Browsing by Author "Naicker, Nivashnee."

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Acceptability of early antiretroviral therapy among South African women.
(Springer., 2018) Garrett, Nigel Joel.; Norman, Emily.; Leask, Kerry.; Naicker, Nivashnee.; Asari, Villeshni.; Majola, Nelisile.; Abdool Karim, Quarraisha.; Abdool Karim, Salim Safurdeen.
Abstract available in pdf.
Beyond syndromic management: opportunities for diagnosis-based treatment of sexually transmitted infections in low- and middle-income countries.
(Public Library of Science., 2018) Garrett, Nigel Joel.; Osman, Farzana.; Maharaj, Bhavna.; Naicker, Nivashnee.; Gibbs, Andrew.; Norman, Emily.; Samsunder, Natasha.; Ngobese, Hope.; Mitchev, Nireshni.; Singh, Ravesh.; Abdool Karim, Salim Safurdeen.; Kharsany, Ayesha Bibi Mahomed.; Mlisana, Koleka Patience.; Rompalo, Anne.; Mindel, Adrian.
Abstract available in pdf.
Challenges of diagnosing acute HIV-1 subtype C infection in African women: performance of a clinical algorithm and the need for point-of-care nucleic-acid based testing.
(Plos., 2012) Mlisana, Koleka Patience.; Sobieszczyk, Magdalena E.; Werner, Lise.; Feinstein, Addi.; van Loggerenberg, Francois.; Naicker, Nivashnee.; Williamson, Carolyn.; Garrett, Nigel Joel.
Background. Prompt diagnosis of acute HIV infection (AHI) benefits the individual and provides opportunities for public health intervention. The aim of this study was to describe most common signs and symptoms of AHI, correlate these with early disease progression and develop a clinical algorithm to identify acute HIV cases in resource limited setting. Methods. 245 South African women at high-risk of HIV-1 were assessed for AHI and received monthly HIV-1 antibody and RNA testing. Signs and symptoms at first HIV-positive visit were compared to HIV-negative visits. Logistic regression identified clinical predictors of AHI. A model-based score was assigned to each predictor to create a risk score for every woman. Results. Twenty-eight women seroconverted after a total of 390 person-years of follow-up with an HIV incidence of 7.2/100 person-years (95%CI 4.5–9.8). Fifty-seven percent reported ≥1 sign or symptom at the AHI visit. Factors predictive of AHI included age <25 years (OR = 3.2; 1.4–7.1), rash (OR = 6.1; 2.4–15.4), sore throat (OR = 2.7; 1.0–7.6), weight loss (OR = 4.4; 1.5–13.4), genital ulcers (OR = 8.0; 1.6–39.5) and vaginal discharge (OR = 5.4; 1.6–18.4). A risk score of 2 correctly predicted AHI in 50.0% of cases. The number of signs and symptoms correlated with higher HIV-1 RNA at diagnosis (r = 0.63; p<0.001). Conclusions. Accurate recognition of signs and symptoms of AHI is critical for early diagnosis of HIV infection. Our algorithm may assist in risk-stratifying individuals for AHI, especially in resource-limited settings where there is no routine testing for AHI. Independent validation of the algorithm on another cohort is needed to assess its utility further. Point-of-care antigen or viral load technology is required, however, to detect asymptomatic, antibody negative cases enabling early interventions and prevention of transmission.
HIV disease progression in seroconvertors from the CAPRISA 004 tenofovir gel pre-exposure prophylaxis trial.
(Lippincott Williams & Wilkins., 2015) Garrett, Nigel Joel.; Werner, Lise.; Naicker, Nivashnee.; Naranbhai, Vivek.; Sibeko, Sengeziwe.; Samsunder, Natasha.; Gray, Clive M.; Williamson, Carolyn.; Morris, Lynn.; Abdool Karim, Quarraisha.; Abdool Karim, Salim Safurdeen.
Abstract available in pdf.
Predictors of HIV acquisition in high risk women in Durban, South Africa.
(2015) Naicker, Nivashnee.; Kharsany, Ayesha Bibi Mahomed.; Abdool Karim, Salim Safurdeen.
In South Africa young women bear a disproportionate burden of HIV infection however, risk factors for HIV acquisition are not fully understood in this setting. In a cohort of 245 HIV negative women, we used proportional hazard regression analysis to examine the association of demographic, clinical and behavioural characteristics with HIV acquisition. The overall HIV incidence rate (IR) was 7.20 per 100 women years (wy), 95% Confidence Interval (CI) 4.20–9.80]. Women 18 to 24 years had the highest HIV incidence [IR 13.20 per 100 wy, 95% CI 6.59–23.62] and were almost three times more likely to acquire HIV compared to women 25 years and older [adjusted Hazard Ratio (aHR) 2.61, 95% CI 1.05–6.47]. Similarly, women in relationships with multiple sex partners [IR 8.97 per 100 wy, 95% CI 5.40–14.0] had more than twice the risk of acquiring HIV when compared to women who had no partner or who had a husband or stable partner (aHR 2.47, 95% CI 0.98–6.26). HIV prevention programmes must address young women’s vulnerability and promote safer sex practices for high risk women.
