 5% reported ever having sex with other men. Most (65%) participants were taking antiretroviral treatment (ART), with a median CD4+ count of 445 cells/µL (IQR, 328-567). Prevalence of any-HPV infection at enrolment was 39% (88/227). In total, 226 men had anal HPV DNA results at both enrolment and final visits. Persistence of any-anal HPV infection among 80 men who had infection at enrolment was 26% (21/80). Any persistent anal HPV infection was more frequent among MLHIV with low CD4+ count (<200 vs. >500 cells/µL; aOR = 6.58; 95%CI: 2.41-17.94). Prevalence of anal SILs at enrolment was 49% (118/242) while incidence of SILs among MLHIV who had no anal dysplasia at enrolment was 27% (34/124). Of the 118 men who had anal dysplasia at enrolment, 15% had regressed and 38% persisted by month 18. Persistent anal HPV infection was associated with persistent SILs (aOR = 2.95; 95%CI: 1.08-10.89). ART status or duration at enrolment were not associated with persistent anal HPV infection or persistent SILs during follow-up. CONCLUSION: In spite of a high prevalence of anal HPV, HIV-positive heterosexual men have a low burden of anal HPV related disease. HPV vaccine and effective ART with immunological reconstitution could reduce this burden of infection.

Incidence, Persistence, Clearance, and Correlates of Genital Human Papillomavirus Infection and Anogenital Warts in a Cohort of Men Living With Human Immunodeficiency Virus in South Africa.

OBJECTIVE: To estimate the incidence; persistence and correlates of human papillomavirus (HPV) infection and anogenital warts (AGW) among men living with human immunodeficiency virus (MLHIV). METHODS: Overall, 304 MLHIV 18 years or older were enrolled and attended follow-up visits at 6, 12, and 18 months. Clinicians examined for AGW, collected blood, and penile swabs for HPV testing (Roche Linear Array) at each visit. Time to AGW incidence or clearance was estimated by Kaplan-Meier method. Factors associated with persistent HPV infection and AGW clearance were evaluated with generalized estimating equations and Cox regression, respectively. RESULTS: Mean age of participants was 38 years (standard deviation, 8 years); 25% reported more than 1 sexual partner in the past 3 months. Most (65%) participants were on antiretroviral treatment (ART) with a median CD4 count of 445 cells/µL (interquartile range, 328-567). Prevalence of HPV infection and AGW at enrolment were 79% (224 of 283) and 12% (36 of 304), respectively. Two hundred fifty-nine men were followed up for a median (interquartile range) 1.4 years (0.5-1.7 years). Incidence of any-genital HPV infection was 2.9 (95% confidence interval, 1.5-5.5) per 100 person-years. Persistence of any-genital HPV infection was 35% (68 of 192) and was higher among MLHIV with low CD4 count (adjusted odds ratio, 3.54; 95% confidence interval, 2.07-6.05). Incidence of AGW was 1.4 per 100 person-years. Men living with human immunodeficiency virus with high CD4 count were more likely to clear AGW than those with low CD4 count (adjusted hazard ratio, 3.69; 95% confidence interval, 1.44-9.47). No associations were observed between persistent genital HPV infection, AGW clearance with enrolment ART status or duration. CONCLUSIONS: Human immunodeficiency virus-positive men have a high burden of genital HPV infection and AGW. The ART and HPV vaccine could reduce this burden.

Patterns and trends of HPV-related cancers other than cervix in South Africa from 1994-2013.

BACKGROUND: HPV infection causes several cancers which include cervical, vaginal, vulval, penile and oropharyngeal cancer (OPC). Understanding the burden of HPV-related cancers is important for guiding cancer prevention and treatment interventions. METHODS: To inform policy, we analysed trends of age-standardised incidence (ASIR) and mortality (ASMR) rates for HPV-related head and neck (HNC) and anogenital cancers (AGC) in South Africa between 1994 and 2013. RESULTS: A total of 1 028 330 incident cancers and 617 044 cancer-related deaths were reported during the study period. The overall ASIR (-5.5%) and ASMR (-2.2%) for HNC declined, in part related to the anti-smoking legislation. In contrast, incidence (2.9%) and mortality (0.8%) rates for AGC increased with the rising HIV prevalence. ASIR for oral cavity cancer (OCC: -6.3%) and laryngeal cancer (LC: -11.3%) declined, including mortality associated with these cancers (OCC:-1.9%, and LC:-2.6%). However, oropharyngeal cancer showed a slower rate of decline in ASIR (-4.4%) and ASMR did not change. Compared to women, ASIR and ASMR for HNC were 3-fold higher among men. ASIR for both anal (7.5%) and vulval cancer (16.1%) increased. Median age at diagnosis of vulval cancer declined by 18 years (p-value = 0.01). Mortality rates for anal (3.9%) and vulval (2.6%) cancer increased. ASIR (-3.2%) and ASMR (-2.0%) for penile cancer declined. Rates for vaginal cancer did not change. CONCLUSIONS: Anal and vulval cancers have increased over the reporting period. There is need to continuously monitor trends of these cancers. Implementation of HPV vaccination could significantly reduce the burden of HPV-related cancers.

