South African women are vulnerable to HIV acquisition during the postpartum period which can result in perinatal transmission via breastfeeding; many male partners do not know their HIV status. Biomedical approaches to preventing HIV for postpartum women include pre-exposure prophylaxis (PrEP) and antiretroviral treatment for male partners with HIV. Gaps in implementation include low uptake of PrEP among postpartum women and infrequent testing of men who may be motivated to test for HIV to protect the health of their infant.

We will conduct a randomised pilot trial in KwaZulu-Natal (KZN) Province, South Africa among postpartum women and their male partners. The study will pilot a combination intervention consisting of cognitive behavioural strategies (including communication skills training, motivational interviewing and problem-solving) to promote HIV self-testing (HIVST) for Partners and PrEP uptake for HIV-uninfected Postpartum Women, the ‘H4P’ intervention. The study aims to determine the feasibility, acceptability and preliminary effectiveness of the H4P intervention. We will enrol 60 HIV-uninfected women, aged 18 years and older, in their third trimester of pregnancy and reporting a partner whose HIV-serostatus is unknown. Sixty male partners will also be eligible to enrol. Enrolled women will receive three oral HIVST kits to distribute to their male partners and standard of care information on HIVST and PrEP. Women randomised to the intervention arm will receive additional counselling and reproductive health-centred HIVST information for the male partner, including information about why HIV testing is important during their partners’ postpartum period. To evaluate feasibility, we will calculate screening-to-enrolment ratios for women and men, the number of women who distribute HIVST kits to their male partners and the number of men who test. Acceptability will be evaluated using the Client Satisfaction Questionnaire and qualitative interviews. Effectiveness will be assessed at 3 months by measuring the proportion of women initiating PrEP via self-report and urine tenofovir measurements or receipt of injectable PrEP and the proportion of men who test positive who link to HIV care. Qualitative interviews will explore perceptions of the intervention.

Ethics approval for this study was obtained from the Human Research Ethics Committee at The University of the Witwatersrand, Johannesburg, South Africa (Reference number: 250612) and the Institutional Review Boards at Massachusetts General Brigham (2025P002271, Boston, Massachusetts, USA) and the University of Alabama at Birmingham (300015167, Birmingham, Alabama, USA) in the USA. Site support and approvals were obtained from the health facility and the KwaZulu-Natal Provincial Department of Health. Results will be disseminated through peer-reviewed manuscripts, reports and both local and international presentations.

NCT07194902.

The burden of rheumatoid arthritis (RA) is profound, although treated with the treat-to-target strategy for RA patients according to the two most influential organisations for rheumatology worldwide. The need to timely achieve the control of disease activity for RA patients, especially for those difficult-to-treat individuals, is still unmet. Besides, the data on the diagnosis and prognosis of RA-related complications or comorbidities such as sarcopenia, cardiovascular diseases (CVD), malignancies and infections in large real-world cohorts are still limited. Therefore, the aim of this large-scale cohort study is to identify the development of clinical, biomedical, histopathological and imaging biomarkers for the diagnosis and prognosis of difficult-to-treat RA, and RA-related complications/comorbidities and to evaluate their impact on the prognosis of RA.

In this real-world multicentre prospective cohort, consecutive RA patients are planned to be recruited during 2024 and 2033 and with at least 5-year follow-up. Sociodemographic characteristics collection, clinical assessment, muscle assessment, histopathological assessment, imaging examination and biological samples collection will be performed at baseline, 1st, 3rd, 6th and 12th month during the first year and subsequently every 6 months until 5 years to repeat the assessments and collect the information of interested outcomes. The outcomes of interest include RA disease outcomes (including disease activity, functional and radiographic indicators) and RA-related complications/comorbidities (eg, sarcopenia, CVD, malignancies and specific infection).

Ethical approval has been approved by the Medical Ethics Committee of Sun Yat-sen Memorial Hospital, Sun Yat-sen University (ID: SYSKY-2023-1235-01); the Affiliated Panyu Central Hospital of Guangzhou Medical University (ID: PYRC-2024-214-01); and ShenShan Medical center, Memorial Hospital of Sun Yat-sen University (ID: 2024-SSKY-118-01). All study participants sign an informed consent form. Dissemination of results will occur via national and international conferences, in peer-reviewed journals, public conferences and social media.

NCT06233929.