Pregnancy incidence and correlates during the HVTN 503 Phambili HIV vaccine trial conducted among South African women.
(Plos., 2011) Latka, Mary H.; Fielding, Katherine L.; Gray, Glenda Elizabeth.; Bekker, Linda-Gail.; Nchabeleng, Maphoshane.; Mlisana, Koleka Patience.; Nielson, Tanya.; Roux, Surita.; Mkhize, Baningi.; Mathebula, Matsontso.; Naicker, Nivashnee.; De Bruyn, Guy.; Kublin, James.; Churchyard, Gavin J.
Background: HIV prevention trials are increasingly being conducted in sub-Saharan Africa. Women at risk for HIV are also at risk of pregnancy. To maximize safety, women agree to avoid pregnancy during trials, yet pregnancies occur. Using data from the HVTN 503/‘‘Phambili’’ vaccine trial, we report pregnancy incidence during and after the vaccination period and identify factors, measured at screening, associated with incident pregnancy. Methods: To enrol in the trial, women agreed and were supported to avoid pregnancy until 1 month after their third and final vaccination (‘‘vaccination period’’), corresponding to the first 7 months of follow-up. Unsterilized women, pooled across study arms, were analyzed. Poisson regression compared pregnancy rates during and after the vaccination period. Cox proportional hazards regression identified associations with first pregnancy. Results: Among 352 women (median age 23 yrs; median follow-up 1.5 yrs), pregnancy incidence was 9.6/100 women-years overall and 6.8/100 w-yrs and 11.3/100 w-yrs during and after the vaccination period, respectively [Rate Ratio = 0.60 (0.32– 1.14), p = 0.10]. In multivariable analysis, pregnancy was reduced among women who: enrolled at sites providing contraception on-site [HR = 0.43, 95% CI (0.22–0.86)]; entered the trial as injectable contraceptive users [HR = 0.37 (0.21–0.67)] or as consistent condom users (trend) [HR = 0.54 (0.28–1.04)]. Compared with women with a single partner of HIV-unknown status, pregnancy rates were increased among women with: a single partner whose status was HIV-negative [HR = 2.34(1.16–4.73)] and; 2 partners both of HIV-unknown status [HR = 4.42(1.59–12.29)]. Women with 2 more of these risk factors: marijuana use, heavy drinking, or use of either during sex, had increased pregnancy incidence [HR = 2.66 (1.24–5.72)]. Conclusions: It is possible to screen South African women for pregnancy risk at trial entry. Providing injectable contraception for free on-site and supporting consistent condom use may reduce incident pregnancy. Screening should determine the substance use, partnering, and HIV status of both members of the couple for both pregnancy and HIV prevention.
Randomized cross-sectional study to compare HIV-1 specific antibody and cytokine concentrations in female genital secretions obtained by menstrual cup and cervicovaginal lavage.
(Public Library of Science., 2015) Archary, Derseree.; Liebenberg, Lenine Julie.; Werner, Lise.; Tulsi, Sahil.; Majola, Nelisile.; Naicker, Nivashnee.; Dlamini, Sarah Alexandra.; Hope, Thomas J.; Samsunder, Natasha.; Abdool Karim, Salim Safurdeen.; Morris, Lynn.; Passmore, Jo-Ann Shelley.; Garrett, Nigel Joel.
Abstract available in pdf.
Risk factors for HIV acquisition in high risk women in a generalised epidemic setting.
(Springer., 2015) Naicker, Nivashnee.; Kharsany, Ayesha Bibi Mahomed.; Werner, Lise.; van Loggerenberg, Francois.; Mlisana, Koleka Patience.; Garrett, Nigel Joel.; Abdool Karim, Salim Safurdeen.
Abstract available in pdf.
Safety and efficacy of the HVTN 503/Phambili Study of a clade-B-based HIV-1 vaccine in South Africa: a double-blind, randomised, placebo-controlled test-of-concept phase 2b study.
(Elsevier., 2011) Gray, Glenda Elizabeth.; Allen, Mary.; Moodie, Zoe.; Churchyard, Gavin J.; Bekker, Linda-Gail.; Nchabeleng, Maphoshane.; Mlisana, Koleka Patience.; Metch, Barbara.; De Bruyn, Guy.; Latka, Mary H.; Roux, Surita.; Mathebula, Matsontso.; Naicker, Nivashnee.; Ducar, Constance.; Carter, Donald K.; Puren, Adrian.; Eaton, Niles.; McElrath, Margaret Juliana.; Robertson, Michael.; Corey, Lawrence.; Kublin, James.
