SRC prides itself on conducting high-quality clinical trials with excellent recruitment and retention rates and high-quality data.
The site’s core focus upon inception was conducting HIV prevention studies. Since then, the site has demonstrated the ability to expand its portfolio to include HIV and
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Scopus Publications
Scopus Publications
The impact of ethical implications intertwined with tuberculosis household contact investigation: A qualitative study Lebohang M. Mlambo, Minja Milovanovic, Colleen F. Hanrahan, Kegaugetswe Motsomi, Mashido T. Morolo, et al. Plos One, 2026 Background Household contact investigation (HCI) is an effective and widely used approach to identify persons with tuberculosis (TB) disease and infection globally. Despite widespread recommendations for the use of HCI, there remains poor understanding of the impact on and value of contact investigation for participants. Further, how HCI as a practice impacts psychosocial factors, including stigma and possible unintended disclosure of illness among persons with TB, their families, and communities, is largely unknown. Methods This exploratory qualitative study nested within a randomized trial (ClinicalTrials.gov: NCT04520113, 17 August 2020) was conducted in South Africa to understand the impacts of HCI on index patients living with TB and their household contact persons in two rural districts in the Limpopo province (Vhembe and Capricorn) and Soshanguve, a peri-urban township in Gauteng province. People with TB and household members of people with TB were recruited to participate in in-depth interviews and focus group discussions using semi-structured guides. We explored individual, interpersonal, and community-level perceptions of potential impacts of household contact investigation to elucidate their perceptions of HCI. Thematic analysis identified key themes. Results Twenty-four individual interviews and six focus group discussions (n = 39 participants) were conducted. Participants viewed HCI as an effective approach to finding TB cases, helpful in educating households about TB symptoms and reducing barriers to health-related services. At the interpersonal level, HCI aided people with TB in safely disclosing their TB status to family members and facilitated family and social support for accountability. The introduction of HIV testing during HCI was reported by some participants as making household members slightly uncomfortable, decreasing interest in household members being tested for TB. HCI negatively impacted community-level TB and HIV-related stigma due to healthcare worker visibility at home. Conclusion Our data suggests varying impacts of HCI on people with TB, their families and interpersonal relationships, and communities, highlighting the importance of considering approaches that address concerns about community stigma and HIV testing to enhance acceptance of HCI. Trial registration ClinicalTrials.gov NCT 04520113
Molecular Epidemiology of Mycobacterium tuberculosis Across 3 Distinct Geographic Sites in South Africa Theresa S Ryckman, Lincoln Hopkins, Linrui Tang, Patrick Biché, Mbali Mohlamonyane, et al. Journal of Infectious Diseases, 2025 Background Whole genome sequence data can generate insights about Mycobacterium tuberculosis (Mtb) transmission. We used whole genome sequencing and linked epidemiology data from a recent randomized trial to characterize Mtb relatedness across 3 geographically distinct South African sites. Methods We sequenced culture isolates from participants with culture-positive tuberculosis in the Kharituwe study, which evaluated household contact investigation strategies in 1 urban and 2 rural sites. We adapted a previous bioinformatic pipeline to clean, extract, and filter Mtb reads; perform reference alignment; calculate single-nucleotide polymorphism (SNP) distances between isolates; and group isolates into clusters linked by recent transmission based on 3 SNP-based cutoffs. Sequence data were linked to individual data on demographics and risk factors. We analyzed clustering across and within study sites and used log-binomial regression to assess characteristics associated with clustering. Results At a cutoff of 12 SNPs, 213 of 714 sequenced isolates passing quality control filters were clustered. While only 3 of 45 pairs included participants from different sites, the majority of clusters with ≥4 participants included representation from at least 2 sites. Expanding to a 20-SNP cutoff revealed a large cluster containing 10% of isolates, with urban/rural representation mirroring that of all the isolates (61% urban, 39% rural). Participants from the urban site, TB household contacts, and participants reporting a history of incarceration were more likely to be in a cluster. Conclusions Observed clustering and strain diversity across sites indicate the presence of multiple ongoing and geographically dispersed outbreaks in this setting.
No evidence of MMR induced trained immunity to prevent SARS COV2: results from a multi-centre RCT Sinead Delany-Moretlwe, Hakim-Moulay Dehbi, Izukanji Sikazwe, George Kyei, Kwadwo Koram, et al. Frontiers in Immunology, 2025 BackgroundMeasles-containing vaccines (MCV), by training innate immune cells, are hypothesized to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease 2019 (COVID-19).MethodsIn this international, double-blind, placebo-controlled trial, we randomly assigned adults, 18 years and older, to receive MCV or saline. The primary outcome was polymerase chain reaction (PCR) confirmed symptomatic COVID-19, up to 60 days after intervention. Secondary outcomes were PCR-confirmed symptomatic COVID-19 and serologically confirmed SARS-CoV-2 infection, up to 150 days after intervention.ResultsOf 3411 randomised participants, the modified intention-to-treat population included 1607 in the MCV and 1545 in the saline group. The estimated risk of symptomatic COVID-19 by 60 days was 1.5% in the MCV and 1.2% in the saline group (risk difference, 0.3 percentage points, 95% CI, -0.5 to 1.1; p=0.52). At 150 days, these percentages were 4.1% (65/1585) and 4.1% (64/1544) in the MCV and saline groups, respectively (risk difference, 0.04 percentage points, 95% CI, -1.4 to 1.3; p=0.95). Based on serology results available at 0 and 150 days, 10.6% (100/945) of participants in the MCV and 10.3% (98/951) in the saline group had infection with SARS-CoV-2 over the course of the trial (risk difference, 0.3 percentage points, 95% CI, -2.6 to 3.1; p=0.84). Three patients were hospitalised with COVID-19 disease in the MCV and one in the saline group.ConclusionsAdministering MCVs to stimulate trained immunity did not prevent COVID-19 or SARS-CoV2 infection. Stimulating trained immunity might not be useful for preventing respiratory illness during future pandemics.Clinical trial registrationhttps://clinicaltrials.gov/, identifier NCT04333732.
