Socio-cultural and behavioral determinants of condom use among youths in Limpopo Province, South Africa

Introduction South Africa is one of the countries hardest hit by HIV/AIDS. Of particular concern, new infections among young people, especially young women and girls are on the rise. Despite widespread awareness and prevention campaigns, the prevalence of HIV and deaths caused by AIDS are still on the increase, whereas condom use particularly in rural areas remains low. Consistent condom use is central to the prevention of unwanted pregnancies, HIV and other STIs, yet young men and women alike are hesitant to use condoms because of threats to their relationships, cultural roles and at times economic survival. Purpose The purpose of this study is to identify socio-cultural and behavioral factors that influence condom use among youths in Limpopo province, South Africa. This adds to a growing body of knowledge on the determinants of condom use and how they might shape effective HIV prevention programs. Objectives 1. To conduct a secondary data analysis that examines the determinants of condom use, for men and women separately in relation to the following factors: Socio-demographic characteristics- age, education, marital status, migration and iv socio-economic status Sexual behavior characteristics- partnership type (spousal, non spousal, or both), age at sexual debut, number of lifetime sexual partners, contraceptive use (females only) and HIV-status Socio-cultural characteristics - perceived risk of HIV infection, condom self efficacy (males only), partner communication on sex, condoms, HIV and other STI’s, beliefs on gender norms, attitudes towards gender violence, knowledge on HIV/AIDS and HIV/AIDS related stigma To compare the results of this analysis to other national studies on condom use among young people. To use the results of this analysis to make recommendations to improve HIV control in rural South Africa.Methods This study is a secondary analysis of data collected from a sample of 2236 sexually active young people aged between 14-35 years in Limpopo province, South Africa. The data used in this study is part of a wider public health intervention, the Intervention with Micro-finance for AIDS and Gender Equity (IMAGE) study. STATA 8.0 was used to analyze data in bivariate and multivariate analyses to assess determinants of consistent condom use and condom use at last sex for males and females separately as the patterns of associations are likely to differ between them. Results Overall condom use in this population was low: less than a quarter of respondents used condoms consistently and less than one third of men and women used condoms at last sex. This is especially true of females, married couples and those who have multiple partners. In multivariate analysis, significant predictors of consistent condom use for both sexes included good communication, older age at sexual debut, low risk perception of HIV infection, progressive attitudes towards gender violence and high HIV-related stigma. High condom self-efficacy, defined as the intention to pick up or purchase condoms with the intention of use, was the most powerful predictor of both condom use indices among males. Among females only, having fewer than three lifetime sexual partners was positively associated with using condoms consistently. Lastly, females who used condoms as their main method of contraception were up to 20 times more likely to use them consistently and at last sex. Conclusions HIV prevention programmes in this population should focus on delaying sexual debut, increasing perceived risk of HIV infection, encouraging partner communication, making condoms more easily accessible to young men and addressing gender inequalities. Furthermore, the dual protection offered by condoms against unwanted pregnancies and against HIV and other STI’s should be emphasized in this population as it plays an important role in the prevention of HIV

Southern African HIV Clinicians Society 2022 guideline for the management of sexually transmitted infections : moving towards best practice

Sexually transmitted infections (STIs) are among the most common acute conditions worldwide with sub-Saharan Africa ranking among the regions with the highest burdens globally. Adolescent girls and young women (AGYW), people living with HIV (PLHIV), pregnant women, and key and vulnerable populations are disproportionally affected by STIs. The social determinants of health, gender inequality, and STI-associated stigma and discrimination (at both the community and facility level) are important contributors to the sustained high burden of infection.http://www.sajhivmed.org.za/index.php/hivmeddm2022Medical Microbiolog

Safety and efficacy of four drug regimens versus standard-of-care for the treatment of symptomatic outpatients with COVID-19: A randomised, open-label, multi-arm, phase 2 clinical trial