Assessment of adolescent and youth friendly services in primary healthcare facilities in two provinces in South Africa.

BACKGROUND: Health services for adolescents are increasingly recognised as a priority in low- and middle-income countries (LMICs). The Adolescent and Youth Friendly Service (AYFS) approach has been promoted in South Africa by the National Department of Health and partners, as a means of standardising the quality of adolescent health services in the country. The objective of this paper is to detail the evaluation of AYFS against defined standards to inform initiatives for strengthening these services. METHODS: A cross-sectional assessment of AYFS was carried out in 14 healthcare facilities in a sub-district of Gauteng Province and 16 in a sub-district in North West Province, South Africa. Data on adolescent care and service management systems were collected through interviews with healthcare providers, non-clinical staff and document review. Responses were scored using a tool based on national and World Health Organisation criteria for ten AYFS standards. RESULTS: Mean scores for the ten standards showed substantial variation across facilities in the two sub-Districts, with Gauteng Province scoring lower than the North West for 9 standards. The sub-district median for Gauteng was 38% and the North West 48%. In both provinces standards related to the general service delivery, such as Standards 4 and 5, scored above 75%. Assessment of services specifically addressing sexual, reproductive and mental health (Standard 3) showed that almost all these services were scored above 50%. Exploration of services related to psycho-social and physical assessments (Standard 8) demonstrated differences in the healthcare facilities' management of adolescents' presenting complaints and their comprehensive management including psycho-social status and risk profile. Additionally, none of the facilities in either sub-district was able to meet the minimum criteria for the five standards required for AYFS recognition. CONCLUSION: Facilities had the essential components for general service delivery in place, but adolescent-specific service provision was lacking. AYFS is a government priority, but additional support for facilities is needed to achieve the agreed standards. Meeting these standards could make a major contribution to securing adolescents' health, especially in preventing unintended pregnancies and HIV as well as improving psycho-social management.

Maternal traditional dietary pattern and antiretroviral treatment exposure are associated with neonatal size and adiposity in urban, black South Africans.

This study examines the associations between maternal Traditional dietary pattern adherence and HIV/treatment with neonatal size and adiposity in urban, black South Africans, as well as how specific maternal factors - that is BMI and gestational weight gain (GWG) - may influence these associations. Multiple linear regression models were used to examine associations among maternal Traditional diet pattern adherence (pattern score), HIV/treatment status (three groups: HIV negative, HIV positive (antenatal antiretroviral treatment (ART) initiation), HIV positive (pre-pregnancy ART initiation)), BMI and GWG (kg/week), and newborn (1) weight:length ratio (WLR, kg/m) in 393 mother-neonate pairs, and (2) Peapod estimated fat mass index (FMI, kg/m3) in a 171-pair subsample. In fully adjusted models, maternal obesity and GWG were associated with 0·25 kg/m (P=0·008) and 0·48 kg/m (P=0·002) higher newborn WLR, whereas Traditional diet pattern score was associated with lower newborn WLR (-0·04 kg/m per +1 sd; P=0·033). In addition, Traditional diet pattern score was associated with 0·13 kg/m3 (P=0·027) and 0·32 kg/m3 (P=0·005) lower FMI in the total sample and in newborns of normal-weight women, respectively. HIV-positive (pre-pregnancy ART) v. HIV-negative (ref) status was associated with 1·11 kg/m3 (P=0·002) higher newborn FMI. Promotion of a Traditional dietary pattern, alongside a healthy maternal pre-conception weight, in South African women may reduce newborn adiposity and metabolic risk profiles. In HIV-positive women, targeted monitoring and management strategies are necessary to limit treatment-associated effects on in utero fat deposition.