True and False Positive HIV Point of Care Test Results in a Prospective Multinational Study of At-Risk African Women: Implications for Large-Scale Repeat HIV Testing in HIV Prevention Programs Susan Morrison, Joanne Batting, Valentine Wanga, Ivana Beesham, Jennifer Deese, et al. Journal of Acquired Immune Deficiency Syndromes 1999, 2024 Background: Accurate HIV point of care testing is the cornerstone of prevention and treatment efforts globally, though false (both negative and positive) results are expected to occur. Setting: We assessed the spectrum of true and false positive HIV results in a large prospective study of HIV incidence in African women using three contraceptive methods tested longitudinally in Eswatini, Kenya, South Africa, and Zambia. Methods: HIV serologic testing was conducted quarterly using two parallel rapid HIV tests. When one or both tests were positive, additional confirmatory testing was conducted, including HIV enzyme immunoassay (EIA) and ribonucleic acid (RNA). Results: 7730 women contributed 48,234 visits: true positive results occurred at 412 visits (0.9%) and false positives at 96 visits (0.2%). Of 412 women with HIV seroconversion, 10 had discordant (i.e., one negative and one positive) rapid tests and 13 had undetectable HIV RNA levels. Of 62 women with false positive rapid HIV results, most had discordant rapid testing but six (9.7%) had dually-positive rapid results and four (6.5%) had false positive or indeterminate EIA results. The positive predictive value of dual positive rapid results was 98.3%. Conclusion: Although the majority of rapid test results were accurate, false positive results were expected and occurred in this population of initially HIV seronegative individuals tested repeatedly and prospectively. When HIV infection occurred, not all cases had textbook laboratory results. Our findings highlight the importance of confirmatory testing, particularly for individuals undergoing repeat testing and in settings where the point prevalence is expected to be low.
Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women Linda-Gail Bekker, Moupali Das, Quarraisha Abdool Karim, Khatija Ahmed, Joanne Batting, et al. New England Journal of Medicine, 2024 BACKGROUND There are gaps in uptake of, adherence to, and persistence in the use of preexposure prophylaxis for human immunodeficiency virus (HIV) prevention among cisgender women. METHODS We conducted a phase 3, double-blind, randomized, controlled trial involving adolescent girls and young women in South Africa and Uganda. Participants were assigned in a 2:2:1 ratio to receive subcutaneous lenacapavir every 26 weeks, daily oral emtricitabine-tenofovir alafenamide (F/TAF), or daily oral emtricitabine-tenofovir disoproxil fumarate (F/TDF; active control); all participants also received the alternate subcutaneous or oral placebo. We assessed the efficacy of lenacapavir and F/TAF by comparing the incidence of HIV infection with the estimated background incidence in the screened population and evaluated relative efficacy as compared with F/TDF. RESULTS Among 5338 participants who were initially HIV-negative, 55 incident HIV infections were observed: 0 infections among 2134 participants in the lenacapavir group (0 per 100 person-years; 95% confidence interval [CI], 0.00 to 0.19), 39 infections among 2136 participants in the F/TAF group (2.02 per 100 person-years; 95% CI, 1.44 to 2.76), and 16 infections among 1068 participants in the F/TDF group (1.69 per 100 person-years; 95% CI, 0.96 to 2.74). Background HIV incidence in the screened population (8094 participants) was 2.41 per 100 person-years (95% CI, 1.82 to 3.19). HIV incidence with lenacapavir was significantly lower than background HIV incidence (incidence rate ratio, 0.00; 95% CI, 0.00 to 0.04; P<0.001) and than HIV incidence with F/TDF (incidence rate ratio, 0.00; 95% CI, 0.00 to 0.10; P<0.001). HIV incidence with F/TAF did not differ significantly from background HIV incidence (incidence rate ratio, 0.84; 95% CI, 0.55 to 1.28; P = 0.21), and no evidence of a meaningful difference in HIV incidence was observed between F/TAF and F/TDF (incidence rate ratio, 1.20; 95% CI, 0.67 to 2.14). Adherence to F/TAF and F/TDF was low. No safety concerns were found. Injection-site reactions were more common in the lenacapavir group (68.8%) than in the placebo injection group (F/TAF and F/TDF combined) (34.9%); 4 participants in the lenacapavir group (0.2%) discontinued the trial regimen owing to injection-site reactions. CONCLUSIONS No participants receiving twice-yearly lenacapavir acquired HIV infection. HIV incidence with lenacapavir was significantly lower than background HIV incidence and HIV incidence with F/TDF. (Funded by Gilead Sciences; PURPOSE 1 ClinicalTrials.gov number, NCT04994509.).