BackgroundThis exploratory study investigated four repurposed anti-infective drug regimens in outpatients with COVID-19.MethodsThis phase 2, single centre, randomised, open-label, clinical trial was conducted in South Africa between 3rd September 2020 and 23rd August 2021. Symptomatic outpatients aged 18-65 years, with RT-PCR confirmed SARS-CoV-2 infection were computer randomised (1:1:1:1:1) to standard-of-care (SOC) with paracetamol, or SOC plus artesunate-amodiaquine (ASAQ), pyronaridine-artesunate (PA), favipiravir plus nitazoxanide (FPV + NTZ), or sofosbuvir-daclatasvir (SOF-DCV). The primary endpoint was the incidence of viral clearance, i.e., the proportion of patients with a negative SARS-CoV-2 RT-PCR on day 7, compared to SOC using a log-binomial model in the modified intention-to-treat (mITT) population.FindingsThe mITT population included 186 patients: mean age (SD) 34.9 (10.3) years, body weight 78.2 (17.1) kg. Day 7 SARS-CoV-2 clearance rates (n/N; risk ratio [95% CI]) were: SOC 34.2% (13/38), ASAQ 38.5% (15/39; 0.80 [0.44, 1.47]), PA 30.3% (10/33; 0.69 [0.37, 1.29]), FPV + NTZ 27.0% (10/37; 0.60 [0.31, 1.18]) and SOF-DCV 23.5% (8/34; 0.47 [0.22, 1.00]). Three lower respiratory tract infections occurred (PA 6.1% [2/33]; SOF-DCV 2.9% [1/34]); two required hospitalisation (PA, SOF-DCV). There were no deaths. Adverse events occurred in 55.3% (105/190) of patients, including one serious adverse event (pancytopenia; FPV + NTZ).InterpretationThere was no statistical difference in viral clearance for any regimen compared to SOC. All treatments were well tolerated.FundingMedicines for Malaria Venture, with funding from the UK Foreign, Commonwealth and Development Office, within the Covid-19 Therapeutics Accelerator in partnership with Wellcome, the Bill and Melinda Gates Foundation, and Mastercard

Final 192-week efficacy and safety results of the ADVANCE trial, comparing 3 first-line antiretroviral regimens

BACKGROUND: ADVANCE compared 3 World Health Organization-recommended first-line regimens in participants with HIV who were antiretroviral naive. METHODS: This randomized, open-label, noninferiority trial enrolled participants living with HIV with no antiretroviral exposure in the previous 6 months to 1 of the following arms: tenofovir alafenamide (TAF) / emtricitabine (FTC) + dolutegravir (DTG) (2 tablets), tenofovir disoproxil fumarate (TDF) / FTC + DTG (2 tablets), or a fixed-dose combination of TDF / FTC / efavirenz (EFV) (1 tablet). We report the final safety and efficacy data up to 192 weeks. RESULTS: Repeat consent from the original 351 participants randomized to each arm was obtained from 230 participants (66%) in the TAF/FTC + DTG arm, 209 (60%) in the TDF/FTC + DTG arm, and 183 (52%) in the TDF/FTC/EFV arm. At 192 weeks, 213 (61%) of the original 351 participants in the TAF/FTC + DTG arm, 195 (56%) in the TDF/FTC + DTG arm, and 172 (49%) in the TDF/FTC/EFV arm had confirmed RNA <50 copies/mL, with low virologic failure in all groups and no significant integrase inhibitor mutations in any arm. Mean weight gain was 8.9 kg (SD, 7.1) in the TAF/FTC + DTG arm, 5.9 kg (SD, 7.1) in the TDF/FTC + DTG arm, and 3.2 kg (SD, 8.1) in the TDF/FTC/EFV arm at 192 weeks from baseline and was greatest among women, those taking TAF, and those with lower baseline CD4 counts. The weight trajectory slowed after week 96. There were few clinical events and minor laboratory changes and differences among arms after 96 weeks. There were no significant differences in treatment-emergent hypertension or pregnancy outcomes by arm. CONCLUSIONS: High viral suppression was seen across arms, with no resistance to DTG. Weight gain continued but slowed after 96 weeks, with few clinical events or laboratory changes

Guidelines to support HIV-affected individuals and couples to achieve pregnancy safely: Update 2018

No abstract available

AGILE: a seamless phase I/IIa platform for the rapid evaluation of candidates for COVID-19 treatment: an update to the structured summary of a study protocol for a randomised platform trial letter.