Temporal trends in the epidemiology of cervical cancer in South Africa (1994-2012).

Cervical cancer (CC) is the leading cause of cancer death among female South Africans (SA). Improved access to reproductive health services following multi-ethnic democracy in 1994, HIV epidemic, and the initiation of CC population-based screening in early 2000s have influenced the epidemiology of CC in SA. We therefore evaluated the trends in CC age-standardised incidence (ASIR) (1994-2009) and mortality rates (ASMR) (2004-2012) using data from the South African National Cancer Registry and the Statistics South Africa, respectively. Five-year relative survival rates and average per cent change (AAPC) stratified by ethnicity and age-groups was determined. The average annual CC cases and mortalities were 4,694 (75,099 cases/16 years) and 2,789 (25,101 deaths/9 years), respectively. The ASIR was 22.1/100,000 in 1994 and 23.3/100,000 in 2009, with an average annual decline in incidence of 0.9% per annum (AAPC = -0.9%, p-value < 0.001). The ASMR decreased slightly by 0.6% per annum from 13.9/100,000 in 2004 to 13.1/100,000 in 2012 (AAPC = -0.6%, p-value < 0.001). In 2012, ASMR was 5.8-fold higher in Blacks than in Whites. The 5-year survival rates were higher in Whites and Indians/Asians (60-80%) than in Blacks and Coloureds (40-50%). The incidence rate increased (AAPC range: 1.1-3.1%, p-value < 0.001) among young women (25-34 years) from 2000 to 2009. Despite interventions, there were minimal changes in overall epidemiology of CC in SA but there were increased CC rates among young women and ethnic disparities in CC burden. A review of the CC national policy and directed CC prevention and treatment are required to positively impact the burden of CC in SA.

Prevalence, incidence and correlates of low risk HPV infection and anogenital warts in a cohort of women living with HIV in Burkina Faso and South Africa.

OBJECTIVE: To report the prevalence and incidence of low-risk human papillomavirus infection (LR-HPV) and anogenital warts (AGW) among women living with HIV (WLHIV) in Burkina Faso (BF) and South Africa (SA), and to explore HIV-related factors associated with these outcomes. METHODS: We enrolled 1238 WLHIV (BF = 615; SA = 623) aged 25-50 years and followed them at three time points (6, 12 and 16 months) after enrolment. Presence of AGW was assessed during gynaecological examination. Cervico-vaginal swabs for enrolment and month 16 follow-up visits were tested for HPV infection by Inno-LiPA® genotyping. Logistic regression was used to assess risk factors for prevalent infection or AGW. Cox regression was used to assess risk factors for incident AGW. RESULTS: Women in SA were more likely than those in BF to have prevalent LR-HPV infection (BF: 27.1% vs. SA: 40.9%; p<0.001) and incident LR-HPV infection (BF: 25.8% vs. SA: 31.6%, p = 0.05). Prevalence of persistent LR-HPV was similar in the two countries (BF: 33.3% vs. SA: 30.4%; p = 0.54), as were prevalence and incidence of AGW (Prevalence: BF: 7.5% vs. SA: 5.7%; p = 0.21; Incidence: BF: 2.47 vs. SA: 2.33 per 100 person-years; p = 0.41). HPV6 was associated with incident AGW (BF: adjusted Hazard Ratio (aHR) = 4.88; 95%CI: 1.36-17.45; SA: aHR = 5.02; 95%CI: 1.40-17.99). Prevalent LR-HPV (BF: adjusted Odds Ratio [aOR = 1.86]; 95%CI: 1.01-3.41; SA: aOR = 1.75; 95%CI: 0.88-3.48); persistent LR-HPV (BF: aOR = 1.92; 95%CI: 0.44-8.44; SA: aOR = 2.81; 95%CI: 1.07-7.41) and prevalent AGW (BF: aOR = 1.53; 95%CI: 0.61-3.87; SA: aOR = 4.11; 95%CI: 1.20-14.10) were each associated with low CD4+ counts (i.e. <200 vs. >500 cells/µL). Duration of ART and HIV plasma viral load were not associated with any LR-HPV infection or AGW outcomes. CONCLUSION: LR-HPV infection and AGW are common in WLHIV in sub-Saharan Africa. Type-specific HPV vaccines and effective ART with immunological reconstitution could reduce the burden of AGW in this population.

