RESUMO
Scaling up of newer innovations that address the limitations of the dried blood spot and the logistics of plasma monitoring is needed. We employed a multi-site, cross-sectional assessment of the plasma separation card (PSC) on blood specimens collected from all consenting adults, assenting young and pediatric patients living with HIV from 10 primary healthcare clinics in South Africa. Venous blood for EDTA-plasma samples was collected and analyzed according to the standard of care assay, while collected capillary blood for the PSC samples was analyzed using the Roche COBAS AmpliPrep/Cobas TaqMan (CAP/CTM) HIV-1 Test at the National Reference laboratories. McNemar tests assessed the differences in concordance between the centrifuged plasma and dried plasma spots. The usability of PSC by blood spotting, PSC preparation, and pre-analytical work was assessed by collecting seven-point Likert-scale data from healthcare and laboratory workers. We enrolled 538 patients, mostly adults [n = 515, 95.7% (95% CI: 93.7%-97.1%)] and females [n = 322, 64.2% (95% CI: 60.0%-68.1%)]. Overall, 536 paired samples were collected using both PSC- and EDTA-plasma diagnostics, and 502 paired PSC- and EDTA-plasma samples assessed. Concordance between the paired samples was obtained for 446 samples. Analysis of these 446 paired samples at 1,000 copies per milliliter threshold yielded an overall sensitivity of 87.5% [95% CI: 73.2%-95.8%] and specificity of 99.3% [95% CI: 97.9%-99.8%]. Laboratory staff reported technical difficulties in most tasks. The usability of the PSC by healthcare workers was favorable. For policymakers to consider PSC scale-up for viral load monitoring, technical challenges around using PSC at the clinic and laboratory level need to be addressed. IMPORTANCE: Findings from this manuscript emphasize the reliability of the plasma separation card (PSC), a novel diagnostic method that can be implemented in healthcare facilities in resource-constrained settings. The agreement of the PSC with the standard of care EDTA plasma for viral load monitoring is high. Since the findings showed that these tests were highly specific, we recommend a scale-up of PSC in South Africa for diagnosis of treatment failure.
Assuntos
Infecções por HIV , HIV-1 , Adulto , Feminino , Humanos , Criança , Sensibilidade e Especificidade , HIV-1/genética , Carga Viral/métodos , África do Sul , Estudos Transversais , Ácido Edético , Reprodutibilidade dos Testes , RNA ViralRESUMO
OBJECTIVE: To explore the syndemic interaction between social, environmental, and structural contexts and HIV infection in peri-mining areas in South Africa. DESIGN: Mixed qualitative methods consisting of in-depth interviews (IDIs) and focus group discussions (FGDs) exploring the interaction between HIV infection and the social, environmental and structural factors affecting people living in the peri-mining areas of South Africa. Themes were analysed following the syndemic theoretical framework. SETTING: Participants were recruited from three mining companies and locations in the peri-mining communities surrounding the mining companies in Limpopo, Mpumalanga, and Northern Cape provinces. PARTICIPANTS: Inclusion criteria included mineworkers, healthcare workers, female sex workers (FSWs), injection drug users (IDUs), and other community members, ≥18 years, living in the peri-mining area at the time of participation. Three FGDs were conducted (n=30): 13 men and 17 women aged 18-55 years. IDIs were conducted with 45 participants: mineworkers (n=10), healthcare workers (n=11), FSWs (n=15), truck drivers (n=4) and IDUs (n=5). RESULTS: The findings from this study indicate that a syndemic of four socio-behavioural factors is associated with HIV acquisition in peri-mining areas. These are migrancy, accessibility to alcohol and substance use, commercial and transactional sex, and uptake of HIV prevention services. CONCLUSIONS: Our findings have implications for HIV prevention programmes in mining companies, which rely on male condom usage promotion. More emphasis on better education about HIV prevalence, transmission and up-to-date prevention alternatives, such as pre-exposure prophylaxis for mineworkers is recommended. Furthermore, collaboration with community-based organisations is recommended to wholly address the syndemic factors influencing HIV transmission in peri-mining communities.
Assuntos
Infecções por HIV , Profissionais do Sexo , Feminino , Masculino , Humanos , Infecções por HIV/epidemiologia , Infecções por HIV/prevenção & controle , África do Sul/epidemiologia , Comportamento Sexual , SindemiaRESUMO
Adolescents face a higher risk for HIV, STIs, and unintended pregnancy than any other age group in sub-Saharan Africa, and have unique health care needs as they navigate this period of growth and developmental milestones. We conducted the Youth Friendly Services study among adolescents in Rustenburg, South Africa to address some of these concerns. Participants aged 12-19 were followed quarterly for 12 months, asked at baseline about demographics, their sexual behavior, and tested for HIV, STIs, and pregnancy (girls). Report of sexual activity was not a requirement for enrollment. Assent and parental consent were obtained for participants under 18. Some follow up visits fell during COVID-mandated shutdowns, and we worked with participants to reschedule and extend follow up as appropriate. Here we present data on reported behaviors, participant attrition, risk of HIV, other STI, and pregnancy. From May 2018 to August 2019, we enrolled 223 HIV-negative, non-pregnant adolescents (64% girls). The median age was 17 (IQR: 14-18). Among the 119 (53%) participants who reported being sexually active at baseline, the median age at first sex was 16 years (IQR: 15-17). During follow-up, an additional 16 (7%) participants reported having their first sexual encounter. Among the sexually active participants, the incidence of HIV was 1.5 cases / 100 person-years at risk (PYAR, 95% CI: 0.4-6.0), the incidence of chlamydia was 15.7 cases (95% CI: 10.1-24.4), gonorrhea was 4.7 cases (95% CI: 2.1-10.5), and HSV was 6.3 cases (95% CI: 3.1-12.6); we observed no cases of incident syphilis. The incidence of pregnancy among sexually active girls was 15.0 pregnancies / 100 PYAR (95% CI: 8.5-26.5). Despite small numbers, the incidence of most STIs was significantly higher in females compared to males. We also observed two pregnancies and 5 incident STIs among participants who reported never having had sex, these tended to be younger participants. From March to September 2020, the clinic was shut down for COVID-19, and 53 study visits were postponed. Follow up was concluded in November 2020, a total of 19 participants were lost to follow up, however only one participant dropped off-study during COVID-19 shutdowns. Retention at the final visit was 91.5%. We successfully completed a prospective study of adolescents to learn more about the risks they face as they navigate sexual debut in the context of a program of youth-friendly counseling and services. Among self-reported sexually active participants, we observed a high rate of HIV, STI and pregnancy, however we also observed pregnancy and STIs among those who reported no sexual activity.