Funder: UnitaidBACKGROUND: There is an urgent unmet clinical need for the identification of novel therapeutics for the treatment of COVID-19. A number of COVID-19 late phase trial platforms have been developed to investigate (often repurposed) drugs both in the UK and globally (e.g. RECOVERY led by the University of Oxford and SOLIDARITY led by WHO). There is a pressing need to investigate novel candidates within early phase trial platforms, from which promising candidates can feed into established later phase platforms. AGILE grew from a UK-wide collaboration to undertake early stage clinical evaluation of candidates for SARS-CoV-2 infection to accelerate national and global healthcare interventions. METHODS/DESIGN: AGILE is a seamless phase I/IIa platform study to establish the optimum dose, determine the activity and safety of each candidate and recommend whether it should be evaluated further. Each candidate is evaluated in its own trial, either as an open label single arm healthy volunteer study or in patients, randomising between candidate and control usually in a 2:1 allocation in favour of the candidate. Each dose is assessed sequentially for safety usually in cohorts of 6 patients. Once a phase II dose has been identified, efficacy is assessed by seamlessly expanding into a larger cohort. AGILE is completely flexible in that the core design in the master protocol can be adapted for each candidate based on prior knowledge of the candidate (i.e. population, primary endpoint and sample size can be amended). This information is detailed in each candidate specific trial protocol of the master protocol. DISCUSSION: Few approved treatments for COVID-19 are available such as dexamethasone, remdesivir and tocilizumab in hospitalised patients. The AGILE platform aims to rapidly identify new efficacious and safe treatments to help end the current global COVID-19 pandemic. We currently have three candidate specific trials within this platform study that are open to recruitment. TRIAL REGISTRATION: EudraCT Number: 2020-001860-27 14 March 2020 ClinicalTrials.gov Identifier: NCT04746183  19 February 2021 ISRCTN reference: 27106947

Population pharmacokinetics of tenofovir given as either tenofovir disoproxil fumarate or tenofovir alafenamide in an African population

Abstract Tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) are prodrugs of the nucleotide analogue tenofovir, which acts intracellularly to inhibit HIV replication. Whereas TDF converts to tenofovir in plasma and may cause kidney and bone toxicity, TAF mostly converts to tenofovir intracellularly, so it can be administered at lower doses. TAF leads to lower tenofovir plasma concentrations and lower toxicity, but there are limited data on its use in Africa. We used data from 41 South African adults living with HIV from the ADVANCE trial and described, with a joint model, the population pharmacokinetics of tenofovir given as TAF or TDF. The TDF was modeled to appear in plasma as tenofovir with a simple first‐order process. Instead, two parallel pathways were used for a TAF dose: an estimated 32.4% quickly appeared as tenofovir into the systemic circulation with first‐order absorption, whereas the rest was sequestered intracellularly and released into the systemic circulation as tenofovir slowly. Once in plasma (from either TAF or TDF), tenofovir disposition followed two‐compartment kinetics and had a clearance of 44.7 L/h (40.2–49.5), for a typical 70‐kg individual. This semimechanistic model describes the population pharmacokinetics of tenofovir when dosed as either TDF or TAF in an African population living with HIV and can be used as a tool for exposure prediction in patients, and to simulate alternative regimes to inform further clinical trials

Response to comments by Taramasso and colleagues on weight gain stopping/switch rules for antiretroviral clinical trials

A response to Kouamou et al's comment on our paper : VENTER, W D Francois et al. Weight gain stopping/switch rules for antiretroviral clinical trials. In: AIDS, 2021, vol. 35, n° Suppl 2, p. S183–S188 https://archive-ouverte.unige.ch/unige:161553</a