Access to HIV care and treatment for migrants between Lesotho and South Africa: a mixed methods study.

BACKGROUND: HIV treatment and care for migrants is affected by their mobility and interaction with HIV treatment programs and health care systems in different countries. To assess healthcare needs, preferences and accessibility barriers of HIV-infected migrant populations in high HIV burden, borderland districts of Lesotho. METHODS: We selected 15 health facilities accessed by high patient volumes in three districts of Maseru, Leribe and Mafeteng. We used a mixed methods approach by administering a survey questionnaire to consenting HIV infected individuals on anti-retroviral therapy (ART) and utilizing a purposive sampling procedure to recruit health care providers for qualitative in-depth interviews across facilities. RESULTS: Out of 524 HIV-infected migrants enrolled in the study, 315 (60.1%) were from urban and 209 (39.9%) from rural sites. Of these, 344 (65.6%) were women, 375 (71.6%) were aged between 26 and 45 years and 240 (45.8%) were domestic workers. A total of 486 (92.7%) preferred to collect their medications primarily in Lesotho compared to South Africa. From 506 who responded to the question on preferred dispensing intervals, 63.1% (n = 319) preferred 5-6 month ARV refills, 30.2% (n = 153) chose 3-4 month refills and only 6.7% (n = 34) opted for the standard-of-care 1-2 month refills. A total of 126 (24.4%) defaulted on their treatment and the primary reason for defaulting was failure to get to Lesotho to collect medication (59.5%, 75/126). Treatment default rates were higher in urban than rural areas (28.3% versus 18.4%, p = 0.011). Service providers indicated a lack of transfer letters as the major drawback in facilitating care and treatment for migrants, followed by discrimination based on nationality or language. Service providers indicated that most patients preferred all treatment services to be rendered in Lesotho, as they perceive the treatment provided in South Africa to be different often less strong or with more serious side effects. CONCLUSION: Existing healthcare systems in both South Africa and Lesotho experience challenges in providing proper care and treatment for HIV infected migrants. A need for a differentiated model of ART delivery to HIV infected migrants that allows for multi-month scripting and dispensing is warranted.

Different adiposity indices and their association with blood pressure and hypertension in middle-aged urban black South African men and women: findings from the AWI-GEN South African Soweto Site.

BACKGROUND: To report associations between different adiposity indices [anthropometric and dual-energy X-ray absorptiometry (DXA) measures] and blood pressure (BP) and hypertension in urban black South African adults. METHODS: Anthropometric and DXA whole body measures were performed on 1026 men and 982 women. Participants were classified as being hypertensive if they had a systolic BP (SBP) ≥ 140 mmHg and/or diastolic (DBP) ≥ 90 mmHg. Within each gender the relationship of adiposity with BP and hypertension risk was assessed using linear and logistic regression models respectively. Bivariate models were computed for each body composition variable. Furthermore, we computed a multiple regression model to illustrates how body composition parameters are associated with the outcome variables independent of each other. RESULTS: The males were significantly taller and had a higher fat free soft tissue mass (FFSTM), DBP and socio-economic status, and were more likely to use tobacco and be hypertensive (48.0% vs. 38.8%). The females had higher body mass index (BMI), waist circumference (WC), fat mass (FM), subcutaneous adipose tissue (SAT), visceral adipose tissue (VAT), FM/FFSTM ratio and body fat % than males. All body composition parameters were positively associated with hypertension. In both males and females, the FM/FFSTM ratio associated the strongest with hypertension illustrating the following odds ratios [males: 70.37 (18.47, 268.16) p ≤ 0.001; females 2.48 (0.86,7.21) p = 0.09]. The multiple regression model, indicated that the VAT and WC significantly associated with both SBP and DBP in the men and women respectively, whilst WC was the only significant predictor for hypertension. CONCLUSIONS: All body composition parameters were associated with hypertension and FM/FFSTM ratio showed the strongest relationship. It was reassuring that WC remains a useful measure of central adiposity that can be used as a risk indicator for hypertension if more sophisticated measures are not available. Furthermore, our data in part, implies that reducing abdominal adiposity in aging adults could contribute to reducing the risk of elevated blood pressure and hypertension.