Background. The MRKAd5 HIV-1 gag/pol/nef subtype B vaccine was designed to elicit T-cell-mediated immune responses capable of providing complete or partial protection from HIV-1 infection or a decrease in viral load after acquisition. We aim to assess the safety and efficacy of the vaccine in South Africa, where the major circulating clade is subtype C. Methods. We did a phase 2b double-blind, randomised test-of-concept study in sexually active HIV-1 seronegative participants at five sites in South Africa. Randomisation was by a computer-generated random number sequence. The vaccine and placebo were given by intramuscular injection on a 0, 1, 6 month schedule. Our coprimary endpoints were a vaccine-induced reduction in HIV-1 acquisition and viral-load setpoint. These endpoints were assessed independently in the modified intention-to-treat (MITT) cohort with two-tailed significance tests stratified by sex. We assessed immunogenicity by interferon-γ ELISPOT in peripheral-blood mononuclear cells. After the lack of efficacy of the MRKAd5 HIV-1 vaccine in the Step study, enrolment and vaccination in our study was halted, treatment allocations were unmasked, and follow-up continued. This study is registered with the South Africa National Health Research Database, number DOH-27-0207-1539, and ClinicalTrials.gov, number NCT00413725. Findings. 801 of a scheduled 3000 participants, of whom 360 (45%) were women, were randomly assigned to receive either vaccine or placebo. 445 participants (56%) had adenovirus serotype 5 (Ad5) titres greater than 200, and 129 men (29%) were circumcised. 34 MITT participants in the vaccine group were diagnosed with HIV-1 (incidence rate 4·54 per 100 person-years) and 28 in the placebo group (3·70 per 100 person-years). There was no evidence of vaccine efficacy; the hazard ratio adjusted for sex was 1·25 (95% CI 0·76–2·05). Vaccine efficacy did not differ by Ad5 titre, sex, age, herpes simplex virus type 2 status, or circumcision. The geometric mean viral-load setpoint was 20 483 copies per mL (n=33) in the vaccine group and 34 032 copies per mL (n=28) in the placebo group (p=0·39). The vaccine elicited interferon-γ-secreting T cells that recognised both clade B (89%) and C (77%) antigens. Interpretation. The MRKAd5 HIV-1 vaccine did not prevent HIV-1 infection or lower viral-load setpoint; however, stopping our trial early probably compromised our ability to draw conclusions. The high incidence rates noted in South Africa highlight the crucial need for intensified efforts to develop an efficacious vaccine.
Symptomatic vaginal discharge is a poor predictor of sexually transmitted infections and genital tract inflammation in high-risk women in South Africa.
(Oxford University Press., 2011) Mlisana, Koleka Patience.; Naicker, Nivashnee.; Werner, Lise.; Roberts, Lindi.; van Loggerenberg, Francois.; Baxter, Cheryl.; Passmore, Jo-Ann Shelley.; Grobler, Anna Christina.; Sturm, Adriaan Willem.; Williamson, Carolyn.; Ronacher, Katharina.; Walzl, Gerhard.; Abdool Karim, Salim Safurdeen.
Background. Diagnosis and treatment of sexually transmitted infections (STIs) is a public health priority, particularly in regions where the incidence of human immunodeficiency virus (HIV) infection is high. In most developing countries, STIs are managed syndromically. We assessed the adequacy of syndromic diagnosis of STIs, compared with laboratory diagnosis of STIs, and evaluated the association between STI diagnosis and the risk of HIV acquisition in a cohort of high-risk women. Methods. HIV-uninfected high-risk women (n = 242) were followed for 24 months. Symptoms of STIs were recorded, and laboratory diagnosis of common STI pathogens was conducted every 6 months. Forty-two cytokines were measured by Luminex in cervicovaginal lavage specimens at enrollment. Human immunodeficiency virus type 1 (HIV-1) infection was evaluated monthly. Results. Only 12.3% of women (25 of 204) who had a laboratory-diagnosed, discharge-causing STI had clinically evident discharge. Vaginal discharge was thus a poor predictor of laboratory-diagnosed STIs (sensitivity, 12.3%; specificity, 93.8%). Cervicovaginal cytokine concentrations did not differ between women with asymptomatic STIs and those with symptomatic STIs and were elevated in women with asymptomatic STIs, compared with women with no STIs or bacterial vaginosis. Although laboratory-diagnosed STIs were associated with increased risk of HIV infection (hazard ratio, 3.3 [95% confidence interval, 1.5–7.2)], clinical symptoms were not. Conclusions. Syndromic STI diagnosis dependent on vaginal discharge was poorly predictive of laboratory-diagnosed STI. Laboratory-diagnosed STIs were associated with increased susceptibility to HIV acquisition, while vaginal discharge was not.