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

Weight gain after HIV therapy initiation : pathophysiology and implications

DATA AVAILABILITY : Data sharing is not applicable to this article as no data sets were generated or analyzed during the current study.Rapid advances in the potency, safety, and availability of modern HIV antiretroviral therapy (ART) have yielded a near-normal life expectancy for most people living with HIV (PLWH). Ironically, considering the history of HIV/AIDS (initially called “slim disease” because of associated weight loss), the latest dilemma faced by many people starting HIV therapy is weight gain and obesity, particularly Black people, women, and those who commenced treatment with advanced immunodeficiency. We review the pathophysiology and implications of weight gain among PLWH on ART and discuss why this phenomenon was recognized only recently, despite the availability of effective therapy for nearly 30 years. We comprehensively explore the theories of the causes, from initial speculation that weight gain was simply a return to health for people recovering from wasting to comparative effects of newer regimens vs prior toxic agents, to direct effects of agents on mitochondrial function. We then discuss the implications of weight gain on modern ART, particularly concomitant effects on lipids, glucose metabolism, and inflammatory markers. Finally, we discuss intervention options for PLWH and obesity, from the limitations of switching ART regimens or specific agents within regimens, weight-gain mitigation strategies, and potential hope in access to emerging antiobesity agents, which are yet to be evaluated in this population.The National Institutes of Health (NIH) and the HLB-SIMPLe Alliance, sponsored by the National Heart, Lung and Blood Institute and funded with the US Department of Health and Human Services, NIH, National Heart, Lung and Blood Institute (NIH/NHLBI).https://academic.oup.com/jcemhj2024School of Health Systems and Public Health (SHSPH)SDG-03:Good heatlh and well-bein

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

DORA : 48-week weight and metabolic changes in Black women with HIV, in a phase IIIb switch study from dolutegravir- or efavirenz- to doravirine-based first-line antiretroviral therapy

DATA AVAILABILITY STATEMENT The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions. Requests for access to the DORA study data should be sent to [email protected]. De-identified participant data and a data dictionary can be made available and shared under a data transfer agreement.OBJECTIVES : Treatment-related weight gain and metabolic complications with antiretroviral integrase-based regimens, especially among Black women, suggest the need for alternative options. METHODS : We conducted a 48-week, open-label, single-arm, single-centre, phase IIIb switch study to evaluate the tolerability, safety and efficacy of switching from stable efavirenz- or dolutegravir-based antiretroviral therapy to doravirine/lamivudine/tenofovir disoproxil fumarate in Black women. RESULTS : The 101 participants enrolled (median age 35 years; interquartile range 31–40) were on efavirenz (n = 46; mean duration on therapy 1.7 years) or dolutegravir-based (n = 55; mean duration 1.5 years) antiretrovirals at screening. Retention at 48 weeks was 92/101 participants, and viral suppression was >90% throughout the study, with a single case of doravirine resistance (106 M, V108I and H221Y mutations). The mean weight percentage change at week 48 was 4.7% (95% confidence interval [CI] 3.0–6.5; p < 0.001), and the adjusted mean change was 2.7 kg (95% CI 1.50–3.98; p < 0.001); for efavirenz, the percentage change was 5.0% (95% CI 2.9–7.1; p < 0.001), and the adjusted weight gain was 3.5 kg (95% CI 1.93–5.13); for dolutegravir, the percentage change was 4.5% (95% CI 1.8–7.3; p < 0.001), and the adjusted weight gain was 2.1 kg (95% CI 0.26–3.90). Statistically significant decreases in lipid panel percent mean to week 48 included: total cholesterol −8.4% (95% CI −11.3 to −5.5; p < 0.001), triglycerides −10.4% (95% CI −16.4 to −4.4; p < 0.001) and high-density lipoprotein −14.8% (95% CI −18.5 to −11.2%; p < 0.001), with minor differences when disaggregating the mean percent change in lipids between previous efavirenz/dolutegravir regimens. Adverse events due to doravirine were few and mild. CONCLUSIONS : Our findings suggest that a switch to doravirine from efavirenz or dolutegravir is safe and effective in Black women, with significant improvement in lipid profiles, but does not arrest progressive weight gain.MSD Sharp and Dohme.http://wileyonlinelibrary.com/journal/hivhj2024School of Health Systems and Public Health (SHSPH)SDG-03:Good heatlh and well-bein

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

Southern African HIV Clinicians Society Guideline for the clinical management of syphilis

Syphilis, ‘the great imitator’, caused by Treponema pallidum infection, remains a complex and multifaceted disease with a rich history of clinical diversity. This guideline aims to be a comprehensive guide for healthcare workers in Southern Africa, offering practical insights into the epidemiology, pathogenesis, clinical manifestations, diagnostic testing, therapeutic principles, and public health responses to syphilis. Although the syphilis burden has declined over the years, recent data indicate a troubling resurgence, particularly among pregnant women and neonates. This guideline highlights the diagnostic challenges posed by syphilis, stemming from the absence of a single high-sensitivity and -specificity test. While treatment with penicillin remains the cornerstone of treatment, alternative regimens may be used for specific scenarios. We highlight the importance of thorough patient follow-up and management of sex partners to ensure optimal care of syphilis cases. In the context of public health, we emphasise the need for concerted efforts to combat the increasing burden of syphilis, especially within high-risk populations, including people living with HIV

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

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

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